Guidance for Industry 

Presenting Risk Information in 

Prescription Drug and Medical 

Device Promotion 

DRAFT GUIDANCE
 

This guidance document is being distributed for comment purposes only. 

Comments and suggestions regarding this draft document should be submitted within 90 days of 

publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be 

identified with the docket number listed in the notice of availability that publishes in the Federal 

Register. 

For questions regarding this draft document contact (CDER) Kristin Davis at 301-796-1200, 

(CBER) Ele Ibarra-Pratt at 301-827-3028, (CVM) Martine Hartogensis at 240-453-6833, or 

(CDRH) Ann Simoneau at 240-276-0100. 

U.S. Department of Health and Human Services
 

Food and Drug Administration
 

Center for Drug Evaluation and Research (CDER)
 

Center for Biologics Evaluation and Research (CBER) 

Center for Veterinary Medicine (CVM) 

Center for Devices and Radiological Health (CDRH) 

May 2009 
 

 

Guidance for Industry 

Presenting Risk Information in 

Prescription Drug and Medical 

Device Promotion 

Additional copies are available from: 

 Office of Communication, Training and 

Manufacturers Assistance, HFM-40 

Center for Biologics Evaluation and Research

 Food and Drug Administration
 

1401 Rockville Pike, Rockville, MD 20852-1448

 http://www.fda.gov/cber/guidelines.htm. 

(Tel) at 800-835-4709 or 301-827-1800
 

Office of Training and Communication
 

Division of Drug Information, HFD-240
 

Center for Drug Evaluation and Research
 

Food and Drug Administration 

5600 Fishers Lane
 

Rockville, MD 20857 

(Tel) 301-827-4573

 http://www.fda.gov/cder/guidance/index.htm 

Office of Communication, Education and Radiological
 

Programs
 

Division of Small Manufacturers, International and 

Consumer Assistance (HFZ-220)
 

Center for Devices and Radiological Health 

Food and Drug Administration 

1350 Piccard Drive 

Rockville, MD 20850-4307 U.S.A. 

http://www.fda.gov/cdrh/ggpmain.html
 

Email: dsmica@cdrh.fda.gov
 

Fax: 240.276.3151
 

(Tel) 800-638-2041 or 240-276-3150
 

* 

Communications Staff, HFV-12
 

Center for Veterinary Medicine 

Food and Drug Administration 

7500 Standish Place, 

Rockville, MD 20855 

(Tel) 301-594-1755
 

http://www.fda.gov/cvm/guidance/guidance.html
 

U.S. Department of Health and Human Services
 

Food and Drug Administration
 

Center for Drug Evaluation and Research (CDER)
 

Center for Biologics Evaluation and Research (CBER) 

Center for Veterinary Medicine (CVM) 

Center for Devices and Radiological Health (CDRH) 

May 2009 
 

 

Contains Nonbinding Recommendations 

Draft — Not for Implementation 

TABLE OF CONTENTS 

I. INTRODUCTION............................................................................................................................ 1
 

II. BACKGROUND............................................................................................................................... 2
 

A. LEGAL OVERVIEW ...................................................................................................................... 3
 

B. POLICY OVERVIEW..................................................................................................................... 4
 

III. FACTORS CONSIDERED IN THE REVIEW OF RISK COMMUNICATION ................... 6
 

A. GENERAL CONSIDERATIONS .................................................................................................. 7
 

1. Consistent Use of Language .............................................................................................................. 7
 

2. Use of Signals..................................................................................................................................... 7
 

3. Framing Risk Information.................................................................................................................. 8
 

4. Hierarchy of Risk Information ........................................................................................................... 9
 

B. CONSIDERATIONS OF CONTENT.......................................................................................... 10
 

1. Quantity ............................................................................................................................................ 10
 

2. Materiality and Comprehensiveness................................................................................................ 11
 

C. CONSIDERATIONS OF FORMAT............................................................................................ 14
 

1. Print Promotion................................................................................................................................ 15
 

2. Non-Print Promotion........................................................................................................................ 18
 

IV. CONCLUSION............................................................................................................................... 21
 

ATTACHMENT: STATUTORY AND REGULATORY REQUIREMENTS FOR LABELING 

AND ADVERTISING ................................................................................................................................. 22
 
 

 

 

 

 

 

 

 

 

 

 

 

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1 Guidance for Industry 

2 Presenting Risk Information in Prescription Drug and Medical 

3 Device Promotion 

4 

5 

6 

7 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 

8 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 

9 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 

10 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 

11 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 

12 the appropriate number listed on the title page of this guidance. 

13 

14 

15 

16 I. INTRODUCTION 

17 

18 This draft guidance describes factors FDA considers when evaluating advertisements (ads) and 

19 promotional labeling for prescription drugs,1

 ads for restricted medical devices,2 and promotional labeling 

20 for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C 

21 Act or the Act) and relevant regulations.3 The draft guidance discusses factors that are relevant to the 

22 disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these 

23 factors. This guidance responds to stakeholder requests for specific guidance on how FDA evaluates 

24 prescription drug and medical device promotional pieces to determine whether they adequately present 

25 risk information. The recommendations contained in this draft guidance apply to promotional materials 

26 directed to both consumers and healthcare professionals. 

27 

28 

1 This draft guidance does not address over-the-counter (OTC) drug promotional labeling, which FDA also 

regulates. FDA encourages all manufacturers to ensure that their promotional labeling is truthful and nonmisleading. FDA recognizes that the marketing status of animal drugs may vary, depending upon the intended 

species. For example, several anthelmintics on the market are available only by prescription for dogs and cats, yet 

very similar products are available OTC for horses and food animals. OTC drugs intended for food animals, in 

particular, may carry significant risks that may affect not only the intended food animal, but also other animal 

species and humans. OTC promotional labeling for animal drugs should convey the serious risks associated with 

use of the products, especially those affecting the public health. 

2

 Devices may become restricted, either by regulation issued under section 520(e) of the Act (21 U.S.C. 360j(e), or 

by order approving an application for premarket approval (PMA), pursuant to section 515(d)(1)(B)(ii) (21 U.S.C. 

360e(d)(1)(B)(ii)). 

3

 This draft guidance also does not apply to those reminder promotions (labeling or advertising that calls attention to 

the name of a drug or device but does not include indications, dosage recommendations, or other information) that 

are exempted by regulation from the requirements under the FD&C Act for the disclosure of risk information. See 

21 CFR 200.200, 201.100(f), 201.105(d)(2), 202.1(e)(2)(i), 801.109(d). But see 21 U.S.C. 352(r) (requiring certain 

risk information in all restricted device advertisements). 

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29 Although this draft guidance focuses on the presentation of risk information in prescription drug and 

30 medical device promotion, the factors relating to effective communication outlined below are also 

31 applicable to the presentation of benefit information in promotion. Indeed, when FDA evaluates 

32 promotional pieces for compliance with the Act and relevant regulations, it determines whether claims 

33 about both risk and benefit of the product are accurate and non-misleading, and it also looks at whether 

34 risks and benefits are presented in a comparably prominent manner. Thus, considerations involving the 

35 content and format of benefit information are an inherent part of FDA’s evaluation of risk presentations in 

36 promotional pieces. FDA recommends that companies take the factors outlined in this document into 

37 account when developing both risk and benefit presentations in their promotional pieces, as the public 

38 health is best served when risk and effectiveness information about drug and device products is clearly 

39 and accurately communicated. 

40 

41 FDA’s guidance documents, including this draft guidance, do not establish legally enforceable 

42 responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed 

43 only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the 

44 word should in Agency guidances means that something is suggested or recommended, but not required. 

45 

46 

47 II. BACKGROUND 

48 

49 The regulation of prescription drug and medical device promotion to healthcare professionals and 

50 consumers is a broad and complex topic.4 This document addresses one key aspect of this topic – the 

51 presentation of risk information. FDA believes it is critically important to disclose risk information in 

52 prescription drug and medical device promotion appropriately and effectively to healthcare professionals 

53 and consumers.5

 This information helps consumers know whether drugs or devices may be appropriate 

54 for them as well as what they should tell their healthcare professionals about before taking or using or 

55 while taking or using a product. It also lets consumers know what risks they might experience and what 

56 steps they need to take for safety reasons (e.g., no driving) because of taking or using a product. 

57 Appropriate risk disclosures help healthcare professionals by giving them some of the information they 

58 need to know about the product that will enable them to safely use or prescribe it. Recently published 

59 industry guidelines encourage manufacturers to develop prescription medicine promotion that is 

4

 Although beyond the scope of this document, the complexity of the topic can be demonstrated by past studies that 

have shown potential positive and negative effects of direct-to-consumer (DTC) advertising for prescription drugs. 

For example, FDA research suggests that DTC advertising seems to increase awareness of conditions and 

treatments, to motivate questions for the healthcare provider, and to help patients ask better questions. Yet this 

research also suggests that almost half of physicians feel some pressure to prescribe as a result of DTC advertising, 

and patients and physicians report a belief that these ads overstate the drug product’s efficacy and do not present a 

fair balance of benefit and risk information. For the complete study results, see K. Aikin, J. Swasy & A. Braman, 

Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs – Summary 

of FDA Survey Research Results, Final Report, November 19, 2004, available at: 

http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf. 

5 Effectively disclosing risk information also requires a consideration of whether an advertisement or promotional 

material over warns. For example, a drug advertisement that includes a listing of side effects that are not included in 

the drug's approved labeling may lead to under-emphasis of the most important and serious risks. FDA takes care to 

ensure that important risk information is included in the drug's approved labeling, and sponsors have an obligation to 

update their labeling with appropriate new safety information. 21 CFR 201.57(c)(6); 201.80(e). Nothing in this 

guidance should be construed as recommending that the sponsor of a drug include in advertising or promotional 

materials risk information not in the product's approved labeling or appropriate for inclusion in the labeling. See 73 

Fed. Reg. 2848, 2851 (January 16, 2008). 

