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******

* * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2023–25684 Filed 11–17–23; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 202 

[Docket No. FDA–2009–N–0582] 

RIN 0910–AG27 

Direct-to-Consumer Prescription Drug 

Advertisements: Presentation of the 

Major Statement in a Clear, 

Conspicuous, and Neutral Manner in 

Advertisements in Television and 

Radio Format 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is issuing a final rule to amend its 

regulations concerning direct-toconsumer (DTC) advertisements (ads) 

for human prescription drugs presented 

in television or radio format and stating 

the name of the drug and its conditions 

of use (DTC TV/radio ads). Specifically, 

the final rule implements a requirement 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), added by the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA), that in such DTC TV/ 

radio ads, the major statement relating 

to side effects and contraindications 

must be presented in a clear, 

conspicuous, and neutral manner. As 

directed by FDAAA, FDA is establishing 

standards to determine whether the 

major statement in DTC TV/radio ads is 

presented in a clear, conspicuous, and 

neutral manner. 

DATES: This rule is effective May 20, 

2024. The compliance date of this rule 

is November 20, 2024. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

With regard to human drug products: 

Suzanna Boyle, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1200, CDEROPDP-RPM@fda.hhs.gov. 

With regard to human biological 

products: Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

With regard to the information 

collection: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Final Rule 

B. Summary of the Major Provisions of the 

Final Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. Overview of Direct-to-Consumer 

Prescription Drug Advertising and Its 

Regulation 

B. History of the Rulemaking 

C. Summary of Comments to the Proposed 

Rule 

D. General Overview of Final Rule and 

Changes to the Proposed Rule 

IV. Legal Authority 

V. Comments on the Proposed Rule and FDA 

Response 

A. Introduction 

B. General Comments 

C. Research Studies—Comments and FDA 

Response 

D. The Major Statement—Comments and 

FDA Response 

E. Standards To Determine a Clear, 

Conspicuous, and Neutral Manner— 

General Comments and FDA Response 

F. Consumer/Audience—Comments and 

FDA Response 

G. Proposed Standard #1 (Final Standard 

#1) (Language)—Comments and FDA 

Response 

H. Proposed Standard #2 (Final Standard 

#2) (Audio)—Comments and FDA 

Response 

I. Proposed Standard #3 (Final Standard 

#4) (Presentation of Text)—Comments 

and FDA Response 

J. Proposed Standard #4 (Final Standard 

#5) (Elements That Interfere)— 

Comments and FDA Response 

K. Dual Modality (Final Standard #3)— 

Comments and FDA Response 

L. First Amendment Freedom of Speech— 

Comments and FDA Response 

M. Role of Healthcare Professional— 

Comments and FDA Response 

N. Costs—Comments and FDA Response 

O. Enforcement—Comments and FDA 

Response 

VI. Effective/Compliance Dates 

VII. Economic Analysis of Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose of the Final Rule 

This final rule implements a statutory 

requirement that in human prescription 

drug advertisements presented directly 

to consumers in television or radio 

format and stating the name of the drug 

and its conditions of use (DTC TV/radio 

ads), the major statement relating to side 

effects and contraindications (major 

statement) (Ref. 1) must be presented in 

a clear, conspicuous, and neutral 

manner. (As used in this document, 

unless specifically stated otherwise, 

references to DTC ads and similar terms 

encompass ads for human prescription 

drugs only.) In enacting that 

requirement, Congress directed FDA to 

issue regulations establishing standards 

for determining whether a major 

statement is presented in a clear, 


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1 In this document, ‘‘firm’’ refers to 

manufacturers, packers, and distributors of 

prescription drugs and all of their representatives, 

including both individuals and corporate entities. 

conspicuous, and neutral manner. The 

final rule establishes five standards that, 

independently and collectively, help 

ensure that the major statement is 

presented in a clear, conspicuous, and 

neutral manner. This rule does not 

change the content of the major 

statement. 

This rule is an incremental addition 

to a longstanding body of prescription 

drug advertising regulations. The statute 

and regulations regarding DTC ads have 

long required that, with limited 

regulatory exceptions, prescription drug 

ads include information about the 

advertised drug’s risks as well as its 

effectiveness. This final rule 

complements the longstanding 

requirements for including risk 

information in prescription drug ads, 

setting standards for the manner of 

presentation of the major statement of 

side effects and contraindications in 

DTC TV/radio ads to help ensure that 

this risk information is presented 

effectively—that is, in a way that helps 

consumers notice, attend to, and 

understand the drug’s risks. 

By helping consumers notice, attend 

to, and understand a drug’s risks, the 

final rule directly advances two 

substantial Government interests. First, 

the measures required by the final rule 

help ensure that DTC TV/radio ads 

convey a truthful and non-misleading 

net impression about the advertised 

drug, including its risks. Second, these 

measures help ensure that consumers 

are better informed when they 

participate in healthcare decision 

making. Although prescription drugs 

must be prescribed by a healthcare 

provider (HCP) and cannot be accessed 

by consumers directly, consumers make 

decisions that have a critical effect on 

health and well-being, such as whether 

to fill a prescription, whether to initiate 

taking the prescribed drug, and whether 

to continue taking the drug in adherence 

to a prescribed regimen. The clear, 

conspicuous, and neutral presentation 

of risk information in DTC TV/radio 

ads, in addition to benefit information, 

helps ensure that these ads convey a 

truthful and non-misleading net 

impression about the advertised drug 

and that consumers are better informed 

when they participate in healthcare 

decision making. 

B. Summary of the Major Provisions of 

the Final Rule 

This final rule specifies five standards 

that, independently and collectively, 

help ensure that the major statement is 

presented in a clear, conspicuous, and 

neutral manner. The final rule 

establishes that the information must be 

presented in consumer-friendly 

language and terminology that is readily 

understandable. The audio information 

in the major statement must be at least 

as understandable as the audio 

information presented in the rest of the 

ad. In ads in TV format, the information 

presented in the audio portion of the 

major statement must also be presented 

concurrently in text for a sufficient 

duration to allow it to be read easily. In 

ads in TV format, the information in text 

must be formatted such that the 

information can be read easily. The ad 

must not include audio or visual 

elements during the presentation of the 

major statement that are likely to 

interfere with comprehension of the 

major statement. 

C. Legal Authority 

This final rule amends FDA’s 

prescription drug advertising 

regulations to be consistent with the 

current requirements of the FD&C Act, 

as amended by FDAAA, that in human 

prescription drug ads presented directly 

to consumers in television or radio 

format and stating the name of the drug 

and its conditions of use, the major 

statement relating to side effects and 

contraindications shall be presented in 

a clear, conspicuous, and neutral 

manner. In addition, FDAAA directed 

FDA to establish standards for 

determining whether the major 

statement in DTC TV/radio ads is 

presented in a clear, conspicuous, and 

neutral manner—and does so in this 

rule. Furthermore, this rule is 

authorized by various provisions of the 

FD&C Act. 

D. Costs and Benefits 

The benefits of this final rule stem 

from and include helping consumers 

notice, attend to, and understand the 

major statement in DTC TV/radio ads. 

The standards in the final rule help to 

ensure that DTC TV/radio ads convey a 

truthful and non-misleading net 

impression about the advertised drug 

and help ensure that consumers are 

better informed when they participate in 

healthcare decision making. We discuss 

the benefits qualitatively. 

The costs of this final rule include the 

cost to read and understand the rule, to 

revise a firm’s 1 standard operating 

procedures, and to revise TV and radio 

ads during the transition period leading 

up to the compliance date. We also 

expect there to be modest ongoing costs 

for industry to review future DTC TV/ 

radio ads to ensure that these 

advertisements comply with this final 

rule and an ongoing opportunity cost 

related to a potential change in the 

relative allocation of time within the ad 

between the presentation of the major 

statement and the presentation of other 

content. The total present value of costs 

over a 10-year time horizon ranges from 

$104.8 million to $331.8 million, with a 

primary estimate of $218.3 million, at a 

7 percent discount rate; the present 

value ranges from $123.8 million to 

$393.0 million, with a primary estimate 

of $258.4 million, at a 3 percent 

discount rate. Annualized costs over a 

10-year time horizon range from $14.9 

million to $47.2 million, with a primary 

estimate of $31.1 million, at a 7 percent 

discount rate; annualized costs over a 

10-year time horizon range from $14.5 

million to $46.1 million, with a primary 

estimate of $30.3 million, at a 3 percent 

discount rate. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

Abbreviation/acronym What it means 

CBER .................................................................. Center for Biologics Evaluation and Research. 

CDER .................................................................. Center for Drug Evaluation and Research. 

CFR ..................................................................... Code of Federal Regulations. 

CMP .................................................................... Civil Monetary Penalties. 

DTC ..................................................................... Direct-to-Consumer. 

FDA ..................................................................... United States Food and Drug Administration. 

FDAAA ................................................................ Food and Drug Administration Amendments Act of 2007. 

FD&C Act ............................................................ Federal Food, Drug, and Cosmetic Act. 

FR ....................................................................... Federal Register. 

FTC ..................................................................... Federal Trade Commission. 

HCP .................................................................... Healthcare provider, healthcare professional, healthcare practitioner. 


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Abbreviation/acronym What it means 

OMB .................................................................... Office of Management and Budget. 

SUPERs .............................................................. Superimposed text. 

TV ....................................................................... Television. 

U.S.C .................................................................. United States Code. 

III. Background 

A. Overview of Direct-to-Consumer 

Prescription Drug Advertising and Its 

Regulation 

American consumers encounter ads 

for an enormous variety of goods and 

services, each ad seeking to attract their 

attention, pique their interest, and 

ultimately drive demand for the 

advertised product or service. But few 

ads provide information about products 

as important as prescription drugs. 

Prescription drugs are integral to 

healthcare, and decisions about their 

use can have critical effects on health 

and well-being. These decisions about 

prescription drug use not only impact 

each individual patient’s health and 

well-being but also affect others, 

including family, friends, and 

caregivers. 

Of course, by definition, prescription 

drugs cannot be accessed directly by 

consumers; they must be prescribed by 

a practitioner licensed by law to 

administer such drugs (commonly 

referred to as a healthcare professional, 

provider, or practitioner, here referred 

to as HCPs). But the billions of dollars 

drug manufacturers spend annually to 

promote their prescription drugs 

directly to consumers through TV ads 

and other media demonstrate 

recognition that consumers make 

critical choices related to treatment with 

prescription drugs. For example, 

consumers decide whether to make an 

initial appointment with an HCP, 

whether to ask the HCP about a 

particular drug, whether to fill a 

prescription, whether to take the drug, 

and whether to continue taking it in 

adherence to the prescribed regimen. 

These decisions are informed by what 

consumers know about a drug, starting 

with the most basic awareness of the 

drug’s availability and the health 

condition(s) for which it is approved. 

For U.S. consumers, that knowledge is 

often derived from DTC ads, a major 

source of information about human 

prescription drugs (Refs. 2 to 6). 

Analysis of submissions by firms to 

FDA’s Center for Drug Evaluation and 

Research (CDER) of ads that the firms 

identify as DTC radio or TV ads, 

together with spending data, illustrates 

the widespread use of these formats for 

prescription drug advertising. For 

example, in 2007, when the clear, 

conspicuous, and neutral manner 

requirement was enacted, firms 

identified 74 new DTC radio ads in 

submissions to FDA’s CDER, spending 

$30 million on all prescription drug 

DTC radio ads in that year (Ref. 7). In 

2020, firms identified 56 new DTC radio 

ads in submissions to FDA’s CDER, 

while spending on all prescription drug 

DTC radio ads increased to $57.4 

million for that same year (Ref. 8). 

TV ads for prescription drugs are even 

more prevalent, and attract enormous 

absolute and relative spending. In 2007, 

firms identified 434 new DTC TV ads in 

submissions to FDA’s CDER, and the 

reported expenditure for all prescription 

drug DTC TV ads in that year was $2.87 

billion of a total of $4.77 billion spent 

on DTC advertising (Ref. 7). In 2020, 

firms identified 564 new DTC TV ads in 

submissions to FDA’s CDER, and the 

reported expenditure for all prescription 

drug DTC TV ads that year was $4.58 

billion of a total of $6.58 billion spent 

on DTC advertising (Ref. 9). While the 

number of TV ads has increased, a 

published analysis of DTC TV ads found 

that ads in 2016 presented many of the 

same elements (e.g., use of emotional 

appeals, focus on drug benefits over 

health information) as ads in a 2004 

analysis, indicating a general 

consistency in such ads over time (Ref. 

10). 

Prescription drug firms have long 

maintained that their DTC ads respond 

to consumer desire for information 

about prescription drugs (Ref. 11). 

However, in light of their pervasiveness, 

consumers are likely to be exposed to 

DTC TV/radio ads even if they are not 

actively seeking information about any 

prescription drug. 

Evidence shows that DTC ads inform 

important consumer decisions about 

healthcare. For example, surveys 

indicate that DTC advertising influences 

whether consumers seek more 

information about a drug, decide to visit 

and discuss an advertised drug with an 

HCP, or decide not to see an HCP (Refs. 

12 to 17). This is one reason why 

Congress enacted the requirement in 

section 502(n) of the FD&C Act 

addressed by this final rule, requiring 

the major statement of side effects and 

contraindications in DTC TV/radio ads 

to be presented in a clear, conspicuous, 

and neutral manner. As one lead 

sponsor explained during Senate floor 

consideration, a motivation for the 

legislation was ‘‘[r]esearch . . . 

show[ing] that people are more likely to 

go to the doctor, ask thoughtful 

questions, and discuss sensitive health 

issues with their doctors as a result of 

DTC ads.’’ See 153 Cong. Rec. S5631 

(May 7, 2007) (statement of Sen. 

Roberts). 

Like all advertisers, prescription drug 

firms have ample business incentives to 

present their products in a positive light 

to potential consumers. But those 

business incentives do not assure clear 

communication of the advertised drug’s 

negative attributes to consumers. Firms’ 

lack of business incentives, combined 

with DTC ads’ ability to inform and 

influence consumer participation in 

healthcare decision making, points to 

the need for Government regulation of 

prescription drug ads in particular. 

Ensuring that DTC ads that provide 

benefit information about prescription 

drugs also effectively communicate risk 

information is particularly important 

because the effective presentation of risk 

information is critical to helping to 

ensure that DTC TV/radio ads convey a 

truthful and non-misleading net 

impression about the advertised drug, 

including its risks, and that consumers 

are better informed when they 

participate in healthcare decision 

making, as described elsewhere in this 

document. Further, the consumer is 

uniquely positioned to know about 

particular, personal circumstances or 

limitations (e.g., other medicines and 

supplements being taken, constraints on 

time or other resources, allergies, 

preferences) that are important factors 

in decision making about prescription 

drug treatments. See Ref. 18 noting the 

changing role of consumer as processor 

of health information. When taking into 

account their own specific 

circumstances and what they know 

about a prescription drug, a consumer 

decides whether they will accept 

undesirable side effects in light of 

health benefits, whether they will 

devote the necessary ongoing attention 

to monitoring and management to 

optimize net outcomes, or even whether 

they need to avoid or prefer to avoid a 

drug completely because the risks for 

that individual are too great. As further 

explained below, the measures in this 

rule join other longstanding 


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requirements that help remedy the lack 

of business incentive for prescription 

drug firms to effectively communicate 

the risks of their products to consumers, 

and thus, the standards established in 

this rule, independently and 

collectively, advance the substantial 

Government interests in helping to 

ensure that DTC TV/radio ads convey a 

truthful and non-misleading net 

impression about the advertised drug 

and that consumers are better-informed 

when they participate in healthcare 

decision making. 

1. Government Interests in This 

Regulation 

For DTC TV/radio ads, the measures 

in this rule enhance the manner of 

presentation of risk information to 

increase the likelihood that consumers 

will notice, attend to, and understand 

the major statement in these ads, which 

conveys the drug’s major side effects 

and contraindications. Improving 

consumer understanding of these risks 

helps ensure that an ad conveys a 

truthful and non-misleading net 

impression about the advertised drug. 

And improving consumer 

understanding also helps ensure that 

consumers are better-informed when 

they participate in healthcare decision 

making. 

As the Supreme Court has recognized, 

‘‘there is no question that [the 

Government’s] interest in ensuring the 

accuracy of commercial information in 

the marketplace is substantial’’ 

(Edenfield v. Fane, 507 U.S. 761, 769 

(1993)). Consistent with this overall 

interest for all advertising, this rule 

helps ensure that DTC TV/radio ads 

communicate risk so that they convey a 

truthful and non-misleading net 

impression about the advertised drug. 

This purpose was also identified by an 

author of the statutory provision 

underlying this regulation. See 153 

Cong. Rec. S5631 (May 7, 2007) 

(statement of Sen. Roberts during floor 

consideration) (‘‘My amendment 

requires that major statements about a 

drug’s side effects, contraindications, 

and effectiveness in television or radio 

ads be presented in a clear and 

conspicuous manner so as not to 

mislead the public.’’). In addition, 

although Federal law does not prohibit 

DTC advertising of any legally marketed 

drug, research indicates that some 

consumers erroneously believe that 

drugs that have serious side effects 

cannot be advertised to consumers (Ref. 

19). While this rule does not change the 

content of the major statement in 

prescription drug ads, presenting the 

major statement in a clear, conspicuous, 

and neutral manner will help 

consumers understand if there are 

serious risks associated with a drug. 

Thus, this rule seeks to help ensure that 

DTC ads communicate risk information 

in a manner that helps consumers 

notice, attend to, and understand the 

drug’s risks. 

The Government also has a 

substantial interest in promoting 

consumer understanding of a 

prescription drug’s risks in order to help 

ensure that consumers are better 

informed when they participate in 

healthcare decision making at each of 

the many important healthcare decision 

points already described, taking account 

of their individual circumstances. See, 

e.g., American Hosp. Ass’n v. Azar, 983 

F.3d 528, 538 (D.C. Cir. 2020) 

(‘‘providing consumers with factual 

price information to facilitate more 

informed health care decisions’’); 

CTIA—The Wireless Ass’n v. City of 

Berkeley, 928 F.3d 832, 846 (9th Cir. 

2019) (informing consumers regarding 

radiation emissions from cell phone and 

methods of avoiding excessive 

exposure); Discount Tobacco City & 

Lottery, Inc. v. United States, 674 F.3d 

509, 567 (6th Cir. 2012) (‘‘effectively 

communicat[ing] the associated health 

risks [of tobacco products] so that 

consumers possess accurate, factual 

information when deciding whether to 

buy tobacco products’’); Nat’l Elec. Mfrs. 

Ass’n v. Sorrell, 272 F.3d 104, 115 (2d 

Cir. 2001) (‘‘increasing consumer 

awareness of the presence of mercury in 

a variety of products’’). 

Ensuring that a drug’s specific risks 

are effectively communicated in DTC 

TV/radio ads helps inform consumers— 

another purpose identified by an author 

of the legislation underlying this 

rulemaking. See 153 Cong. Rec. S5645 

(May 7, 2007) (statement of Sen. Harkin) 

(stating that the amendment seeks ‘‘to 

help the FDA and the companies to 

provide better information so that 

consumers can make real choices’’). 

