Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84339 

3See, e.g., Part I of Proposed Order, In the Matter 

of Bionatrol Health, LLC, et. al. (Dec. 2020). 

4See FDA Press Release, FDA approves first drug 

comprised of an active ingredient derived from 

marijuana to treat rare, severe forms of epilepsy 

(June 25, 2018), available at: https://www.fda.gov/ 

news-events/press-announcements/fda-approvesfirst-drug-comprised-active-ingredient-derivedmarijuana-treat-rare-severe-forms. 

5See, e.g., Statement of Commissioner Maureen 

K. Ohlhausen, In the Matter of Health Discovery 

Corporation and FTC v. Avrom Boris Lasarow, et al. 

(Feb. 2015), https://www.ftc.gov/public-statements/ 

2015/02/dissenting-statement-commissionermaureen-k-ohlhausen-matter-health; Statement of 

Commissioner Joshua D. Wright, FTC v. Kevin 

Wright; HCG Platinum, LLC; and Right Way 

Nutrition, LLC (Dec. 2014), https://www.ftc.gov/ 

public-statements/2014/12/statementcommissioner-joshua-d-wright-federal-tradecommission-v-kevin; Statement of Commissioner 

Joshua D. Wright, In the Matter of GeneLink, Inc., 

and foru International Corporation (January 2014), 

https://www.ftc.gov/public-statements/2014/01/ 

statement-commissioner-joshua-d-wright-mattergenelink-inc-foru; Statement of Commissioner 

Maureen K. Ohlhausen Dissenting in Part and 

Concurring in Part, In the Matter of GeneLink, Inc. 

and foru International Corporation (January 2014), 

https://www.ftc.gov/public-statements/2014/01/ 

statement-commissioner-maureen-k-ohlhausendissenting-part-concurring-part; Dissenting 

Statement of Commissioner Maureen K. Ohlhausen, 

FTC v. Springtech 77376, et al. (July 2013), https:// 

www.ftc.gov/public-statements/2013/07/dissentingstatement-commissioner-maureen-k-ohlhausen; see 

also J. Howard Beales, III and Timothy J. Muris, In 

Defense of the Pfizer Factors, George Mason Law & 

Economics Research Paper No. 12–49 (May 2012), 

available at: https://papers.ssrn.com/sol3/ 

papers.cfm?abstract_id=2087776. 

6See Statement of Commissioner Rohit Chopra 

Regarding the Cannabidiol (CBD) Enforcement 

Actions (Dec. 17, 2020). 

and the marketers have made virtually 

no effort to possess and rely on 

scientific evidence to support their 

strong, express disease claims, as we 

allege in our complaint, I agree that law 

enforcement is appropriate. 

The Commission’s proposed consent 

orders in these matters require 

respondents to possess and rely on 

competent and reliable evidence, 

defined as randomized, double-blind, 

placebo-controlled human clinical trials 

to support disease and other serious 

health claims for these types of products 

in the future.3 Although I support this 

requirement in these cases, for these 

types of claims, I caution that the 

Commission should impose this 

stringent substantiation requirement 

sparingly. Credible science supports the 

use of CBD products to treat certain 

conditions—specifically, the FDA has 

approved a drug containing CBD as an 

active ingredient to treat rare, severe 

forms of epilepsy.4 And I understand 

that many research studies are currently 

seeking to determine whether there are 

other scientifically valid and safe uses 

of this ingredient. 

I agree with my predecessors who 

have stated that the Commission should 

be careful to avoid imposing an unduly 

high standard of substantiation that 

risks denying consumers truthful, useful 

information, may diminish incentives to 

conduct research, and could chill 

manufacturer incentives to introduce 

new products to the market.5 And I 

agree with the observation of my 

colleague Commissioner Chopra in his 

statement that ‘‘[b]aseless claims give 

patients false hope, improperly increase 

or divert their medical spending, and 

undermine ‘a competitor’s ability to 

compete’ on honest attributes.’’ 6

Although I support these cases, I hope 

that the Commission’s actions here, 

which challenge wholly unsubstantiated 

disease claims, do not discourage 

research into the potential legitimate 

benefits of CBD and a wide array of 

other products. In addition, going 

forward, I urge the Commission to focus 

our scarce resources on marketers that 

make strong, express claims about 

diseases and serious health issues with 

little to no scientific support and engage 

in deceptive practices that cause 

substantial consumer injury. 