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60 “designed to achieve a balanced presentation of both the benefits and the risks associated with the 

61 advertised” product.6 

62 

63 However, omission or minimization of risk information is the most frequent violation of the regulations 

64 cited in advertising and promotion enforcement letters sent to sponsors, and illustrative research in one of 

65 the areas this guidance covers, direct-to-consumer prescription drug advertising, has shown that 60 

66 percent of patients believe ads directed at them do not provide enough information about risks, 60 percent 

67 of physicians believe that patients have little or no understanding from these ads about what the possible 

68 risks and negative effects of the products are, and 72 percent of physicians believe that patients have little 

69 or no understanding from these ads about who should not use the product.7 

70 

71 FDA is issuing this draft guidance to aid sponsors in effectively communicating risk information in their 

72 promotion to both healthcare professionals and consumers. This draft guidance describes how FDA 

73 reviews prescription drug and medical device promotional pieces to determine whether they adequately 

74 present risk information. The document begins with some background information, including a brief 

75 overview of legal requirements and a discussion of policy considerations related to drug and device 

76 promotional materials. The draft guidance then describes factors FDA considers when reviewing risk 

77 communication in promotional materials. Because the principles within this guidance are based on 

78 universal concepts of communication and understanding of risk information, the guidance will address 

79 promotion aimed at both lay consumer and healthcare professional audiences. 

80 

81 A. LEGAL OVERVIEW 

82 

83 Under the FD&C Act and FDA's implementing regulations, promotional pieces (such as promotional 

84 labeling for drugs and devices and advertisements for prescription drugs and restricted devices) making 

85 claims about a product are deemed misleading if they fail to disclose certain information about the 

86 product's risks.8

 Generally, to comply with the FD&C Act and FDA’s implementing regulations, such 

87 promotional pieces:9 

88 

89 — Cannot be false or misleading in any particular10 

90 — Must reveal material facts about the product being promoted, including facts about the 

91 consequences that can result from use of the product as suggested in the promotional piece11 

6

 PhRMA, PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines, Principle 

11, November 2005, available at: http://www.phrma.org/files/DTCGuidingprinciples.pdf. 

7

 K. Aikin, J. Swasy & A. Braman, Patient and Physician Attitudes and Behaviors Associated With DTC Promotion 

of Prescription Drugs – Summary of FDA Survey Research Results, Final Report, November 19, 2004, available at: 

http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf. 

8 The relevant statutory provisions and regulations are discussed in more detail in the Attachment to this guidance. 

9

 The terms promotional piece, promotional materials, and promotional communications are used in this guidance to 

refer generally to both advertising and promotional labeling, regardless of format. Promotional materials include, 

among others, television ads, brochures, booklets, detailing pieces, internet web sites, print ads, exhibits, and sound 

recordings or radio ads. As noted in the introduction, this guidance applies to all types of promotion for prescription 

drugs, advertisements for restricted devices and promotional labeling for all devices. 

10 Drugs and devices are misbranded under the Act if their labeling is false or misleading in any particular (21 

U.S.C. 352(a)). Similarly, prescription drugs and restricted devices are misbranded if their advertising is false or 

misleading in any particular (21 U.S.C. 352(n) & (q)(1); 21 CFR 202.1(e)(5)(i)). 

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92 and 

93 — Should present information about effectiveness and information about risk in a balanced 

94 manner12
 

95 

96 This draft guidance document describes factors FDA considers when evaluating risk disclosure in 

97 prescription drug and medical device promotional materials to determine whether these materials comply 

98 with the statutory and regulatory requirements. The draft guidance also makes recommendations about 

99 how manufacturers can develop the content and format of promotional communications to comply with 

100 these requirements. The examples and recommendations provided are intended to provide guidance and 

101 illustrate possible approaches; manufacturers are free to use alternative approaches if these approaches 

102 satisfy the requirements of the statute and regulations. Unless otherwise specified in this draft guidance, 

103 the principles set forth below apply to all promotional pieces, regardless of the medium used or the target 

104 audience. 

105 

106 B. POLICY OVERVIEW 

107 

108 Section III of this guidance highlights several factors, including those related to content and format, that 

109 FDA uses to evaluate the risk communication in a promotional piece. We recommend that manufacturers 

110 consider these factors when trying to achieve effective risk communication. It is important to emphasize 

111 that when FDA evaluates the risk communication in a promotional piece, FDA looks not just at specific 

112 risk-related statements, but at the net impression – i.e., the message communicated by all elements of the 

113 piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an 

114 accurate and non-misleading impression of the benefits and risks of the promoted product. Manufacturers 

115 should therefore focus not just on individual claims or presentations, but on the promotional piece as a 

116 whole.13 A promotional communication that conveys a deceptive net impression of the product could be 

117 misleading, even if specific individual claims or presentations are not misleading. 

118 

119 FDA’s consideration of the net impression of risk information is based on well-developed social science 

120 principles supported by decades of scientific research14 and is consistent with the approach of other 

121 agencies and organizations. For example, the Federal Trade Commission (FTC) uses the interpretation of 

122 the net impression of the piece to determine whether a promotional piece is likely to mislead a 

123 consumer.15 Pharmaceutical industry members have also conducted social science research showing that, 

124 when evaluating a promotional piece, the net impression conveyed by the piece as a whole is an important 

125 element to consider, independent of individual statements within the piece. 

11 21 U.S.C. 321(n); 21 CFR 1.21 & 202.1(e)(5)(iii). 

12 See 21 CFR 202.1(e)(5)(ii). 

13 Manufacturers should note that, although this guidance focuses on risk disclosures in promotional pieces, any 

claims in a promotional piece that are misleading, whether risk-related or not, can cause the product being promoted 

to become misbranded ( 21 U.S.C. 352(a), (n) & (q)(1); 21 CFR 202.1(e)(5)(i)). 

14 For reviews of this field, see Kimble, G.A. (1985) The psychology of learning enters its second century. In 

Hammonds, B.L. (Ed.), Psychology and learning. Washington, DC: American Psychological Association (pp. 5-47) 

and Mayer, R.E. (2003) Memory and information processes. In Reynolds, W.M., & Miller, G.E. (Eds.), Handbook 

of Psychology: Educational Psychology, 7. New York: John Wiley & Sons, Inc. (pp. 47-57). 

15 See Federal Trade Commission, FTC Policy Statement on Deception, (Oct. 14, 1983), appended to FTC v. 

Cliffdale Associates, Inc., et al., 103 F.T.C. 110, 170 (1984) (hereinafter “FTC Policy Statement on Deception” with 

page references to 103 F.T.C. 110). 

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126 

127 Section III of the guidance contains examples of how various aspects of content and format can contribute 

128 to a misleading net impression in promotional pieces. The following two examples also illustrate this. 

129 

130 Example 1: A broadcast television ad for a cholesterol-lowering drug contains a factually 

131 accurate audio risk statement that discloses the drug’s major side effects and contraindications. 

132 This audio presentation is accompanied by quick scene changes showing comforting visual 

133 images of patients benefiting from the drug. It is also accompanied by loud, upbeat music. In 

134 this case, the audio disclosure may not adequately communicate risks because of the 

135 accompanying discordant visuals and distracting music. 

136 

137 Example 2: A one-page prescription drug ad for an arthritis drug, run in a medical journal, 

138 prominently presents the following headline claims in large bolded font and with abundant 

139 surrounding white space: 

140 • Benefits! DrugX is proven safe and effective for the relief of arthritis pain and 

141 stiffness, 

142 • Difference! DrugX’s unique gel formulation is convenient and easy to use, and 

143 • Reason to Believe! Drug X is the most frequently prescribed arthritis drug in the 

144 United States 

145 The bottom of the page contains an inconspicuous statement in small, non-bolded font and 

146 without surrounding white space: “Like all arthritis medications, Drug X has been associated 

147 with a risk of serious infection.” The emphasis on benefit information in this piece – in terms of 

148 the way the information is formatted and framed – overwhelms the risk information and may 

149 cause readers to receive an erroneous impression that the drug is safer than it has proven to be, 

150 even though the statements themselves may be factually accurate. 

151 

152 Using the factors explained in Part III of this draft guidance, trained professionals at FDA with expertise 

153 in areas including communication, drug information, medicine and law, apply these factors and evaluate 

154 claims in promotional pieces from the perspective of a reasonable consumer. As FDA has stated,16 the 

155 agency believes that the reasonable consumer standard is the appropriate standard to use in determining 

156 whether a claim in the labeling of a dietary supplement or conventional food is misleading. The agency 

157 confirms that the reasonable consumer standard will be used to evaluate communications covered by this 

158 guidance document. The reasonable consumer standard used by FDA in evaluating promotional 

159 materials is similar to the FTC standard: 

160 

161 [W]e examine the practice from the perspective of a consumer acting reasonably in the 

162 circumstances. If the representation or practice affects or is directed primarily to a 

163 particular group, the Commission examines reasonableness from the perspective of that 

17 164 group.

165 

16 Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements 

(Dec. 2002) (replaced by Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the 

Labeling of Conventional Food and Human Dietary Supplements (July 2003)); see 70 Fed. Reg. 824 (Jan. 5, 2005) 

(noting that, although the Guidance for Industry on Qualified Health Claims in Labeling of Conventional Foods and 

Dietary Supplements (Dec. 2002) “has been ‘replaced’ by subsequent guidance, the agency has not abandoned the 

position in the 2002 guidance regarding reasonable consumer standard”). 