This regulation, by helping to assure 

that ads that address a prescription 

drug’s benefits also facilitate 

understanding of risks, helps consumers 

when they are exploring healthcare 

options. 

Improving consumer understanding of 

an advertised prescription drug’s risks 

to better inform those consumers when 

they participate in healthcare decision 

making is especially important in the 

American healthcare environment. 

Evidence indicates that HCPs have 

limited time with patients (Refs. 20 to 

23) and discussions with patients are 

only one among varied HCP duties that 

may include clinical care, research, 

mentoring, teaching, electronic health 

recordkeeping, and other administrative 

duties (Refs. 24 and 25). Moreover, as 

previously noted, consumers have 

information about their individual 

circumstances that may be relevant, or 

even critical, to any decision about use 

of a particular prescription drug. 

Helping ensure consumers have the 

information they need to formulate 

appropriate questions or bring up 

relevant information about their 

personal circumstances during 

interactions with HCPs helps consumers 

make productive use of those 

interactions. 

2. Consistency With Longstanding 

Statutory and Regulatory Measures 

Regarding Prescription Drug Risk 

Presentation 

The basic concepts of the rule 

continue the approach taken in many 

longstanding measures applicable to 

prescription drug advertising and 

labeling. For example, since 1938 (for 

labeling) and 1976 (for advertising), 

section 201(n) of the FD&C Act has 

reflected the principle that disclosing 

material facts that include the 

‘‘consequences’’ of using the drug to 

which labeling or advertising relates is 

key to ensuring that such 

communications are not misleading. 

Moreover, the more precise principle 

that when drug manufacturers choose to 

advertise prescription drugs, those ads 

must provide risk information was 

recognized with the 1962 enactment of 

section 502(n) of the FD&C Act, 

specifying that prescription drug ads 

must include ‘‘a true statement 

of. . .other information in brief 

summary relating to side effects, 

contraindications and effectiveness as 

shall be required in regulations . . . .’’ 

Accordingly, a specific regulatory 

requirement to convey a prescription 

drug’s risks in its advertising has been 

in place since 1963. See 28 FR 6375 at 

6376 (June 20, 1963). And since 1969, 

the prescription drug advertising 

regulations have specifically addressed 

the use of a statement of the advertised 

drug’s major side effects and 

contraindications in TV and radio 

advertising. See 34 FR 7802 (May 16, 

1969). Similarly, many drug firms have 

also long acknowledged that DTC ads 

that convey benefit information should 

also contain risk information (Ref. 11). 

After industry’s initial forays into 

DTC prescription drug advertising in the 

early 1980s, FDA confirmed that DTC 

advertising was likewise subject to these 

established prescription drug 

advertising regulations. See 50 FR 36677 

at 36678 (September 9, 1985) and 

§ 202.1(e)(1) (1985). This was the 

regulatory framework that was in place 

in 2007, when Congress amended the 


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2The definition of ‘‘clear and conspicuous’’ in 

one regulation cited in the proposed rule, 12 CFR 

40.3, is now part of 12 CFR 1016.3. 

underlying statutory provision in 

section 502(n) of the FD&C Act to codify 

the importance of ads effectively 

communicating risk to consumers by 

further specifying that this ‘‘major 

statement relating to side effects and 

contraindications’’ in human 

prescription drug advertisements 

presented directly to consumers in 

television or radio format and stating 

the name of the drug and its conditions 

of use, be presented in a clear, 

conspicuous, and neutral manner. 

The specific ‘‘clear, conspicuous, and 

neutral manner’’ provision that this 

regulation addresses is also part of a 

longstanding line of statutory and 

regulatory provisions that help ensure 

that an inadequate manner of 

presentation does not undermine 

required disclosures about prescription 

drugs. See, e.g., 21 U.S.C. 352(c) 

(enacted by Pub. L. 75–717 (June 25, 

1938)), establishing misbranding if 

prominence, conspicuousness, and 

terms used to present required elements 

of labeling for drugs and devices are not 

sufficient to ‘‘render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ In fact, provisions 

for presenting required information 

clearly and prominently have been a 

part of requirements for prescription 

drug advertising since the first such 

regulations were issued. See 28 FR 6375 

at 6377 (initial regulations issued under 

section 502(n) of the FD&C Act, 

including 21 CFR 1.105(i), requiring 

information concerning side effects and 

contraindications to appear ‘‘in 

reasonably close association with the 

information concerning effectiveness’’ 

with ‘‘the same relative degree of 

prominence as the information 

concerning effectiveness, taking into 

account all pertinent factors, including 

typography, layout, contrast, and other 

printing features.’’); see also current 

§ 202.1(e)(7)(viii). 

This rulemaking complements these 

longstanding prescription drug 

advertising requirements. This rule 

brings additional clarity to existing 

provisions about the major statement in 

DTC TV/radio ads by providing 

information on how that major 

statement must sound and (in the case 

of TV ads) look. 

In sum, this rulemaking is an 

important incremental measure, adding 

to a longstanding body of legal 

requirements addressing effective 

communication of risk information 

about prescription drugs in consumerdirected promotional communications. 

The rule helps ensure that DTC TV/ 

radio ads convey a truthful and nonmisleading net impression about the 

advertised drug and helps ensure that 

consumers are better informed when 

they participate in healthcare decision 

making. 

B. History of the Rulemaking 

In the proposed rule (Federal Register 

of March 29, 2010 (75 FR 15376)), we 

proposed to amend our regulations 

regarding DTC TV/radio ads in 

accordance with section 901(d)(3) of 

FDAAA (see 21 U.S.C. 352(n)). 

Specifically, we proposed to implement 

provisions of FDAAA requiring that in 

human prescription drug 

advertisements presented directly to 

consumers in television or radio format 

and stating the name of the drug and its 

conditions of use, the major statement 

relating to side effects and 

contraindications shall be presented in 

a clear, conspicuous, and neutral 

manner. 

We proposed the following four 

standards for determining whether the 

major statement in these ads is 

presented in the statutorily required 

manner: 

#1. Information is presented in 

language that is readily understandable 

by consumers. 

#2. Audio information is 

understandable in terms of the volume, 

articulation, and pacing used. 

#3. Textual information is placed 

appropriately and is presented against a 

contrasting background for sufficient 

duration and in a size and style of font 

that allows the information to be read 

easily. 

#4. The advertisement does not 

include distracting representations 

(including statements, text, images, or 

sounds or any combination thereof) that 

detract from the communication of the 

major statement. 

We also solicited comment on a 

potential fifth standard to require that in 

TV ads, the major statement be 

presented simultaneously in both audio 

and visual portions of the ad—a practice 

known as dual modality. 

In developing these proposed 

standards, FDA considered standards 

developed by other Federal Agencies, 

including the Federal Trade 

Commission (FTC), the Department of 

the Treasury, the Commodity Futures 

Trading Commission, and the Securities 

and Exchange Commission, for 

determining whether disclosures in TV/ 

radio ads, as well as disclosures in other 

contexts, are ‘‘clear and conspicuous’’ 

(75 FR 15376 at 15377–15379). Then, as 

now, the Agency considered these 

standards to be highly relevant because 

they aim to ensure that required 

disclosures are effectively presented so 

that consumers are not misled about the 

attributes of the product or service that 

is the subject of the communication. As 

discussed in section III.A.1 of this 

document, FDA has a similar interest in 

ensuring that DTC TV/radio ads convey 

a truthful, non-misleading net 

impression about the advertised drug. 

FDA noted in the preamble of the 

proposed rule that these other Federal 

standards revealed the widespread 

incorporation of common themes, 

which FDA in turn incorporated in its 

own proposed standards, and now 

incorporates in its final standards, 

because they are all factors that 

contribute to whether the audience will 

notice, attend to, and understand the 

risk information in the major statement 

(75 FR 15376 at 15378–15379). These 

themes were: ‘‘ease of comprehension of 

the language used in the disclosure; the 

formatting and location of textual 

information in the disclosure; audio 

considerations such as pacing, volume, 

and qualities of speech; and the 

presence of any distracting elements 

during the disclosure’’ (75 FR 15376 at 

15378). The language of the standards 

from other Federal Agencies cited in the 

proposed rule and the themes 

incorporated by those other Federal 

standards remain unchanged.2

In the proposed rule, FDA also noted 

that its proposed standards were 

consistent with factors described and 

discussed in its draft guidance entitled 

‘‘Presenting Risk Information in 

Prescription Drug and Medical Device 

Promotion’’ (May 2009) (draft Risk 

Guidance; Ref. 26) (available at https:// 

www.fda.gov/media/76269/download) 

(75 FR 15376 at 15379). That draft 

guidance reflects consideration of a 

broad body of social science research 

into human cognition and factors that 

impact attention and comprehension. 

The Agency also noted in the 

proposed rule that it was unaware of 

any previous standards or regulations 

concerning the definition of ‘‘neutral 

manner’’ in the context of required 

disclosures but considered ‘‘neutral 

manner’’ to mean ‘‘unbiased manner’’ of 

presentation and thus proposed 

standards accordingly. The Agency 

suggested, ‘‘To achieve a ‘neutral,’ 

unbiased presentation of the major 

statement and to avoid undercutting its 

effectiveness, the major statement must 

not be presented in competition with 

other elements if these elements would 

arrest the attention and distract 

consumers from the presentation of the 

risk information’’ (75 FR 15376 at 

15380). As part of the overall 


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3See, e.g., Ipsos, ‘‘Half of American TV viewers 

watch 10 or more hours of TV during the week,’’ 

Report, July 28, 2021, available at https://

www.ipsos.com/en-us/news-polls/american-tvviewing-habits-2021, accessed September 7, 2023; 

Leiner, D.J. and N.L. Neuendorf, ‘‘Does Streaming 

TV Change Our Concept of Television?’’ Journal of 

Broadcasting & Electronic Media, 66(1):153–175, 

2022. doi:10.1080/08838151.2021.2013221; 

Radioworld, ‘‘How Technology Helps Radio and Its 

Listeners,’’ April 9, 2019, available at https://

www.radioworld.com/columns-and-views/guestcommentaries/rab-audio-technology-helps-radio, 

accessed September 7, 2023. 

4See also Little Sisters of the Poor Saints Peter 

& Paul Home v. Pennsylvania, 140 S. Ct. 2367, 

2385, (2020) (The Administrative Procedure Act 

(APA) prescribes the ‘‘maximum procedural 

requirements that an agency must follow in order 

to promulgate a rule.’’) (internal quotation marks 

omitted); Sanofi-Aventis US LLC v. HHS, 58 F.4th 

696, 706 (3d Cir. 2023) (‘‘all the APA requires of 

an agency before publishing a final rule is (1) 

putting a notice of proposed rulemaking in the 

Federal Register, (2) accepting comments on that 

proposal, and (3) considering those comments. See 

5 U.S.C. 553(b)–(c).’’) 

establishment of standards for 

effectively communicating necessary 

risk information in a clear, conspicuous, 

and neutral way, we requested 

comments on standards to establish 

what is ‘‘neutral’’ (75 FR 15376 at 

15380). 

In the proposed rule (75 FR 15376 at 

15379), we noted that FDA had 

conducted a study on the impact of 

certain types of visual distraction on 

consumer understanding of risk and 

benefit information in DTC TV ads for 

prescription drugs (referred to in this 

document as the Distraction Study), the 

results of which were at that time still 

undergoing analysis (and, consequently, 

were not the basis of any specific 

provision in the proposed rule). FDA 

acknowledged the limitations of this 

study, but because FDA believed it 

could be relevant to the rulemaking, 

announced plans to place the report of 

the results into the docket for the 

proposed rule with opportunity for 

comment. Accordingly, in the Federal 

Register of January 27, 2012 (77 FR 

4273), we announced the addition of the 

Distraction Study report to the docket 

(Ref. 27), and we reopened the 

rulemaking comment period until 

February 27, 2012, to provide an 

opportunity for interested parties to 

comment on the study as it relates to the 

proposed standards (Docket No. FDA– 

2009–N–0582). In the Federal Register 

of March 29, 2012 (77 FR 16973), we 

reopened the comment period for the 

rulemaking proceeding again until April 

9, 2012, in response to a request for 

more time to submit comments to the 

Agency on the Distraction Study report 

as it related to the proposed standards. 

The Distraction Study examined three 

factors that might influence viewers’ 

understanding of the risk information 

presented in the audio portion of a TV 

ad. This research evaluated the effects 

of: 

• Presence or absence of 

superimposed text (SUPERs) that 

concurrently presented verbatim, key 

words and phrases from the audio 

presentation of risk; 

• Variations in the positive (affective) 

tone of visual images; and 

• Visual information that was either 

inconsistent or consistent with the 

audio risk information. 

The results of the Distraction Study 

indicate that presenting the same risk 

information visually (i.e., in SUPERs) 

and in audio at the same time (dual 

modality) improves consumers’ 

understanding of the risk information. 

The Distraction Study did not find 

support for the hypotheses that 

understanding of the risk information is 

adversely influenced by concurrently 

presenting positively toned visual 

images or by concurrently presenting 

information in visuals that is 

inconsistent with the risk information 

presented in audio (Ref. 27). While the 

Distraction Study and its results were a 

consideration during the formulation of 

the standards in this final rule, they 

were neither the sole justification for, 

nor the only information considered in, 

the development of any of the proposed 

or final standards. 

FDA based the standards in the 

proposed rule on scientific research, 

literature, and existing Government 

standards, all of which continue to be 

relevant for the final rule. Research 

findings supporting the proposed rule’s 

standards—including research findings 

on dual modality and distraction—were 

available during the public comment 

periods and have been subsequently 

corroborated by additional research, 

including research supporting that 

comprehension and recall is increased 

when information is provided in both 

audio and text and also when 

information is presented without 

distraction. In this final rule, the 

fundamental concepts remain the same 

as those articulated in the proposed 

rule. Evolving technologies have 

allowed for DTC TV/radio ads to be 

presented on a broader range of devices 

and disseminated via a broader range of 

platforms since the issuance of the 

proposed rule.3 However, from an 

informal review of ads firms recently 

submitted to FDA in accordance with 

regulatory requirements (21 CFR 

314.81(b)(3)(i) and 601.12(f)(4)), FDA 

observes that firms have not developed 

distinct ads for dissemination on these 

new devices and platforms and that 

DTC TV/radio ads remain essentially 

the same. Moreover, fundamental 

attributes of communication that impact 

the likelihood that audiences will 

notice, attend to, and comprehend 

information, which the standards in the 

proposed and final rules concentrate on, 

do not turn on the delivery technology. 

We recognize the passage of time 

between the closure of the last comment 

period on the proposed rule and the 

issuance of this final rule, which 

resulted in large part from competing 

demands for limited Agency resources, 

such as repeated redirection of 

personnel into emergency operations for 

natural disasters, the opioid epidemic, 

and infectious disease outbreaks 

including Ebola, Zika, and the COVID– 

19 pandemic. Despite this passage of 

time, FDA concludes that this 

rulemaking is both procedurally and 

substantively sound. A central purpose 

of notice-and-comment rulemaking is to 

obtain public input, see Make the Rd. 

N.Y. v. Wolf, 962 F.3d 612, 634 (D.C. 

Cir. 2020) and United States v. Cain, 

583 F.3d 408, 420 (6th Cir. 2009). The 

Agency has provided three public 

comment periods, offering meaningful 

opportunities for any interested persons 

to comment on the rulemaking and the 

bases for the standards laid out in this 

rulemaking.4 Indeed, no parties have 

requested additional opportunity for 

comment since closure of the last 

comment period, even though the 

Agency’s plans to issue a final rule have 

been consistently made public through 

the Unified Agenda since 2017. 

Moreover, as noted above, the Agency 

has determined that there are no 

material changes in the fundamental 

concepts, relevant facts (including 

evolving technologies), scientific 

research, literature, or existing 

Government standards underlying the 

rule. For these reasons, FDA concludes 

that it is appropriate to issue this final 

rule without offering a fourth 

opportunity for public comment. 

C. Summary of Comments to the 

Proposed Rule 

There were three public comment 

periods for the proposed rule. In total, 

FDA received over 70 submissions from 

consumers, public interest or consumer 

groups, trade and industry associations, 

healthcare providers, and drug firms. 

Overall, the majority of comments 

express support for the proposed rule. 

Several comments request that FDA edit 

the proposed rule, provide clarification, 

or provide more detail. Several 

comments suggest that FDA undertake 

additional research before finalizing the 

rule. We address these and other 

comments throughout this document. 


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D. General Overview of Final Rule and 

Changes to the Proposed Rule 

This final rule implements a FDAAA 

requirement (codified in 21 U.S.C. 

352(n)) that in human prescription drug 

advertisements presented directly to 

consumers in television or radio format 

and stating the name of the drug and its 

conditions of use, the major statement 

relating to side effects and 

contraindications shall be presented in 

a clear, conspicuous, and neutral 

manner. This statutory requirement has 

been in effect since March 25, 2008. In 

line with other Government standards, 

findings from scientific research and 

literature, and the proposed rule, this 

final rule establishes standards for 

determining whether the major 

statement in these ads is presented in a 

clear, conspicuous, and neutral manner. 

We discuss the following: 

• In the final rule, we do not address 

‘‘neutral’’ separately from the overall 

concept of a ‘‘clear, conspicuous, and 

neutral manner’’ of presentation, nor do 

we associate that attribute exclusively 

with any single standard. Rather, we 

conclude that the final standards, 

independently and collectively, 

contribute to a clear, conspicuous, and 

neutral manner of presentation. 

• Proposed standard #1 (final 

standard #1; § 202.1(e)(1)(ii)(A)): 

‘‘Information is presented in language 

that is readily understandable by 

consumers.’’ The final standard 

specifies that the major statement must 

be presented in consumer-friendly 

language and terminology that is readily 

understandable. 

• Proposed standard #2 (final 

standard #2; § 202.1(e)(1)(ii)(B)): ‘‘Audio 

information is understandable in terms 

of the volume, articulation, and pacing 

used.’’ The final rule clarifies that the 

audio information in the major 

statement must be at least as 

understandable as the audio information 

presented in the rest of the ad in terms 

of the volume, articulation, and pacing 

used. 

• Proposed potential standard #5 

(final standard #3; § 202.1(e)(1)(ii)(C)): 

The final rule includes a standard 

requiring that for ads in TV format, the 

major statement be presented 

concurrently using both audio and text 

(dual modality). To achieve dual 

modality: (1) either the text displays the 

verbatim key terms or phrases from the 

corresponding audio, or the text 

displays a verbatim complete transcript 

of the corresponding audio; and (2) the 

text is displayed for a sufficient 

duration to allow it to be read easily. 

For the purposes of this standard, the 

duration is considered sufficient if the 

text display begins at the same time and 

ends at approximately the same time as 

the corresponding audio. 

• Proposed standard #3 (final 

standard #4; § 202.1(e)(1)(ii)(D)): 

‘‘Textual information is placed 

appropriately and is presented against a 

contrasting background for sufficient 

duration and in a size and style of font 

that allows the information to be read 

easily.’’ The final rule removes the 

duration requirement from this 

standard, including it instead in final 

standard #3, and clarifies that this 

standard applies to the text portion of 

the major statement in ads in television 

format. For clarity, we also reorganized 

the phrasing of this standard. 

