• On June 4, a California federal judge dismissed a putative class action complaint challenging Nestle USA, Inc.’s labels on its “Nestle Toll House’s Premier White Morsels.”  Prescott, et al. v. Nestle USA, Inc., Case No. 19-cv-07471-BLF (N.D. Cal. June 4, 2020).
  • Plaintiffs alleged that Nestle’s labeling and advertising misled consumers into believing that the product contained white chocolate. As stated in the complaint, plaintiffs argued that Nestle violated FDA labeling standards by attempting to pass its “Premier White Morsels” as white chocolate through use of the words “white” and “premier,” even though the product did not contain any cocoa or cocoa derivatives. However, the product’s label did not state that it contained white chocolate, or even use the word “chocolate.”
  • U.S. District Judge Beth Labson Freeman noted that similar claims brought by the same plaintiffs were dismissed against Ghirardelli Chocolate Co. in April. In agreement with the Ghirardelli dismissal, Judge Freeman held that the word “white” alone does not lead reasonable customers to believe that the product is white chocolate. Likewise, she stated that the word “premier” was nonactionable puffery.
  • Judge Freeman also denied plaintiffs’ request for an injunction against Nestle, ruling that plaintiffs could not be harmed in the future given that they pled they would not have purchased the morsels had they known they were not white chocolate.
  • Lastly, Judge Freeman denied Nestle’s request to dismiss the complaint with prejudice. Plaintiffs were granted leave to amend the complaint, and stated that they plan to file an amended complaint with a “large-scale, statistically significant” consumer survey that shows 90% of consumers are deceived by Nestle’s white morsel marketing.
  • On June 3, 2020, the Sugar Association filed a Citizen Petition for Prohibition of Misleading Labeling Sweeteners and Request for Enforcement Action (the “Petition”).  The Petition seeks FDA guidance and enforcement on what the association believes are false and misleading sugar reduction claims.  The association observes that “added sugar” labeling requirements have led food manufacturers to replace sugar with alternative sweeteners.  As a result, the association argues that the reformulated products are not understood by consumers to contain alternative sweeteners and, further, use claims that mislead consumers into believing that the reformulated products are healthier.
  • In order to remedy the alleged misleading claims and lack of transparent labeling, the Petition calls upon the FDA to issue regulatory guidance requiring that food labels:
    1. Clearly identify the presence of each sweetening ingredient in the ingredient list that is not already disclosed on the Nutrition Facts label by providing the term “(Sweetener)” following the sweeting ingredient’s name.
    2. Indicate the type and quantity of alternative sweeteners on the fronts of food and beverage products consumed by children.
    3. Disclose gastrointestinal effects of various sweeteners, including all sugar alcohols, at minimum thresholds of effect.
    4. Accompany any “no/reduced sugar” claims with the following disclosures:
      • “Not lower in calories,” unless the reformulated products have 25% fewer calories than the comparison.
      • “Sweetened with [name of Sweeteners(s)]” when sugar alternatives are present.
  • By regulation, the FDA has 180 days to respond to the Petition but a substantive response can take much longer.  Including functional labeling for food additives is reserved only for a few select categories, such as preservatives.  Thus, the request to identify all sweeteners by their functional class name is a big change that could have an impact on the declaration of other food additives. Keller and Heckman will continue to monitor and report on the progress of this petition and any changes to food labeling regulations.

 

  • After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, the market for FDA-regulated food and dietary supplement products that contain cannabidiol (CBD) continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.  Although FDA has not clearly formulated an interim enforcement discretion policy, its CBD enforcement actions thus far have targeted only CBD-containing products that make disease and health-related claims or contain unsafe contaminants.
  • An FDA spokesperson told Food Navigator-USA last week that the Agency has made “substantial progress” toward a goal of providing additional guidance on ingestible CBD products but offered no specific details and continued to emphasize that FDA has questions about the science, safety, effectiveness, and quality of CBD products.  The FDA spokesperson declined to comment on FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry’” which was recently posted as pending review by the Office of Management and Budget (OMB) and was taken as an encouraging sign for industry.
  • It is not clear whether this new guidance document on human clinical studies of CBD represents progress toward a regulatory pathway for food and dietary supplements, since the title suggests that it addresses scientific issues rather than regulatory ones.  Nevertheless, human clinical studies would help address FDA’s safety concerns with the use of CBD in such products (although animal studies would certainly be important too).
  • Last year we reported on FDA’s announcement on the “New Era of Smarter Food Safety”, an effort intended to combine the implementation of Food Safety Modernization Act (FSMA) with new and emerging technologies. The effort was set to begin with the development of the “Blueprint for a New Era of Smarter Food Safety.”
  • On June 2, 2020, FDA released an update on the effort titled “Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety,” in which they announced that—due to the COVID-19 pandemic—plans to announce the Safety Blueprint had been delayed.