[FR Doc. 2020–28543 Filed 12–23–20; 8:45 am] 

BILLING CODE 6750–01–P 

FEDERAL TRADE COMMISSION 

[File No. 202 3114] 

Bionatrol Health, LLC; Analysis To Aid 

Public Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed consent agreement; 

request for comment. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

federal law prohibiting unfair or 

deceptive acts or practices. The attached 

Analysis to Aid Public Comment 

describes both the allegations in the 

complaint and the terms of the consent 

order—embodied in the consent 

agreement—that would settle these 

allegations. 

DATES: Comments must be received on 

or before January 27, 2021. 

ADDRESSES: Interested parties may file 

comments online or on paper by 

following the instructions in the 

Request for Comment part of the 

SUPPLEMENTARY INFORMATION section 

below. Please write ‘‘Bionatrol Health, 

LLC, FTC File No. 202 3114’’ on your 

comment, and file your comment online 

at https://www.regulations.gov by 

following the instructions on the webbased form. If you prefer to file your 

comment on paper, mail your comment 

to the following address: Federal Trade 

Commission, Office of the Secretary, 

600 Pennsylvania Avenue NW, Suite 

CC–5610 (Annex D), Washington, DC 

20580, or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW, 

5th Floor, Suite 5610 (Annex D), 

Washington, DC 20024. 

FOR FURTHER INFORMATION CONTACT: 

Keith Fentonmiller (202–326–2775), 

Bureau of Consumer Protection, Federal 

Trade Commission, 600 Pennsylvania 

Avenue NW, Washington, DC 20580. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 6(f) of the Federal Trade 

Commission Act, 15 U.S.C. 46(f), and 

FTC Rule 2.34, 16 CFR 2.34, notice is 

hereby given that the above-captioned 

consent agreement containing a consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained from the FTC 

website at this web address: https://

www.ftc.gov/news-events/commissionactions. 

You can file a comment online or on 

paper. For the Commission to consider 

your comment, we must receive it on or 

before January 27, 2021. Write 

‘‘Bionatrol Health, LLC, FTC File No. 

202 3114’’ on your comment. Your 

comment—including your name and 

your state—will be placed on the public 

record of this proceeding, including, to 

the extent practicable, on the https://

www.regulations.gov website. 

Because of the public health 

emergency in response to the COVID–19 

pandemic and the agency’s heightened 

security screening, postal mail 

addressed to the Commission will be 

subject to delay. We strongly encourage 

you to submit your comments online 

through the https://www.regulations.gov 

website. 

If you prefer to file your comment on 

paper, write ‘‘Bionatrol Health, LLC; 

File No. 202 3114’’ on your comment 

and on the envelope, and mail your 

comment to the following address: 

Federal Trade Commission, Office of the 

Secretary, 600 Pennsylvania Avenue 

NW, Suite CC–5610 (Annex D), 

Washington, DC 20580; or deliver your 

comment to the following address: 

Federal Trade Commission, Office of the 

Secretary, Constitution Center, 400 7th 

Street SW, 5th Floor, Suite 5610 (Annex 

D), Washington, DC 20024. If possible, 

submit your paper comment to the 


tkelley on DSKBCP9HB2PROD with NOTICES
84340 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

Commission by courier or overnight 

service. 

Because your comment will be placed 

on the publicly accessible website at 

https://www.regulations.gov, you are 

solely responsible for making sure your 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include sensitive personal information, 

such as your or anyone else’s Social 

Security number; date of birth; driver’s 

license number or other state 

identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure your 

comment does not include sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on the https://

www.regulations.gov website—as legally 

required by FTC Rule 4.9(b)—we cannot 

redact or remove your comment from 

that website, unless you submit a 

confidentiality request that meets the 

requirements for such treatment under 

FTC Rule 4.9(c), and the General 

Counsel grants that request. 

Visit the FTC website at http://

www.ftc.gov to read this Notice and the 

news release describing the proposed 

settlement. The FTC Act and other laws 

that the Commission administers permit 

the collection of public comments to 

consider and use in this proceeding, as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before January 27, 2021. For information 

on the Commission’s privacy policy, 

including routine uses permitted by the 

Privacy Act, see https://www.ftc.gov/ 

site-information/privacy-policy. 

Analysis of Proposed Consent Order To 

Aid Public Comment 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) has accepted, 

subject to final approval, an agreement 

containing a consent order with 

Bionatrol Health, LLC (‘‘Bionatrol’’); Isle 

Revive, LLC also doing business as Isle 

Revive CBD (‘‘Isle Revive’’); Marcelo 

Torre, individually and as a manager of 

Bionatrol and Isle Revive; and Anthony 

McCabe, individually (collectively, 

‘‘Respondents’’). 