• Proposed standard #4 (final 

standard #5; § 202.1(e)(1)(ii)(E)): ‘‘The 

advertisement does not include 

distracting elements (including 

statements, text, images, or sounds or 

any combination thereof) that detract 

from the communication of the major 

statement.’’ The final rule revises the 

standard to specify that, in order to 

satisfy it, during presentation of the 

major statement, the ad does not include 

audio or visual elements, alone or in 

combination, that are likely to interfere 

with comprehension of the major 

statement. 

We also made the following nonsubstantive editorial changes on our 

own initiative: 

• Section 202.1: Relocated text that 

defines prescription drug for purposes 

of this section (previously included in 

§ 202.1(e)(1)). Within this definition, 

replaced the phrase ‘‘drugs for use by 

man’’ with the phrase ‘‘drugs intended 

for use by humans.’’ 

• Section 202.1(e): Divided 

information into subordinate paragraphs 

for clarity, ease of reading, and plain 

language. 

• Section 202.1(e)(1)(i): Added 

subparagraphs for ease of reading and 

reference to § 202.1(e)(1)(ii)(C) for 

clarity. Replaced ‘‘approved or 

permitted package labeling’’ with 

‘‘approved or permitted product 

labeling.’’ 

• Section 202.1(e)(1)(ii): Revised 

introductory language to reflect that it is 

the manner of presentation of the major 

statement that is ‘‘clear, conspicuous, 

and neutral,’’ if the standards that 

follow are met. 

IV. Legal Authority 

This final rule amends § 202.1 to be 

consistent with the current 

requirements of section 502(n) of the 

FD&C Act, as amended by section 

901(d)(3) of FDAAA, which establishes 

a requirement that in human 

prescription drug ads presented directly 

to consumers in television or radio 

format and stating the name of the drug 

and its conditions of use, the major 

statement relating to side effects and 

contraindications shall be presented in 

a clear, conspicuous, and neutral 

manner. In addition, FDA was directed 

by FDAAA (see section 901(d)(3)(B)) to 

establish standards for determining 

whether the major statement in DTC 

TV/radio ads is presented in a clear, 

conspicuous, and neutral manner—and 

does so in this rule. Furthermore, this 

rule is authorized by various statutory 

provisions, including sections 201, 301, 

502, 505, 512, and 701 of the FD&C Act. 

V. Comments on the Proposed Rule and 

FDA Response 

A. Introduction 

During the initial comment period 

(March 29 to June 28, 2010), FDA 

received more than 30 submissions on 

the proposed rule from consumers, 

public interest groups, trade 

associations, and the drug industry. 

When we reopened the comment period 

to allow for comment on the Distraction 

Study report as it relates to the proposed 

standards (January 27 to February 27, 

2012, and March 29 to April 9, 2012), 

we received nearly 40 additional 

submissions. 

In sections V.B through V.O of this 

document, we describe the comments 

received on the proposed rule and 

provide our responses. To make it easier 

to identify the comments and our 

responses, the word ‘‘Comment,’’ in 

parentheses, appears before the 

comment’s description, and the word 

‘‘Response,’’ in parentheses, appears 

before our response. We have numbered 

each comment to help distinguish 

between different comments. We have 

grouped similar comments together 

under the same number and, in some 

cases, we have separated different 

subjects discussed in the same comment 

and designated them as distinct 

comments for purposes of our 

responses. The number assigned to each 

comment or comment topic is purely for 

organizational purposes and does not 

signify the comment’s value or 

importance or the order in which 

comments were received. We reviewed 

all comments and carefully considered 

all points and perspectives. However, 

comments not directly relevant to this 

rulemaking were read and considered 

but are not discussed in this document. 

B. General Comments 

The majority of comments, including 

input from industry, support the 

proposed rule, while only a few 

comments oppose the rule. Several 


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comments indicate that the proposed 

rule was an important first step, but 

even more needs to be done, and some 

suggest that FDA needs additional 

information or research results before 

the regulation is finalized. Various other 

comments request clarification on 

certain issues in the proposed rule. We 

address these and other comments 

throughout this document. 

C. Research Studies—Comments and 

FDA Response 

In the proposed rule, FDA referenced 

a number of research studies relevant to 

the proposed standards generally and to 

dual modality specifically, and also 

referenced the Agency’s draft Risk 

Guidance, which itself describes a wellestablished body of social science 

research relevant to the standards in the 

proposed and final rule. As previously 

described, FDA also mentioned the 

Distraction Study in the proposed rule, 

although its results were still 

undergoing analysis at that time, and 

indicated that FDA intended to add the 

study report to the docket for the 

rulemaking when available and provide 

opportunity for public comment, as 

FDA believed those study results might 

provide helpful information to consider 

in the rulemaking. FDA subsequently 

provided two opportunities for the 

public to comment on the results and 

FDA’s analyses of the study and how it 

related to the proposed standards (77 FR 

4273 and 77 FR 16973). Many of the 

comments discuss how the Distraction 

Study relates to the proposed standards. 

Several comments conclude that the 

results of the study directly support the 

proposed rule. However, several other 

comments argue that the study design 

was flawed or did not support the 

proposed rule. Several comments 

suggest that additional research should 

be conducted regarding distraction and 

the understanding of risk information by 

consumers. 

Comments on the results of the 

Distraction Study as it relates to 

proposed standard #4 regarding 

distracting elements that detract from 

the communication of the major 

statement are addressed in section V.J of 

this document (final standard #5). 

Comments pertaining to the use of 

dual modality in the Distraction Study 

are addressed in section V.K of this 

document. 

However, we briefly address several 

general comments related to the 

Distraction Study and other research 

here. 

(Comment 1) Several comments 

suggest that the Distraction Study did 

not examine a sufficient number of 

factors regarding consumers’ 

understanding of risk information. One 

comment notes that the Distraction 

Study did not examine all four proposed 

standards to determine what would be 

considered clear, conspicuous, and 

neutral. Another comment points out 

that there are many factors beyond those 

studied that affect the assessment of 

risk. This comment suggests that FDA 

should examine how individual 

perception of risk is influenced by 

personal experiences, education level, 

race, gender, age, and knowledge of the 

agent creating the risk. 

Another comment states that the 

Distraction Study failed to address the 

full context in which the benefits and 

risks of prescription drugs are actually 

considered, specifically with respect to 

the doctor-patient relationship. The 

comment argues that doctor-patient 

interaction is an integral part of the 

communication of benefits and risks for 

prescription drugs and thus must be 

considered in any assessment regarding 

risk communication. The comment 

suggests additional studies be 

conducted, including: (1) studies that 

measure the effect of DTC ads on the 

quality of any subsequent discussions 

between the patient and physician and 

(2) studies that measure comprehension 

of benefits and risks only after 

consultation with a physician. 

One comment suggests that FDA 

should consider additional research to 

determine the elements of advertising 

that may distract a viewer’s attention 

from the major statement. Another 

comment notes that no study can 

account for all possible distractions 

consumers might face. 

(Response 1) Many of these comments 

appear to overstate the role of the 

Distraction Study with regard to the 

development of the standards for a 

clear, conspicuous, and neutral 

presentation of the major statement. We 

conclude that there is a strong basis for 

the final rule without the Distraction 

Study or the additional research that 

some comments suggest be conducted. 

The Distraction Study was designed 

only to examine the effects of three 

particular, pre-defined factors: the 

presence or absence of SUPERs that 

concurrently presented verbatim, key 

words and phrases from the audio 

presentation of risk; variations in the 

positive (affective) tone of visual 

images; and visual information that was 

either inconsistent or consistent with 

the audio risk information. Consistent 

with the limitations of the Distraction 

Study, which FDA acknowledged in the 

proposed rule (see 75 FR 15376 at 

15379), neither the proposed nor final 

standards for ‘‘clear, conspicuous, and 

neutral manner’’ of presentation of the 

major statement are contingent on its 

results. 

Indeed, a much larger body of social 

science research, together with 

disclosure standards of other Federal 

agencies and ordinary experience with 

situations where multiple factors 

compete for attention and may affect 

comprehension, informs the proposed 

and final standards for a clear, 

conspicuous, and neutral manner of 

presentation of the major statement. For 

example, the Agency’s draft Risk 

Guidance, referenced in the proposed 

rule as describing factors consistent 

with the proposed rule’s standards (75 

FR 15376 at 15379), included cognitive 

science research that predated the 

Agency’s Distraction Study and 

demonstrated that, while there is some 

variation based on expertise, all people 

have limits on the amount of 

information they can think through and 

process at one time (see draft Risk 

Guidance, at p. 6 and fn. 20 (in this rule, 

Refs. 28–30)). Further, the draft 

guidance notes that to process 

information, a person must first pay 

attention to it. The guidance then goes 

on to discuss multiple factors (with 

underlying research) that contribute to 

whether people will pay attention to 

information, including formatting 

factors. Among other things, the draft 

guidance points to the well-established 

body of research that existed at the time 

of the proposed rule—and has been 

further corroborated since that time— 

that various elements can interfere with 

attention and comprehension. See, e.g., 

draft guidance p. 18, fn. 47 (in this rule, 

Refs. 31–33); p. 19, fns. 54 to 56 (in this 

rule, Refs. 34–36); and p. 20, fn. 61 (in 

this rule, Ref. 37). References cited in 

the Distraction Study report that was 

added to the docket for this rulemaking 

and made available for public comment 

include additional research on welldocumented distracting effects of 

certain other elements. (See Distraction 

Study report, p. 3, fn. 1, citing research 

on scene changes (in this rule, Ref. 38) 

and music (in this rule, Ref. 39).) 

Similar information about social science 

research relevant to other aspects of 

proposed standards #1 through #4 also 

appears in the draft Risk Guidance, 

which the proposed rule itself 

references. The public had the 

opportunity to comment on the rule and 

the Agency’s use of the guidance and 

research to inform the proposed 

standards. That research remains 

relevant to this final rule. The proposed 

and final standards also have a basis in 

disclosure standards of other Federal 

agencies (cited in the proposed rule and 

unchanged since) and ordinary 


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experience with situations where 

multiple factors compete for attention 

and may affect comprehension. As to 

dual modality, the proposed rule 

summarized a substantial body of 

research supportive of the utility of this 

technique, predating the Distraction 

Study (75 FR 15376 at 15383). As 

discussed in section V.K of this 

document, findings of this research 

regarding the positive impact of dual 

modality have been corroborated 

subsequently by the Distraction Study 

and other research. 

Other comments submitted to the 

docket for the final rule discuss 

technical details of the Distraction 

Study’s methodology and analyses, 

rather than the standards in the rule. 

Sections V.J and V.K of this document 

address non-technical comments related 

to the Distraction Study’s methodology 

as it relates to final standard #3 (section 

V.J) and final standard #5 (section V.K). 

However, because the Distraction Study 

was only one of many pieces of 

information FDA considered when 

formulating the standards for this rule, 

technical comments on the study 

methodology are not further discussed 

here. 

(Comment 2) One comment 

recommends that FDA develop 

strategies to ensure consumer 

understanding of the information 

contained in DTC ads, such as using 

patient focus groups to pre-approve the 

most common risk statements. 

Additionally, the comment suggests that 

other elements, such as font size, color, 

and placement, should be tested with 

consumers. The comment further 

suggests that FDA should conduct 

research to provide an evidence-based 

assessment of the proposed standards to 

ensure that they result in consumerdirected ads that effectively 

communicate risk in a clear, 

conspicuous, and neutral way. The 

comment concludes that this research 

would allow FDA to use quantitative, 

documented evidence, rather than 

relying on the consensus of expert 

opinion. 

Two comments also suggest that FDA 

should consider conducting research 

and a further analysis on how 

individual elements combined and 

presented together would affect the 

overall communication of the advertised 

drug’s potential benefits and associated 

risks. A separate comment suggests that 

the communication of benefits and risks 

in DTC ads should be tested on an adto-ad basis against quantitative 

standards for evaluating comprehension 

and understanding among the intended 

audience. 

(Response 2) As part of the 

rulemaking process culminating in the 

standards in this final rule, FDA 

considered many resources, including 

the many comments submitted during 

the multiple comment periods, and the 

literature, research, and other 

Government standards described 

elsewhere in this document. In light of 

the consistency of findings in the 

research evaluating the presentation of 

risk information in DTC ads for 

prescription drugs from the time of the 

proposed rule through now, as well as 

the other Federal Government standards 

for clear and conspicuous disclosures of 

information cited in the proposed rule 

and still in place today, we conclude 

that we have sufficient information to 

finalize this regulation without 

additional research. 

D. The Major Statement—Comments 

and FDA Response 

In proposed § 202.1(e)(1)(i), FDA 

proposed to add the term ‘‘major 

statement’’ in parentheses after the 

phrase ‘‘major side effects and 

contraindications’’ to reflect the 

Agency’s interpretation that this is the 

meaning of the terminology used in 

section 502(n) of the FD&C Act as 

amended, an interpretation consistent 

with previous usage (see 75 FR 15376 

and 15379; Ref. 1). We did not receive 

comments directly on this proposal and 

our final rule includes this provision for 

the same reasons we proposed it. We 

did receive comments and questions 

about the major statement in general. 

(Comment 3) One comment suggests 

that FDA should incorporate the 

concept of ‘‘net impression’’ (the 

message communicated by all elements 

of the piece as a whole) by adding the 

following language to the end of 

proposed § 202.1(e)(1)(i): ‘‘The adequacy 

of the major statement will be 

determined not just in relation to riskrelated statements, but by the net 

impression of the advertisement as a 

whole.’’ 

(Response 3) We disagree with adding 

the suggested language. Although both 

the major statement and other 

components of the ad collectively 

contribute to the overall net impression, 

under section 502(n) of the FD&C Act, 

the requirement that certain information 

be presented in a ‘‘clear, conspicuous, 

and neutral manner’’ applies 

specifically to ‘‘the major statement 

relating to side effects and 

contraindications’’—not to the ad as a 

whole. Because this requirement is 

specific to the presentation of the major 

statement, a failure to satisfy this 

requirement cannot be remedied by the 

presentation of statements in other 

portions of the ad. For this reason, we 

decline to add the proposed language, 

which would allow for the 

interpretation that an inadequately 

presented major statement can be made 

adequate by statements in other parts of 

the ad. 

FDA will, however, continue to 

evaluate the net impression created by 

a DTC TV/radio ad in determining 

whether that ad is false or misleading. 

FDA considers net impression as well as 

evaluates specific risk-related 

statements in these ads. It is consistent 

with this approach to issue regulations 

that recognize the need for the major 

statement to satisfy, on its own, specific 

statutory requirements. Furthermore, 

presenting the major statement in a 

clear, conspicuous, and neutral manner 

should help ensure DTC TV/radio ads 

convey a truthful and non-misleading 

net impression about the advertised 

drug. 

(Comment 4) One comment 

recommends that the rule specify the 

location of the major statement in the 

ad. This comment suggests that the 

major statement should not appear in 

the middle of the ad ‘‘where it can be 

bookended by benefit information and is 

least likely to be retained by 

consumers.’’ 

(Response 4) We decline to include in 

the final rule a provision specifying 

exactly where the major statement must 

appear in the ad. This final rule’s 

standards for presenting the major 

statement in a clear, conspicuous, and 

neutral manner complement, rather than 

displace, FDA’s longstanding approach 

to assessing whether the ad as a whole 

complies with other requirements. To 

ensure that the ad provides fair balance 

between information relating to side 

effects and contraindications and 

information relating to effectiveness of 

the drug, and to assess whether it 

conveys a truthful and non-misleading 

net impression about the advertised 

drug, FDA already considers the 

placement of risk information together 

with many other elements of the piece, 

including framing, signaling, themes, 

and other risk presentation factors. 

E. Standards To Determine a Clear, 

Conspicuous, and Neutral Manner— 

General Comments and FDA Response 

In this final rule, as directed by 

FDAAA, FDA establishes standards for 

determining whether the major 

statement in DTC TV/radio ads is 

presented in a clear, conspicuous, and 

neutral manner as required by section 

502(n) of the FD&C Act. (Of five final 

standards, two apply only to ads in 

television format.) 


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5See, e.g., Belmont Mun. Light Dep’t v. FERC, 38 

F.4th 173, 188 (D.C. Cir. 2022) (finding severability 

of a portion of an administrative action, applying 

the principle that severability is appropriate where 

‘‘the agency prefers severability to overturning the 

entire regulation’’ and where the remainder of the 

regulation ‘‘could function sensibly without the 

stricken provision’’) (citations omitted). 

Although we believe that the five 

standards established by this rule, when 

applied collectively, will best help 

ensure that the major statement in a 

DTC TV/radio ad is presented in a clear, 

conspicuous, and neutral manner, each 

standard independently enhances the 

manner of presentation to increase the 

likelihood that consumers will notice, 

attend to, and understand the advertised 

drug’s major side effects and 

contraindications. In the event of a stay 

or invalidation of any standard(s), those 

that remain in effect would continue to 

function sensibly 5 to advance these 

statutory objectives and provide useful 

standards for firms to meet their existing 

statutory obligation. For example, 

invalidation of a standard that addresses 

visual aspects of presentation would 

have no effect on standards addressing 

audio aspects or terminology. Likewise, 

in the absence of final standard #3 (dual 

modality) or final standard #5 (audio or 

visual elements that are likely to 

interfere with comprehension), each of 

the other standards would continue to 

contribute to a clear, conspicuous, and 

neutral manner of presentation of the 

major statement. Therefore, it is FDA’s 

intent to preserve each of the rule’s 

standards to the fullest possible extent, 

to help advance the important 

Government interests described in 

section III.A.1. 

As noted in section III.B of this 

document, in the proposed rule, FDA 

stated that it was unaware of any 

previous standards or regulations 

concerning the definition of ‘‘neutral 

manner’’ in the context of required 

disclosures and requested comment on 

this topic. In addition, in conjunction 

with proposed standard #4, FDA stated, 

‘‘To achieve a ‘neutral,’ unbiased 

presentation of the major statement and 

to avoid undercutting its effectiveness, 

the major statement must not be 

presented in competition with other 

elements if these elements would arrest 

the attention and distract consumers 

from the presentation of the risk 

information’’ (75 FR 15376 at 15380). 

However, FDA did not intend to suggest 

that the ‘‘neutral’’ element of the 

statutory requirement is only explained 

by or only relates to proposed standard 

#4, nor did we intend to foreclose the 

possibility that the other standards 

contribute to achieving a manner of 

presentation that is neutral as well as 

clear and conspicuous. We received 

comments suggesting ways in which ‘‘a 

neutral manner’’ could be explained 

through the other standards. To the 

extent that comments discuss neutrality 

specifically with respect to any of the 

five final standards, we discuss the 

comments within the sections that 

address those standards. 

(Comment 5) One comment supports 

the maintenance of a neutral tone in 

DTC ads to ensure that consumers are 

able to glean as much information about 

risk as possible. One comment asks FDA 

to confirm that ‘‘neutral’’ relates to the 

way in which the ad presents the major 

statement as opposed to the substantive 

content of the major statement. Another 

comment suggests that neutrality means 

that the major statement should only 

include FDA-approved uses and some 

measure of the risks of potential side 

effects. 