17 See FTC Policy Statement on Deception at 170. 

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166 This standard does not preclude multiple interpretations of a claim, as long as they are reasonable. As the 

167 FTC’s Policy Statement provides: 

168 

169 To be considered reasonable, the interpretation or reaction does not have to be the only 

170 one. When a seller’s representation conveys more than one meaning to reasonable 

171 consumers, one of which is false, the seller is liable for the misleading interpretation.18 

172 

173 In applying the reasonable consumer standard, FDA, like FTC, takes into account the different levels of 

174 expertise of lay consumers and healthcare professionals. Due to their training and experience, healthcare 

175 professionals develop a level of knowledge related to scientific concepts and medical conditions and 

176 products that lay consumers do not possess. FDA takes this difference in knowledge and experience into 

177 account when assessing promotional materials directed at healthcare professionals versus those directed at 

178 lay audiences. However, research has shown that experts (in this case, healthcare professionals) are 

179 subject to the same cognitive biases and processing limitations as non-experts.19 

180 

181 Cognitive science research has demonstrated that all people, regardless of expertise, are only able to think 

182 through and process a limited amount of information at one time.20 However, our ability to process 

183 information can be greatly improved by considering and controlling for the factors that affect attention 

184 and comprehension. This guidance discusses those factors, how we apply them to our review of 

185 promotional materials, and what manufacturers can do to ensure that their materials comply with the 

186 regulations. 

187 

188 

189 III. FACTORS CONSIDERED IN THE REVIEW OF RISK COMMUNICATION 

190 

191 FDA relies on a vast scientific body of knowledge regarding human cognition in assessing which factors 

192 to consider in evaluating promotional pieces and making regulatory decisions about the presentation of 

193 risk information. The following sections highlight factors that FDA considers when determining whether 

194 risk information is communicated in a fashion consistent with the regulations. 

195 

18 Id. at 177. 

19 Although physicians generally do not believe that they are influenced by advertising, (Spiller & Wymer, 2001), 

research has shown that physicians are influenced by promotional activities (e.g., advertising: Avorn et al., 1982; 

sales representatives: Gonul et al., 2001). Avorn, J., Chen, M. & Hartley, R. (1982) Scientific versus commercial 

sources of influence on the prescribing behavior of physicians. American Journal of Medicine, 73, 4-8. Gonul, F.F., 

Carter, F., Petrova, E., & Srinivasan, K. (2001) Promotion of prescription drugs and its impact on physicians’ choice 

behavior. Journal of Marketing, 65, 79-90. Spiller, L.D., & Wymer, W.W. (2001) Physicians’ perceptions and uses 

of commercial drug information sources: An examination of pharmaceutical marketing to physicians. Health 

Marketing Quarterly, 19, 91-106. 

20 See, e.g., Lavie, N. (2001) Capacity limits in selective attention: Behavioral evidence and implications for neural 

activity. In Braun, J., Koch, C., et al. (Eds.), Visual attention and cortical circuits. Cambridge, MA: The MIT 

Press (pp. 49-68); Miller, G.A. (1994) The magical number seven, plus or minus two: Some limits on our capacity 

for processing information. Reprinted in Gutfreund, H., & Toulouse, G. (Eds.), Biology and computation: A 

physicist’s choice. River Edge, NJ: World Scientific Publishing Co. (pp. 207-233); Shapiro, K. (Ed.) (2001) The 

limits of attention: Temporal constraints in human information processing. London: Oxford University Press. 

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196 A. GENERAL CONSIDERATIONS 

197 

198 This section explores some important factors that relate to both the content and the format of a 

199 promotional piece. FDA will consider the use of language and signals and how information is framed and 

200 ordered. 

201 

202 1. Consistent Use of Language Appropriate for Target Audience 

203 

204 Both language used to communicate benefits and language used to communicate risks should be 

205 comprehensible to the same audience for a piece to be considered accurate and non-misleading. Thus, 

206 promotional materials directed to professionals can reasonably describe benefits and risks in medical 

207 language, but promotional materials directed to consumers should convey benefits and risks in language 

208 understandable to consumers.21 

209 

210 Example 3: A consumer-directed ad for a drug that presents benefit claims in consumer friendly 

211 language should mention a risk of “fainting,” not “syncope.” 

212 

213 With respect to consumer-directed materials, FDA encourages manufacturers to present both benefit and 

214 risk information in clear, understandable, and non-technical language for consumer audiences.22 

215 

216 2. Use of Signals 

217 

218 Signaling is an important component of information communication.23 In written materials, signaling has 

219 been defined as the use of “writing devices designed to emphasize aspects of a text’s structure or content 

220 without altering the information in the text.”24 Headlines and subheads are examples of commonly used 

221 signals.25 Depending on the circumstance, “accurate information in the text may not remedy a false 

222 headline [or signal] because reasonable consumers may only glance at the headline” and skip the 

21 See Root, J., & Stableford, S. (1999) Easy-to-read consumer communications: A missing link in Medicaid 

managed care. Journal of Health Politics, Policy, & Law, 24, 1-26. 

22 Although not a true measure of “understandability,” text reading level, often expressed as “grade level,” is one 

way to assess text difficulty. Text that scores at a higher grade level (e.g., 12th grade) is considered more complex 

than text scoring at a lower grade level (e.g., 8th grade). Several validated reading level measures are available to 

provide an approximate measure of text complexity. See, e.g., Kincaid, J.P., Fishburne, R., Rogers, R.L., Chissom, 

B.S. (1975) Derivation of New Readability Formulas (Automated Reliability Index, Fog Count, and Flesch Reading 

Ease Formula) for Navy Enlisted Personnel. Research Branch Report 8-75. Memphis: Naval Air Station; 

McLaughlin, G.H. (1969) SMOG grading: A new readability formula. Journal of Reading, 12, 639-646; Mosenthal, 

P.B. (1998) A new measure of assessing document complexity: The PMOSE/IKIRSCH document readability 

formula. Journal of Adolescent and Adult Literacy, 41, 620-638. We encourage manufacturers to test text 

comprehensibility as well. 

23 Loman, N.L., & Mayer, R.E. (1983) Signaling techniques that increase the understandability of expository prose. 

Journal of Educational Psychology, 75, 402-412; Meyer, B.J.F. (2003) Text coherence and readability. Topics in 

Language Disorders, 23, 204-224; Spyridakis, J.H., & Standal, T.C. (1987) Signals in expository prose: Effects on 

reading comprehension. Reading Research Quarterly, 22, 285-298. 

24 Lorch, R.F., Lorch, E.P., & Inman, W.E. (1993) Effects of signaling structure on text recall. Journal of 

Educational Psychology, 85, 281-290, p. 281. 

25 Hyona, J., & Lorch, R.F. (2004) Effects of topic headings on text processing: Evidence from adult readers’ eye 

fixation patterns. Learning and Instruction, 14, 131-152. 

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223 remainder of the text.26 Signals are also used in broadcast situations, such as when an announcer draws 

224 attention to different items of information, when a word on the screen identifies a new topic, or when 

225 headlines emphasize some messages but not others. 

226 

227 When reviewing promotional materials, FDA looks to see if the use of signals is consistent across benefit 

228 and risk information, so that the materials provide accurate and non-misleading impressions of a drug or 

229 device. 

230 

231 Example 4: If a piece contains headlines that signal benefit information, (e.g., “Drug X Provides 

232 Highly Effective Control”), some sort of headline should also signal risk information (e.g., “Side 

233 Effects for Drug X”). 

234 

235 However, the mere presence of similar signals for both benefit and risk information is not necessarily 

236 sufficient to make a piece accurate and non-misleading. The content of the signals is also important. 

237 Certain headlines may frame (see next section) subsequent risk information in ways that emphasize or 

238 minimize its importance. 

239 

240 Example 5: The headline “Important Risk Information about Device X” is preferable to 

241 “Important Information about Device X” because the former headline indicates what type of 

242 information follows. Similarly, “Common Side Effects Seen with Drug X,” is preferable to 

243 “Other Information about Drug X.” Specific and clear signals are preferable because they are 

244 more effective than vague or abstract terms. 

245 

246 Presenting risk information with no signal, or beginning the presentation of risk information with 

247 unrelated information (e.g. presenting risk information in a paragraph that begins with information on 

248 indication or dosing) can also minimize the risks of the product and mislead the audience. For example, 

249 the headlines in the following example convey additional benefit information, potentially misleading the 

250 audience about the overall risk-benefit profile of the product. 

251 

252 Example 6: Placing risk information under headlines such as “Now Approved for Epilepsy” or 

253 “Safe Enough for Children Under 5” minimizes the risk information that follows, particularly if 

254 individuals only look at the headlines. Instead, headlines preceding risk presentations should 

255 signal that a risk presentation follows, for example, “Important Risk Information About Drug X.” 

256 

257 In videos, broadcast ads, and other promotional pieces with audio components, a change of announcer or 

258 a statement in the audio portion of the piece to signal to the audience that risk information follows can aid 

259 effective communication. However, manufacturers should consider comparable voice characteristics, as 

260 discussed in Section III.C.2. Risk information may also be signaled graphically or visually. Similar to 

261 print pieces, specific and straightforward audio signals are most likely to adequately convey risk 

262 information. 

