Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84335 

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). 

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). 

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 

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. 2020–28545 Filed 12–23–20; 8:45 am] 

BILLING CODE 6750–01–P 

FEDERAL TRADE COMMISSION 

[File No. 202 3047] 

EasyButter, 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 ‘‘EasyButter, LLC; 

File No. 202 3047’’ on your comment, 

and file your comment online at https:// 

www.regulations.gov by following the 

instructions on the web-based 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: 

Gideon Sinasohn (404–656–1356), 

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 


tkelley on DSKBCP9HB2PROD with NOTICES
84336 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

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 

‘‘EasyButter, LLC; File No. 202 3047’’ 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 ‘‘EasyButter, LLC; File No. 

202 3047’’ 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 

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 

EasyButter, LLC, (‘‘EasyButter’’) and 

Michael Solomon, individually and as 

an officer and owner of EasyButter, LLC. 

(‘‘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 the Respondents’ 

advertising of products containing 

cannabidiol (‘‘CBD Products). The 

complaint alleges that Respondents 

violated Sections 5(a) and 12 of the FTC 

Act by disseminating false and 

unsubstantiated advertisements 

claiming that: (1) Their CBD Products 

prevent diabetes and treat acne, AIDS, 

autism, bipolar disorder, cancer, 

depression, epilepsy, PTSD, seizures, 

and substance abuse; (2) tests or studies 

prove that their CBD products treat 

autism; and (3) doctors recommend CBD 

over prescription medications for 

depression and PTSD. 

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 the Respondents sell, market, 

promote, or advertise, including CBD 

Products. 

Part I prohibits Respondents from 

making any representation about the 

efficacy of any covered product, 

including that such product will: (1) 

Alleviate or cure seizures; or (2) cure, 

mitigate, or treat any disease, including 

but not limited to acne, AIDS, autism, 

bipolar disorder, cancer, depression, 

diabetes, epilepsy, post-traumatic stress 

disorder, and substance abuse, unless 

the representation is non-misleading, 

including that, at the time such 

representation is made, he possesses 

and relies 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 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84337 

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 

Continued 

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, 

including that, at the time such 

representation is made, 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 

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 the Respondents rely to 

substantiate any claim covered by the 

order, the 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: (1) That any covered 

product is scientifically proven to treat 

autism; (2) that doctors recommend any 

covered product over prescription 

medications for depression, and PTSD; 

(3) that the performance or benefits of 

any product are scientifically or 

clinically proven; or (4) the existence, 

contents, validity, results, conclusions, 

or interpretations of any test, study, or 

other research; are scientifically or 

clinically proven. 

Part V provides Respondents a safe 

harbor for making claims approved by 

the Food and Drug Administration 

(‘‘FDA’’). Part VI requires Respondents 

to pay the Commission $36,254.37 

within 8 days of the effective date of the 

order. Part VII requires Respondents to 

relinquish dominion and all legal and 

equitable right, title, and interest in all 

assets transferred pursuant to the order. 

Part VIII requires Respondents to send 

notices to consumers who purchased 

their CBD products informing them 

about the settlement. Part IX requires 

Respondents to submit an 

acknowledgement of receipt of the 

order, and for the individual 

Respondent to serve the order on certain 

individuals, including all officers or 

directors of any business the individual 

Respondent controls 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 a 

Respondent has delivered a copy of the 

order. 

Part X 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 XI 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 XII 

contains other requirements related to 

the Commission’s monitoring of the 

Respondents’ order compliance. Part 

XIII 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


tkelley on DSKBCP9HB2PROD with NOTICES
84338 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 

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. 

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. 

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, 

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 


tkelley on DSKBCP9HB2PROD with NOTICES
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