One comment argues that neutrality 

has nothing to do with distraction and 

suggests that Congress intended to 

incorporate a different meaning of 

neutrality because it had the 

opportunity to require that the major 

statement be totally devoid of all 

potentially distracting information by 

mandating that it be in plain black-andwhite or ‘‘tombstone’’ format. This 

comment also notes that the definition 

of ‘‘neutral’’ from Black’s Law 

Dictionary is ‘‘indifferent; unbiased; 

impartial; not engaged on either side; 

not taking an active part with either of 

the contending sides.’’ The comment 

states that a DTC ad in TV/radio format 

is qualitatively neutral if it neither 

under-warns consumers about the major 

risks nor overly deters consumers from 

using a beneficial product. Thus, the 

comment concludes that neutral should 

relate to the content or substance of an 

ad and not the style or manner in which 

the content is presented. 

Furthermore, within a discussion 

about neutrality, the same comment 

notes that a DTC TV/radio ad that 

overemphasizes risks is potentially as 

misleading as one that overemphasizes 

benefits. Several other comments 

express similar views. One of these 

comments states that how consumers 

feel about prescription medications and 

the impressions they have regarding the 

safety of these products can affect 

appropriate use of the products. The 

comment also notes that the company’s 

research suggests that adherence to a 

prescribed medication is based on three 

factors: (1) concerns about the drug (i.e., 

short- and long-term risks), (2) 

perceived need for the drug, and (3) 

concerns about drug cost. Another 

comment encourages FDA to further 

consider issuing standards to clarify 

what could be a subjective concept open 

to issues of interpretation and meaning. 

This comment encourages FDA to 

evaluate through research with target 

audiences whether an ad is balanced in 

the presentation of benefits and risks 

and whether serious risk information in 

ads is understood. 

Another comment suggests that a 

broad definition of ‘‘neutral’’ should be 

adopted. The comment proposes that to 

present information ‘‘neutrally’’ DTC 

advertisements should compare the 

advertised product’s risks with the 

expected benefits (including 

considerations relating to consumer 

convenience, comfort, cost, and 

expected benefits); compare the safety 

and efficacy of the advertised product 

with other products for the same 

indication (e.g., existing products both 

under patent and generic); and compare 

the safety and efficacy of the advertised 

product with non-pharmaceutical 

approaches for the same indication (e.g., 

lifestyle modifications). This comment 

claims that including this information 

will result in a more neutral 

presentation by giving consumers a 

balanced picture of the benefits and 

risks of the advertised product. A 

separate comment expresses its support 

of these views. 

In response to those comments, 

another comment says that FDA should 

not reconstruct the substantive contours 

of the major statement requirement in 

the guise of defining neutrality, for 

example, by requiring such concepts as 

comparative safety and effectiveness 

versus other pharmacologic and nonpharmacologic approaches to treatment, 

including lifestyle modifications. 

(Response 5) We agree with the 

general principle that it is in the interest 

of the public health that the risk 

information in an ad is presented in an 

engaging manner and is neither 

overstated nor understated. However, 

several of these comments focused in 

some way on a perceived requirement 

that neutrality apply to DTC TV/radio 

ads generally and were mistaken as to 

what information is required to be 

included in the major statement or 

thought that FDA might change the 

content of the major statement through 

this rulemaking. DTC TV/radio ads, like 

all prescription drug ads, are required to 

contain a fair balance of risk and benefit 

information (§ 202.1(e)(5)(ii)). However, 

the requirement of a clear, conspicuous, 

and neutral manner of presentation, as 

laid out in the statute, relates to the 

manner of presentation of the major 

statement and not to the manner of 

presentation of the ad as a whole. 

Further, FDA is not using this 

rulemaking and the requirement of a 


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‘‘clear, conspicuous, and neutral 

manner’’ of presentation to change the 

content of the major statement (e.g., the 

risk information provided). Thus, this 

rulemaking, which addresses the 

manner of presentation of the major 

statement, does not require that the 

major statement include benefit 

information in comparison to risks, 

quantitative information, or information 

about other pharmacologic or nonpharmacologic approaches for the same 

indications. 

FDA agrees that neutral means 

unbiased, and to provide more specific 

direction to firms, we establish final 

standards that, independently and 

collectively, help to ensure that the 

major statement is presented in a 

neutral, as well as clear and 

conspicuous manner. We acknowledge 

the research cited by the comment that 

describes how patients’ beliefs about 

prescription drugs relate to patient 

propensity to adhere to certain 

prescription drugs. We agree that 

consumers’ beliefs and understanding 

about a prescription drug informs their 

participation in important healthcare 

decision making, including decisions 

about whether to take the prescription 

drug. This rule, by establishing 

standards for the clear, conspicuous, 

and neutral presentation of the major 

statement in DTC TV/radio ads, helps 

ensure that consumers are better 

informed when they participate in 

healthcare decision making and helps 

ensure that DTC TV/radio ads convey a 

truthful, non-misleading net impression 

about the advertised drug. 

(Comment 6) One comment makes 

two suggestions to overcome what it 

described as biases held by 

manufacturers and consumers. First, it 

asks that the rule require inclusion of 

the statement that ‘‘The FDA has not 

approved this ad’’ to correct misleading 

beliefs that FDA approves all ads and 

that only drugs that are proven to be 

very safe can be advertised on TV. This 

comment argues that this required 

disclosure would make the major 

statement more neutral by 

disassociating the ad from any 

Government imprimatur regarding the 

safety of the drug or whether such safety 

is adequately described by the ad the 

consumer is seeing. Second, it asks that 

the rule require that the MedWatch 

hotline statement be included in DTC 

TV/radio ads to communicate that, 

overall, the drug being advertised is not 

known to be risk-free. 

(Response 6) FDA has decided that we 

will not require through this rulemaking 

the additional language requested by 

this comment addressing FDA nonapproval of the ad and the MedWatch 

hotline. As explained more fully 

throughout this document, this 

rulemaking does not change the content 

of the major statement, but rather 

establishes standards that address the 

statutory requirement that the major 

statement be presented in a clear, 

conspicuous, and neutral manner. 

(Comment 7) Another comment states 

that the Distraction Study did not 

provide helpful information for FDA to 

consider in determining whether a 

major statement is presented in a 

neutral manner or provide evidence that 

a neutral presentation of the major 

statement is essential for the consumer 

to fully understand the risk and benefit 

information. 

(Response 7) The results of the 

Distraction Study are not the sole 

justification for any part of this rule; 

rather, the results of that study 

constitute one of many pieces of 

information FDA considered when 

formulating the final standards for this 

rule. Furthermore, to the extent the 

comment suggests that it may be 

unnecessary to present the major 

statement in a ‘‘neutral’’ manner, we 

note that Congress has established the 

requirement that the major statement be 

presented in a ‘‘clear, conspicuous, and 

neutral’’ manner, and this rule is being 

issued consistent with that statutory 

requirement (21 U.S.C. 352(n)). 

F. Consumer/Audience—Comments and 

FDA Response 

The clear, conspicuous, and neutral 

statutory requirement applies to ads for 

human prescription drugs that state the 

name of the drug and its conditions of 

use that are presented directly to 

consumers in TV or radio format (21 

U.S.C. 352(n)). So, this final regulation 

applies to such ads directed toward 

consumers. FDA proposed in standard 

#1 that to be considered clear, 

conspicuous, and neutral, the major 

statement must be ‘‘presented in 

language that is readily understandable 

by consumers.’’ In the final rule, the 

language of ‘‘by consumers’’ is not 

included within this standard, for 

reasons explained below. 

(Comment 8) One comment suggests 

that FDA add the word ‘‘reasonable’’ 

before ‘‘consumer’’ in proposed 

standard #1 to be consistent with FDA’s 

draft Risk Guidance. A second comment 

suggests adding more substance to the 

standard by requiring the firm to take 

into account its audience either by 

adding ‘‘reasonable consumer’’ or 

‘‘consumer[s] to who[m] the ad is 

directed’’ to the end of proposed 

standard #1. Another comment, citing 

Sims v. GC Services, L.P., 445 F.3d 959, 

963 (7th Cir. 2006), suggests that FDA 

use the standard that the FTC adopted 

in relation to debt collection practices, 

i.e., a ‘‘least sophisticated consumer’’ 

standard—someone who is 

‘‘uninformed, naı ̈ve, or trusting’’ but 

who has a ‘‘rudimentary knowledge 

[about the subject] and who is capable 

of making logical deduction[s] and 

inferences.’’ 

(Response 8) Because this regulation 

applies only to DTC TV/radio ads, it is 

inherent that the audience for these ads 

is consumers, and it is unnecessary to 

specify a consumer audience in the 

codified text of individual standards. 

Accordingly, although the proposed 

regulatory text for standard #1 included 

the words, ‘‘by consumers’’, we do not 

include ‘‘by consumers’’ in the text of 

standard #1 as finalized. It is FDA’s 

position that the ‘‘consumer’’ audience 

for a DTC TV/radio ad is an ordinary 

consumer and that the ordinary 

consumer acts reasonably—a position 

that is consistent with the Agency’s 

longstanding approach in evaluating 

DTC prescription drug advertising, 

including the approach reflected in the 

2009 draft Risk Guidance (Ref. 26), an 

approach which remains unchanged 

since the proposed rule. For the 

purposes of this rulemaking, FDA 

declines to adopt the ‘‘least 

sophisticated consumer’’ standard used 

by FTC for debt collection practices, 

which primarily focuses on specific 

content related to such practices. The 

ordinary consumer better aligns with 

FDA’s interests in addressing the 

presentation of risk in DTC ads. 

G. Proposed Standard #1 (Final 

Standard #1) (Language)—Comments 

and FDA Response 

FDA proposed in standard #1 

(proposed § 202.1(e)(1)(ii)(A)) that to be 

considered clear, conspicuous, and 

neutral, the major statement must be 

‘‘presented in language that is readily 

understandable by consumers.’’ The 

concept of using language tailored to the 

consumer audience is consistent with 

other approaches for consumer 

disclosures (Refs. 40 and 26) (75 FR 

15376 at 15378). We retain this concept 

in the final rule but, as further 

explained in this section, we modified 

this standard (final standard #1) to 

require that the major statement ‘‘is 

presented in consumer-friendly 

language and terminology that is readily 

understandable.’’ We have made these 

changes in response to comments we 

received. 

(Comment 9) Several comments 

suggest that the terminology of the 

major statement, as well as the language 

used, should be readily understandable 

by consumers. Some comments say that 


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the risk language in DTC ads is often 

cumbersome, confusing, and difficult 

for most consumers to understand. One 

comment says that most people will not 

really listen to this information, and a 

different comment says that ambiguous 

terms are problematic. One comment 

also notes that using scientific language 

in ads may mislead consumers by 

creating a false impression that the drug 

has been more rigorously tested and is 

thus safer than has actually been shown. 

Another comment requests that the 

proposed standards mimic FTC phone 

ad requirements, which require that the 

disclosure of risk information use the 

same language (e.g., Spanish) as the 

presentation of benefit or other parts of 

the ad. 

(Response 9) We generally agree with 

these comments—both the language and 

terminology used in the major statement 

should be readily understandable by 

consumers. We note that there seemed 

to be some confusion regarding the 

meaning of the word ‘‘language’’ in the 

proposed rule. FDA did not intend to 

focus on foreign language requirements 

through this rulemaking. To help clarify 

our intent, we added ‘‘consumerfriendly’’ and ‘‘terminology’’ to this 

standard. These revisions are intended 

to clarify that the major statement must 

use consumer-friendly language and 

terminology that is readily 

understandable, rather than medical or 

technical jargon or terms usually more 

familiar to HCPs. 

(Comment 10) One comment states 

that the neutrality requirement should 

mean that the risks and benefits 

presented in DTC ads in TV/radio 

format are presented at a uniform 

literacy level with minimum technical 

jargon and that the information is 

relayed in a uniform typeface and 

uniform speed of speaking to minimize 

the under-comprehension of risks and 

the distortion of benefits. 

Several comments request that FDA 

define specific criteria for assessing 

whether the major statement is ‘‘readily 

understandable by consumers,’’ such as 

in terms of a standard acceptable 

reading level. The comments suggest a 

variety of standards: (1) the FleschKincaid Grade Level readability score; 

(2) the Agency for Healthcare Research 

and Quality’s Effective Health Care 

Program guides, which are written at a 

sixth-grade literacy level; (3) the least 

informed person of limited literacy 

likely to view and be influenced by an 

ad; or (4) a general sixth-grade reading 

level. 

(Response 10) FDA agrees that final 

standard #1 is part of the evaluation of 

whether a major statement is presented 

in a neutral (as well as clear and 

conspicuous) manner. As discussed 

above, the regulation requires 

consumer-friendly language and 

terminology that is readily 

understandable. However, FDA declines 

to limit this standard through this 

rulemaking to language associated with 

a particular grade level of reading or 

similar criterion as it may be necessary 

to include certain terms (e.g., reference 

a disease like ‘‘tuberculosis’’) in the 

major statement that could result in a 

relatively high grade level rating. This 

final standard requires that the language 

used to provide the major statement’s 

risk information is understandable to 

the ordinary consumer while providing 

manufacturers with flexibility in 

designing their ads. 

(Comment 11) Several comments 

seem to respond to our suggestion in the 

proposed rule that vague terms subject 

to more than one interpretation should 

be avoided (e.g., say ‘‘more than half’’ 

rather than ‘‘some patients’’) (75 FR 

15376 at 15379). One comment suggests 

that safety information should be 

described in ways that are similar to the 

full FDA-approved product labeling. 

Another comment expresses concern 

about the potential for the example used 

in the proposed rule to evolve toward a 

general requirement to use more 

quantitative descriptors (e.g., frequency 

of risk, such as ‘‘more than half’’) and 

the impact it might have on 

comprehension of risk information. 

Instead of a general requirement to use 

more quantitative descriptors, the 

comment requests a more case-specific 

approach applied on an ad-by-ad basis 

that could be objectively tested with the 

target audience to assess whether risk 

information is comprehended and 

understood. 

Another comment recommends that 

FDA include clarification of appropriate 

threshold levels for quantifying risks for 

bothersome, significant, serious, or lifethreatening risks attributable to the 

drug. The comment suggests that these 

thresholds be based on research in the 

field of risk communication to ensure 

that patients can interpret risk at the 

optimal level. The comment also notes 

that describing risks in quantitative 

terms may increase the conspicuousness 

of the risk information by drawing a 

consumer’s attention to the reality of the 

risk described and may provide 

consumers with an evidence-based 

presentation that is scientifically 

justifiable, increasing the neutrality of 

the ad. 

(Response 11) We did not intend to 

propose, and have not included in the 

final rule, a general requirement that the 

major statement use quantitative 

descriptors. As we stated in the 

preamble of the proposed rule, ‘‘The 

major statement should also avoid the 

use of vague terms or explanations that 

are readily subject to different 

interpretations,’’ such as ‘‘some’’ 

(emphasis in original) (75 FR 15376 at 

15379). Although this example involved 

quantitative terminology (‘‘more than 

half’’), we did not intend to require that 

the major statement always include 

quantitative descriptors but rather to 

clarify that to be ‘‘readily 

understandable,’’ the major statement 

must avoid language or terminology that 

is so vague as to be readily subject to 

different interpretations. 

H. Proposed Standard #2 (Final 

Standard #2) (Audio)—Comments and 

FDA Response 

FDA proposed in § 202.1(e)(1)(ii)(B) 

that audio information in the major 

statement must be understandable in 

terms of the volume, articulation, and 

pacing used. This standard remains 

important for consumers to notice, 

attend to, and understand a drug’s risk 

and benefits. We modified this standard 

in the final rule to clarify that the audio 

information presented during the major 

statement, in terms of the volume, 

articulation, and pacing used, must be at 

least as understandable as the audio 

information presented in the rest of the 

ad (standard #2). 

(Comment 12) We received several 

comments supporting this proposed 

standard but also containing suggestions 

for improvement. One comment notes 

that proposed standard #2 is especially 

important to older adults or to 

consumers who, as a result of their 

literacy level or of visual or other 

limitations, may rely more heavily on 

the audio portions of an ad. Several 

comments note that the speed at which 

risk information in the major statement 

is presented in broadcast ads often 

makes it difficult to understand the 

information. One comment states that it 

is unacceptable for risk information to 

be ‘‘raced through as if being uttered by 

an auctioneer’’ and suggests that the 

pace of risk information should be 

identical to the pace of benefit 

information. 

Two comments express concern that 

the proposed standards would increase 

the length of ads. One of these 

comments states that proposed 

standards #2 (audio information) and #3 

(textual information) could impact the 

duration of an ad for a drug with 

substantial risk information. 

(Response 12) We agree with the 

comments stating that this standard is 

especially important to consumers who 

may rely on the audio portion of an ad 

to understand the major statement, 


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particularly older adults, as older adults 

watch more television (Ref. 41) and are 

more likely to take prescription drugs 

(Refs. 42 and 43). As such, this standard 

in the final rule clarifies that the audio 

information presented during the major 

statement, in terms of the volume, 

articulation, and pacing used, must be at 

least as understandable as the audio 

information presented in the rest of the 

ad. The intention of this final standard 

is to ensure that the volume, pacing, and 

articulation of risk information 

presented in audio allow the 

information to be understood. Firms 

have an incentive to present the benefits 

of a drug in audio using volume, 

articulation, and pacing that ensure that 

those benefits are understood. 

Therefore, requiring that, in terms of 

these same attributes, the audio 

presentation of the major statement 

must be at least as understandable as the 

rest of the ad, will help ensure that the 

risk information in the major statement 

is similarly likely to be understood. This 

final standard provides a concrete way 

for firms to help meet the requirement 

that the major statement be presented in 

a clear, conspicuous, and neutral 

manner. 

We disagree with the comments that 

assert that the rule will necessarily 

lengthen DTC TV/radio ads. As 

discussed in section V.K of this 

document (see comment 21), no 

comments, including those from 

industry, provided specific data, 

information, or examples of how the 

rule would require an increase in the 

length of these ads. FDA concludes that 

the rule will not require DTC TV/radio 

ads to be longer. 

(Comment 13) One comment notes 

that the focus on volume, articulation, 

and pacing is important but overlooks 

the existing regulatory framework for 

the disclosure of risk information in 

DTC ads that results in a long disclosure 

of numerous risks, some of which are 

more relevant to the physician and to 

the patient-physician interaction once 

the decision has been made by the 

physician to prescribe a prescription 

drug product. This comment requests 

that FDA consider how much 

information is appropriate for the 

format. 

(Response 13) The manner of 

presentation of the major statement is 

the focus of this rule. Neither the 

proposed rule nor this final rule changes 

the content of the major statement. 

I. Proposed Standard #3 (Final Standard 

#4) (Presentation of Text)—Comments 

and FDA Response 

The third proposed standard for 

presenting the major statement in a 

clear, conspicuous, and neutral manner 

includes requirements for ‘‘[t]extual 

information [to] be placed appropriately 

and . . . presented against a contrasting 

background for sufficient duration and 

in a size and style of font that allows the 

information to be read easily.’’ (See 

proposed § 202.1(e)(1)(ii)(C)). We 

revised proposed standard #3 (named 

final standard #4 in this final rule, 

codified as revised in 

§ 202.1(e)(1)(ii)(D)) in response to 

comments, to clarify that the standard 

applies to the text portion of the major 

statement in TV ads and not to textual 

information in the TV ad generally. We 

have also removed the requirement for 

duration of display of text from this 

standard and address that topic in final 

standard #3, the dual modality standard. 