263 

264 3. Framing Risk Information 

265 

266 FDA evaluates how risk information is framed because framing can affect the presentation of risks and 

267 benefits in a promotional piece. Framing commonly refers to how a particular piece of information is 

268 stated or conveyed, such as by emphasizing either the positive or negative aspects of the information or 

269 by presenting the information in vague versus specific terms. Research consistently shows that framing 

26 FTC Policy Statement on Deception at 182. 

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270 the same information in different ways can change the way audience members respond to that 

271 information.27 Thus, the way information is phrased can significantly influence the message the audience 

272 receives from a promotional piece. 

273 

274 Framing risk information in non-specific terms can undermine the effective communication of that 

275 information to the audience. Risk information should be presented in the same terms or with the same 

276 degree of specificity as benefit information. For example, if a promotional piece refers to the product by 

277 name in presenting efficacy information, it should refer to the product by name in presenting risk 

278 information, rather than by referring to the product’s device or drug class. 

279 

280 Example 7: If the benefit information refers to the brand name, “Drug X,” then “Common side 

281 effects associated with Drug X” would be preferable to “Common side effects associated with 

282 [the generic name].” 

283 

284 Moreover, within the risk information presentation, phrases such as “Like all medicines, Drug X has some 

285 side effects,” may have the effect of minimizing the risks that follow. Framing risk information in a way 

286 that minimizes the severity of a risk event may also cause a promotional piece to be considered false or 

287 misleading. 

288 

289 Example 8: If a drug’s package insert contains a boxed warning about the risk of life-threatening 

290 fevers associated with its use and reports that 55 percent of patients taking the drug experience 

291 dizziness, a statement such as “Adverse events associated with drug X include fevers. Some 

292 patients experienced dizziness” misleadingly describes the risk profile of the drug by failing to 

293 convey the seriousness of the fevers and the frequency of the dizziness. Statements like “Life294 threatening fevers have been reported with the use of Drug X” and “More than half of patients 

295 taking Drug X experienced dizziness” would convey the seriousness and frequency of the two 

296 risks appropriately. 

297 

298 In addition, the risks conveyed in the piece should be framed in a way that accurately reflects their nature. 

299 

300 Example 9: A statement such as “continuation of therapy may necessitate certain monitoring” is 

301 too vague for a product that requires monthly blood tests to check for liver damage. This 

302 statement fails to convey the risk of liver damage and also misleadingly suggests that routine 

303 monitoring may not be necessary for some patients. A statement like “Monthly blood tests 

304 should be performed to check for liver damage” would accurately convey the type of monitoring 

305 needed and the risk involved. 

306 

307 4. Hierarchy of Risk Information 

308 

309 FDA considers the ordering of risks within a presentation an important factor in determining the risk 

310 profile conveyed by a piece, regardless of whether it is directed toward healthcare professionals or 

27 See Armstrong, K., Schwartz, J.S., Fitzgerald, G., Putt, M., & Ubel, P.A. (2002) Effect of framing as gain versus 

loss on understanding and hypothetical treatment choices: survival and mortality curves. Medical Decision Making, 

22, 76-83; Dunegan, K.J. (1993) Framing, cognitive modes, and imagery theory: Toward an understanding of a glass 

half full. Journal of Applied Psychology, 78, 491-503; Rothman, A.J., & Salovey, P. (1997) Shaping perceptions to 

motivate healthy behavior: The role of message framing. Psychological Bulletin, 121, 3-19; Smith, S.M., & Petty, 

R.E. (1996) Message framing and persuasion: A message processing analysis. Personality and Social Psychology 

Bulletin, 22, 257-268; Tversky, A., & Kahneman, D. (1981) The framing of decisions and the psychology of choice. 

Science, 211, 453-458. 

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311 consumers. As discussed in Section III.B.2 (below) and reflected in the format of the package insert for 

312 prescription drugs and medical devices, risks associated with a specific product are assigned a hierarchy 

313 of importance. 

314 

315 Memory research consistently shows that, in an experimental setting, when people process an entire list or 

316 text, they are better able to recall items at the beginning and the end than items in the middle.28 

317 Consequently, in a broadcast ad, where viewers do not have the opportunity to control the speed at which 

318 information is presented to help them to process it, the beginning or end, or both, should be reserved for 

319 the most important risk information. On the other hand, when reading a print promotional piece under 

320 normal circumstances, readers may lose interest toward the end of a lengthy paragraph, and it is not likely 

321 that the information at the end will be as well-comprehended as the information at the beginning. If a 

322 product’s most important risks are located in the middle of a list of less important risks, the important 

323 risks may not be effectively communicated. FDA therefore recommends that the most important risk 

324 information, including relevant warnings and contraindications, be placed or stated first, especially in 

325 print materials. As discussed in Section III.C.1 (below), manufacturers should also note, however, that 

326 risk information should not just be presented in one location in a piece, but should, like benefit 

327 information, appear as an integral part of the piece. 

328 

329 FDA also considers the order in which risk information is presented to determine whether this ordering 

330 suggests that certain risks apply only to certain populations or only under certain conditions when this is 

331 not the case. 

332 

333 Example 10: A statement in a broadcast ad that “Patients should not drink alcohol when taking 

334 Drug X. Common side effects are drowsiness and nausea” may suggest that these side effects 

335 occur only if alcohol is consumed when taking the drug. Instead, the sponsor should consider 

336 adding intervening information or changing the order of the presentation so that it is clear the side 

337 effects listed are not caused by drinking alcohol while taking the drug. 

338 

339 B. CONSIDERATIONS OF CONTENT 

340 

341 This section discusses how FDA evaluates the content of risk presentations in determining whether a 

342 promotional piece is accurate and non-misleading. 

343 

344 1. Quantity 

345 

346 One content factor FDA considers is the amount or quantity of information conveyed by a promotional 

347 piece. For example, a 30-second broadcast ad is likely to present less information than a 60-second 

348 broadcast ad. As the amount of benefit information conveyed increases, the amount of risk information 

349 conveyed should similarly increase. 

350 

351 The quantity of information presented can affect the net impression of the piece. The amount of 

352 information presented is one component that, together with choice of words, color, graphics, voiceover, 

353 and other aspects of the piece, can affect cognitive load, the mental effort required to understand the 

28 See Botvinik, M.M., & Plaut, D.C. (2006) Short-term memory for serial order: A recurrent neural network model. 

Psychological Review, 113, 201-233; Capitani, E.; della Sala, S.; Logie, R.H.; & Spinnier, H. (1992) Recency, 

primacy, and memory: Reappraising and standardizing the serial position curve. Cortex, 28, 315-342; Murdock, 

B.B. (1962) The serial position effect of free recall. Journal of Experimental Psychology, 64, 482-488. 

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354 various components of information in the piece.29 If the benefit information is easily understood and 

355 maintained through repetition or other reinforcing techniques, and the risk information is not similarly 

356 reinforced, the net impression may not be appropriately balanced. 

357 

358 To ensure comparable benefit and risk presentations, manufacturers should consider the space or time 

359 devoted to benefits and risks, the comprehensibility of the language used, and the information provided 

360 on benefits and risks. FDA will look to see that promotional communications allot sufficient time and 

361 space to convey the important benefits and risks of the product being promoted to ensure that, as a whole, 

362 the communication provides an accurate and non-misleading impression of the product. 

363 

364 A promotional piece with several paragraphs of information regarding benefits differs from a piece 

365 consisting mainly of one-line benefit claims. The treatment of risk information in each piece should be 

366 comparable to the treatment of benefit information, including how it is conveyed. 

367 

368 Promotional pieces do not have to convey an identical number of benefits and risks, and a given drug or 

369 device may have few or many risks.30 FDA considers these factors when determining the comparability 

370 of benefits and risks in a piece: 

371 

372 — The number of statements about benefits and risks 

373 — The completeness and depth of detail given about benefits and risks 

374 — The amount of time (in both the audio and visual portions) devoted to benefits and risks in a 

375 video, audio, or broadcast communication 

376 — The amount of space devoted to benefits and risks in a print communication 

377 — The use of audio or visual components that enhance or distract from the presentation of risk 

378 or benefit information 

379 

380 As stated in the Background and discussed above, FDA evaluates the net impression created by 

381 promotional communications. This evaluation includes considering the above factors as well as the 

382 differences in the inherent risks associated with various drugs or devices. Simply satisfying one of the 

383 above factors (e.g., devoting the same amount of time or space to risk and benefit information) will not 

384 necessarily make a promotional piece accurate and non-misleading. Furthermore, certain important risk 

385 information should be in all promotional pieces regardless of their length (see Section III.B.2 below). 

386 

387 2. Materiality and Comprehensiveness 

388 

389 Generally speaking, materiality is determined by the degree to which information is objectively 

390 important, relevant, or substantial to the target audience. A promotional piece that omits material 

391 information about a product’s risks could be considered misleading even if the piece devotes similar 

392 space or time to risk and effectiveness presentations.31 

29 See Mayer, R.E., & Moreno, R. (2003) Nine ways to reduce cognitive load in multimedia learning. Educational 

Psychologist, 38, 43-52; Pass, F., Renkl, A., & Sweller, J. (2004) Cognitive load theory: Instructional implications 

of the interaction between information structures and cognitive architecture. Instructional Science, 32, 1-8. 

30 If the drug or device being promoted is associated with a minimal number of risks, and all of these risks are 

conveyed in a format that is comparably prominent to the presentation of benefit information, then the risk 

presentation in such an ad or promotional labeling piece would be considered accurate, non-misleading and balanced 

even if the ad presented several more benefit than risk claims. 

31 21 U.S.C. 321(n); see also 21 CFR 1.21 & 202.1(e)(5)(iii). Please see the Attachment to this document for a full 

description of the relevant requirements. 

