National Advertising Division (NAD)

The halfway point of 2022 finds NAD digging deep on supplement substantiation and looking closely at whether product names convey misleading claims.  Here are highlights from the past quarter and links to our posts from earlier this year.  Enjoy!

The Proof Is In the Testing (NAD Case No. 7067)NAD recommended that Dakota Nutrition, Inc., discontinue a broad range of claims relating to the presence of elderberry in the company’s Elderberry Capsules and Elderberry Gummies products, including claims that the products even contain elderberry or provide benefits commonly associated with elderberry.  NAD also recommended that Dakota Nutrition discontinue use of the term “elderberry” in the product name given that Dakota Nutrition was unable to provide a reasonable basis that its products contain elderberry, based on HPLC and HPTLC testing provided by the advertiser.  This case is a reminder of the importance of robust ingredient and finished product testing, particularly as many companies have shifted to alternate suppliers during the pandemic to meet consumer demands.

Mmmm…Chicle (NAD Case No. 7077):  NAD also went deep into ingredient testing in a challenge filed by global confectioner Perfetti Van Melle USA, Inc., against Mazee, LLC, maker of Glee Gum.  Mazee advertised Glee Gum as, among other things, an all-natural, eco-friendly chewing gum made from chicle, a tree sap that Mazee claimed is sustainably harvested from the rainforests of Central America.  To support its claims that Glee Gum contained chicle, Mazee provided information from its supplier stating that the gum base is 94% chicle tree sap (the other 6% consists of candelilla wax and natural citrus acid), along with the results of Carbon-14 testing by Beta Analytic.

Perfetti rebutted that the supplier information did not show that chicle is an ingredient because the CAS Registry Number it listed to identify “Chicle Tree Sap” is not the CAS Registry Number of chicle or any other known chemical substance.  Further, the challenger argued that the results of Mazee’s Carbon-14 tests do not provide any information as to whether the gum base in Glee Gum contains chicle, but only purport to provide information regarding whether the carbon in Glee Gum is plant or fossil-based.  Perfetti further attacked Mazee’s claims with analysis from two experts who concluded that Glee Gum did not exhibit typical chicle-related characteristics and, instead, their analysis suggested the presence of synthetic materials.   Based on this, NAD recommended that the advertiser discontinue claims that the gum base of Glee Gum is “made with chicle.”
Continue Reading Mid-Year Check-in on NAD Food, Supplement and Personal Care Product Cases

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

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

Last week, NAD launched a new, expedited process that will allow companies to challenge advertising claims made by competitors and get a decision within weeks as opposed to months.  The process, “Single Well-defined Issue Fast Track” or “SWIFT” is limited to single-issue cases, condenses and simplifies the standard NAD timeline and process, and is slightly

This month, NAD announced a decision involving T-Mobile’s ads for its TVision service. The service currently allows subscribers to watch TV over a wired broadband connection, though T-Mobile plans to offer wireless technology in the future. The decision covers a lot of ground, but we’ll focus on some key points related to product and feature