The proposed consent order (‘‘order’’) 

has been placed on the public record for 

30 days so that interested persons may 

submit comments. Comments received 

during this period will become part of 

the public record. After 30 days, the 

Commission will again review the order 

and the comments received, and will 

decide whether it should withdraw the 

order or make it final. 

This matter involves Respondents’ 

advertising for products containing 

cannabidiol (‘‘CBD Products), including 

Bionatrol Full-Spectrum CBD Oil 

Extract. The complaint alleges that 

Respondents violated Sections 5(a) and 

12 of the FTC Act by disseminating false 

and unsubstantiated advertisements 

claiming that their CBD Products, 

among other things: Are safe for all 

users; treat pain better than prescription 

medicine like OxyContin; prevent and 

treat age-related cognitive decline, 

chronic pain, including arthritis pain, 

heart disease, hypertension, and 

migraines; and are ‘‘medically proven’’ 

to (a) improve anxiety, insomnia, 

chronic pain, hypertension, and 

cardiovascular health; (b) treat 

depression and bipolar disorder; (c) 

reduce age-related cognitive decline; (d) 

improve memory recall; and (e) reduce 

arthritis pain, migraines, and headaches. 

The complaint further alleges that 

Respondents misrepresented the cost to 

purchase one bottle of their CBD Oil 

Extract and unfairly charged consumers’ 

credit cards for the additional cost 

without their express informed consent. 

The order includes injunctive relief 

that prohibits these alleged violations 

and fences in similar and related 

conduct. The product coverage would 

apply to any dietary supplement, drug, 

or food that Respondents sell or market, 

including CBD Products. 

Part I prohibits Respondents from 

making any representation about the 

efficacy of any covered product, 

including that such product: 

A. Treats, alleviates, or cures agerelated cognitive decline; 

B. prevents age-related cognitive 

decline; pain, including arthritis pain; 

hypertension; or migraines; 

C. treats, alleviates, or cures any 

disease, including but not limited to 

bipolar disorder; pain, including 

arthritis pain; depression; heart disease; 

hypertension; and migraines; 

D. replaces the need for prescription 

painkillers like oxycontin; or 

E. is safe for all consumers, unless the 

representation is non-misleading, 

including that, at the time such 

representation is made, they possess 

and rely upon competent and reliable 

scientific evidence that substantiates 

that the representation is true. 

For purposes of Part I, competent and 

reliable scientific evidence must consist 

of human clinical testing of the covered 

product, or of an essentially equivalent 

product, that is sufficient in quality and 

quantity based on standards generally 

accepted by experts in the relevant 

disease, condition, or function to which 

the representation relates, when 

considered in light of the entire body of 

relevant and reliable scientific evidence, 

to substantiate that the representation is 

true. Such testing must be: (1) 

Randomized, double-blind, and 

placebo-controlled; and (2) conducted 

by researchers qualified by training and 

experience to conduct such testing. 

Part II prohibits Respondents from 

making any representation, other than 

representations covered under Part I, 

about the health benefits, performance, 

efficacy, safety, or side effects of any 

covered product, unless the 

representation is non-misleading, and, 

at the time of making such 

representation, they possess and rely 

upon competent and reliable scientific 

evidence that is sufficient in quality and 

quantity based on standards generally 

accepted by experts in the relevant 

disease, condition, or function to which 

the representation relates, when 

considered in light of the entire body of 

relevant and reliable scientific evidence, 

to substantiate that the representation is 

true. 

For purposes of Part II, ‘‘competent 

and reliable scientific evidence’’ means 

tests, analyses, research, or studies that 

(1) have been conducted and evaluated 

in an objective manner by experts in the 

relevant disease, condition, or function 

to which the representation relates; (2) 

that are generally accepted by such 

experts to yield accurate and reliable 

results; and (3) that are randomized, 

double-blind, and placebo-controlled 

human clinical testing of the covered 

product, or of an essentially equivalent 

product, when such experts would 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84341 

1 In the Matter of EasyButter, LLC et al., Comm’n 

File No. 2023047; In the Matter of Reef Industries, 

Inc. et al., Comm’n File No. 2023064; In the Mater 

of Steves Distributing, LLC et al., Comm’n File No. 

2023065; In the Matter of CBD Meds, Inc. et al., 

Comm’n File No. 2023080; In the Matter of 

Epichouse, LLC et al., Comm’n File No. 2023094; In 

the Matter of Bionatrol Health, LLC et al., Comm’n 

File No. 2023114. 

