Welcome to our curated selection of highlights of regulatory and litigation developments in the dietary supplement and personal care product industries for March 2021. In case you were wondering what pain relief, teeth whitening, and CBD have in common (and, who wasn’t?) it seems that one year into the pandemic, these are the advertising battles
Food Litigation and Regulatory Highlights – February 2021
Welcome to our monthly digest of litigation and regulatory highlights impacting the food and beverage industry. February saw another win for industry on the vanilla front, a preemption win in California state court, and FDA continuing with COVID-19-related warning letters and foreign supplier verification enforcement. Let’s take a look….
Litigation
Industry scored another win on
Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021
Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries. Sit back, relax, and enjoy the read. February was a short month, with a lot going on.
Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”)
The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).
The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.
While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.
This decision is a helpful discussion of the competent and reliable scientific evidence standard. Anyone seeking to understand health claims substantiation better should check it out.
Continue Reading Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021
Ad Law Access Podcast – What to Expect in Consumer Financial Protection and FinTech in 2021
Often when people think about the Consumer Financial Protection Bureau (CFPB) they say to themselves, “well, I’m not a bank so that doesn’t really apply to me.” But consumer financial protection laws are actually much broader and cover all aspects of consumer financial products, any way that consumers bank, pay, or finance transactions and the
Dietary Supplement and Personal Care Products Regulatory Highlights – January 2021
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
ICYMI: The FTC Has Civil Penalty Authority Relative To COVID-Related Advertising
As 2020 drew to a close and Congress scrambled to reach a deal to continue funding the federal government, tucked in amidst the 2124 pages of the 2021 Appropriations Bill is a new power for the FTC: civil penalty authority for deceptive COVID-related acts and practices. Titled the COVID-19 Consumer Protection Act (see page 2094
What If . . . Section 19 of the FTC Act Becomes the FTC’s Best Path to Monetary Relief: Revisiting Figgie International
With one eye on the U.S. Supreme Court, which is being asked to confirm that the FTC has authority to seek monetary relief under Section 13(b) in AMG Capital Management, LLC v. Federal Trade Commission, and the other eye on Congress which may or may not pass legislation authorizing monetary relief under Section 13(b),
FTC Mobile App Enforcement: Mobile App’s Acne Treatment Claims Require 2 Clinical Studies
Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.
In the AcneApp case, the defendants claimed that their apps could treat
FTC Seeks Comment Regarding Retail Food Store Advertising and Marketing Practices Rule
Posted by Sarah Roller
On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission’s review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16
Growing FDA and FTC Collaboration Changes Regulatory Landscape for Marketers
It is no secret that marketers are striving for ways to legally and effectively educate consumers about the health benefits provided by food and dietary supplement products. In fact, Natasha Singer of the New York Times recently reported on the growth of “functional foods” marketed with health benefit claims — a $37.3 billion market in