We also reorganized the remaining 

information in this standard for clarity. 

Like the corresponding standard of the 

proposed rule, final standard #4 is 

informed by relevant social science 

research as well as by the common 

themes seen in standards of other 

Federal agencies for ‘‘clear and 

conspicuous’’ disclosures (see Refs. 40, 

44–50; 75 FR 15376 at 15377–15379). 

(Comment 14) One comment is 

concerned that proposed standard #3 

(final standard #4) could be interpreted 

to require that all major statements in all 

DTC ads in TV format include textual 

information. The comment recommends 

that FDA clarify the proposed standard 

for the manner of presentation of text in 

the major statement by inserting ‘‘if 

included’’ after ‘‘[t]extual information.’’ 

If information from the major statement 

is presented visually in text, the 

comment also questions how it should 

be presented with other information, 

such as ‘‘Available by prescription’’ or 

‘‘See our ad in. . . .’’ 

(Response 14) Proposed standard #3 

(final standard #4) addressed how to 

present textual information as part of 

the major statement, without requiring 

that any textual information be 

included. However, in this final rule, we 

require a dual modality presentation of 

the major statement for ads in TV 

format, through a separate standard. See 

section V.K of this document and 

§ 202.1(e)(1)(ii)(C). We therefore decline 

to add the suggested phrase, ‘‘if 

included.’’ We agree that this final 

standard #4 does not alone create an 

obligation to present the major 

statement using text, but we consider it 

applicable to any text used to present 

the major statement. We also revised 

language to clarify that this standard 

applies only to the text portion of the 

major statement in TV ads and not to 

other text. (Regarding the presentation 

of other information, see also section V.J 

of this document discussing final 

standard #5 (proposed standard #4) and 

addressing other audio or visual 

elements during the presentation of the 

major statement.) 

(Comment 15) One comment says that 

the standard should take into account 

that many patients seeing broadcast ads, 

such as older adults and those with 

diseases that affect vision, may need 

larger letters or other accommodations. 

Two comments state that text placed in 

the lower portion of the TV screen is so 

small and rapidly displayed as to make 

information illegible. A few other 

comments request that FDA require 

firms to present risks in large, clear text, 

while another comment quantifies the 

preferred size of the text to be at least 

as large as 7 percent of the screen. 

(Response 15) We agree that text used 

in presenting the major statement, 

including the font used, should allow 

the information to be read easily. We 

disagree that it is necessary to dictate a 

specific font size or other similar 

criterion. After considering comments, 

we conclude that this level of detail is 

unnecessary because there is more than 

one way to present the textual 

information that will allow the text to be 

read easily. Different presentational 

elements may interact and must be 

considered together, with more than one 

combination allowing for the textual 

information to be read easily. For 

example, increasing the amount of 

contrast between the font and the 

background may improve readability. 

And, even at a smaller size, some styles 

of font are more easily read compared to 

others. Duration of text is addressed in 

the final rule as an aspect of dual 

modality. (See discussion in section V.K 

of this document.) 

(Comment 16) One comment 

expresses concern that proposed 

standard #3 is overly prescriptive and 

does not adequately take into account 

the limitations of using text in audiovisual media such as TV. The comment 

recommends that textual information be 

used as secondary support to audio 

disclosure for the purpose of 

emphasizing particular risks when 

necessary. The comment further 

recommends a more objective, dataoriented approach to determine if 

information is understood and when 

text information might be useful to 

emphasize a specific point, rather than 

ensuring compliance with a specified 

text format. 

(Response 16) We disagree with the 

portion of the comment stating that 

proposed standard #3 is ‘‘overly 

prescriptive.’’ Like its counterpart in the 

proposed rule, this standard in the final 

rule does not dictate particular font 


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6The comment provided reference to Sorqvist, P., 

et al., ‘‘Individual Differences in Susceptibility to 

the Effects of Speech on Reading Comprehension,’’ 

Applied Cognitive Psychology 24: 67–76, 2010, 

which concluded that irrelevant speech presented 

in audio disrupted reading comprehension. 

colors, sizes, placements, or 

backgrounds but instead requires that 

these aspects of text together result in an 

easily readable presentation. As 

suggested in comments, FDA intends 

these regulations to be flexible enough 

to allow for a variety of techniques firms 

may choose. 

We disagree with the comment’s 

suggestion that text should be used to 

emphasize only particular risks rather 

than all risks contained in the major 

statement. We note that the major 

statement, to which the standards in 

this rule apply, is a selected 

presentation of the major side effects 

and contraindications of the drug and 

not a listing of every risk. In this final 

rule, we require a dual modality 

presentation (audio and text) of the 

major statement for ads in TV format, 

for reasons explained in section V.K of 

this document. 

(Comment 17) One comment states 

that the proposed language about textual 

information being placed appropriately 

and being presented against a 

contrasting background is not consistent 

with the draft Risk Guidance. The 

comment asserts that the draft guidance 

recommends that risk information have 

a ‘‘comparable background.’’ The 

comment also requests alignment with 

the draft Risk Guidance or clarification 

regarding why there is a difference in 

opinion between the draft guidance and 

the proposed rule for presenting risk 

information in TV/radio ads versus 

through other media. 

(Response 17) We conclude that the 

final rule’s requirement (that placement 

on the screen and contrast with the 

background, as well as size and style of 

font, enable the text portion of the major 

statement to be read easily) provides 

better assurance that the manner of the 

presentation is clear, conspicuous, and 

neutral than the comment’s proposed 

requirement of a ‘‘comparable 

background.’’ Furthermore, contrary to 

the comment, we believe these aspects 

of the standard are consistent with the 

draft Risk Guidance, which was cited in 

the proposed rule as describing factors 

and supportive research consistent with 

the proposed rule’s standards. 

Specifically, with respect to the 

recommendations for non-print 

promotion such as TV ads and video, 

the draft Risk Guidance discusses the 

comparable presentation of risk and 

benefit information, not ‘‘comparable 

background’’ (Ref. 26, p. 15, line 528). 

In fact, in its specific discussion of 

visual elements in non-print 

promotions, the draft guidance also 

recommends that risk disclosures 

presented in SUPERs contrast with 

background visuals (Ref. 26, p. 20, line 

676). 

With regard to the comment’s 

question about distinctions in 

presentation based on the medium used 

for the promotional communication, we 

note that the draft Risk Guidance 

addresses communications in the whole 

range of media; whereas, this rule is 

specific to DTC TV/radio ads. 

Characteristics of effective 

communication, including how 

consumers receive and understand 

information, can be impacted by 

different factors for each type of media, 

as reflected in the draft Risk Guidance 

recommendations and the research that 

guidance cites, as well as in the final 

standards established by this rule. 

J. Proposed Standard #4 (Final Standard 

#5) (Elements That Interfere)— 

Comments and FDA Response 

FDA proposed in § 202.1(e)(1)(ii)(D) 

that for a major statement to be 

presented in a clear, conspicuous, and 

neutral manner, the major statement 

must not include distracting 

representations (including statements, 

text, images, or sounds or any 

combination thereof) that detract from 

the communication of the major 

statement. 

As described in section III.B of this 

document, in proposing this standard, 

FDA noted that the presence of 

distracting elements during the 

disclosure was one of several common 

themes addressed by standards of other 

Federal agencies to ensure that 

disclosures were ‘‘clear and 

conspicuous’’ (75 FR 15376 at 15378). 

FDA also noted that this standard (and 

the other proposed standards) was 

consistent with the factors described 

and discussed in the draft Risk 

Guidance (75 FR 15376 at 15379). The 

standard we finalize in this rule is 

generally consistent with these 

approaches. We have modified this 

standard slightly from the proposed rule 

as a result of the comments received 

(and to help ensure effective 

communication). 

In this final rule, we revised proposed 

standard #4, now final standard #5 

(codified as revised in 

§ 202.1(e)(1)(ii)(E)), to clarify that the 

standard is intended to preclude the use 

of audio or visual elements during the 

presentation of the major statement that 

are likely to interfere with 

comprehension of the major statement, 

but the standard does not address 

elements during other portions of the 

ad. Audio or visual elements may 

include, for example, music or other 

sounds, statements, text, and images. 

The standard does not categorically 

prohibit particular types of elements 

during the major statement but will be 

applied by considering the facts and 

circumstances presented by specific ads. 

(Comment 18) Several comments 

support limiting distractions during the 

presentation of the major statement. One 

comment states that presenting the 

major statement without distraction is 

the key to improving audience 

understanding. Another comment says 

that distracting images or sounds can 

seriously undermine the clarity and 

conspicuousness of the presentation of 

risk information. One comment goes 

further and states that the major 

statement cannot be allowed to compete 

with distracting text, images, or sounds 

because it disrupts comprehension.6

Several comments say that 

implementing proposed standard #4 is 

particularly important because the 

visual depiction of benefits distracts 

from any simultaneous verbal 

presentation of risks, especially when 

the risk information is listed in a 

monotone or reassuring tone of voice. 

One comment argues that allowing 

positive scenes to be shown while 

presenting risk information has an 

adverse effect on a consumer’s 

perception of the drug’s risks. The 

comment suggests that FDA require a 

more restrictive standard limiting drug 

manufacturers from inserting the ads in 

an overly positive environment or 

cheery setting and instead require that 

the text be displayed simultaneously 

with visual scenes that reinforce the 

risk. 

Other comments express reservations 

about proposed standard #4. One 

comment states that proposed standard 

#4 could be misinterpreted to suggest 

that all representations are ‘‘distracting’’ 

and detract from communication of the 

major statement. The comment suggests 

that FDA revise this standard to clarify 

that it does not intend to prohibit all 

‘‘representations,’’ including text, 

images, or sounds, during 

communication of the major statement. 

The comment suggests adding ‘‘certain’’ 

before ‘‘statements’’ and adding 

‘‘significantly’’ before ‘‘detract.’’ 

One comment states that it does not 

generally oppose the proposed standard 

but seeks clarification. In general, the 

comment interprets the proposed 

standard as intending to require 

‘‘neutral’’ imagery. The comment opines 

that the concept of image neutrality is 

vaguely defined and subjective, 


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requiring further definition in a final 

standard to avoid the risk it could be 

interpreted in an unnecessarily 

restrictive manner that would make 

DTC advertising impractical for 

pharmaceutical firms. More specifically, 

the comment understands the proposed 

standard to be intended to limit visuals 

that may be distracting during the major 

statement and interprets this to include 

specifically the types of positive images 

tested in the Distraction Study; 

however, it concludes that the study did 

not support the position that such 

images would impede the 

understanding of the safety information 

presented during the major statement. 

The comment also says that a restriction 

on positive imagery during the major 

statement could lead to a sterile ‘‘public 

service’’ style presentation of the 

messaging and limit its efficacy. The 

comment says that patient retention of 

messaging and motivation to learn more 

could be decreased because, the 

comment asserts, such messages would 

be less engaging and be ignored. The 

comment also says it is unclear to what 

degree ‘‘positive’’ imagery before and 

after the major statement would be 

allowable. 

Another comment similarly expresses 

concern that proposed standard #4 

could require firms to begin presenting 

risk information in a very bland manner 

that would be inconsistent with the 

overall flow and tone of an ad, such that 

viewers may become disengaged with 

the ad when risk information is being 

communicated. The comment 

encourages FDA to study the impact of 

removing creative elements employed 

during communication of risk 

information and how it affects 

comprehension. This comment opposes 

including proposed standard #4 

because, the comment opines, it is too 

subjective and likely inadequate as a 

surrogate for whether the target 

audience understands the risks 

communicated. The comment expresses 

concern that FDA would apply an 

overly prescriptive approach to 

evaluating proposed standard #4 and 

suggests instead an objective, sciencebased approach to evaluating audience 

understanding and comprehension of 

risk information. 

(Response 18) We agree with 

comments that support the proposal to 

limit distractions during presentation of 

the major statement. Final standard #5 

requires that during the presentation of 

the major statement, the ad does not 

include audio or visual elements 

(music, sounds, text, images, etc.) that, 

alone or in combination, are likely to 

interfere with comprehension of the 

major statement of risk information. 

Several of the comments suggest a 

desire for clarification of the focus or 

scope of proposed standard #4 (final 

standard #5). Some are concerned that 

this standard precludes any elements 

during the presentation of the major 

statement at all, while others appear to 

equate this standard narrowly with the 

specific topics of study in the 

Distraction Study or the concept of 

‘‘neutral’’ alone—none of which aligns 

with FDA’s intention. In response, in 

the final rule, we revised the wording to 

emphasize that in order to be presented 

in a clear, conspicuous, and neutral 

manner, during the presentation of the 

major statement, the ad must not 

include audio or visual elements that, 

alone or in combination, are likely to 

interfere with comprehension of the 

major statement. We conclude that the 

revised wording of this provision better 

captures the standard for determining 

whether an element or a combination of 

elements distracts from the mandatory 

presentation of the major statement. The 

changes to the wording of final standard 

#5 also clarify that this requirement 

applies during the limited part of the ad 

that presents the major statement, not to 

other portions of the ad. This standard 

independently contributes to achieving 

a clear, conspicuous, and neutral 

manner of presentation of the major 

statement, adding to the effect of other 

standards in this rule. 

We do not conclude that all audio or 

visual elements are likely to interfere 

with comprehension of the major 

statement. In fact, as addressed in 

section V.K of this document, in the 

final rule, by requiring dual modality— 

the concurrent use of both text (a visual 

element) and audio to present the major 

statement in ads in TV format—we 

acknowledge that multiple elements can 

actually be used to reinforce risk 

information. 

This standard does not categorically 

prohibit use of other creative elements 

during the major statement, nor does it 

prohibit narrower categories of such 

elements (e.g., it does not bar music, 

sound effects, or drawings). The 

standard does not even categorically 

prohibit any subtypes of elements (e.g., 

it does not bar upbeat music or amusing 

drawings). Notably, the standard does 

not categorically prohibit visual 

depictions of benefits or positive 

imagery during presentation of the 

major statement in TV ads. 

It is not our intent that the major 

statement be presented in a bland 

manner such that the audience becomes 

disengaged during this part of the ad, 

nor do we intend to require a 

‘‘tombstone’’ presentation of the major 

statement. Rather, final standard #5 is a 

common-sense measure that adds to the 

others to help ensure that consumers 

notice, attend to, and understand the 

major statement by prohibiting the 

simultaneous presentation of other 

audio or visual elements, alone or in 

combination, that are likely to interfere 

with comprehension of the major 

statement. This requirement applies 

only during the limited portion of the ad 

that presents the major statement and 

places no restrictions on any other part 

of the ad. 

(Comment 19) Several comments 

discuss what effect the results of the 

Distraction Study should have on FDA 

policy regarding proposed standard #4 

(final standard #5). One comment argues 

that design flaws resulted in the failure 

of the Distraction Study to detect any 

significant effects upon risk 

comprehension resulting from various 

forms of distraction; therefore, the 

results must be disregarded. Another 

comment states that the Distraction 

Study did not appear to provide an 

adequate factual or rational basis upon 

which FDA can rely to augment FDA’s 

authority with respect to final standard 

#5 and the entire rule. One comment 

states that certain design characteristics 

of and results from the Distraction 

Study raise significant questions about 

its utility to support regulatory decision 

making. Another comment states that 

after reviewing the results of the 

Distraction Study, any additional 

restrictions imposed on the clear, 

conspicuous, and neutral standard 

would only ‘‘muddy the waters’’ and 

that a broad requirement, with as little 

nuance as possible, would enable the 

Agency to determine, unhindered, that 

a particular ad committed a violation of 

the clear, conspicuous, and neutral 

requirement. One comment says that in 

light of the results of the Distraction 

Study, it seems that the only way to 

present the risk information is to require 

a standard format for conveying risks. 

Experts could then continuously 

evaluate the standard format and 

determine whether it was the most 

effective method to convey the risk 

information. 

(Response 19) Final standard #5 rests 

on a well-established principle that 

presenting more than one element 

during the same period of time, in some 

cases, interferes with comprehension of 

information. This is often referred to as 

‘‘distraction.’’ As manifested in 

numerous other Federal disclosure 

standards (see 75 FR 15376 at 15377), in 

order to support the effective 

presentation of required disclosures, it 

is important to avoid distractions. 

Addressing this concern is especially 

important in the ads in TV/radio format 


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7A 5-year study by DRMetrix included data from 

2015 to 2018 and captured a total of 50 million DTC 

TV ad presentations. The study evaluated the 

frequency with which different lengths of TV ads 

were run. Ads of 30 seconds in length were run the 

most. See ‘‘5 × 5 Industry Study,’’ DRMetrix, 2019, 

available at https://www.drmetrix.com/public/5_x_

5_Industry_Study_Oct_2019.pdf. 

8For additional corroboration, also see Murray, 

N.M., L.A. Manrai, and A.K. Manrai, ‘‘Public Policy 

Relating to Consumer Comprehension of Television 

Commercials: A Review and Some Empirical 

Results,’’ Journal of Consumer Policy, 16(2):145– 

170, 1993; Tindall-Ford, S., P. Chandler, and J. 

Sweller, ‘‘When Two Sensory Modes Are Better 

Than One,’’ Journal of Experimental Psychology: 

Applied, (3):257–287, 1997. 

that are subject to this rule because 

these ads are fleeting—appearing for a 

brief interval in the midst of other 

content—and within each ad’s overall 

running time, consumers typically do 

not control how much time they have to 

absorb the information from the major 

statement. For example, the average 

length of ads in TV format is between 

30 and 60 seconds overall.7 In 

prescription drug ads, the presentation 

of the major statement occupies only a 

part of the ad, so in a 30- or 60-second 

ad, consumers are not given much time 

to notice and understand that important 

information. If, during the presentation 

of the major statement, the consumer’s 

attention is instead focused on other 

elements of the ad, the major statement 

may be relayed without being 

understood. 

The possibility of distraction 

interfering with comprehension is 

apparent from ordinary experience, and 

it is also amply supported by social 

science research. For example, visual 

and auditory elements that have been 

shown to detract from or interfere with 

the communication of information and 

viewer comprehension include noise, 

loud music, and rapid scene changes 

(Refs. 34, 35, 38, 39, 51–53). The 

reasonable approach embodied by final 

standard #5 is to assess, case-by-case, 

the particulars of a specific ad to 

determine whether, during the 

presentation of the major statement, it 

includes audio or visual elements that, 

alone or in combination, are likely to 

interfere with comprehension of the 

major statement. 