2 In re Pfizer, Inc., 81 F.T.C. 23, 62 (1972). 

3See, e.g., Jon Kamp & Arian Campo-Flores, The 

Opioid Crisis, Already Serious, Has Intensified 

During Coronavirus Pandemic, Wall Street J. (Sept. 

8, 2020), https://www.wsj.com/articles/the-opioidcrisis-already-serious-has-intensified-duringcoronavirus-pandemic-11599557401; Issue brief: 

Reports of increases in opioid- and other drugrelated overdose and other concerns during COVID 

pandemic, AMERICAN MEDICAL ASSOCIATION 

(last updated on Oct. 31, 2020), https://www.amaassn.org/delivering-care/opioids/covid-19-may-beworsening-opioid-crisis-states-can-take-action. 

4For example, recent reporting describes the 

‘‘Florida Shuffle,’’ where treatment facilities pay 

brokers to recruit patients through 12-step meetings, 

conferences, hotlines, and online groups, leading to 

serious harm. See German Lopez, She wanted 

addiction treatment. She ended up in the relapse 

capital of America, VOX (Mar. 2, 2020), https://

www.vox.com/policy-and-politics/2020/3/2/ 

21156327/florida-shuffle-drug-rehab-addictiontreatment-bri-jayne. See also Letter from 

Commissioner Chopra to Congress on Deceptive 

Marketing Practices in the Opioid Addiction 

Treatment Industry (July 28, 2018), https://

www.ftc.gov/public-statements/2018/07/lettercommissioner-chopra-congress-deceptivemarketing-practices-opioid (calling on the FTC to 

do more to tackle this problem). 

5Public Law 115–271 §§ 8021–8023 (codified in 

15 U.S.C. 45d). The Act also allows the Commission 

to prosecute deceptive marketing of opioid 

treatment products. Notably, a number of 

respondents in this sweep are alleged to have made 

claims that CBD could replace OxyContin. 

generally require such human clinical 

testing to substantiate that the 

representation is true. 

Part III requires that, with regard to 

any human clinical test or study (‘‘test’’) 

upon which Respondents rely to 

substantiate any claim covered by the 

order, Respondents must secure and 

preserve all underlying or supporting 

data and documents generally accepted 

by experts in the field as relevant to an 

assessment of a test. 

Part IV prohibits Respondents from 

misrepresenting the existence, contents, 

validity, results, conclusions, or 

interpretations of any test, study, or 

other research or that any benefit of any 

covered product is scientifically or 

clinically proven. Part V prohibits 

Respondents from misrepresenting, 

among other things, any cost to the 

consumer to purchase, receive, use, or 

return the initial good or service; that a 

good or service is offered on a ‘‘free,’’ 

‘‘trial,’’ ‘‘sample,’’ ‘‘bonus,’’ ‘‘gift,’’ ‘‘no 

obligation,’’ ‘‘discounted’’ basis, or 

words of similar import; and any 

material aspect of the nature or terms of 

a refund, cancellation, exchange, or 

repurchase policy for the good or 

service. Part VI prohibits Respondents 

from charging any consumer without 

obtaining the consumer’s express 

informed consent to the charge and 

having created and maintained a record 

of such consent. Part VII provides 

Respondents a safe harbor for making 

claims approved by the Food and Drug 

Administration (‘‘FDA’’). 

Parts VIII and IX require Respondents 

Bionatrol and Isle Revive to pay the 

Commission $20,000.00 and describes 

the procedures and legal rights related 

that payment. 

Part X requires Respondents 

Bionatrol, Isle Revive, and Torre to send 

email notices to consumers who 

purchased Bionatrol Full-Spectrum CBD 

Oil Extract informing them about the 

settlement. Part XI requires Respondents 

to submit an acknowledgement of 

receipt of the order, to serve the order 

on certain individuals, including all 

officers or directors of any business 

Respondents control and employees 

having managerial responsibilities for 

conduct related to the subject matter of 

the order, and to obtain 

acknowledgements from each 

individual or entity to which 

Respondents have delivered a copy of 

the order. 

Part XII requires Respondents to file 

compliance reports with the 

Commission and to notify the 

Commission of bankruptcy filings or 

changes in corporate structure that 

might affect compliance obligations. 