  • FDA announced that it will release the blueprint in the coming weeks that will outline its plan to create a safer food system over the next decade.  In light of lessons learned during the pandemic, FDA has revised and accelerated measures in the blueprint, including enhanced traceability, smarter tools for protecting food ordered online, and promotion of a food safety culture, as described below:
    • Food Traceability – FDA has noted that enhanced traceability could help FDA and the food industry anticipate marketplace imbalances, such as those that resulted in shortages of certain commodities during the pandemic.
    • Smarter Tools for Foods Ordered Online – Online food ordering and delivery have skyrocketed in recent months due to COVID-19 and are likely to continue in popularity; the blueprint will discuss tools like root cause analyses to understand how foods were contaminated and use data to anticipate the likelihood of contamination.
    • Food Safety Culture – the plan addresses the establishment and support of food safety cultures on farms, food facilities, and at home—primarily through education initiatives.
  • As consumers spend more time online during COVID-19, FDA has increased its oversight of product claims made through testimonials, customer reviews, and blog posts posted to company social media accounts and websites, as those may signal a company’s intent to communicate information about its products.  In particular, FDA has been concerned about products that claim to treat COVID-19 or products that make mental health claims.
  • FDA has sent out warning letters to manufacturers that make claims on social media, whether made directly by the company or endorsed by the company through a retweet on Twitter or a “like” on Facebook.  For example, on May 4, 2020, FDA sent a warning letter to Honey Colony LLC where it cited social media posts and retweets to claims that the company’s products could treat COVID-19.  In the letter, FDA noted that it reviewed the company’s Twitter and Instagram pages because the company used these sites to direct customers to buy products on the company’s website.
  • By way of background, FDA has viewed “retweets” or “likes” as company endorsement, as FDA considers social media posts and claims as part of a product’s labeling.  Under the Food, Drug and Cosmetic Act, labeling is defined as “written, printed or graphic material accompanying a product.”  The Agency has interpreted this to include infomercials, website, brochures, and social media as an extension of labeling; however, some argue that FDA has no jurisdiction over social media.  Instead, some argue that social media falls under the Federal Trade Commission’s (FTC) jurisdiction, as FTC regulates advertising.  We will continue to monitor any developments.
  • On May 27, 2020, U.S. District Judge Edgardo Ramos in the U.S. District Court for the Southern District of New York entered an order of permanent injunction against two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs, including their Organic Hemp Seed Oil and Cassava Meal. The complaint was filed by the U.S. Department of Justice on behalf of the FDA. See FDA’s news release regarding the injunction here.
  • The court concluded that Sundial’s products have no published adequate and well-controlled studies to support their claims, and that the FDA has not approved any application for any of Sundial’s drugs, despite Sundial claiming that their products can cure, treat, or prevent a wide variety of disease such as syphilis, cancer, and HIV/AIDS. For example, Sundial claims that the hemp seed oil “suppresses the growth of cancer” and the cassava meal “prevents heart disease.”
  • Under the injunction, Sundial and the named individuals cannot directly or indirectly receive, label, hold, or distribute drugs at or from their facility until steps are taken to ensure all products comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the injunction, including recalling their drugs, hiring qualified experts to ensure conformity with the FD&C Act, and receiving written permission from the FDA to resume operations.
  • Sundial had received previous warnings from the FDA and, according to the federal complaint, repeatedly promised to correct any violations. For example, FDA conducted multiple inspections at Sundial between 2012 and 2017, as well as issued a warning letter to Sundial in 2013. According to the FDA, Sundial did not make any of the necessary corrections.
  • The EU’s European Food Safety Authority is expected to approve the sale of insects for human consumption in a move which could mean that European grocery stores will soon be lined with the likes of whole or ground mealworms, lesser mealworms, locusts, crickets and grasshoppers. Although insects have not traditionally been regarded as a food in Western cultures, in some parts of the world insects are considered delicacies and cultural staples, and globally more than 2 billion people in over 113 countries eat insects.
  • The coming century is predicted to bring rapidly rising populations and warming climates that will change the agricultural landscape, and the commercialization of insect consumption has been offered as a means to continue to sustain the global food supply despite these challenges. While insects may be part of the solution to these long-term problems, the immediate challenges of the COVID-19 pandemic in the U.S., including meat shortages resulting from closures of processing facilities, have generated conversation regarding the prospect of edible insects as an alternative source of nutrition. Edible insects are in fact rich in protein and good fats, and high in calcium, iron, and zinc.
  • Edible insects must however overcome significant hurdles in the U.S. market. Perhaps most importantly, public perception will have to change to view insects as food. Furthermore, while the FDA seems to have tacitly accepted that insects used as food or components of food are “food” as defined in the Federal Food Drug and Cosmetic Act (the “FD&C Act”), if regulated as “food,” insects would be subject to the regulatory framework of food generally, including that the food not be adulterated. Since FDA regulation of insects to date has focused on regulating them as “filth,” the presence of which renders a food adulterated under the FD&C Act, such a regulatory framework, which would have to distinguish between insects as food and insects as filth, poses significant challenges that likely will require further guidance from the FDA as more insect based food products become available. Keller and Heckman will continue to monitor updates to the regulation of edible insects.

