Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.
NAD tackled substantiation for “#1 Dermatologist Recommended” claims in a challenge involving L’Oreal’s CeraVe moisturizer and use of syndicated survey data to support related claims.
Health claim substantiation was front and center in
The year ended with a flurry of activity related to the FTC’s ability to obtain permanent injunctions and restitution under Section 13(b) of the FTC Act. As we head into 2020, a level-set is in order.
To File or Not File is No Longer the Question
On December 19, 2019, the FTC filed a petition
In 2019, Ad Law Access published 124 stories on a wide range of topics. However, two topics stood out above the others:
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
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
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
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,
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
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.
Continue Reading Is It Time to Rethink Establishment Claims?
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
