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
Following weeks of speculation about a potential role for Columbia Law Professor Tim Wu in the Biden Administration, the White House announced on March 5 that Wu has been named Special Assistant to the President for Technology and Competition Policy. As an official housed in the National Economic Council (“NEC”), Wu will not directly command staff within federal agencies or set the agencies’ enforcement or regulatory agendas. Instead, Wu will most likely focus on coordinating federal agencies’ efforts to identify and address competition issues. Given his history, Wu could seek to have particular influence on the Federal Communications Commission (“FCC”) and Federal Trade Commission (“FTC”) as they shape their Biden Administration agendas.
Continue Reading Competition Policy Gets a Top Spot in the White House
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
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.
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
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
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),
The FTC recently announced that glue maker, Chemence, paid a landmark $1.2 million settlement to resolve allegations that the company failed to comply with a 2016 Order regarding “Made in USA” claims. The 2016 Order required Chemence to pay $220,000 and to stop making misleading claims that its products were made in the United States.
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
Seven months after being called upon by members of Congress to investigate Zoom’s data security practices, a divided FTC announced on November 9 a settlement with the videoconferencing platform.
The FTC’s five-count administrative complaint alleges that Zoom deceived users about several of its security features and harmed users by circumventing security and privacy controls provided