Godiva Can’t Slip Suit Over Using ‘Belgium 1926’ on Labels (subscription to Law360 required)

  • A proposed class action lawsuit filed against Godiva Chocolatier in January 2019 alleges that consumers in New York and California were misled by the claim “Belgium 1926” on chocolate that was made in Pennsylvania.  The plaintiffs assert that Belgium, the country of origin implied by the claim, is recognized “as producing among the highest quality chocolates in the world,” and that American chocolate is different.  Godiva motioned to dismiss the lawsuit, arguing that a reasonable consumer would realize that the disputed claim only means that the company was founded in Belgium in 1926.
  • On May 29, 2020, a judge in the U.S. District Court for the Southern District of New York ruled that the disputed claim creates a “plausible inference” that the chocolates are made in Europe.  Thus, numerous claims alleging violations of New York and California consumer protection laws may proceed.  The judge denied injunctive relief, however, ruling that plaintiffs lacked standing because their potential for future harm is conditional, being dependent on plaintiffs choosing to purchase the chocolate again.
  • Godiva reportedly told Law360 that it will continue to fight the proposed class action lawsuit, maintaining the “Belgium 1926” claim clearly pertains only to the company’s heritage.  Godiva is concurrently defending a lawsuit filed by an individual under the District of Columbia’s consumer protection laws based on the “Belgium 1926” claim.  On February 18, 2020 in an order remanding the individual lawsuit to the D.C. Superior Court, the U.S. District Court for the District of Columbia concluded that it lacked subject matter jurisdiction and denied Godiva’s request to transfer the case to the federal court in the Southern District of New York.
  • On May 26, 2020, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint warning letters to four companies for the marketing and sale of products deemed fraudulent for the treatment or prevention of COVID-19 (Coronavirus Disease 2019).
  • FDA warned CBD Gaze (CBD products), Alternavita (grapefruit seed extract, colostrum, and cod liver oil products), Musthavemom.com (colloidal silver, vitamins, minerals, herb oils, and a homeopathic drug product), and Careful Cents, LLC (essential oil products), regarding the companies’ promotion, including through referrals as Amazon Associates, of their respective products with claims that they mitigate, prevent, treat, diagnose, or cure COVID-19.
  • FDA demanded that the four companies immediately cease to promote and participate in the sale of the products at issue, and requested confirmation in writing, within 48 hours, of the specific steps being taken by the companies to correct the violations. In addition, FDA indicated that the companies will be added to a list published on FDA’s website of companies that have received FDA warning letters for fraudulent products related to COVID-19.
  • There are currently no FDA-approved products for the prevention or treatment of COVID-19, and FDA indicates it is taking urgent measures to protect consumers from products that—without approval or authorization by FDA—claim to mitigate, prevent, treat, diagnose, or cure COVID-19. In addition, it is unlawful to market or advertise that a product can prevent, treat, or cure human disease, unless adequately substantiated by competent and reliable scientific evidence (including, when appropriate, well-controlled human clinical studies) supporting the validity of the claims at the time they are made (and there is no such evidence that applies to the products at issue here). Companies that sell products with unapproved claims regarding COVID-19 may be subject to enforcement actions such as seizure, injunction, and restitution.
  • On May 27, 2020, the U.S. Food and Drug Administration (FDA) released a guidance document entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.”  FDA issued this guidance to provide certain FDA-regulated food establishments (i.e., human food facilities and farms, but not restaurants and retail food establishments), with a convenient mechanism to voluntarily report if they have temporarily ceased or significantly reduced production, or if they are considering doing so.  FDA noted that this reporting mechanism may also be used to request assistance from the Agency regarding issues that may affect continuity of operations during the pandemic.
  • By way of background, facilities that manufacture/process, pack or hold food for consumption in the U.S. must register with FDA when initially beginning operations and then update that registration on a biennial basis and within 60 days of when certain changes in their operations occur.  FDA noted that rapid notification regarding certain FDA-regulated food establishments that are temporarily closing or reducing production will help FDA better understand the current status of the food supply and address challenges facing food producers to help support food production.
  • To address issues that may affect continuity of operations during the pandemic, FDA can provide information, such as relevant guidance, in areas including protecting worker safety, inability to access protective equipment for personnel, and supply chain imbalances.  In its guidance, FDA noted that it will work with other agencies, like the Centers for Disease Control and Prevention, Department of Homeland Security, Department of Agriculture, Occupational Safety and Health Administration, the Federal Emergency Management Agency, and State, local, tribal and territorial regulatory partners to provide the most up-to-date information.
  • This guidance is intended to remain in effect only for the duration of the public health emergency related to COVID-19.