With CBD projected to be a $450 Million industry in the coming year, FDA hosted a packed house of industry stakeholders last week in a day-long public meeting that was the kickoff of a discussion to determine whether there is a pathway for CBD in ingestible products such as foods and dietary supplements. See our
FTC Can’t Challenge Prior Acts in Federal Court Says Third Circuit
In a decision that will limit the Federal Trade Commission’s (FTC) ability in both consumer protection and antitrust matters to bring certain claims in federal court, the Third Circuit Court of Appeals held in FTC v. Shire Viropharma, Inc. that the FTC may only bring a case under Section 13(b) of the FTC Act when
FDA Tightening Oversight of Dietary Supplement Industry
This morning, the FDA announced its intention to engage in greater oversight of the dietary supplement industry. The announcement also conveyed that the Agency had sent 12 warning letters and five advisory letters to companies over the prior two weeks. Some of these letters were jointly issued by FDA and the Federal Trade Commission, focusing
Five Cannabidiol (CBD) Regulatory Myths
The 2018 Farm Bill legalized cultivation and processing of industrial hemp and various by-products. One hemp-based derivative of considerable interest to manufacturers of personal care products, dietary supplements, cosmetics, and OTC drugs is cannabidiol (“CBD”). As industry races to commercialize and advertise CBD, it’s important to understand the regulatory hurdles that remain. Ad law partner,
FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act. In addition to the 11 joint warning letters
Is It Time to Rethink Establishment Claims?
The decision in Kwan v. Sanmedica International, 854 F.3d 1088 (9th Cir. 2017) in April, has occasioned a lot of discussion about the apparent demise of the establishment claim “standard” in California. What the Kwan decision should have done, but did not, is provoke some hard thinking about what this “standard” is and how we use it. From the Kwan decision, it is apparent that the Ninth Circuit does not understand where the establishment claim principle came from and what it means. But its error is understandable, because attorneys and judges have been careless with the principle and arguably have made much more of it than it should be.
Kwan has been accepted as standing for two propositions. The first, which should be non-controversial and unsurprising, is that in private suits brought under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA), a plaintiff must allege and ultimately prove that the offending advertising claim is false, not merely unsubstantiated. There has been no serious dispute about this since the California Court of Appeal (Second District) decision in National Council Against Health Fraud, Inc. v. King Bio Pharmaceuticals, Inc., 107 Cal. App. 4th 1336, 133 Cal. Rptr. 2d 207 (2003). What made Kwan news was that the court also rejected plaintiff’s allegations that defendant’s dietary supplements were “clinically tested to boost [human growth hormone] by a mean of 682%,” is provably false, and in so doing refused to “incorporate Lanham Act provisions into California’s unfair competition and consumer protection law by distinguishing between ‘establishment’ and ‘non-establishment’ claims.” 854 F.3d at 1097.
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Case Dismissed in FTC v. Quincy Bioscience
On Thursday, a federal court in New York dismissed an FTC and New York Attorney General action against Quincy Bioscience, which sells the dietary supplement, Prevagen. Quincy bases claims for its product on research that includes a randomized, controlled clinical study. The court observed that the parties agreed that this “gold standard” study followed “normal
“Free Speech in the Fog of Scientific Uncertainty” by Professor Jane Bambauer
In the following article authored by University of Arizona Law Professor Jane Bambauer, the professor makes a compelling argument that FTC/FDA regulation of health claims should focus on situations where the government has compelling evidence of actual harm. Professor Bambauer offers an opinion that high standards for health benefit claims can effectively silence commercial speech
TINA Has Eyes on Goop
The consumer advocacy non-profit Truth in Advertising, Inc. (TINA.org) has set its sights on Goop, the lifestyle brand launched by Gwyneth Paltrow. In a complaint filed earlier this week with the Santa Clara and Santa Cruz County California district attorneys, both members of the California Food and Drug and medical Device Task Force, TINA alleges they found over 50 instances where claims were made that products Goop produces or promotes “can treat, cure, prevent, alleviate the symptoms of, or reduce the risk of developing a number of ailments.” TINA has requested that the California district attorneys investigate Goop’s marketing practices.
This is not the first time Goop has been forced to defend claims that it promotes. Last summer, the National Advertising Division took issue with claims related to using “dust” dietary supplements, such as Action Dust and Brain Dust, both sold by Moon Juice. The NAD closed the case after Goop agreed to permanently discontinue the dust claims.
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NAD Gives Bill of Good Health to Dietary Supplement Immunity Claims
The National Advertising Division of the Better Business Bureaus, a self-regulatory body that polices national advertising, recently gave an a-OK to certain dietary supplement immunity claims. The action was initiated under NAD’s partnership with the Council for Responsible Nutrition against dietary supplement maker Olly Public Benefit Corporation. CRN requested that NAD determine whether Olly had