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Kristi L. Wolff

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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litigation, updates on green claims, thoughts on whether light beer should taste like beer, FDA’s plant-based milks draft guidance, and USDA’s enhanced authority on “organic” claims with the same level of fascination.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

Anyone who has strolled the supermarket alcohol aisle in recent months may fairly stand in awe of the proliferation of boozy and not-so-boozy drinks in pretty packages, with small cans and pastel colors making it difficult to immediately discern whether they contain alcohol and, if so, how much.  According to Nielsen data, in 2021,…

On October 4th, the FDA and CDC announced that the agencies have entered into a Memorandum of Understanding, renewing their collaboration to reduce the occurrence of foodborne illness in retail and foodservice establishments.  The stated purpose of the partnership is to “help increase the consistency and capacity of retail food protection programs…

Earlier this week, as part of the White House Conference on Hunger, Nutrition, and Health, President Biden announced a goal of ending hunger and increasing healthy eating and physical activity by 2030 so fewer Americans experience diet-related diseases.  The strategy identifies actions to be taken across five guiding pillars: first, improving food access and affordability, second, integrating nutrition and health, third, empowering all consumers to make and have access to healthy choices, fourth, supporting physical activity for all, and finally, enhancing nutrition and food security research.  In order to achieve the third pillar, President Biden proposes, among other things, to develop a front-of-packaging labeling scheme for food packages, facilitate sodium reduction in the food supply by issuing longer-term, voluntary sodium targets for industry, and finally to propose an update to the nutrition criteria for a “healthy” claim on food packages. On the heels of this announcement, FDA released a proposed rule that would bring the requirements to use the word “healthy” in a claim in-line with modern dietary guidance.

What Is Changing?

The proposed rule attempts to harmonize the definition of “healthy” with the current recommendations published in the Dietary Guidelines for Americans 2020-2025.  Accordingly, the proposed “healthy” definition uses a food group-based approach in addition to nutrients to limit (based on the understanding that each food group contributes an array of important nutrients to the diet), which has changed since 1994, when the current definition of “healthy” was promulgated.  The proposed rule would also require a food to contain a certain amount from at least one of the food groups or subgroups (vegetables, fruits, grains, dairy, and protein foods) recommended by the Dietary Guidelines in order to use the “Healthy” claim, e.g., there must be at least ½ cup of fruits or vegetables, 3/4 cup of dairy, a range of 1-1 and 1/2 ounces of protein depending on the type, or no less than 3/4 ounce whole grain. Additionally, the new rule discards certain nutrient requirement provisions as no longer relevant while prescribing limits on three specific nutrients – sodium, saturated fat, and added sugar.  Required amounts and limits are all adjusted for each specific food group, as well as the type of item (a mixed product, a main dish, a meal) in question.  Finally, the proposed rule creates a group of foods, including raw and whole fruits and vegetables, and water, that will be automatically considered “healthy” and can use the claim without being subject to requirements for food group equivalent amounts or the nutrients to limit.
Continue Reading FDA Proposes New “Healthy” Definition As Part of Comprehensive Biden Administration Nutrition and Health Initiatives

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

This month’s update kicks off spring with a Best in Show throwback ad comparing dog flea and tick medication, pivots to claims for survivalist ready-to-eat meals (don’t even try to act like you saw that coming), highlights FDA’s recently-issued voluntary recall guidance, provides a food court update on the latest ingredient class actions and cleans…

Food + Personal Care Litigation and Regulatory Highlights – January 2022Welcome to our 2022 inaugural issue of Food and Personal Care Litigation and Regulatory Highlights, where we explore trends and developments from around these industries.  It’s fair to say that the year has started off very busy in both the courtroom and the regulatory arena.  On this chilly winter day, our first stop is in California.

Prop 65

Our friends at Kelley Green Law Blog get the starting position for this issue by highlighting a precipitous uptick in the number of Prop 65 filings over the prior year.  While the Covid-19 pandemic caused all sorts of disruptions to society and the economy, at least one area of business has thrived over the last two years:  private plaintiff enforcement of California Proposition 65.  In 2020-2021, over 40% more Prop 65 actions were brought by private plaintiff “bounty hunters” than in the two years prior to the pandemic (2018-2019).  Compared to a decade ago, private plaintiff groups now initiate three times more Prop 65 actions each year, and five times more than in 2008.  Learn more here about the most frequently cited chemicals and those that are emerging, including PFAS.
Continue Reading Food + Personal Care Litigation and Regulatory Highlights – January 2022