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393 

394 Material facts are those that would influence reasonable consumers (or healthcare professionals when 

395 they are the intended audience) about a product. Material facts include those that influence such people’s 

396 understanding of the following: 

397 

398 — The relevant properties of a product 

399 — Whether or not the product is appropriate for them or their patients 

400 — Whether or not they are willing to accept the risks or burdens associated with using or 

401 prescribing a product 

402 

403 Some drug and device risks are material regardless of the amount or type of benefit claims in a piece. 

404 The most serious risks set forth in a product’s labeling are generally material to any presentation of 

405 efficacy. A promotional piece that communicates a product’s benefits should similarly communicate the 

406 most serious risks involved in using the product. Similarly, the most frequently occurring risks would 

407 usually be material to consumers and healthcare professionals in promotion, particularly if a product is 

408 only associated with a small number of more serious risks, because of the likelihood that they will affect 

409 patients taking the drug or using the device. 

410 

411 • Consideration of Target Audience 

412 

413 FDA considers the target audience of a promotional piece to be critical in determining what risk 

414 information is material. FDA evaluates the promotion from the perspective of a reasonable member of 

415 the targeted population (e.g., consumers, specific patient populations, healthcare professionals). As is 

416 explored in more detail below (e.g., Examples 11 and 13), different information can be material to 

417 different audiences. For example, in a piece promoting use of a product in a selected class of patients, 

418 risks especially applicable to that selected class of patients are material (see “The Nature of Benefit 

419 Claims,” below).32 

420 

421 Generally speaking, communications directed to healthcare professionals should convey the most critical 

422 information they need to know about the product to help them decide whether it is appropriate for their 

423 patients and to help enable them to safely use the product or counsel patients on the safe use of the 

424 product. Consumer-directed communications should generally convey the following: 

425 

426 — What the drug or device is used for 

427 — Who should or should not take a drug or use a device 

428 — What can be expected from a drug or device 

429 — What patients should ask their healthcare professionals about a drug or device 

430 — What patients should tell their healthcare professionals about before or while taking a drug or 

431 using a device 

432 

433 Example 11: A drug’s package insert includes a warning for healthcare professionals about dosing 

434 adjustments in patients with kidney disease. This information is material for healthcare professionals, 

435 both because of the seriousness indicated by its warning status and because of its relevance to safe 

436 prescribing. However, although this information is important to the safe use of the drug and should 

437 be considered by prescribers, it is not material to consumers, although the reasons for such care in 

438 dosing (e.g., the consequences of inappropriate dosing) could be. 

439 

32 See 21 CFR 202.1(e)(7)(x). 

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440 • Importance of Package Insert 

441 

442 In determining the materiality of the risks associated with a drug or device, FDA refers to the product’s 

443 package insert. FDA is more likely to consider as important or material a product’s most serious or most 

444 frequently occurring risks than a product’s less serious or less commonly occurring risks.33 FDA 

445 characterizes the risks associated with a specific product along a hierarchy of importance reflected by 

446 placement in a risk-related section of the product’s package insert – traditionally , the Contraindications, 

447 Warnings or Hazards, Precautions, Adverse Reactions or Side Effects sections, as well as the 

448 Overdosage, and Drug Abuse and Dependence sections in the case of prescription drugs – and in the use 

449 of various means to emphasize certain risks, such as boxed warnings and bolded statements. For labeling 

450 that complies with the new formatting requirements in the recently finalized Physician Labeling Rule for 

451 prescription drugs,34 the risk-related sections include Boxed Warning, Contraindications, Warnings and 

452 Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Drug Abuse & 

453 Dependence, and Overdosage. 

454 

455 For prescription drug physician labeling that follows the new requirements, the risks included in the 

456 Highlights section of labeling are the most important risks associated with the drug. For other labeling, 

457 contraindications and warnings or hazards are considered to contain the most serious and material risk 

458 information associated with a drug or device and convey information that must be understood before the 

459 product is prescribed or used. Contraindications and boxed warnings are generally considered the most 

460 important. Precautions also convey important risk information that can help healthcare professionals and 

461 patients use a drug or device more safely. These include ways to avoid adverse effects and information 

462 about important differences in individual response and, for drugs, about interactions with other drugs or 

463 food. Risks conveyed only in the adverse events or side effects section are generally less serious or less 

464 well-documented than those in the preceding three categories. They are often the most commonly 

465 experienced risks associated with a product, however, and they therefore may constitute important 

466 information for both healthcare professionals and consumers. 

467 

468 • The Nature of Benefit Claims 

469 

470 Promotional pieces should reveal risk information that is material in light of the specific benefit claims 

471 made in the piece. 

472 

473 Example 12: If a piece claims convenience because the promoted drug is dosed once-weekly, 

474 information about risks directly related to the regimen’s convenience is material. Such risk 

475 information might include, for example, that inflammatory reactions such as swelling have been 

476 reported at the application site for a topical product, or that patients must restrict their activities 

477 for some time after taking an oral medication because of a risk of fainting. 

33 As indicated above, the most serious risks set forth in a product’s labeling are generally material to any 

presentation of efficacy. Frequently occurring, less serious risks (e.g., those reflected in Adverse Reactions) can be 

material, particularly for a product that is not associated with serious risks, but these less serious risks may not be 

material for a product that has many serious risks that need to be disclosed in promotion, or whose most frequently 

occurring risks occur at a very low rate. In general, FDA believes that exhaustive lists of minor risks distract from 

and make it difficult to comprehend and retain information on the more important risks. To this end, we have issued 

a draft guidance for prescription drugs entitled Brief Summary Disclosing Risk Information in Consumer-Directed 

Print Advertisements, which suggests approaches to communicating less, but better, information in consumer brief 

summaries. Once finalized, this guidance will represent the Agency's thinking on this topic. 

34 See 71 Fed. Reg. 3922 (Jan. 24, 2006). The rule became effective June 30, 2006. 

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478 

479 Similarly, as stated above, for promotional pieces that promote a product’s benefits in a selected class of 

480 patients, the significant risks applicable to that class of patients are material.35 

481 

482 Example 13: If a Web site for a product approved to treat high blood pressure presents 

483 information about a product’s benefits in postmenopausal women, any risks specific to 

484 postmenopausal women are particularly material. 

485 

486 • Accuracy and Comprehensiveness of Risk Information 

487 

488 When it evaluates the content of a promotional piece’s risk information, FDA assesses the quality as well 

489 as the quantity of the information. Both consumer and professional audiences expect that certain 

490 information will be present in promotions for prescription drugs and medical devices. This expectation 

491 results from schemas,36 or mental frameworks, about these promotional pieces that have developed from 

492 previous exposures (i.e., preconceived expectations based on past experience). Consumers have 

493 preconceived ideas about the amount of scrutiny these ads undergo. Many believe FDA exercises tight 

494 regulatory control over the content of these ads and to some extent, believe that all ads have been pre495 reviewed prior to airing.37 As a result, consumers are likely to expect that the most relevant risks have 

496 been included in the ad. Because people expect to see risk information, there is no reason for them to 

497 imagine that the product has important risks that have been omitted. Instead, the audience is likely to 

498 believe that all significant risks are included, especially if some risks are included. This missing risk 

499 information can have serious effects; it may cause consumers to fail to inform their healthcare 

500 professionals of important considerations, and healthcare professionals to prescribe inappropriately or 

501 even dangerously. 

502 

503 Example 14: A product is associated with the rare but serious risk of a heart attack. FDA is likely 

504 to consider an ad misleading if it devotes a certain amount of time or space to the presentation of 

505 claims about the product’s efficacy in treating migraines and then devotes a similar amount of 

506 time or space to describing only the frequently occurring, least serious adverse events, or only 

507 one of several significant risks. 

508 

509 Even though a similar quantity of risk and benefit information may be conveyed, a promotional piece that 

510 presents information on the benefits of the product but then communicates only its least serious risks, or 

511 an inadequate set of its serious risks, will not have conveyed an accurate understanding of the product’s 

512 relevant properties. 

513 

514 C. CONSIDERATIONS OF FORMAT 

515 

516 FDA also considers formatting factors when assessing whether a piece is false or misleading. Format 

517 includes the shape, size, and general layout of all portions of a print promotional piece, as well as the 

35 See 21 CFR 202.1(e)(7)(x). 

36 See Kardash, C.A.M., Royer, J.M., & Greene, B.A. (1988) Effects of schemata on both encoding and retrieval of 

information from prose. Journal of Educational Psychology, 80, 324-329; Smith, E.E., & Swinney, D.A. (1992) 

The role of schemas in reading text: A real-time examination. Discourse Processes, 15, 303-316. 

37 See, e.g., K. Aikin, J. Swasy & A. Braman, Patient and Physician Attitudes and Behaviors Associated With DTC 

Promotion of Prescription Drugs – Summary of FDA Survey Research Results, Final Report, November 19, 2004, 

available at: http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf; Prevention Magazine (2004) 5th 

Annual Survey: Consumer Reaction to DTC Advertising of Prescription Medicines. Emmaus, PA: Rodale. 

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518 general plan of organization, arrangement, and theme in non-print promotional pieces such as videos and 

519 broadcast ads. 

520 

521 To process information, a person must first pay attention to it. Several factors contribute to whether 

522 people will pay attention to information. These factors also may help or hinder people’s understanding of 

523 information once it has drawn their attention. When evaluating whether a promotional piece 

524 appropriately communicates risk information, FDA considers several formatting factors.38 Because these 

525 factors apply to information processing in general, prescription drug and medical device manufacturers 

526 should keep them in mind when developing promotional pieces. 