Part XIII contains recordkeeping 

requirements for accounting records, 

personnel records, consumer 

correspondence, advertising and 

marketing materials, and claim 

substantiation, as well as all records 

necessary to demonstrate compliance or 

non-compliance with the order. Part 

XIV contains other requirements related 

to the Commission’s monitoring of 

Respondents’ order compliance. Part XV 

provides the effective dates of the order, 

including that, with exceptions, the 

order will terminate in 20 years. 

The purpose of this analysis is to aid 

public comment on the order. It is not 

intended to constitute an official 

interpretation of the complaint or order, 

or to modify in any way the order’s 

terms. 

By direction of the Commission. 

April J. Tabor, 

Acting Secretary. 

Statement of Commissioner Rohit 

Chopra 1

Summary 

• When companies lie about the 

effectiveness of their treatments for 

serious conditions, this harms patients 

and diverts sales away from firms that 

tell the truth. 

• Congress gave the FTC a new 

authority to crack down on abuses in 

the opioid treatment industry, but the 

agency has not prioritized this issue. 

This should change. 

• The FTC can increase its 

effectiveness when it comes to health 

claims by shifting resources away from 

small businesses and by deploying the 

unused Penalty Offense Authority. 

Today, the Federal Trade Commission 

is taking action against several outfits 

regarding their outlandish—and 

unlawful—claims about cannabidiol 

(CBD). While CBD is currently the 

subject of considerable scientific 

research, there is no evidence yet that 

CBD can treat or cure cancer, 

Alzheimer’s, or other serious diseases. 

Baseless claims give patients false hope, 

improperly increase or divert their 

medical spending, and undermine ‘‘a 

competitor’s ability to compete’’ on 

honest attributes.2

I support these actions and 

congratulate those who made them a 

reality. Going forward, however, the 

FTC will need to refocus its efforts on 

health claims by targeting abuses in the 

substance use disorder treatment 

industry, shifting attention toward large 

businesses, and making more effective 

use of the FTC’s Penalty Offense 

Authority. 

First, COVID–19 and the resulting 

economic and social distress are fueling 

new concerns about substance use 

disorders. In particular, there are signs 

that the pandemic is leading to greater 

dependence on opioids.3 It is critical 

that the FTC take steps to prevent 

exploitation of patients seeking 

treatment for substance use disorders. 

I am particularly concerned about 

abusive practices in the for-profit opioid 

treatment industry, and believe this 

should be a high priority. This industry 

has grown exponentially by profiting off 

those suffering from addiction. Many of 

these outfits use lead generators to steer 

Americans into high-cost, subpar 

treatment centers, and some even hire 

intermediaries—so-called ‘‘body 

brokers’’—who collect kickbacks from 

this harmful practice.4

More than two years ago, Congress 

passed the SUPPORT for Patients and 

Communities Act. Among other 

provisions, the Act authorized the 

Commission to seek civil penalties, 

restitution, damages, and other relief 

against outfits that engage in 

misconduct related to substance use 

disorder treatment.5 The Commission is 

well positioned to help shut down these 

abuses, ensure they are not profitable, 


tkelley on DSKBCP9HB2PROD with NOTICES
84342 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

6 Given public reports regarding private equity 

rollups of smaller opioid treatment facilities, the 

Commission can also examine whether 

anticompetitive M&A strategies are leading to 

further patient harm. See Statement of 

Commissioner Rohit Chopra Regarding Private 

Equity Roll-ups and the Hart-Scott-Rodino Annual 

Report to Congress, Comm’n File No. P110014 (July 

8, 2020), https://www.ftc.gov/public-statements/ 

2020/07/statement-commissioner-rohit-chopraregarding-private-equity-roll-ups-hart. 

7Press Release, Fed. Trade Comm’n, Marketers of 

Pain Relief Device Settle FTC False Advertising 

Complaint (Mar. 4, 2020), https://www.ftc.gov/ 

news-events/press-releases/2020/03/marketerspain-relief-device-settle-ftc-false-advertising. 

8 In one of these matters, the respondents are 

paying nothing. 

9 15 U.S.C. 45(m)(1)(b). 

10See Rohit Chopra & Samuel A.A. Levine, The 

Case for Resurrecting the FTC Act’s Penalty Offense 

Authority (Oct. 29, 2020), https://papers.ssrn.com/ 

sol3/papers.cfm?abstract_id=3721256. Particularly 

given challenges to the FTC’s 13(b) authority, 

incorporating a penalty offense strategy can 

safeguard the Commission’s ability to seek strong 

remedies against lawbreakers. 

