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

Kristi Wolff
FDA Is Still Keeping Up With The Kardashians
When it comes to the legal side of working with influencers, smart companies focus on ensuring that influencers clearly disclose that they are working with the company. After all, that’s where regulators have focused most of their attention in recent years. But that’s not where a company’s obligations stop – companies also need to take…
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
Food Litigation and Regulatory Highlights – January 2021
Welcome to our monthly digest of litigation and regulatory highlights impacting the food and beverage industry. As it has been for many months, the story was mostly about what’s going on in the food court. Let’s take a look….
Vanilla, vanilla, and more vanilla….The plaintiff’s bar remains skeptical of any product labeled as vanilla. …
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…
You Can Hide Your Covid-Brows, But Don’t Hide Covid Fees
Two articles from the weekend perusal of the Washington Post are worthy of mention here. First, it seems that pandemic eyebrows are driving us all crazy. I don’t have an answer for that problem other than to acknowledge that the struggle is real and none of us stands alone.
Pandemic…
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 …
Federal Trade Commission’s CBD Crackdown: Something Old and Something New
FTC’s CBD Crackdown: Something Old and Something New
This week the FTC announced settlements with six companies accused of making a broad range of unsubstantiated health claims, including that CBD can treat cancer, heart disease, hypertension, Alzheimer’s disease, bipolar disorder, and chronic pain, among others. Nicknamed, “Operation CBDeceit,” the enforcement sweep is part of the…
Webinar Replay: Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims
Find the replay of our webinar Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims here.
COVID-19 has brought a proliferation of products claiming to kill or otherwise inhibit viruses, bacteria and other germs. These products, before they can be legally sold, are heavily regulated by the U.S. Environmental Protection Agency…