527 

528 As a general matter, risk and benefit information should be comparably noticeable or conspicuous in 

529 promotional pieces, and audiences should be able to read both risk and benefit information with similar 

530 ease (e.g., comparably legible and understandable; see Section III.A.1 above).39 Manufacturers should 

531 note that any one of the following formatting factors could make a piece false or misleading and that each 

532 factor could interact with others to increase this problem or to create a false or misleading impression 

533 when there might not be one if a factor were considered in isolation. 

534 

535 1. Print Promotion 

536 

537 The layout of a print promotional piece (generally, its plan, design, or arrangement) influences readers’ 

538 ability to pay attention to and process specific features of the piece.40 FDA considers the following 

539 selected aspects of the layout of a print promotional piece when assessing the comparable prominence and 

540 readability of risk and efficacy information. This is not an exhaustive list; other issues, such as language 

541 comprehension and the risk hierarchy, are covered in other sections. 

542 

543 • Overall Location of Risk Information 

544 

545 For a piece to be accurate and non-misleading, risk information should be included in the main part of a 

546 piece. If the omission of risk information in any part of a piece makes that part of the piece false or 

547 misleading, the problem cannot be corrected simply by including the risk information in a separate part of 

548 the piece.41 To be comparably prominent to benefit information, risk information should generally appear 

549 in the same parts of the piece as the benefits. 

38 See, e.g., 21 CFR 202.1(e)(7)(viii) for a list of implementing factors FDA takes into consideration when 

evaluating the balance between benefit and risk information in an ad. See generally 21 CFR 202.1(e)(6)-(7). 

39 See 21 U.S.C. § 352(c). 

40 See Adams, A.S., & Edworthy, J. (1995) Quantifying and predicting the effects of basic text display variables on 

the perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color. Ergonomics, 38, 

2221-2237; Brundage, M., Feldman-Stewart, D., Leis, A., Bezjak, A., Degner, L., Velji, K., et al. (2005) 

Communicating quality of life information to cancer patients: A study of six presentation formats. Journal of 

Clinical Oncology, 23, 6949-6956; Frantz, J.P. (1993) Effect of location and presentation format on attention to and 

compliance with product warnings and instructions. Journal of Safety Research, 24, 131-154; Morrow, D., Leirer, 

V., Altieri, P. (1995) List formats improve medication instructions for older adults. Educational Gerontology, 21, 

151-166; Niemela, M., & Saariluoma, P. (2003) Layout attributes and recall. Behaviour and Information 

Technology, 22, 353-363; Wogalter, M.S., & Vigilante, W.J., Jr. (2003) Effects of label format on knowledge 

acquisition and perceived readability by younger and older adults. Ergonomics, 46, 327-344. 

41 See 21 CFR 202.1(e)(3)(i). The prescription drug regulations allow the presentation of risk information in a 

particular part of a promotional piece to be concise if it is supplemented by a prominent reference on each page to 

the presence and location of a more complete discussion of such information elsewhere in the piece. Id. However, 

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550 

551 Complete separation of benefit and risk information (e.g., presenting several pages of benefits before any 

552 risks) is one example of a lack of appropriate prominence.42 FDA will also look to see that risk 

553 information is not placed in such a way as to interfere with readers’ perceptions of the relative importance 

554 or utility of the information. 

555 

556 • Location of Risk Information within a Part of the Promotional Piece 

557 

558 In addition to appearing with or near benefit presentations, risk information should appear as an integral 

559 part of the piece, just as benefit information does. For example, a prescription drug ad should not present 

560 risks only on a brief summary page. 

561 

562 Example 15: A product’s logo and a tagline are often used to signal the end of a piece. Readers 

563 may assume that any risk information placed below the logo and tagline is there only for liability 

564 purposes or to fulfill a regulatory requirement and is unrelated to the main message, especially if 

565 the information is presented in small type or otherwise lacking in emphasis. 

566 

567 Example 16: A seven-page sales aid devotes the first six pages to effectiveness claims, which are 

568 prominently presented with colorful graphics, abundant white space, and large, colorful headers. 

569 Three of these pages also include a footnote referring readers to “Important Information on page 

570 7.” The seventh page summarizes some risk information from the PI in single-spaced paragraph 

571 format without headers or other presentation elements to emphasize to the reader that it is 

572 important risk information. Such a presentation creates problems regarding the adequate 

573 presentation of risk. The important risk information about the drug should instead be integrated 

574 into the piece and presented with similar prominence to the effectiveness claims. 

575 

576 Similarly, problems can arise when parts of a print promotional piece appear so unrelated that the risks do 

577 not look to be part of the piece. 

578 

579 Example 17: Risk information is placed in a thin column along the side of an ad in a different font 

580 and color scheme, so that the visuals and benefit information form a complete whole, separate 

581 from the risk information. This is not likely to be considered an adequate presentation of risk 

582 information. 

583 

584 • Font Size and Style 

585 

586 Font size and type style are format factors that can affect the prominence and readability of information.43 

587 FDA does not object to a presentation on the basis of minor differences in font size alone, depending on 

although the regulations allow for the “concise” presentation of such information, the nature and importance of this 

information should be accurately conveyed. For example, if a drug contains a boxed warning with information on 

the risk of elevations in potassium levels that can lead to life-threatening complications in some patients, a statement 

in a part of a promotional piece that “Drug X may increase your potassium levels; see Prescribing Information (PI) 

for more information” is not likely to convey to consumers or healthcare professionals the magnitude (i.e., lifethreatening nature) of the risk. 

42 21 CFR 202.1(e)(3)(i); see also 21 U.S.C. 321(n), 21 CFR 202.1(e)(5)(iii). 

43 Adams, A.S., & Edworthy, J. (1995) Quantifying and predicting the effects of basic text display variables on the 

perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color. Ergonomics, 38, 

2221-2237; Arditi, A., & Cho, J. (2005) Serifs and font legibility. Vision Research, 45, 2926-2933; Baker, S. 

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588 other factors used to achieve emphasis (e.g., bolded lettering, bullets). However, FDA may object to 

589 substantial differences in font size or the presentation of risk information in a difficult to read font size, 

590 irrespective of the font size of benefit information, because this may seriously reduce the ability to see or 

591 comprehend the risk information. 

592 

593 Even with identical risk and benefit font sizes, differences in type styles can render some information 

594 easier to read than other information.44 To be comparably prominent and readable, FDA recommends that 

595 risk and benefit information be presented in type styles that are similar in the use of capitalization, serifs, 

596 the weight of the type-face, the angle of the letters, the degree of flourishes and scripting, and other 

597 typographical factors such as spacing (e.g., leading and kerning).45 

598 

599 • Contrast 

600 

601 Contrast between text and background should not highlight the benefit information more than the risk 

602 information. 

603 

604 Example 18: If benefit information in a piece is presented in white letters on a black background, 

605 risk information should be presented with similar contrast. If the piece presents risk information 

606 in a way that would make it difficult to discern (e.g., using white letters on a light gray 

607 background or gray letters on a black background), the presentation may be considered false or 

608 misleading. 

609 

610 Even if the background is a color designed to attract attention, the contrast influences the prominence of 

611 the words once attention has been gained. In fact, printing words in some attention-grabbing colors (e.g., 

612 red) may make the words difficult to read.46 Similarly, the placement of risk information over pictures or 

(2006). Provision of effective information. British Dental Journal, 201, 100; Sheedy, J.E., Subbaram, M.V., 

Zimmerman, A.B., & Hayes, J.R. (2005) Text legibility and the letter superiority effect. Human Factors, 47, 797-

815; Tantillo, J., Di Lorenzo-Aiss, J., & Mathisen, R.E. (1995) Quantifying perceived differences in type styles: An 

exploratory study. Psychology and Marketing, 12, 447-457; Wogalter, M.S., & Vigilante, W.J. (2003) Effects of 

label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics, 46, 327-

344. 

44 English, E. (1944) A study of the readability of four newspaper headline types. Journalism Quarterly, 21, 217-

229; Mansfield, J.S., Legge, G.E., & Bane, M.C. (1996) Psychophysics of reading. XV: Font effects in normal and 

low vision. Investigative Opthamology and Visual Science, 37, 1492-1501; Sheedy, J.E., Subbaram, M.V., 

Zimmerman, A.B., & Hayes, J.R. (2005) Text legibility and the letter superiority effect. Human Factors, 47, 797-

815; Tantillo, J., Di Lorenzo-Aiss, J., & Mathisen, R.E. (1995) Quantifying perceived differences in type styles: An 

exploratory study. Psychology and Marketing, 12, 447-457. 

45 See Arditi, A., & Cho, J. (2005) Serifs and font legibility. Vision Research, 45, 2926-2933; Baker, S. (2006) 

Provision of effective information. British Dental Journal, 201, 100; Moriarty, S.E., & Scheiner, E.C. (1984) A 

study of close-set text type. Journal of Applied Psychology, 69, 700-702; Paterson, D.G., & Tinker, M.A. (1947) 

Influence of leading upon readability of newspaper type. Journal of Applied Psychology, 31, 160-163; Smither, 

J.A., & Braun, C.C. (1994) Readability of prescription drug labels by older and younger adults. Journal of Clinical 

Psychology in Medical Settings, 1, 149-159; Tinker, M.A., & Paterson, D.G. (1946) Effect of line width and leading 

on readability of newspaper type. Journalism Quarterly, 23, 307-309. 

46 See Pearson, R., & van Schaik, P. (2003) The effect of spatial layout and link colour in web pages on performance 

in a visual search task and an interactive search task. International Journal of Human-Computer Studies, 59, 327-

353; but see Adams, A.S., & Edworthy, J. (1995) Quantifying and predicting the effects of basic text display 

variables on the perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color. 

