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

Function claimed that it had “over 110,000 5-star product reviews” for its hair care products, the majority of which come from its “shampoo and conditioner” category. A competitor filed an NAD challenge pointing out that the total number of 5-star reviews across all product categories was only 63,831. So how did Function get to 110,000?

As part of its routine monitoring program, NAD asked ACT to provide substantiation for statements the company made online about its standardized college entrance test. NAD was concerned about whether ACT sufficiently disclosed the likelihood of cancellations due to COVID-19 and statements about test center availability. The decision is interesting because it sheds light on

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

The American Association of Orthodontists ran a series of social media ads for Happy Mouth Now, a fictional teledentistry company, which showed consumers struggling with the company’s products. The ads are funny, unless you work for a non-fictional teledentistry company, in which case you’d likely choose another adjective to describe them. 

SmileDirectClub challenged the ads

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.

NAD

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….

Litigation

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

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

Comcast recently challenged a number of claims that AT&T made about its Wi-Fi services in two blog posts on the AT&T website. The posts claimed that the company provided the “best possible Wi-Fi experience,” the “best possible in-home connections,” and the “best possible home internet experience.”

Comcast argued that consumers would read the posts to