Dietary Supplements

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This past week, the internet lit up over whether it was okay for President Biden and the First Lady to order the same dish at the Red Hen.  In this issue, we invite you to read the February highlights on clean labeling false advertising litigation, updates on green claims, thoughts on whether light beer should taste like beer, FDA’s plant-based milks draft guidance, and USDA’s enhanced authority on “organic” claims with the same level of fascination.  

“Clean at Sephora” Motion to Dismiss A Test for the Reasonable Consumer Standard

Clean claims on foods, supplements, OTC drugs and cosmetics have surged in popularity as have retailers’ efforts to curate product selections and ingredients to eliminate disfavored ingredients, such as synthetic dyes, preservatives, fragrances, parabens, phthalates, etc.  “Clean” is not defined in regulations, which means that each brand or retailer must explain to shoppers how it’s defined within that brand.  In fact, many popular lifestyle-related terms – vegetarian, vegan, keto, cruelty-free, etc. – also are not defined by regulation. 

To the delight of advertising lawyers and the chagrin of marketers, the answer to the question of how to deal with potentially vague terms is through clear and conspicuous disclosures.  It is just this scenario that is at issue in a pending false advertising lawsuit, Finster v. Sephora USA Inc.…

Continue Reading Food + Personal Care Product Litigation and Regulatory Highlights – February 2023

Welcome to the 2023 inaugural issue of our newsletter, where we explore litigation and regulatory trends and developments from around the food, dietary supplement, and personal care industries.  Like most everybody else, we’ve given up on our new year’s resolutions, so let’s go to the food court.

The Food Court – Vanilla Cases Melt Away But Other Ingredient Theories Rise

With courts expressing continued skepticism about vanilla bean false advertising theories, plaintiffs are targeting a slew of other ingredient-based false advertising angles.  For example, in Patoni et al. v. Spindrift Beverage Co., the plaintiff claims that Spindrift’s “clean” branding and messaging trumpeting that the drinks contain only water and fruit are false and misleading because the products also contain citric acid, which is plainly disclosed on the ingredient declaration.  Because many courts do not expect consumers to look beyond a product’s front panel to read ingredient declarations, those three words – yup, that’s it – which are pervasive in Spindrift’s branding, are likely to be highly significant because they expressly tell the consumer that there is nothing else in the products.

Where consumers are basing their lawsuits on assumptions rather than express claims, courts are more likely to view them as… half-baked.  An Illinois court dismissed a claim that Bimbo Bakery’s brown bread was falsely advertised because the bread’s dark color, visible flecks of grain and “brown bread” name caused consumers to believe it has a higher grain content, when it is actually made with enriched flour and has only 4% of the daily fiber value.  The court found that the plaintiff’s assumptions about the bread content were unreasonable.  Even if the bread’s color and obvious presence of grain suggested that the product had whole grains, it was no guarantee of the product’s precise grain content.  The court stated: No reasonable consumer could conclude what percentage of whole wheat the bread contains merely by these toppings.…

Continue Reading Food + Personal Care Industry Insights – January 2023

Yesterday, the FTC’s Bureau of Consumer Protection released its Health Products Compliance Guidance—a sweeping overhaul of the 1998 Guidance, Dietary Supplements: An Advertising Guide for Industry.  Unlike the recently announced effort to review its Green Guides, the FTC did not seek public comment prior to issuing this update. 

According to an FTC blog post that accompanied its release, the new Guidance purports to “correct misunderstandings” and “urban myths” that have circulated about FTC substantiation standards.  In actuality, however, the new Guidance represents a recitation of some of the positions the agency has taken in health-related enforcement matters over the last decade, continuing a stark departure from the prior “flexible” approach to substantiation set forth in the 1998 Guidance.

While FTC guidance does not have the force and effect of law, if a person or company fails to comply with a guide, the Commission might bring an enforcement action alleging an unfair or deceptive practice in violation of the FTC Act.  This makes the new Guidance a must-read for any company operating in the food, supplement, personal care, health equipment or app, or related industries. 

While there is quite a bit of material to digest in this new Guidance, including a new definition of what constitutes a clear and conspicuous disclosure and an entirely new section addressing advertisers’ mischaracterization of FDA approval, here are two main takeaways: 

First, the 2022 Guidance encompasses a far wider industry scope than its predecessor.  While the 1998 Guidance was, by title and content, focused on dietary supplement products, the 2022 Guidance purports to guide advertising practices for “any health-related product,” including dietary supplements, foods, over-the-counter (OTC) drugs, homeopathic products, devices, health equipment, diagnostic tests, and health-related apps.” …

Continue Reading Misguided:  The FTC Attempts to Redefine the Law with its Health Products Compliance Guidance

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

As they often have done in the past, the FTC and the FDA issued joint cease and desist letters last week to 10 companies suspected of making unproven health claims – in this instance, claims that dietary supplements treat or cure diabetes. The FTC and the FDA join forces on such letters in order to…

The dietary supplement and personal care product space continued to see enforcement on false CBD, COVID, and fertility claims as well as related litigation involving “germ-killing” claims on hand sanitizers and wipes.  Messy stuff…Let’s take a look…

LITIGATION

Personal Care Products

In a blow to the trending “pink tax” theory of liability in consumer class actions, in May, the Eighth Circuit ruled that various personal care product manufacturers and retailers did not violate Missouri’s anti-discrimination laws by charging more for products marketed towards women as compared to allegedly identical products that were either marketed towards men or utilized gender-neutral marketing.  The Court found that the plaintiff “mistakes gender-based marketing for gender discrimination” and, in the process, ignores numerous differences between the products that account for the higher price tag.  There has been a handful of similar “pink tax” cases filed over the last year or two, but this is the first appellate court to rule on the issue.
Continue Reading Dietary Supplement and Personal Care Products Regulatory and Litigation Highlights – May and June 2021

Welcome to our monthly digest of litigation and regulatory highlights impacting the personal care product and dietary supplement industry.  April saw a re-emphasis on restriction of COVID-related claims in advertisements for supplements and therapies, developments in various class action cases, including a win for consumers challenging hand sanitizer’s claims of killing 99.99% of germs and a slew of new “natural” class actions, and finally a roller coaster ride for the FTC involving major blows and power moves.

Let’s take a look….
Continue Reading Dietary Supplement and Personal Care Products Regulatory and Litigation Highlights – April 2021

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…

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…

The year ended with a flurry of activity related to the FTC’s ability to obtain permanent injunctions and restitution under Section 13(b) of the FTC Act.  As we head into 2020, a level-set is in order.

To File or Not File is No Longer the Question

On December 19, 2019, the FTC filed a petition…