Ergonomics, 38, 2221-2237. 

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613 other visual elements with multiple colors can cause this information or portions of this information to 

614 lack prominence and be difficult to read.47 Furthermore, a print piece that superimposes risk information 

615 over a visual image could compromise the accuracy of the piece as a whole by drawing attention away 

616 from the risk information.48 

617 

618 • White Space 

619 

620 Background space (often called white space) between and around letters can influence the prominence 

621 and readability of text.49 Presenting benefit information in multiple paragraphs with double spaces 

622 between each paragraph, while presenting risk information in one block paragraph without spacing or 

623 indentation could reduce the comparability of the risk and benefit presentations. Moreover, if a 

624 promotional piece uses headings, bullets, and other attention-getting symbols to emphasize product 

625 benefits, FDA recommends that it use similar techniques to present product risks.50 

626 

627 2. Non-Print Promotion 

628 

629 Some print formatting issues also apply to non-print promotion such as videos, broadcast ads, and similar 

630 audio and visual pieces. However, the unique features of non-print media add complexity. As with print, 

631 FDA considers factors such as location, proximity, type size, type style, and contrast when evaluating 

632 these materials. These factors are especially important with regard to text that is superimposed on other 

633 images in videos or broadcast ads (SUPERs) and other visual components, such as graphics, within the 

634 scene. In non-print pieces, FDA also evaluates other formatting factors in addition to those described 

635 above to determine whether a particular piece is considered false or misleading (e.g., audio components, 

636 motion within the visual component, the juxtaposition of visual and audio components, and duration of 

637 exposure). 

638 

639 • Textual Elements 

640 

641 Prescription drug broadcast ads must present major product risks in the audio or audio and visual parts of 

642 the ad.51 Thus, broadcast ads and videos often use SUPERs and other text to present risk-related 

643 qualifying information. When used to disclose risk, SUPERs can pose particular problems of readability, 

644 comprehensibility, and proximity to benefit information. For example, the FTC, which requires that 

47 See, e.g., Hillstrom, A.P., & Chai, Y. (2006) Factors that guide or disrupt attentive visual processing. Computers 

in Human Behavior, 22, 648-656; Petty, R.E., Wells, G.L., & Brock, T.C. (1976) Distraction can enhance or reduce 

yielding to propaganda: Thought disruption versus effort justification. Journal of Personality and Social 

Psychology, 34, 874-884; Zimbardo, P.G., Snyder, M., Thomas, J., Gold, A., & Gurwitz, S. (1970) Modifying the 

impact of persuasive communications with external distraction. Journal of Personality and Social Psychology, 16, 

669-680. 

48 See Shiffrin, R.M., & Schneider, W. (1977) Controlled and automatic human information processing II: 

Perceptual learning, automatic attending, and a general theory. Psychological Review, 84, 127-190. 

49 Adams, A.S., & Edworthy, J. (1995) Quantifying and predicting the effects of basic text display variables on the 

perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color. Ergonomics, 38, 

2221-2237; Pracejus, J.W., Olsen, G.D., & O’Guinn, T.C. (2006) How nothing became something: White space, 

rhetoric, history, and meaning. Journal of Consumer Research, 33, 82-90. 

50 See Luckiesh, M., & Moss, F.K. (1940) Boldness as a factor in type-design and typography. Journal of Applied 

Psychology, 24, 170-183. 

51 21 CFR 202.1(e)(1). 

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645 “[q]ualifying disclosures...be legible and understandable,” recognizes that, “in many circumstances 

646 reasonable consumers do not read the entirety of an ad or are directed away from the importance of the 

647 qualifying phrase by acts or statements of the seller.”52 FDA has similar concerns. 

648 

649 FDA assesses the temporal location of SUPERs within a broadcast ad or video when evaluating whether 

650 it is false or misleading. If claims must be qualified to avoid misleading the audience, we recommend 

651 that the qualifier be vocalized, presented through visual images, or placed in a prominent SUPER that 

652 runs concurrently with the claim.53 If SUPERs do not appear close enough to the claim or risk 

653 information requiring qualification, a misleading impression of the product may result.54 In addition, if 

654 qualifying information is complex and requires more than one line of text, we recommend that 

655 manufacturers use other means to convey this information. 

656 

657 Other issues FDA considers important that manufacturers should keep in mind include the following: 

658 

659 — SUPERs, if used, should be reasonably visible to a person under typical viewing conditions. 

660 — All SUPERs should be on screen long enough to allow the audience to read and understand their 

661 full content. 

662 — Graphics that distract from the presentation of risk information, including from risk-related 

663 SUPERs (e.g., busy scenes, frequent scene changes, vivid and compelling visuals55 and moving 

664 camera angles) can misleadingly minimize the risks of the product being promoted by detracting 

665 from the audience’s comprehension of the risk presentation. 

666 — Competition from other SUPERs (e.g., presenting a SUPER related to a particular risk while 

667 unrelated SUPERs are on the screen) hampers the audience’s ability to read and understand the 

668 SUPERs and could compromise the communication of risk information and make a piece 

669 misleading.56 

670 — Factors such as font size, type style, and capitalization can also affect the readability of 

671 SUPERs.57 Words presented in all upper case letters are more difficult to read than words 

672 presented in upper and lower case letters.58 

673 

52 FTC Policy Statement on Deception at 183. 

53 See 21 CFR 202.1(e)(3)(i). 

54 Manrai, L.A., Manrai, A.K., & Murray, N. (1994) Comprehension of info-aid supers in television advertising for 

social ideas: Implications for public policy. Journal of Business Research, 30, 75-84. 

55 Vivid visual images are those images, pictures or other visual stimuli that are emotionally or cognitively 

interesting, attention-getting, compelling, provoking, or personal in a sensory, temporal or spatial manger (after 

Nisbett, R., and Ross, L. (1980) Human Inference: Strategies and Shortcomings of Social Judgment. Englewood 

Cliffs, NJ: Prentice-Hall). Background music can also be distracting (Furnham, A., & Strbac, L. (2002). Music is as 

distracting as noise: The differential distraction of background music and noise on the cognitive test performance of 

introverts and extraverts. Ergonomics, 45, 203-217). 

56 See, e.g., Mackie, D.M., & Worth, L.T. (1989) Processing deficits and the mediation of positive affect in 

persuasion. Journal of Personality and Social Psychology, 57, 27-40; Manrai, L.A., Manrai, A.K., & Murray, N. 

(1994) Comprehension of info-aid supers in television advertising for social ideas: Implications for public policy. 

Journal of Business Research, 30, 75-84. 

57 Baker, S. (2006) Provision of effective information. British Dental Journal, 201, 100; Manrai, L.A., Manrai, 

A.K., & Murray, N. (1994) Comprehension of info-aid supers in television advertising for social ideas: Implications 

for public policy. Journal of Business Research, 30, 75-84. 

58 Paterson, D.G., & Tinker, M.A. (1941) Caps vs. lower-case in headlines. Editor & Publisher, 74, 51. 

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674 • Contrast 

675 

676 Contrast is an important visual factor59 that FDA considers when evaluating television ads and videos.60 

677 As in print pieces, risk disclosures presented in SUPERs should be in a font color that reasonably 

678 contrasts with the background visuals. Because important non-benefit information is often conveyed by 

679 SUPERs, any obstacle to the prominence and readability of this information, and thus to the audience’s 

680 understanding of SUPERs, may result in a misleading risk presentation. 

681 

682 • Dual Mode Considerations 

683 

684 The interplay of visual and audio components in pieces such as television ads and videos introduces 

685 unique factors FDA must consider when evaluating the adequacy of risk disclosure. The issues raised 

686 above in Textual Elements about distracting visuals apply not only to the SUPER presentation but also to 

687 the audio presentation of risks.61 If visuals in a broadcast ad distract the audience from the statement of a 

688 product’s risks, the ad will not, as a whole, convey an accurate impression of the risks of the advertised 

689 product. This distraction could be caused by factors including busy scenes, frequent scene changes, 

690 moving camera angles, and even inherently compelling, vivid visuals. In addition, the overall tone of the 

691 ad or of specific background visuals can affect the comparable prominence of the risks, particularly if the 

692 tone is contrary to the risk message. 

693 

694 Example 20: A video or broadcast ad depicts a joyous or exhilarating moment, contains images of 

695 people enjoying the benefits of the product, or includes otherwise compelling or distracting non696 risk related images while major risks are communicated in a voiceover. The inconsistent tone or 

697 images may be too distracting for the audience to listen to or process the risks, causing the video 

698 or broadcast ad to communicate a false or misleading net impression of the product. 

699 

700 • Audio Considerations 

701 

702 FDA considers several audio-related factors when evaluating pieces such as sound recordings, videos, or 

703 broadcast ads, including television, radio, and telephone communications. 

704 

705 — The qualities of speech should be similar across benefit and risk information for these 

706 components to be considered comparably prominent. 

707 — A critical speech consideration is pacing. If risk information is considerably more difficult to 

708 hear and process than benefit information because it is presented at a much faster pace, the piece 

709 will not convey an accurate impression of the product. 

710 — Markedly reducing volume or being less articulate when discussing risks compared to benefits 

711 may hinder the audience’s comprehension of the risks. 

712 — Background music should be comparable in volume and distraction potential during both benefit 

713 and risk presentations. 

714 

59 Mitzner, T.L., & Rogers, W.A. (2006) Reading in the dark: Effects of age and contrast on reading speed and 

comprehension. Human Factors, 48, 229-240. 

60 Seibert, W.F., Kasten, D.F., & Potter, J.R. (1959) A study of factors influencing the legibility of televised 

characters. Journal of the Society of Motion Picture & Television Engineers, 68, 467-472. 