11This requirement was first established in the 

Commission’s 1972 Pfizer decision, and it has been 

affirmed repeatedly. Pfizer, Inc., supra note 2 

(finding that ‘‘[f]airness to the consumer, as well as 

fairness to competitors’’ compels the conclusion 

that affirmative claims require a reasonable basis); 

In re Thompson Medical Co., 104 F.T.C. 648, 813 

(1984) (collecting cases), aff’d, 791 F.2d 189 (D.C. 

Cir. 1986). Appended to Thompson Medical was the 

Commission’s Policy Statement Regarding 

Advertising Substantiation, which states that ‘‘a 

firm’s failure to possess and rely upon a reasonable 

basis for objective claims constitutes an unfair and 

deceptive act or practice in violation of Section 5 

of the Federal Trade Commission Act.’’ Id. at 839. 

This standard continues to govern the 

Commission’s approach to substantiation, as 

recently reaffirmed in the Commission’s final order 

against POM Wonderful. In re POM Wonderful LLC 

et al., 155 F.T.C. 1, 6 (2013). 

12Commissioner Bailey made this observation in 

the context of opposing industry efforts to repeal 

this authority, an authority she described as an 

‘‘extremely effective and efficient way to enforce 

the law.’’ Testimony of Commissioner Patricia P. 

Bailey Before the Subcomm. on Com., Tourism and 

Transp. of the Comm. on Energy and Com. of the 

H.R. Concerning the 1982 Reauthorization of the 

Fed. Trade Comm’n, at 11 (Apr. 1, 1982), https:// 

www.ftc.gov/system/files/documents/public_

statements/693551/19820401_bailey_testimony_

before_the_subcorrmittee_on_commerce_

subcommittee_on_commerce_touri.pdf. 

13My colleague, Commissioner Christine S. 

Wilson, has issued a statement in this matter. I 

agree that the Commission should not prioritize 

close-call substantiation cases, especially those 

involving small businesses. 

1Press Release, FTC and FDA Warn Florida 

Company Marketing CBD Products about Claims 

Related to Treating Autism, ADHD, Parkinson’s, 

Alzheimer’s, and Other Medical Conditions, Oct. 

22, 2019, available at https://www.ftc.gov/newsevents/press-releases/2019/10/ftc-fda-warn-floridacompany-marketing-cbd-productsabout-claims; 

Press Release, FTC Sends Warning Letters to 

Companies Advertising Their CBD-Infused Products 

as Treatmentsfor Serious Diseases, Including 

Cancer, Alzheimer’s, and Multiple Sclerosis, Sept. 

10, 2019, available at https://www.ftc.gov/newsevents/press-releases/2019/09/ftc-sends-warningletters-companies-advertising-their-cbdinfused; 

Press Release, FTC Joins FDA in Sending Warning 

Letters to Companies Advertising and Selling 

Products Containing Cannabidiol (CBD) Claiming to 

Treat Alzheimer’s, Cancer, and Other Diseases, 

Apr. 2, 2019, available at https://www.ftc.gov/newsevents/press-releases/2019/04/ftc-joins-fda-sendingwarning-letters-companiesadvertising. 

2Press Release, FTC Order Stops the Marketer of 

‘‘Thrive’’ Supplement from Making Baseless Claims 

It Can Treat, Prevent, or Reduce the Risks from 

COVID–19, July 10, 2020, available at https://

www.ftc.gov/newsevents/press-releases/2020/07/ftcorder-stops-marketer-thrive-supplement-makingbaseless-claims. 

3See, e.g., Part I of Proposed Order, In the Matter 

of Bionatrol Health, LLC, et. al. (Dec. 2020). 

and hold predatory actors and their 

enablers to account.6

Unfortunately, the Commission has 

brought zero cases under this new 

authority. While I have supported 

actions like this one that challenge 

baseless CBD claims, as well as previous 

actions charging that pain relief devices 

and similar products were sold 

deceptively,7 I am concerned that we 

have largely ignored Congressional 

concerns about unlawful opioid 

treatment practices. I urge my fellow 

Commissioners to change course on our 

enforcement priorities, especially given 

our limited resources. 

Second, the FTC should focus more of 

its enforcement efforts on larger firms 

rather than small businesses. Today’s 

actions focus on very small players, 

some of which are defunct. While I 

appreciate that small businesses can 

also harm honest competitors and 

families, they are often judgment-proof, 

making it unlikely victims will see any 

relief.8 I am confident that FTC staff can 

successfully challenge powerful, wellfinanced defendants that break the law. 