We rely on the existing substantial 

body of literature regarding distraction 

as the basis for final standard #5, not 

FDA’s Distraction Study, contrary to the 

implication of some comments. As 

previously addressed (see section V.C of 

this document), FDA’s Distraction Study 

was not an investigation of all elements 

or factors that can contribute to 

distraction. The Distraction Study was 

designed only to examine the effects of 

three particular, pre-defined factors: (1) 

the presence or absence of SUPERs that 

concurrently presented verbatim, key 

words and phrases from the audio 

presentation of risk; (2) variations in the 

positive (affective) tone of visual 

images; and (3) visual information that 

was either inconsistent or consistent 

with the audio risk information. With 

regard to factor 2, this research 

investigated a hypothesis that the visual 

depiction of positively toned imagery 

during the simultaneous audio 

presentation of risk information would 

interfere with comprehension of the risk 

information. Although study 

participants in the strongly positive tone 

conditions showed lower risk 

comprehension than participants in the 

mildly positive tone conditions, this 

difference was not statistically 

significant. As a result, the Distraction 

Study did not find support for the 

hypothesis that the visual depiction of 

positively toned imagery interferes with 

the comprehension of risk information 

in the major statement. Therefore, 

conclusions about the effect of 

positively toned imagery on risk 

comprehension cannot be drawn from 

this study. 

Nonetheless, FDA’s Distraction Study 

did not call into question the substantial 

body of literature on different and more 

obvious types of distractions (e.g., noise, 

loud music, rapid scene changes); this 

study did not include and was not 

designed to test these well-known types 

of interferences. Thus, we rely on the 

existing substantial body of literature on 

this topic to support standard #5 in the 

final rule. 

We also disagree with the comment 

that suggests FDA might use the 

Distraction Study to ‘‘augment’’ its 

authority. Congress passed a law 

requiring that the major statement 

relating to side effects and 

contraindications in DTC TV/radio ads 

be presented in a ‘‘clear, conspicuous, 

and neutral’’ manner, and Congress 

directed FDA to issue standards for 

determining whether a major statement 

is presented in this manner. Final 

standard #5 (as well as the other final 

standards in this regulation) is 

consistent with this grant of statutory 

authority. 

K. Dual Modality (Final Standard #3)— 

Comments and FDA Response 

In the proposed rule, FDA solicited 

public comment on whether to require 

that the major statement in ads in TV 

format be included in both the audio 

and visual parts of the presentation 

(dual modality) (75 FR 15376 at 15380). 

We referenced the FTC standard for 

determining whether an affirmative 

disclosure in a television commercial is 

clear and conspicuous, which states that 

for disclosures in a television 

advertisement to be clear and 

conspicuous, they should be presented 

simultaneously in both the audio and 

video (75 FR 15376 at 15377, 15380). In 

addition, we referenced research 

specifically conducted on the subject of 

dual modality in advertising that 

supported the use of simultaneous 

presentations of key words or full 

sentences in text with the corresponding 

key words or full sentences in audio to 

aid in processing (75 FR 15376 at 

15383), as well as a broader body of 

research that supports the use of dual 

modality in a wide variety of situations 

(75 FR 15376 at 15383–15384).8 We also 

reopened the docket in 2012 to include 

the report of the Distraction Study that 

investigated dual modality presentation 

of the major statement in TV ads (among 

other things) and we requested 

comments on the results of that study as 

those results related to the proposed 

standards. As summarized in the 

document reopening the comment 

period—and further detailed in the 

study report in the docket—the study 

indicated that presenting the same risk 

information at the same time in text and 

in audio improves consumer 

understanding of the risk information 

(see 77 FR 4273–74; Ref. 27). Thus, the 

results of FDA’s Distraction Study 

regarding the effects of dual modality on 

comprehension of risk information were 

in line with the studies described in the 

2010 proposed rule. Not only did the 

Distraction Study find that presenting 

the same risk information at the same 

time in text and in audio improved risk 

comprehension, but it also found that 

presenting risk information in dual 

modality was not associated with any 

reduction in comprehension of benefits 

(Ref. 27). Subsequent research (Refs. 53– 

56) corroborates the evidence— 

originally discussed in the proposed 

rule and again in the Distraction Study 

report that was made available for 

public comment—that presenting 

information in both audio and visual 

(dual modality) improves 

comprehension of the information 

provided. The comments we received 

helped inform our decision to require 

dual modality in this final rule, 

supported by the Distraction Study 

research and subsequent research and 

literature. 

The majority of comments on this 

topic support dual modality, while a 

few comments opposed it. 

(Comment 20) Overall, the comments 

addressing dual modality favor the 

implementation of this standard. 

Comments note that dual modality will 


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help improve consumer understanding 

of the risk information and help make 

a lasting impression on consumers. 

Comments also noted that dual modality 

would account for consumers with 

different learning styles and pointed out 

that research supports dual modality. 

Additionally, comments noted that FTC 

has a similar standard and that 

including the dual modality standard 

would provide firms with direction on 

how to properly adhere to the ‘‘clear, 

conspicuous, and neutral’’ 

requirements. One comment gives 

certain critiques of the Distraction 

Study’s methodology but ultimately 

supports a dual modality requirement. 

Comments that oppose dual modality 

assert that it is unnecessary and could 

distract consumers or have potentially 

negative consequences. One of these 

comments states that presenting 

complex clinical risk information 

simultaneously in both the audio and 

text could prevent consumers from 

effectively receiving this crucial 

information from either mode of 

communication. This comment says that 

viewers who focus on the audio 

component might assume that the text 

qualifies the audio message, leaving 

them to question the veracity of 

whatever portion of the major statement 

they processed and understood. 

One comment says that even though 

the Distraction Study suggests that in 

some contexts it may be possible to 

improve comprehension of benefit and 

risk information through a dual 

modality requirement, there are 

significant questions regarding the 

interpretability of that data. 

Consequently, the comment claims that 

the Distraction Study was not robust 

enough to support imposing a dual 

modality requirement in FDA’s 

regulation. The comment argues that 

although the difference in risk 

comprehension between the no SUPERs 

cohort and the combined large and 

small SUPERs cohorts in the Distraction 

Study appears to be statistically 

significant, there is no indication that it 

is significant from a clinical or 

regulatory point of view. The comment 

states that even if FDA’s study showed 

that consumers had better risk 

comprehension when SUPERs were 

used, it does not follow that ads that do 

not use SUPERs are: (1) false, 

misleading, or otherwise lacking in fair 

balance or (2) not clear, conspicuous, or 

neutral. The comment argues that ads 

both with and without SUPERs could be 

legally acceptable. Therefore, according 

to the comment, the Distraction Study 

may provide useful information 

regarding optimal advertising practices, 

but it does not provide information that 

is relevant from a regulatory 

perspective. 

The comment also states that the 

Distraction Study does not foreclose the 

possibility that other advertising 

techniques, either alone or in 

combination, may be as effective or even 

more effective than a dual modality 

requirement in optimizing 

comprehension of risks and benefits and 

rendering the major statement ‘‘clear, 

conspicuous, and neutral.’’ The 

comment states that advertisers should 

have regulatory flexibility in designing 

DTC TV ads in a manner that complies 

with applicable requirements to 

communicate risks, without FDA 

imposing a dual modality requirement. 

One comment opposes dual modality, 

arguing that it does not improve 

consumer recall or understanding of 

important risk information in DTC ads. 

The comment describes research that 

the submitting firm undertook in 2005, 

the results of which suggest that recall 

of risk and benefit information does not 

vary in consistent or systematic ways 

according to ad risk presentation or 

execution, including when dual 

modality is used to present major risk 

terms. The comment also states that the 

limitations of this study may have 

affected observed results. The same firm 

subsequently submitted the results of 

additional research it undertook several 

years later, described further in the 

response to this comment, which do 

support a dual modality requirement. 

(Response 20) We have included a 

dual modality requirement in this final 

rule (§ 202.1(e)(1)(ii)(C)) after 

consideration of comments we received, 

as well as research and literature 

supporting the positive impacts of dual 

modality on risk comprehension and 

recall that existed at the time of the 

proposed rule. Notably, as detailed 

further in section V.K of this document, 

subsequent research corroborates these 

earlier findings on the positive impact 

of dual modality on recall and 

comprehension of risk. Under this 

standard, for the major statement of an 

ad presented in TV format to be 

presented in a clear, conspicuous, and 

neutral manner, it must be presented 

concurrently using both audio and text 

(dual modality). To achieve dual 

modality, the regulation establishes 

further specific standards for the display 

of text. First, either the text displays the 

verbatim key terms or phrases from the 

corresponding audio, or the text 

displays the verbatim complete 

transcript of the corresponding audio. 

Second, the text must be displayed for 

a sufficient duration to allow it to be 

read easily. Under the final regulation, 

for purposes of this standard, duration 

of the text display is sufficient if it 

begins at the same time and ends at 

approximately the same time as the 

corresponding audio. These duration 

and display characteristics are 

supported by the research studies that 

evaluated concurrent text and audio 

presentations (dual modality), discussed 

in the proposed rule and in section V.C 

of this document. Moreover, as 

discussed in section V.K of this 

document, other research subsequently 

corroborated these research findings 

regarding the positive impact of dual 

modality on consumer recall and 

comprehension. 

We do not agree with the comment 

suggesting that dual modality could 

prevent consumers from effectively 

receiving risk information. No 

references were provided to support this 

assertion. To the contrary, as discussed 

in the preamble of the proposed rule (75 

FR 15376 at 15383–15384), research 

shows that using audio and visual 

presentations to present the same 

information at the same time increases 

comprehension compared to using only 

one mode (See also Refs. 57 and 58). 

Research demonstrates improved recall 

when reinforcing SUPERs are used, and 

suggests that a dual mode of presenting 

information results in greater recall and 

comprehension in a wide variety of 

situations (Refs. 53, 59, and 60–64). The 

positive impact of dual modality on 

recall and comprehension has been 

further demonstrated through 

subsequent research (Refs. 54–56). 

FDA’s Distraction Study examined, in 

part, how an ad’s SUPERs might 

influence understanding of the risk 

information in the audio portion of the 

ad. As summarized in the Federal 

Register document reopening the docket 

to solicit comments on the results of this 

study as related to the proposed 

standards (77 FR 4273–74) and further 

detailed in the study report in the 

docket (Ref. 27), we found that 

presenting the same risk information at 

the same time in text and in audio 

improves consumers’ understanding of 

that risk information compared to audio 

alone. This finding is statistically 

significant and consistent with prior 

research. The Distraction Study also 

found that there was no tradeoff to the 

presentation of risk using dual modality 

in regard to comprehension of benefit; 

the increase in risk comprehension was 

not associated with any reduction in 

benefit comprehension (Ref. 27). 

As noted previously, research results 

submitted by a firm had similar findings 

about use of dual modality. The firm 

undertook research to determine how 

dual modality might affect consumers’ 

recall and comprehension of 


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information in the major statement of 

prescription drug TV ads. The firm’s 

research results demonstrated that dual 

modality increased risk recall and 

understanding of risks. The results also 

demonstrated that dual modality did not 

decrease consumer recall and 

understanding of product benefits. 

Whether the full text of the risk 

statement or keywords were presented 

visually did not affect recall and 

comprehension of risk information. This 

submitted research corroborates other 

research in the record. 

(Comment 21) One comment asserts 

that the proposed rule was unclear 

regarding ‘‘what specific information 

from the major statement should be 

presented visually or how that visual 

information should be presented with 

other information, such as ‘Available by 

prescription’ or ‘See our ad in Health 

magazine.’ ’’ The same comment 

questions whether FDA would require 

‘‘a simultaneous, verbatim presentation’’ 

of the major statement in the audio and 

video or only require the firm to use 

each mode to present the major 

statement at some point in the ad. It 

further asserts that regardless of whether 

dual modality requires simultaneous 

presentation of the major statement in 

both audio and text, a visual 

presentation of the major statement 

would need to appear on screen for a 

significant portion of many ads to allow 

consumers of all abilities sufficient time 

to read and absorb the risk information, 

which in turn might overemphasize risk 

information and thus result in the nonneutral presentation of that risk 

information. That comment also 

suggests that to meet a dual modality 

requirement, TV ads would necessarily 

grow in length to accommodate required 

additional text. However, another 

comment says that fulfilling a dual 

modality requirement would not require 

more ad time, and in fact, requiring 

audio and visual presentation of the 

major statement to occur at the same 

time might even reduce ad length. A 

third comment expresses the view that, 

to improve consumer risk awareness, 

the regulation should require that the 

major statement be presented in dual 

modality, using text that is either 

identical to the audio track or an 

abbreviated, easily processed bullet 

point type of text, using only words that 

occur in the audio track. 

(Response 21) To reinforce the 

presented risk information and 

consequently help improve its 

comprehension, the final rule requires 

the concurrent presentation of the major 

statement in the audio and in text. This 

is consistent with the proposed rule, 

which reflected the expectation that 

where text was used, it would appear 

‘‘concurrently with any directly related 

audio information’’ (75 FR 15376 at 

15379) as well as with the research cited 

in the proposed rule (75 FR 15376 at 

15383). This is also consistent with the 

FTC standard, cited in the proposed 

rule, for determining whether an 

affirmative disclosure in a television 

commercial is clear and conspicuous, 

which states that for disclosures in a 

television advertisement to be clear and 

conspicuous, they should be presented 

simultaneously in both the audio and 

video (Ref. 65) (75 FR 15376 at 15377 

and 15380). Further, the final rule 

provides additional clarity on how to 

achieve a dual modality presentation of 

the major statement regarding what text 

must appear, when the text must appear 

in relation to the audio, and for what 

duration—consistent with research cited 

in the proposed rule (75 FR 15376 at 

15383) and the approach used in the 

Distraction Study, the report of which 

was placed in the docket and the 

comment period reopened expressly to 

solicit comment on the results of that 

study in relation to the proposed 

standards (77 FR 4273–74; Ref. 27). The 

provisions in the final rule collectively 

provide considerable flexibility to firms 

and do not necessitate that the textual 

presentation of the major statement 

remain on screen throughout the ad. 

We agree with the comment noting 

that the text used to achieve dual 

modality should present words that the 

corresponding audio uses, rather than 

synonyms, and also agree that dual 

modality can be achieved using text in 

an abbreviated form. This is consistent 

with the approaches used in research 

that was cited in the proposed rule and 

that supported dual modality (75 FR 

15376 at 15383), as well as the approach 

used in the Distraction Study (Ref. 27). 

Accordingly, the final rule specifies that 

dual modality can be achieved either by 

displaying the verbatim key words or 

phrases from the corresponding audio or 

by displaying the verbatim complete 

transcript of the corresponding audio. 

This provides firms flexibility to choose 

from various presentation options. For 

example, if the audio states, ‘‘The most 

common side effects of DRUGX are dry 

mouth, headache, and heartburn,’’ 

instead of presenting a complete 

verbatim transcript of that statement, 

the accompanying text could present 

bullets stating ‘‘• dry mouth 

• headache • heartburn.’’ 

The final rule also addresses the 

duration of text display. Like proposed 

standard #3 (which alone would not 

have required text, but addressed how 

to present text if it were used in 

addition to the already-required audio 

to present the major statement), the final 

rule requires that text used to present 

the major statement be displayed for a 

duration that allows it to be read easily. 

Discussion of proposed standard #3 also 

indicated our intention to require that 

visually-presented text information from 

the major statement appear 

‘‘concurrently with any directly related 

audio information’’ (75 FR 15376 at 

15379). These elements of proposed 

standard #3 regarding the display of text 

are now picked up as part of the dual 

modality requirement (final standard 

#3). Final standard #3 clarifies their 

relationship to each other and to the 

audio presentation requirements of the 

rule, stating that the duration of display 

of text is sufficient if it starts at the same 

time and ends at approximately the 

same time as the corresponding audio. 

This approach is similar to that required 

for the presentation of closed captioning 

under Federal Communication 

Commission regulations. See 47 CFR 

79.1(j)(2)(ii). In turn, the pace of the 

audio component of the major statement 

is determined by the requirement that 

the audio information be at least as 

understandable as the audio information 

presented in the rest of the ad— 

something that the firm chooses. (See 

final standard #2 (§ 202.1(e)(1)(ii)(B)) 

and section V.H of this document.) With 

this flexibility, we believe the 

presentation of risk information will not 

be overemphasized. None of the 

standards of the final rule that impact 

duration of text display, including the 

dual modality standard, either 

separately or together, require that the 

textual presentation of the major 

statement remain on screen throughout 

the ad or generally require increasing 

the length of ads in order to present the 

major statement. At the same time, we 

think the methods of achieving dual 

modality described by the rule will 

contribute to presenting the major 

statement in a clear, conspicuous, and 

neutral manner. 

L. First Amendment Freedom of 

Speech—Comments and FDA Response 

Two comments question whether the 

proposed rule is consistent with First 

Amendment protections for freedom of 

speech. One addresses the major 

statement’s requirement to disclose side 

effects generally; the other focuses on 

the proposal for presenting the major 

statement using dual modality. 

(Comment 22) One comment asserts 

that the overall requirement for the 

major statement to disclose side effects 

is unconstitutional under the Supreme 

Court’s decision in Central Hudson Gas 

& Elec. Corp. v. Pub. Serv. Comm’n, 447 

U.S. 557 (1980), regarding commercial 


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speech restrictions, but the comment 

does not address any specific elements 

of the proposed manner of presentation 

that are the subject of this rulemaking. 

This comment asserts that, for the 

Government to restrict advertising, 

among other things, the advertising 

must be misleading, and the comment 

states without elaboration that ‘‘lack of 

disclosure or lack of clarity’’ of side 

effects does not make advertising 

misleading. The comment also asserts 

that the Government has no substantial 

interest in mandating disclosure of risk 

information in DTC ads in TV/radio 

format and, consequently, that no 

requirements for a major statement in a 

DTC ad could satisfy the First 

Amendment. The comment states that 

the Government interest implicated by 

requiring disclosure of side effects in 

DTC prescription drug advertising is 

one intended to protect consumer safety 

but that this interest ‘‘cannot be proven 

as substantial’’ because it is already 

addressed by the requirement to obtain 

a prescription to access a prescription 

drug. The comment further suggests that 

the information is unnecessary in ads 

because all prescription orders explain 

drug side effects. 

Another comment raises concerns that 

a dual modality requirement would 

violate the First Amendment. The 

comment suggests that the proposed 

dual modality requirement is subject to 

First Amendment analysis under 

Central Hudson and under Thompson v. 

Western States Medical Center, 535 U.S. 

357 (2002), and also suggests that ‘‘a 

regulatory scheme that formats the style 

and content of advertising in advance of 

its presentation to the public’’ might 

impose an unlawful prior restraint on 

advertising. In addition, the comment 

asserts that to hold a firm liable for 

failing to use dual modality, FDA would 

have to prove that absent dual modality, 

the ad would be false or misleading to 

the consumer, noting that a consumer 

cannot obtain a prescription for an 

advertised drug without consulting a 

physician. The comment suggests that, 

unless FDA can establish in advance 

that all ads that lack dual modality 

would be false or misleading, the dual 

modality requirement is not 

constitutional. 

(Response 22) We disagree that the 

major statement requirement as a whole, 

the dual modality requirement in 

particular, or any other aspect of this 

rule’s standards for presenting the major 

statement in a clear, conspicuous, and 

neutral manner violates the First 

Amendment. 

As the Supreme Court has explained, 

Government mandates for ‘‘health and 

safety warnings’’ have been ‘‘long 

considered permissible,’’ and these 

warnings as well as ‘‘purely factual and 

uncontroversial disclosures about 

commercial products’’ are legal under 

the First Amendment (Nat’l Inst. of 

Family and Life Advocates v. Becerra, 

138 S. Ct. 2361, 2376 (2018)). The 

presentation of the major statement 

addressed in this rule, as well as the 

underlying requirement to provide the 

important side effects and 

contraindications of the drug, fall 

squarely within these categories. 

