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…
Welcome 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.
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
If you’re among the over 40% of U.S. consumers who vowed to change how you eat in the new year, fitting into pants that don’t have elastic waistbands may be one of numerous motivators. For many consumers, climate considerations are increasingly among the dietary priorities, and 2022 looks likely to bring plates filled with climate-friendly…
Welcome back from the annual food coma known as Thanksgiving dinner. If you’re still dreaming of cranberries, stuffing, and pumpkin pie, continue the gastronomic journey with our monthly wrap up of what’s been going on in the food court, NAD’s opining on use of emojis to convey advertising claims , and highlights from FDA’s recent…
If the summer slide and the start of school kept you too busy to follow what’s going on in the food scene, we hear you! Catch up on key developments below in this issue of our Food Industry Litigation and Regulatory Highlights.
The Courts Were Kind to the Food Industry This Summer
This summer brought a series of class action victories to the food industry, including a trio of decisions from the Second and Ninth Circuits, both long-time hot beds for false advertising class actions, as well as four dismissals from the Southern District of New York.
At the appellate level, the Second Circuit affirmed the dismissal of a putative class action challenging Starbucks’ claim that its drinks are the “best coffee for you” and that its coffee is “watched over … from the farm to you,” despite the use of pesticides to kill roaches at certain retail locations. The Court ruled that the challenged claims were not specific enough to misrepresent a quality or characteristic of Starbucks’ coffee, and that no reasonable consumer would interpret them to suggest anything about the use of pesticides in Starbucks’ stores.
The Ninth Circuit decertified a class of consumers claiming that Coca-Cola falsely labels its drinks as having no artificial flavors when they contain phosphoric acid, ruling that consumers lacked standing to pursue injunctive relief. According to the Court, the plaintiffs’ claims that they “would consider purchasing” Coke in the future if certain disclosures were included or if the product’s labels were truthful were insufficient to show an actual or imminent threat of future harm.
Continue Reading Food Industry Litigation and Regulatory Highlights, July – September 2021
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…