Finally, the Commission should 

reduce the prevalence of unlawful 

health claims by triggering civil 

penalties under the FTC’s Penalty 

Offense Authority.9 Under the Penalty 

Offense Authority, firms that engage in 

conduct they know has been previously 

condemned by the Commission can face 

civil penalties, in addition to the relief 

that we typically seek.10 For example, 

the Commission routinely issues 

warning letters to businesses regarding 

unsubstantiated health claims. Future 

warning letters can be more effective if 

they include penalty offense 

notifications. 

The Commission has repeatedly 

found that objective claims require a 

reasonable basis,11 and apprising firms 

of these findings—along with a warning 

that noncompliance can result in 

penalties—makes it significantly more 

likely they will come into compliance 

voluntarily. In fact, when the 

Commission employed this strategy four 

decades ago, it reportedly resulted in a 

‘‘high level of voluntary compliance 

achieved quickly and at a low cost.’’ 12

Going forward, we should pursue this 

strategy. 

I thank everyone who made today’s 

actions possible, and look forward to 

future efforts that address emerging 

harms using the full range of our tools 

and authorities.13

Concurring Statement of Commissioner 

Christine S. Wilson 

Today the Commission announces six 

settlements with marketers of 

cannabidiol (CBD) products resolving 

allegations that they made false, 

misleading, and/or unsubstantiated 

express disease claims for their 

products. I support these cases because 

accurate and complete information 

about products contributes to the 

efficient functioning of the market and 

facilitates informed consumer decisionmaking. In contrast, deceptive or false 

claims inhibit informed decisionmaking and may cause economic injury 

to consumers. 

The Commission’s complaints in 

these matters allege that the marketers 

claimed their products could treat, 

prevent, or cure diseases or serious 

medical conditions, including cancer, 

heart disease, Alzheimer’s, diabetes, and 

Parkinson’s disease, and that scientific 

research or clinical studies supported 

these claims. In fact, according to the 

Commission’s complaints, the proposed 

respondents did not conduct scientific 

research on the efficacy of their 

products to treat these diseases or 

conditions. In addition, the complaints 

allege that some of the proposed 

respondents claimed that their products 

could be taken in lieu of prescription 

medication. The Commission has been 

working with the FDA, and on its own, 

to combat false and unsubstantiated 

claims for CBD products, including 

through warning letters 1 and a law 

enforcement action.2 Here, where 

consumers may have foregone proven 

measures to address serious diseases 

and the marketers have made virtually 

no effort to possess and rely on 

scientific evidence to support their 

strong, express disease claims, as we 

allege in our complaint, I agree that law 

enforcement is appropriate. 

The Commission’s proposed consent 

orders in these matters require 

respondents to possess and rely on 

competent and reliable evidence, 

defined as randomized, double-blind, 

placebo-controlled human clinical trials 

to support disease and other serious 

health claims for these types of products 

in the future.3 Although I support this 

requirement in these cases, for these 

types of claims, I caution that the 

Commission should impose this 

stringent substantiation requirement 

sparingly. Credible science supports the 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84343 

4See FDA Press Release, FDA approves first drug 

comprised of an active ingredient derived from 

marijuana to treat rare, severe forms of epilepsy 

(June 25, 2018), available at: https://www.fda.gov/ 

news-events/press-announcements/fda-approvesfirst-drug-comprised-active-ingredient-derivedmarijuana-treat-rare-severe-forms. 

5See, e.g., Statement of Commissioner Maureen 

K. Ohlhausen, In the Matter of Health Discovery 

Corporation and FTC v. Avrom Boris Lasarow, et al. 

(Feb. 2015), https://www.ftc.gov/public-statements/ 

2015/02/dissenting-statement-commissionermaureen-k-ohlhausen-matter-health; Statement of 

Commissioner Joshua D. Wright, FTC v. Kevin 

Wright; HCG Platinum, LLC; and Right Way 

Nutrition, LLC (Dec. 2014), https://www.ftc.gov/ 

public-statements/2014/12/statementcommissioner-joshua-d-wright-federal-tradecommission-v-kevin; Statement of Commissioner 

Joshua D. Wright, In the Matter of GeneLink, Inc., 

and foru International Corporation (January 2014), 

https://www.ftc.gov/public-statements/2014/01/ 

statement-commissioner-joshua-d-wright-mattergenelink-inc-foru; Statement of Commissioner 

Maureen K. Ohlhausen Dissenting in Part and 

Concurring in Part, In the Matter of GeneLink, Inc. 

