Federal Register, Volume 85 Issue 248 (Monday, December 28, 2020)

[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84339-84343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28544]

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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.

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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 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: 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/commission-actions.
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

[[Page 84340]]

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 age-related 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

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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\
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\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.
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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\
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\2\ In re Pfizer, Inc., 81 F.T.C. 23, 62 (1972).
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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.
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\3\ See, 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-opioid-crisis-already-serious-has-intensified-during-coronavirus-pandemic-11599557401; Issue brief: Reports of increases in opioid- and other
drug-related overdose and other concerns during COVID pandemic,
AMERICAN MEDICAL ASSOCIATION (last updated on Oct. 31, 2020),
https://www.ama-assn.org/delivering-care/opioids/covid-19-may-be-worsening-opioid-crisis-states-can-take-action.
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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\
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\4\ For 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-addiction-treatment-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/letter-commissioner-chopra-congress-deceptive-marketing-practices-opioid
(calling on the FTC to do more to tackle this problem).
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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,

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and hold predatory actors and their enablers to account.\6\
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\5\ Public Law 115-271 Sec. Sec. 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-chopra-regarding-private-equity-roll-ups-hart.
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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.
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\7\ Press 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/marketers-pain-relief-device-settle-ftc-false-advertising.
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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, well-financed defendants that break the law.
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\8\ In one of these matters, the respondents are paying nothing.
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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.
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\9\ 15 U.S.C. 45(m)(1)(b).
\10\ See 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.
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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.
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\11\ This 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).
\12\ Commissioner 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.
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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\
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\13\ My 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.
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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 decision-making. In
contrast, deceptive or false claims inhibit informed decision-making
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.
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\1\ Press 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/news-events/press-releases/2019/10/ftc-fda-warn-florida-company-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/news-events/press-releases/2019/09/ftc-sends-warning-letters-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/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companiesadvertising.
\2\ Press 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/ftc-order-stops-marketer-thrive-supplement-making-baseless-claims.
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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

[[Page 84343]]

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.
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\3\ See, e.g., Part I of Proposed Order, In the Matter of
Bionatrol Health, LLC, et. al. (Dec. 2020).
\4\ See 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-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms.
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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.

\5\ See, 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-commissioner-maureen-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/statement-commissioner-joshua-d-wright-federal-trade-commission-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-matter-genelink-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-ohlhausen-dissenting-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/dissenting-statement-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.
\6\ See Statement of Commissioner Rohit Chopra Regarding the
Cannabidiol (CBD) Enforcement Actions (Dec. 17, 2020).
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[FR Doc. 2020-28544 Filed 12-23-20; 8:45 am]
BILLING CODE 6750-01-P