Specifically, the major statement is 

quintessential health and safety warning 

information, reflecting the 

contraindications and side effects of a 

prescription drug as described in the 

prescription drug’s approved labeling. 

The content of the major statement is 

not changed by this rulemaking. As 

explained in section III of this 

document, there is a long history of 

requirements to provide health and 

safety warnings about a prescription 

drug’s risks, including in its advertising, 

and to ensure that understanding of 

required disclosures about these 

products is not undermined by an 

inadequate manner of presentation of 

the information. 

More generally, the major statement is 

a factual disclosure about a commercial 

product to be included in its 

advertising. The Supreme Court 

examines factual disclosures about 

products and services in commercial 

speech under the analysis in Zauderer 

v. Office of Disciplinary Counsel, 471 

U.S. 626 (1985). See Nat’l Inst. of Family 

and Life Advocates, 138 S. Ct. 2361, 

2377–2378; Milavetz, Gallop & Milavetz, 

P.A. v. United States 559 U.S. 229, 250, 

252–253 (2010). Under the approach 

articulated in Zauderer, courts have 

upheld required disclosures of factual 

and uncontroversial information about a 

product or service in commercial speech 

about that product or service. See, e.g., 

American Hosp. Ass’n, 983 F.3d 528, 

540 (posting negotiated rates for 

hospital services); American Meat Inst. 

v. Dept. of Agric., 760 F.3d 18 (D.C. Cir. 

2014) (en banc) (country of origin 

labeling for meat); N.Y. State Restaurant 

Ass’n v. N.Y.C. City Bd. of Health, 556 

F.3d 114 (2d Cir. 2009) (calorie 

information on menus); Nat’l Elec. Mfrs. 

Ass’n, 272 F.3d 104 (labeling identifying 

presence of mercury in light bulbs). 

Where such disclosures are not 

unjustified or unduly burdensome, their 

imposition does not offend the First 

Amendment. See, e.g., Nat’l Inst. of 

Family and Life Advocates, 138 S. Ct. 

2361, 2377–2378; American Hosp. 

Ass’n, 983 F.3d 528, 541 (required 

publication of standard charges is not 

unduly burdensome in a way that chills 

commercial speech as it ‘‘neither 

requires hospitals to endorse a 

particular viewpoint nor prevents them 

from adding their own message on the 

same website or even in the same file’’; 

alleged financial burden of compliance 

with the disclosure requirement not 

established to be burden on speech); 

Spirit Airlines, Inc. v. United States 

Dep’t of Transp., 687 F.3d 403, 414 

(D.C. Cir. 2012) (requirement for airlines 

to make total price the most prominent 

cost figure does not significantly burden 

airlines’ ability to advertise); Discount 

Tobacco City & Lottery, Inc., 674 F.3d 

509, 524 (size of required tobacco 

warnings is not unduly burdensome 

where remaining portions of their 

packaging are available for other 

information). 

The provisions of this rule likewise 

satisfy the requirements of Zauderer and 

subsequent cases. First, the required 

information about the drug’s side effects 

and contraindications presented in the 

major statement is factual and 

uncontroversial. As already noted, it is 

derived from the drug’s FDA-approved 

labeling, which is based on data and 

information about the product 

submitted by the drug’s sponsor and 

evaluated by FDA. 

Second, requiring that this 

information be presented in DTC TV/ 

radio ads in a clear, conspicuous, and 

neutral manner is justified by the 

interests described in section III of this 

document. Contrary to the implications 

of both comments, the substantial 

Government interests supporting these 

measures are not limited to preventing 

consumers from being misled or 

protecting consumer safety. Rather, the 

substantial Government interests 

underlying this rule also include 

helping to ensure consumers are better 

informed when they participate in 

healthcare decision making, including 

when no HCP is present (see discussion 

in section III.A). Communicating risk 

information in a manner that improves 

the likelihood that consumers notice, 

attend to, and comprehend that 

information is instrumental to 

advancing this purpose of including risk 

information in the first place. See 

Discount Tobacco City & Lottery, Inc., 

674 F.3d 509, 561–564 (enhanced 

warnings on tobacco products advance 

the interests in promoting greater public 

understanding of the risks of those 

products; ‘‘A warning that is not 

noticed, read, or understood by 

consumers does not serve its function’’). 

Third, this rule is not unduly 

burdensome. The final rule’s 

requirements for the manner of 

presenting the major statement— 

including the requirement for dual 


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modality—do not threaten to drown out 

or chill the firm’s other messages. 

Indeed, the firm not only remains free 

to present other messages in the ad; 

under this rule, it retains substantial 

ability to choose how to present the 

major statement. 

For example, the major statement has 

long been required to be presented in 

audio. This rule provides more direction 

on how to do so but leaves many 

implementation details up to the firm. 

With regard to this audio presentation, 

the final standard requires that the 

volume, articulation, and pacing make 

the audio presentation of the major 

statement ‘‘at least as understandable as 

the audio presented in the rest of the 

advertisement’’ (§ 202.1(e)(1)(ii)(B))— 

leaving it substantially up to the firm 

how it wants to use audio for all the 

content in the ad. To fulfill the dual 

modality requirement for ads in TV 

format, the display of text is sufficient 

if it begins at the same time and ends 

at approximately the same time as the 

corresponding audio and displays the 

verbatim key terms or phrases from the 

corresponding audio 

(§ 202.1(e)(1)(ii)(C)). Ultimately, then, 

this final rule, including dual modality, 

retains the firm’s substantial control of 

the overall presentation and duration of 

the major statement and preserves the 

firm’s opportunity to present the 

advertised drug’s benefits or any other 

messages in other parts of the ad. And, 

as discussed in section V.K of this 

document, the use of dual modality 

does not decrease the recall or 

comprehension of benefit information 

even while it improves consumer 

comprehension and recall of the risk 

information, advancing the Government 

interests discussed in section III.A.1 of 

this document. 

While we conclude that Zauderer 

provides the relevant framework for 

analysis of the mandatory risk 

disclosure provisions of this rule and 

that its requirements are satisfied, we 

also conclude that this rulemaking is 

consistent with the First Amendment if 

analyzed under more exacting scrutiny, 

including Central Hudson, a case 

mentioned by both comments. Contrary 

to the implication of both comments, 

FDA’s authority to regulate prescription 

drug advertising is not limited to cases 

in which that speech is misleading (or 

false). Rather, under the Central Hudson 

framework, even if commercial speech 

is truthful, is not inherently or actually 

misleading, and relates to lawful 

activity, the Government may impose 

restrictions that directly advance a 

‘‘substantial’’ Government interest and 

are no ‘‘more extensive than is 

necessary to serve that interest’’ (Central 

Hudson Gas & Elec. Corp., 447 U.S. 557, 

566). 

In cases examining limitations on 

commercial speech, the Supreme Court 

has endorsed ‘‘the principle that 

disclosure of truthful, relevant 

information is more likely to make a 

positive contribution to decisionmaking 

than is concealment of such 

information’’ (Peel v. Attorney 

Registration and Disciplinary Comm’n 

of Illinois, 496 U.S. 91, 108 (1990)). As 

a result, the Court has favored use of 

disclosures over restrictions on speech 

to advance the substantial interests in 

preventing consumers from being 

misled and in making a positive 

contribution to informed decision 

making (id. at 109–110); Shapero v. 

Kentucky Bar Ass’n, 486 U.S. 466, 477– 

478 (1988); In re R.M.J., 455 U.S. 191, 

203 (1982); Bates v. State Bar of 

Arizona, 433 U.S. 350, 375 (1977); 

Virginia State Bd. of Pharmacy v. 

Virginia Citizens Consumer Council, 

425 U.S. 748, 770 (1976). 

Similarly, the FD&C Act and FDA 

implementing regulations require 

disclosures of risk information where 

prescription drug ads promote the 

product’s benefits to directly advance 

the substantial Government interests 

previously described in section III of 

this document. The requirements in this 

rule to ensure that important facts about 

the risks of an advertised drug are 

presented in a clear, conspicuous, and 

neutral manner in its DTC TV/radio ads 

are reasonable in proportion to these 

interests and thus present no 

constitutional infirmity under any 

potentially applicable First Amendment 

standard. 

Three of the standards for presenting 

the major statement address basic 

techniques for any communication 

targeting a broad consumer audience: 

that it uses consumer-friendly language 

and terminology, rather than technical 

language; that its audio be at least as 

understandable as other audio in the 

same ad; and that the visual aspects of 

text used to present the major statement 

allow that text to be read easily. (See 

§ 202.1(e)(1)(ii)(A), (B), and (D).) The 

two remaining standards likewise are 

appropriately tailored to the interests 

behind the rule and do not 

unreasonably burden speech. Dual 

modality has already been discussed, 

and as noted, research indicates that 

using this technique to present risk 

information improves consumer risk 

comprehension and recall—advancing 

the Government interest—without 

decreasing the recall or comprehension 

of benefit information, thus reinforcing 

the reasonableness of this requirement. 

(See § 202.1(e)(1)(ii)(C).) 

The last standard, in 

§ 202.1(e)(1)(ii)(E), is a common-sense 

measure that adds to the others to help 

ensure that consumers notice, attend to, 

and understand the major statement by 

prohibiting the simultaneous 

presentation of other audio or visual 

elements, alone or in combination, that 

are likely to interfere with 

comprehension of the major statement. 

This requirement applies only during 

the limited part of the ad that presents 

the major statement, placing no 

restrictions on any other part of the ad. 

Even during the presentation of the 

major statement, it does not 

categorically prohibit other audio or 

visual elements. In sum, these measures 

to advance the substantial Government 

interests in communicating the major 

side effects and contraindications of a 

prescription drug advertised to 

consumers satisfy the framework for 

analysis described in Central Hudson 

and are consistent with the First 

Amendment. 

FDA has considered and rejects the 

suggestion in the comments that the 

Government interests that justify this 

rule are adequately advanced by the 

requirement to obtain a prescription 

from an HCP to access a prescription 

drug. The comments do not recognize 

consumers as active participants in their 

own healthcare, and do not address the 

Government interest in helping to 

ensure that consumers are better 

informed when they participate in 

healthcare decision making. This 

Government interest is not completely 

or sufficiently addressed by the 

requirement to obtain a prescription or 

visit an HCP before accessing a 

prescription drug. Both before and after 

contact with an HCP, consumers are 

frequently exposed to DTC TV/radio ads 

describing the drug’s benefits. Requiring 

that such ads also convey the advertised 

product’s risks better advances the 

substantial Government interests than 

reliance on the HCP alone. For example, 

for a patient already taking a prescribed 

drug, certain side effects may occur at 

any time, and presenting information 

about that drug’s risks in DTC ads 

provides the patient with information 

about the side effects each time they 

encounter the ad. Providing this 

information helps ensure that 

consumers are better informed about 

side effects that they may experience in 

connection with their use of the drug. 

Furthermore, the assumption in 

comments that HCPs or ‘‘prescription 

orders’’ will communicate prescription 

drug risks to consumers does not 

dispute that consumers should be 

informed of those risks. Rather, it 


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appears to suggest that it is appropriate 

for a pharmaceutical firm to benefit 

from advertising its prescription drug’s 

positive attributes directly to consumers 

while placing the entire burden of 

informing consumers about that 

advertised drug’s risks on other 

members of the healthcare system. The 

First Amendment does not compel us to 

adopt that policy. 

One of the comments also cited 

Western States, in which the Court 

applied the Central Hudson test to 

evaluate the advertising restriction at 

issue (535 U.S. 375 at 368–77). In an 

analysis that broke no ‘‘new ground’’ 

(id. at 368), the Court explained that, in 

general, the Government should not 

restrict the communication of truthful 

and non-misleading information for the 

sole purpose of preventing members of 

the public from making bad decisions 

with the information (id. at 374). That 

holding and rationale has no application 

to this rule, where formatting and 

presentation requirements help ensure 

the effective disclosure of information to 

the public. 

Finally, with regard to the mention of 

prior restraint in the context of the 

comment on dual modality, we disagree 

that this rule presents any constitutional 

infirmity under that analysis. The 

fundamental concern of the prior 

restraint doctrine is with Government 

censorship in advance of publication. 

See Southeastern Promotions, Ltd. v. 

Conrad, 420 U.S. 546, 553 (1975). Here, 

however, neither the dual modality 

requirement nor any other aspect of this 

rule requires a firm to seek any 

permission from FDA before running an 

ad or otherwise enjoins speech before it 

occurs, and therefore the regulation 

does not impose a prior restraint. See, 

e.g., Alexander v. United States, 509 

U.S. 544, 549–553 (1993). 

M. Role of Healthcare Professional— 

Comments and FDA Response 

(Comment 23) One comment asserted 

that too much information in the major 

statement can make it difficult for the 

audience to comprehend the 

information and that the role of the 

prescribing HCP as a learned 

intermediary is an important 

consideration in determining the 

relevancy of risk information to be 

included in a DTC broadcast ad. 

Another comment says that because 

doctors are responsible for their 

patient’s care and well-being, 

prescription drug ads should be 

required to include—‘‘instead of a clear, 

conspicuous, and neutral statement of 

effects and contraindications’’—a 

statement ‘‘that only a patient’s doctor 

can fully provide this vital 

information.’’ 

(Response 23) This rulemaking does 

not change the content of the major 

statement, but focuses on the manner of 

presenting it in DTC TV/radio ads. 

Further, FDA acknowledges the role of 

HCPs regarding prescription drugs; 

however, as discussed in section III.A of 

this document, that role does not 

completely address the reasons to 

require prescription drug firms to 

communicate risk information about 

their products in a clear, conspicuous, 

and neutral manner in DTC TV/radio 

ads that communicate the benefits of 

such products. 

N. Costs—Comments and FDA Response 

(Comment 24) One comment states 

that the specific dollar estimates to 

revise any ad with a life cycle extending 

beyond the compliance date of the final 

rule were optimistically low and 

questions how FDA or its industry 

sources arrived at these estimates. 

Furthermore, the comment requests that 

FDA revisit the cost estimates (and 

publish a more detailed analysis) to 

make certain that they accurately reflect 

the costs that firms will incur in 

bringing their existing campaigns into 

compliance. As part of addressing costs, 

the comment requests that FDA 

consider a longer effective date. 

(Response 24) No comments included 

quantified costs that firms will incur in 

bringing their existing campaigns into 

compliance. With regard to the request 

for an updated estimate of costs, we 

direct readers to the Regulatory Impact 

Analysis (Ref. 66), which evaluates the 

anticipated costs to firms for complying 

with this rule. In light of concerns 

regarding costs, FDA has agreed to a 

compliance date of 365 days after the 

date of the final rule publication for all 

ads. (See section VI of this document.) 

O. Enforcement—Comments and FDA 

Response 

(Comment 25) One comment suggests 

that FDA should enforce these standards 

through civil monetary penalties (CMPs) 

for misleading DTC advertising, as 

authorized under 21 U.S.C. 333(g)(1). 

(Response 25) Failure to follow this 

rule will render a drug misbranded 

under 21 U.S.C. 352(n). The Agency will 

have all compliance tools associated 

with its authority available to enforce 

these provisions; see generally the FD&C 

Act sections 301 (prohibited acts), 302 

(21 U.S.C. 332) (injunction 

proceedings), and 303 (penalties), 

including, as applicable, CMPs for false 

or misleading DTC ads authorized under 

section 303(g)(1) of the FD&C Act (21 

U.S.C. 333(g)(1)). 

VI. Effective/Compliance Dates 

This rule is effective May 20, 2024. 

The compliance date is November 20, 

2024. 

As described in the proposed rule, in 

accordance with FDAAA, the statutory 

requirement that the major statement in 

human prescription drug 

advertisements presented directly to 

consumers in television or radio format 

and stating the name of the drug and its 

conditions of use be presented in a 

clear, conspicuous, and neutral manner 

has been in effect since March 25, 2008 

(75 FR 15376 at 15380). In the proposed 

rule, FDA proposed that the standards 

in the final rule would become effective 

90 days after the publication of the final 

rule in the Federal Register. 

(Comment 26) One comment supports 

the 90-day proposal. Two comments 

request the earliest possible 

implementation of the proposed 

standards. Another comment agrees that 

90 days is reasonable for DTC ads that 

have not already begun production. 

However, the comment suggests 180 

days for ads that are already in 

production or circulation because it 

allows time for modifications if 

required. 

(Response 26) Based on comments, 

FDA agrees that it is appropriate to 

provide a longer period for 

implementation than originally 

proposed. We therefore make the 

effective date 180 days after publication. 

Affected firms are encouraged to comply 

as soon as possible after the effective 

date. However, we recognize that this 

rule could impact existing ads, ads in 

production, and distribution 

agreements. Accordingly, we now 

conclude that a compliance date of 365 

days after the date of publication of the 

final rule is appropriate to enable firms 

to bring all ads subject to this rule into 

compliance without undue burden. One 

schedule of 365 days after publication of 

the final rule for compliance is clearer 

and easier to administer than having 

two different schedules depending on 

where the ad is in production or on 

other factors. While we did not receive 

data to support an alternative estimate 

of costs, given the complexities of 

distribution agreements and concerns 

raised with costs, we have also 

determined that a longer time for 

implementation is appropriate. 

VII. Economic Analysis of Impacts 

A. Introduction 

We have examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, Executive Order 

14094, the Regulatory Flexibility Act (5 

U.S.C. 601–612), the Congressional 


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Review Act/Small Business Regulatory 

Enforcement Fairness Act (5 U.S.C. 801, 

Pub. L. 104–121), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). 

Executive Orders 12866, 13563, and 

14094, direct us to assess all benefits, 

costs and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866, section 3(f)(1) (as amended by 

Executive Order 14094), if they ‘‘have 

an annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of the Office of 

Information and Regulatory Affairs 

(OIRA) for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this final rule is not 

a significant regulatory action under 

Executive Order 12866, section 3(f)(1). 

Because this rule is likely to result in 

an annual effect on the economy of $100 

million or more or meets other criteria 

specified in the Congressional Review 

Act/Small Business Regulatory 

Enforcement Fairness Act, OIRA has 

determined that this rule does fall 

within the scope of 5 U.S.C. 804(2). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the estimated costs of 

compliance in the first year could 

exceed 1 percent of sales revenues for 

the smallest affected entities, we find 

that the final rule will have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before issuing ‘‘any 

rule that includes any Federal mandate 

that may result in the expenditure by 

State, local, and tribal governments, in 

the aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $177 million, using the 

most current (2022) Implicit Price 

Deflator for the Gross Domestic Product. 

This final rule would not result in an 

expenditure in any year that meets or 

exceeds this amount. 