and foru International Corporation (January 2014), 

https://www.ftc.gov/public-statements/2014/01/ 

statement-commissioner-maureen-k-ohlhausendissenting-part-concurring-part; Dissenting 

Statement of Commissioner Maureen K. Ohlhausen, 

FTC v. Springtech 77376, et al. (July 2013), https:// 

www.ftc.gov/public-statements/2013/07/dissentingstatement-commissioner-maureen-k-ohlhausen; see 

also J. Howard Beales, III and Timothy J. Muris, In 

Defense of the Pfizer Factors, George Mason Law & 

Economics Research Paper No. 12–49 (May 2012), 

available at: https://papers.ssrn.com/sol3/ 

papers.cfm?abstract_id=2087776. 

6See Statement of Commissioner Rohit Chopra 

Regarding the Cannabidiol (CBD) Enforcement 

Actions (Dec. 17, 2020). 

use of CBD products to treat certain 

conditions—specifically, the FDA has 

approved a drug containing CBD as an 

active ingredient to treat rare, severe 

forms of epilepsy.4 And I understand 

that many research studies are currently 

seeking to determine whether there are 

other scientifically valid and safe uses 

of this ingredient. 

I agree with my predecessors who 

have stated that the Commission should 

be careful to avoid imposing an unduly 

high standard of substantiation that 

risks denying consumers truthful, useful 

information, may diminish incentives to 

conduct research, and could chill 

manufacturer incentives to introduce 

new products to the market.5 And I 

agree with the observation of my 

colleague Commissioner Chopra in his 

statement that ‘‘[b]aseless claims give 

patients false hope, improperly increase 

or divert their medical spending, and 

undermine ‘a competitor’s ability to 

compete’ on honest attributes.’’ 6

Although I support these cases, I hope 

that the Commission’s actions here, 

which challenge wholly unsubstantiated 

disease claims, do not discourage 

research into the potential legitimate 

benefits of CBD and a wide array of 

other products. In addition, going 

forward, I urge the Commission to focus 

our scarce resources on marketers that 

make strong, express claims about 

diseases and serious health issues with 

little to no scientific support and engage 

in deceptive practices that cause 

substantial consumer injury. 

[FR Doc. 2020–28544 Filed 12–23–20; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Formative Data Collections for ACF 

Program Support (OMB #0970–0531) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) proposes 

to revise the existing overarching 

generic clearance for Formative Data 

Collections for ACF Program Support 

(OMB #0970–0531) to increase the 

estimated number of respondents and, 

therefore, the overall burden estimate. 

DATES: Comments due within 30 days of 

publication. OMB is required to make a 

decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: The goals of the generic 

information collections under this 

approval are to obtain information about 

program and grantee processes or needs, 

and to inform the following types of 

activities, among others: 

• Delivery of targeted assistance and 

workflows related to program and 

grantee processes, and the development 

and refinement of recordkeeping and 

communication systems. 

• Planning for provision of 

programmatic or evaluation-related 

training or technical assistance (T/TA). 

• Obtaining grantee or other 

stakeholder input on the development 

of program performance measures. 

• Use of rapid-cycle testing activities 

to strengthen programs in preparation 

for summative evaluations. 

ACF uses a variety of techniques such 

as semi-structured discussions, focus 

groups, surveys, templates, open-ended 

requests, and telephone or in-person 

interviews, in order to reach these goals. 

Following standard OMB 

requirements, OPRE will submit a 

change request for each individual data 

collection activity under this generic 

clearance. Each request will include the 

individual instrument(s), a justification 

specific to the individual information 

collection, and any supplementary 

documents. OMB should review 

requests within 10 days of submission. 

Respondents: Example respondents 

include: Current or prospective service 

providers, training or T/TA providers, 

grantees, contractors, current and 

potential participants in ACF programs 

or similar comparison groups, experts in 

fields pertaining to ACF programs, key 

stakeholder groups involved in ACF 

projects and programs, individuals 

engaged in program re-design or 

demonstration development for 

evaluation, state or local government 

officials, or others involved in or 

prospectively involved in ACF 

programs. 

Instrument 

Estimated 

total 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual burden 

hours 

Semi-Structured Discussions and Focus Groups ............................................ 5,000 1 2 10,000 

Interviews ......................................................................................................... 2,500 1 1 2,500 

Questionnaires/Surveys ................................................................................... 2,500 1.5 .5 1,875 

Templates and Open-ended Requests ........................................................... 650 1 10 6,500 


tkelley on DSKBCP9HB2PROD with NOTICES