61 See, e.g, Regan, D.T., & Cheng, J.B. (1973) Distraction and attitude change: A resolution. Journal of 

Experimental Social Psychology, 9, 138-147. 

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715 

716 IV. CONCLUSION 

717 

718 The FDA’s regulation of prescription drug and medical device promotion to healthcare professionals and 

719 consumers is a broad and complex topic. A vast scientific body of knowledge is available regarding 

720 human cognition, and FDA relies on this knowledge when evaluating promotional pieces and making 

721 regulatory decisions about the presentation of benefit and risk information. The Agency hopes that by 

722 discussing the most relevant factors and by providing specific examples, manufacturers will gain a better 

723 understanding of what they should consider as they develop the content and format of their promotional 

724 communications. 

725 

726 It is important to re-emphasize that, in addition to specific risk-related claims, FDA also considers the net 

727 impression conveyed by all the elements of a piece. For this reason, manufacturers should focus not just 

728 on individual claims or presentations, but on the messages conveyed by the promotional piece as a whole. 

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729 

730 ATTACHMENT: STATUTORY AND REGULATORY REQUIREMENTS FOR 

731 LABELING AND ADVERTISING 

732 

733 FDA regulates the manufacture, sale, and distribution of drugs and devices in the United States under the 

734 authority of the Federal Food, Drug, and Cosmetic Act (the Act). This authority includes oversight of 

735 labeling for all drugs and devices and of advertising for prescription drugs and restricted devices. 21 

736 U.S.C. 352(a), (n), (q), & (r). In regulating the labeling and advertising of drugs and devices, FDA 

737 attends to the First Amendment. 

738 

739 The Act defines label to mean “a display of written, printed, or graphic matter upon the immediate 

740 container of any article . . . .” 21 U.S.C. 321(k). According to FDA regulations (21 CFR 1.3(b)): “Label 

741 means any display of written, printed, or graphic matter on the immediate container of any article, or any 

742 such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any 

743 consumer commodity.” The Act defines labeling to mean “all labels and other written, printed, or graphic 

744 matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 

745 U.S.C. 321(m). Similarly, FDA regulations (21 CFR 1.3(a)) provide that labeling includes “all written, 

746 printed, or graphic matter accompanying an article at any time while such article is in interstate commerce 

747 or held for sale after shipment or delivery in interstate commerce.” 

748 

749 According to Kordel v. United States, 335 U.S. 345, 350 (1948), the language “accompanying such 

750 article” in the “labeling” definition includes materials that supplement or explain an article, “in the 

751 manner that a committee report of the Congress accompanies a bill. No physical attachment one to the 

752 other is necessary. It is the textual relationship that is significant.” FDA’s prescription drug advertising 

753 regulations (21 CFR 202.1(l)(2)) thus provide as examples of labeling a wide variety of written, printed, 

754 or graphic matter that bears a textual relationship with a product. 

755 

756 FDA generally recognizes two types of labeling for drugs and devices: FDA-required labeling and 

757 promotional labeling. Much FDA-required labeling is subject to FDA review and approval. For 

758 example, after drafting by the manufacturer, required labeling is reviewed and approved by FDA as part 

759 of the new drug application (NDA), new animal drug application (NADA), biologics license application 

760 (BLA) or premarket approval application (PMA) review (21 CFR 314.50(c)(2), 514.1(b)(3), 601.2(a), and 

761 814.20(b)(10)). 

762 

763 For devices that are not subject to premarket approval, but instead are subject to premarket notification 

764 requirements or are exempt from premarket review, there is no agency review or approval of labeling, but 

765 such devices remain subject to all of the requirements of applicable labeling regulations, including those 

766 for adequate directions for use. For a prescription drug or prescription device to be exempted from the 

767 Act’s requirement of adequate directions for use (21 U.S.C. 352(f)(1)), its FDA-required labeling must 

768 contain, among other information, information addressing product hazards and other risk information, as 

769 specified in FDA regulations.62 

770 

771 Promotional labeling is generally any labeling other than the FDA-required labeling that is devised for 

772 promotion of the product. Promotional labeling may include items such as “brochures, booklets, mailing 

773 pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion 

774 picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar 

62 21 CFR 201.100(d)(1), (3), 201.105(c)(1), & 801.109(d). 

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775 pieces of printed, audio, or visual matter . . . .”63 The Act specifies that a drug or device shall be deemed 

776 to be misbranded if its labeling is false or misleading in any particular. 21 U.S.C. 352(a). The Act further 

777 specifies that labeling or advertising may be considered misleading if it fails to reveal material facts about 

778 the product being promoted, including facts about the consequences that can result from use of the 

779 product as suggested in a promotional piece. 21 U.S.C. 321(n). In addition, the Act specifies that a drug 

780 or device will be deemed to be misbranded if any word, statement, or other information required under 

781 the Act to appear on the label or labeling is not “prominently placed thereon with such conspicuousness 

782 (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to 

783 render it likely to be read and understood by the ordinary individual under customary conditions of 

784 purchase and use.” 21 U.S.C. 352(c). 

785 

786 Advertising64 for prescription drugs and restricted devices is also subject to requirements under the Act 

787 for the disclosure of risk and other information. Under section 502(n) of the Act (21 U.S.C. 352(n)) and 

788 FDA’s implementing regulations (21 CFR Part 202), an ad for a prescription drug must include, in 

789 addition to the product’s established name and quantitative composition, a “true statement” of information 

790 in brief summary “relating to side effects, contraindications and effectiveness” of the product with respect 

791 to the use or uses that the message promotes.65 Advertisements for restricted devices must include “a 

792 brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and 

793 contraindications . . . .” 21 U.S.C. 352(r)(2). For prescription drug advertisements, FDA’s implementing 

794 regulations specify that, among other things, the statutory requirement of a “true statement” is not 

795 satisfied if an ad for a prescription drug product is false or misleading with respect to side effects, 

796 contraindications or effectiveness or if it fails to reveal material facts about “consequences that may result 

797 from the use of the drug as recommended or suggested in the advertisement.” 21 CFR 202.1(e)(5). 

798 Similarly, the Act also specifies that restricted device advertisements must not be false or misleading (21 

799 U.S.C. 352(q)(1)) and must reveal facts that are material about the product being advertised, including 

800 facts about the consequences that can result from use of the product as suggested in an ad. 21 U.S.C. 

801 321(n). 

802 

803 The prescription drug regulations also specify that ads must present a fair balance between information 

804 relating to risks and benefits, which is achieved when the treatment of risk and benefit information in a 

805 promotional piece is comparably thorough and complete throughout the piece. 21 CFR 202.1(e)(5)(ii). 

806 These regulations also provide illustrations of the factors FDA considers in determining whether 

807 promotional pieces comply with the above requirements relating to risk disclosure. Specifically, these 

808 regulations identify twenty types of advertising communications that FDA considers “false, lacking in fair 

809 balance, or otherwise misleading.” 21 CFR 202.1(e)(6). These include, for example, representations or 

810 suggestions that a drug is more effective or safer than has been demonstrated by substantial evidence or 

811 substantial clinical experience, the use of pictures or graphics in a way that is misleading, and the 

812 presentation of risk information “by means of a general term for a group” rather than disclosing specific 

63 See, e.g., 21 CFR 202.1(l)(2). 

64 The act does not define “advertising” or “advertisement.” According to FDA regulations (21 CFR 202.1(l)(1)), 

“Advertisements subject to section 502(n) of the act include advertisements in published journals, magazines, other 

periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone 

communication systems.” 

65 According to 21 CFR 202.1(e)(3)(iii), the information in brief summary relating to side effects and 

contraindications must disclose “each specific side effect and contraindication (which include side effects, warnings, 

precautions, and contraindications and include any such information under such headings as cautions, special 

considerations, important notes, etc. . . .) contained in required, approved, or permitted labeling for the advertised 

drug dosage form(s)” (emphasis added). 

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813 risks. 21 CFR 202.1(e)(6)(i), (xviii), & (xx). Representing or suggesting that a drug product is “safer 

814 than has been demonstrated by substantial evidence or substantial clinical experience” means obscuring 

815 or failing to include the most serious risk information set forth in the drug's FDA-approved labeling, and 

816 does not refer to a failure to include risk information that is not set forth in the drug's FDA-approved 

817 labeling. 

818 

819 In addition, these regulations identify thirteen additional types of advertising communications that “may 

820 be false, lacking in fair balance, or otherwise misleading.” 21 CFR 202.1(e)(7). These include, for 

821 example, advertising communications that fail to “present information relating to side effects and 

822 contraindications with a prominence and readability reasonably comparable with the presentation of 

823 information relating to effectiveness of the drug.” 21 CFR 202.1(e)(7)(viii). 

824 

825 Although the regulations discussed above were promulgated in the context of prescription drug 

826 advertising, the guidance they provide on what FDA considers false or misleading in promotion has 

827 broader applicability. For example, promotional pieces that fail to present a balanced view of the risks 

828 and benefits of a product are generally considered to be false or misleading and also generally fail to 

829 reveal material facts about the product being promoted. Because both labeling pieces for drugs and 

830 devices, and advertising pieces for prescription drugs and restricted devices, are considered to misbrand a 

831 product if they are false or misleading or fail to reveal material facts,66 drug and device manufacturers 

832 should take into account the guidance provided by these regulations when developing promotional 

833 labeling and advertising pieces for their products. 

834 

835 

836 

66 21 U.S.C. 352(a), (n), (q)(1) & 321(n); 21 CFR 202.1(e)(5). 

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