Under section 502(n) of the FD&C Act, 

as amended by section 901(d)(3)(A) of 

FDAAA, Congress has mandated that 

the disclosure of the major side effects 

and contraindications of the advertised 

product (known as the ‘‘major 

statement’’) in human prescription drug 

ads presented directly to consumers in 

TV or radio format stating the name of 

the drug and its conditions of use be 

presented in a ‘‘clear, conspicuous, and 

neutral manner.’’ Section 901(d)(3)(B) of 

FDAAA mandates that FDA issue 

regulations that establish standards for 

determining whether a major statement 

is presented in such a manner. In 

accordance with this legislation, this 

final rule requires that the major 

statement in such ads be presented in a 

clear, conspicuous, and neutral manner 

and provides standards for determining 

whether this is the case. 

B. Summary of Costs and Benefits 

The costs of this final rule include the 

cost to read and understand the rule, to 

revise a firm’s standard operating 

procedures, and to revise DTC TV/radio 

ads during the transition period leading 

up to the compliance date. These 

activities and their associated costs will 

occur during the first year. We also 

expect there to be modest ongoing costs 

for industry to review future DTC TV/ 

radio ads to ensure that these ads 

comply with this final rule and an 

ongoing opportunity cost related to a 

potential change in the relative 

allocation of time within the ad between 

the presentation of the major statement 

and the presentation of other content. 

The total present value of costs over a 

10-year time horizon ranges from $104.8 

million to $331.8 million, with a 

primary estimate of $218.3 million, at a 

7 percent discount rate; the present 

value ranges from $123.8 million to 

$393.0 million, with a primary estimate 

of $258.4 million, at a 3 percent 

discount rate. Annualized costs over a 

10-year time horizon range from $14.9 

million to $47.2 million, with a primary 

estimate of $31.1 million at a 7 percent 

discount rate; annualized costs over a 

10-year time horizon range from $14.5 

million to $46.1 million, with a primary 

estimate of $30.3 million at a 3 percent 

discount rate. 

The benefits of this final rule stem 

from and include helping consumers 

notice, attend to, and understand the 

major statement in DTC TV/radio ads. 

The standards in the final rule help to 

ensure that DTC TV/radio ads convey a 

truthful and non-misleading net 

impression about the advertised drug 

and help ensure that consumers are 

better informed when they participate in 

healthcare decisionmaking. 

Table 1 summarizes the annualized 

costs and describes the benefits of this 

final rule. 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year .............................................. ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Annualized Quantified ..................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ........................................................................................ Helping consumers notice, attend to, and understand the major 

statement in DTC TV/radio ads 

Costs: 

Annualized Monetized $millions/year .............................................. 31.1 

30.3 

14.9 

14.5 

47.2 

46.1 

2020 

2020 

7 

3 

10 

10 

Annualized Quantified ..................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ........................................................................................

Transfers: 


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I I I I 
80980 Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE—Continued 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Federal Annualized Monetized $millions/year ................................. ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ........................................................................................... From: To: 

Other Annualized Monetized $millions/year .................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ........................................................................................... From: To: 

Effects: 

State, Local or Tribal Government: None. 

Small Business: Compliance costs in the first year may exceed 1 percent of revenues for the smallest affected entities. 

Wages: None. 

Growth: None. 

We have developed a comprehensive 

Economic Analysis of Impacts that 

assesses the impacts of the final rule. 

The full analysis of economic impacts is 

available in the docket for this final rule 

(docket number FDA–2009–N–0582) 

(Ref. 66) and at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The title, description, and 

respondent description of the 

information collection provisions are 

shown in the following paragraphs with 

an estimate of the annual third-party 

disclosure burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information. 

Title: Prescription Drug 

Advertisements. 

Description: Under § 202.1, FDA has 

established requirements for ads for 

human prescription drug and biological 

products and ads for animal 

prescription drugs. The regulations 

apply to ads including those published 

in journals, magazines, other 

periodicals, and newspapers and those 

broadcast through media, such as radio, 

TV, and telephone communication 

systems. Under § 202.1(e)(1), FDA’s 

regulations describe when a true 

statement of information in brief 

summary relating to side effects, 

contraindications, and effectiveness is 

required. In this final rule, the Agency 

amends these regulations. Specifically, 

under § 202.1(e)(1)(ii), FDA implements 

section 502(n) as amended, which 

requires that in human prescription 

drug advertisements presented directly 

to consumers in television or radio 

format and stating the name of the drug 

and its conditions of use, the major 

statement relating to side effects and 

contraindications must be presented in 

a clear, conspicuous, and neutral 

manner. The rule also includes 

standards for determining whether the 

major statement is presented in a clear, 

conspicuous, and neutral manner. 

General requirements for prescription 

drug ads to include a true statement of 

information in brief summary relating to 

side effects, contraindications, and 

effectiveness are located in the opening 

paragraph of § 202.1(e), and specific 

provisions for prescription drug ads 

broadcast through media such as radio, 

TV, or telephone communications 

systems addressing inclusion of the 

major statement and adequate provision 

of the approved labeling are located in 

§ 202.1(e)(1)(i). These provisions were 

already in effect and approved under 

OMB control number 0910–0686. The 

requirements of § 202.1(e)(1), including 

these existing requirements and new 

requirements imposed by this final rule 

in § 202.1(e)(1)(ii)—which address only 

the manner of presentation of the major 

statement in certain ads while retaining 

the pre-existing content requirements— 

collectively mandate that ads disclose 

information to the public and thus are 

subject to the Paperwork Reduction Act 

of 1995. 

Description of Respondents: 

Respondents to the collection of 

information are manufacturers, packers, 

and distributors; application holders 

and their representatives with approved 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), and biologics licensing 

applications (BLAs) for human 

prescription drugs; and those that 

market prescription drugs for human 

use without an approved application. 

Based on a recent review of data 

collected via FDA Form 2253 

advertisement submissions, we revised 

our previously estimated burden of this 

information collection. Specifically, 

relying on data from calendar year 2020 

Form 2253 submissions, we increased 

the number of corresponding 

disclosures and recalculated the burden 

as an increase to the existing burden, 

using the most recent numbers for that 

burden estimate, under the approved 

OMB control number 0910–0686 

collection covering the regulations 

under § 202.1. The collections of 

information pertaining to FDA Form 

2253 (‘‘Transmittal of Advertisements 

and Promotional Labeling for Drugs and 

Biologics for Human Use,’’ located on 

the FDA website at https://www.fda.gov/ 

about-fda/reports-manuals-forms/forms) 

are approved under OMB control 

numbers 0910–0001 and 0910–0338. 

FDA estimates the burden of the 

collections of information as follows: 


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Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 80981 

TABLE 2—ESTIMATED BURDEN RESULTING FROM REVISING TV/RADIO ADS TO COMPLY WITH 21 CFR 202.1(e)(1) 

21 CFR 202.1—Prescription drug marketing Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Hourly 

burden per 

disclosure 

Total 

hours 

One-time activities: reading and understanding rule, revising company SOPs, 

modifying existing ads (if necessary) ...................................................................... 57 3 171 2.5 427.5 

202.1(e)(1)(ii): Ongoing implementation of revised requirements for future TV and 

radio ads .................................................................................................................. 57 11.02 628 5 3,140 

Total ..................................................................................................................... ........................ .............................. 799 .................... 3,567.5 

According to this 2020 submission 

data from the Center for Drug Evaluation 

and Research (CDER), we estimate 564 

DTC TV ads for prescription drugs will 

be prepared by 37 firms under 

§ 202.1(e)(1)(ii) annually. Likewise, 

based on data from the Center for 

Biologics Evaluation and Research 

(CBER), we estimate that six DTC TV 

ads will be prepared by three firms 

annually. Our total estimated number of 

DTC TV ads under § 202.1(e)(1)(ii), then, 

is 570. Based on our experience with 

reviewing DTC TV ads, we believe an 

expenditure of approximately 5 hours 

per disclosure should be sufficient to 

ensure that the major statement in DTC 

TV ads is presented in a clear, 

conspicuous, and neutral manner in 

accordance with the requirements of 

this final rule. 

Also based on data from CDER, we 

estimate 56 DTC radio ads for 

prescription drugs will be prepared by 

16 firms under § 202.1(e)(1)(ii) annually. 

Based on data from CBER, we estimate 

two DTC radio ads will be prepared by 

one firm annually. The total estimated 

number of DTC radio ads subject to 

disclosures under § 202.1(e)(1)(ii), then, 

is 58. Based on our experience 

reviewing DTC radio ads, we believe an 

expenditure of approximately 5 hours 

per disclosure should satisfy the 

requirements in § 202.1(e)(1)(ii). 

In sum, as shown in table 2, FDA 

estimates that, annually, 57 respondents 

will submit DTC TV or radio ads, 

resulting in 628 disclosures. FDA 

estimates 5 hours per disclosure will 

satisfy the requirements, resulting in an 

estimated annual expenditure of 3,140 

hours. In addition, as noted in the table, 

FDA estimates that, for those 57 

respondents, there will be a one-time 

burden of 427.5 hours. 

The information collection provisions 

in this final rule have been submitted to 

OMB for review as required by section 

3507(d) of the Paperwork Reduction Act 

of 1995. 

Before the effective date of this final 

rule, FDA will publish a notice in the 

Federal Register announcing OMB’s 

decision to approve, modify, or 

disapprove the information collection 

provisions in this final rule. An Agency 

may not conduct or sponsor, and a 

person is not required to respond to, a 

collection of information unless it 

displays a currently valid OMB control 

number. 

X. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this rule in 

accordance with the principles set forth 

in Executive Order 13175. We have 

determined that the rule does not 

contain policies that have substantial 

direct effects on one or more Indian 

Tribes, on the relationship between the 

Federal Government and Indian Tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

Accordingly, we conclude that the rule 

does not contain policies that have 

tribal implications as defined in the 

Executive order and, consequently, a 

tribal summary impact statement is not 

required. 

XII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

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August 1999, available at https://

www.fda.gov/media/75406/download, 

accessed July 12, 2022. 

*2. DeFrank, J.T., N. Berkman, L. Kahwati, et 

al., ‘‘Direct-to-Consumer Advertising of 

Prescription Drugs and the PatientPrescriber Encounter: A Systematic 

Review,’’ Health Communication, 

35(6):739–746, 2020, doi:10.1080/ 

10410236.2019.1584781. 

3. Kornfield, R., J. Donohue, E.R. Berndt, et 

al., ‘‘Promotion of Prescription Drugs to 

Consumers and Providers, 2001–2010,’’ 

PLOS ONE, 8(3):e55504, 2013, 

doi:10.1371/journal.pone.0055504. 

4. Kornfield, R., G.C. Alexander, D.M. Qato, 

et al., ‘‘Trends in Exposure to Televised 

Prescription Drug Advertising, 2003– 

2011,’’ American Journal of Preventive 

Medicine, 48(5):575–579, 2015, 

doi:10.1016/j.amepre.2014.12.001. 

*5. Sullivan, H.W. and M. Campbell, ‘‘Do 

Prescription Drug Ads Tell Consumers 

Enough About Benefits and Side Effects? 

Results from the Health Information 

National Trends Survey, Fourth 

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Communication, 20(12):1391–1396, 

2015, doi:10.1080/ 

10810730.2015.1018635. 

6. Koo, K. and R.L. Yap, ‘‘Trends in 

Urological Direct-to-Consumer 

Advertising During Prime-Time 

Television News Programs,’’ Urology 

Practice, 4(1):7–13, 2017, doi:10.1016/ 

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Prescription Drugs,’’ Report R40590, May 

20, 2009. Available at https://crsreports.

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spending shifted in 2020,’’ March 25, 

2021, available at https://www.mmmonline.com/home/channel/features/howdtc-spending-shifted-in-2020/, accessed 

July 12, 2023. 

9. Bulik, B., ‘‘The Top 10 Ad Spenders in Big 

Pharma for 2020,’’ Fierce Pharma, April 

19, 2021, available at https:// 

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accessed September 27, 2022. 

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Prescription Drugs,’’ Annals of Family 

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doi:10.1370/afm.2220. 

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Direct to Consumer Advertisements 

About Prescription Medicines,’’ 2008, 

revised October 2018. 

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2015,’’ Kaiser Family Foundation, 

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accessed July 12, 2022. 

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Results, Final Report,’’ November 19, 

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Advertising of Prescription 

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Effects of Direct-to-Consumer Drug 

Advertising,’’ Health Affairs, 

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18. Avery, R.J., M. Eisenberg, and K.I. Simon, 

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economic-impact-analyses-fdaregulations. 

List of Subjects in 21 CFR Part 202 

Advertising, Prescription drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 202 is 

amended as follows: 

PART 202—PRESCRIPTION DRUG 

ADVERTISING 

■ 1. The authority citation for part 202 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 352, 355, 

360b, 371. 

■ 2. In § 202.1, add introductory text 

and revise paragraph (e)(1) to read as 

follows: 

§ 202.1 Prescription-drug advertisements. 

Prescription drug as used in this section 

means any drug defined in section 

503(b)(1) of the Federal Food, Drug, 

and Cosmetic Act or § 201.105 of 

this chapter, applicable to drugs 

intended for use by humans and to 

veterinary drugs, respectively. 

* * * * * 

(e) * * * 

(1) When required. All advertisements 

for any prescription drug, except 

advertisements described in 

paragraph (e)(2) of this section, 

must present a true statement of 

information in brief summary 

relating to side effects, 

contraindications (when used in 

this section, ‘‘side effects, 

contraindications’’ include side 

effects, warnings, precautions, and 

contraindications and include any 

such information under such 

headings as cautions, special 

considerations, important notes, 

etc.), and effectiveness. 

(i) Broadcast advertisements. 

Advertisements broadcast through 

media such as radio, television, or 

telephone communications systems 

must: 

(A) Include information relating to the 

major side effects and 

contraindications (‘‘major 

statement’’) of the advertised drugs 

in the audio or audio and visual 

parts of the presentation, unless 

required by paragraph (e)(1)(ii)(C) of 

this section to present the major 

statement using audio and text; and 

(B) Contain a brief summary of all 

necessary information related to 

side effects and contraindications, 

unless adequate provision is made 

for dissemination of the approved 

or permitted product labeling in 

connection with the broadcast 

presentation. 

(ii) Human drug advertisements in 

television or radio format—Clear, 

conspicuous, and neutral manner. 

For advertisements for prescription 

drugs intended for use by humans 

presented directly to consumers in 

television or radio format, the major 

statement must be presented in a 

clear, conspicuous, and neutral 

manner. The major statement is 

presented in a clear, conspicuous, 

and neutral manner if the following 

are met: 

(A) It is presented in consumer-friendly 

language and terminology that is 

readily understandable. 


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80984 Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 

(B) Its audio information, in terms of the 

volume, articulation, and pacing 

used, is at least as understandable 

as the audio information presented 

in the rest of the advertisement. 

(C) In advertisements in television 

format, it is presented concurrently 

using both audio and text (dual 

modality). To achieve dual 

modality: 

(1) Either the text displays the verbatim 

key terms or phrases from the 

corresponding audio, or the text 

displays the verbatim complete 

transcript of the corresponding 

audio; and 

(2) The text is displayed for a sufficient 

duration to allow it to be read 

easily. For purposes of the standard 

in this paragraph (e)(1)(ii)(C)(2), the 

duration is considered sufficient if 

the text display begins at the same 

time and ends at approximately the 

same time as the corresponding 

audio. 

(D) In advertisements in television 

format, for the text portion of the 

major statement, the size and style 

of font, the contrast with the 

background, and the placement on 

the screen allow the information to 

be read easily. 

(E) During the presentation of the major 

statement, the advertisement does 

not include audio or visual 

elements, alone or in combination, 

that are likely to interfere with 

comprehension of the major 

statement. 

* * * * * 

Dated: November 8, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–25428 Filed 11–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 300 

[TD 9982] 

RIN 1545–BQ26 

User Fees Relating to Enrolled 

Actuaries; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations; correction. 

SUMMARY: This document contains a 

correction to Treasury Decision 9982, 

which was published in the Federal 

Register for Friday, October 20, 2023. 

Treasury Decision 9982 issued final 

regulations amending existing 

regulations relating to user fees for 

enrolled actuaries. 

DATES: This correction is effective on 

November 21, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Carolyn M. Lee at (202) 317–6845 (not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9982) that 

are the subject of this correction are 

under 26 CFR part 300—User Fees. 

Corrections to Publication 

Accordingly, the final regulations (TD 

9982) that are the subject of FR Doc 

2023–23301, published on October 20, 

2023, are corrected on page 72370, in 

the first column, in the second line 

under the heading ‘‘List of Subjects in 

26 CFR Part 300’’ by removing ‘‘Use 

fees’’ and adding ‘‘User fees’’ in its 

place. 

Oluwafunmilayo A. Taylor, 

Section Chief, Publications & Regulations 

Section, Associate Chief Counsel, (Procedure 

and Administration). 

[FR Doc. 2023–25438 Filed 11–20–23; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 587 

Publication of Russian Harmful 

Foreign Activities Sanctions 

Regulations Web General Licenses 

13G, 74, 75, and 76. 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of web general 

licenses. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is publishing four 

general licenses (GLs) issued pursuant 

to the Russian Harmful Foreign 

Activities Sanctions Regulations: GLs 

13G, 74, 75, and 76, each of which were 

previously made available on OFAC’s 

website. 

DATES: GLs 13G, 74, 75, and 76 were 

issued on November 2, 2023. See 

SUPPLEMENTARY INFORMATION for 

additional relevant dates. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Compliance, 202– 

622–2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

On November 2, 2023, OFAC issued 

GLs 13G, 74, 75, and 76 to authorize 

certain transactions otherwise 

prohibited by the Russian Harmful 

Foreign Activities Sanctions 

Regulations, 31 CFR part 587. Each GL 

was made available on OFAC’s website 

(https://ofac.treasury.gov) when it was 

issued and has an expiration date of 

January 31, 2024. The text of these GLs 

is provided below. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Russian Harmful Foreign Activities 

Sanctions Regulations 

31 CFR Part 587 

GENERAL LICENSE NO. 13G 

Authorizing Certain Administrative 

Transactions Prohibited by Directive 4 

Under Executive Order 14024 

(a) Except as provided in paragraph 

(b) of this general license, U.S. persons, 

or entities owned or controlled, directly 

or indirectly, by a U.S. person, are 

authorized to pay taxes, fees, or import 

duties, and purchase or receive permits, 

licenses, registrations, certifications, or 

tax refunds to the extent such 

transactions are prohibited by Directive 

4 under Executive Order 14024, 

Prohibitions Related to Transactions 

Involving the Central Bank of the 

Russian Federation, the National 

Wealth Fund of the Russian Federation, 

and the Ministry of Finance of the 

Russian Federation, provided such 

transactions are ordinarily incident and 

necessary to the day-to-day operations 

in the Russian Federation of such U.S. 

persons or entities, through 12:01 a.m. 

eastern standard time, January 31, 2024. 

(b) This general license does not 

authorize: 

(1) Any debit to an account on the 

books of a U.S. financial institution of 

the Central Bank of the Russian 

Federation, the National Wealth Fund of 

the Russian Federation, or the Ministry 

of Finance of the Russian Federation; or 

(2) Any transactions otherwise 

prohibited by the Russian Harmful 

Foreign Activities Sanctions 

Regulations, 31 CFR part 587 (RuHSR), 

including transactions involving any 

person blocked pursuant to the RuHSR, 

unless separately authorized. 

(c) Effective November 2, 2023, 

General License No. 13F, dated August 


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