• Danone US, LLC (“Danone”) has successfully challenged Chobani LLC (“Chobani”) before the National Advertising Division (NAD) of BBB National Programs for claiming that Chobani’s Less Sugar Greek Yogurt contains “45% less sugar than other yogurts.”  NAD decided that Chobani’s claim was overly broad and recommended that the claim be revised.
  • Danone argued that the Chobani claim mislead consumers to believe that “other yogurts” includes plain yogurts and yogurts made with non-nutritive sweeteners.  NAD agreed that the Chobani claim was misleading because it implied that “other yogurts” includes non-nutritive sweetened yogurts, but disagreed that the claim includes plain yogurt products.  Chobani has agreed to comply with NAD’s decision and will revise its claim to clarify that “other yogurts” does not include yogurts made with non-nutritive sweeteners.
  • The Danone-Chobani challenge is the latest NAD case in which sugar claims have been challenged by a competitor, and we expect to see more competitive challenges of sugar claims given their popularity.  Keller and Heckman advises and represents clients in various stages and types of NAD proceedings.
  • On December 30, 2020, FDA issued an alert to pet owners and veterinary professionals about the recalls of certain Sportmix pet food products. Midwestern Pet Food, Inc. announced a recall of nine total lots of Sportmix pet food products after the reports of at least 28 dogs that have died and 8 that have fallen ill after consuming the products. The Missouri Department of Agriculture tested multiple product samples and found very high levels of aflatoxin. Aflatoxin is a toxin produced by the mold Aspergillus flavus and at high levels can cause illness and death in pets. The toxin can be present even if there is no visible mold.
  • According to the FDA, pets are highly susceptible to aflatoxin poisoning because they generally eat the same food continuously over extended periods of time. If a pet’s food contains aflatoxin, the toxin could accumulate in the pet’s system as they continue to eat the same food. Pets with aflatoxin poisoning may experience symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), and/or diarrhea. In some cases, this toxicity can cause long-term liver issues and/or death. Some pets suffer liver damage without showing any symptoms. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, the FDA recommends that pet owners always wash their hands after handling pet food.
  • FDA’s alert warned pet owners to discontinue feeding the recalled pet food products – a list of the affected products is provided by FDA on their website. Retailers have also been advised not to sell or donate the recalled products and to contact consumers who have purchased such products, if possible. Additionally, FDA asked veterinarians who suspect that their patients have aflatoxin poisoning to report the events through a Safe Reporting Portal or by calling local FDA Consumer Complaint Coordinators. Pet owners are also encouraged to report suspected cases.
  • FDA is conducting follow-up activities at the manufacturing facility and notes that, as this is a developing situation, the Agency will update the alert with additional information as it becomes available.
  • On December 29, 2020, the U.S. Department of Agriculture (USDA) and Health and Human Services (HHS) published the Dietary Guidelines for Americans, 2020-2025. The Dietary Guidelines are updated every five years by these agencies and are intended to provide science-based guidance to promote healthy eating, reduce risk of chronic disease, and prevent disease.
  • These Dietary Guidelines are the first to provide guidance on healthy eating by life stage, from birth through older adulthood, including pregnant and lactating women.
  • Its key recommendations are:
    • Limiting added sugars to less than 10% of calories per day for ages 2 and older and to avoid added sugars for infants and toddlers;
    • Limiting saturated fat to less than 10% of calories per day starting at age 2;
    • Limiting sodium intake to less than 2,300 mg per day (or even less if younger than 14);
    • Limiting alcoholic beverages to 2 drinks or less a day for men and 1 drink or less a day for women.
  • The Dietary Guidelines make the following comments regarding plant-based products.  First, the Guidelines state that shifts in protein intake are needed and recommend replacing processed or high-fat meats with seafood or beans, peas, and lentils to reduce intake of fat and sodium. The Guidelines also include soy beverages (i.e., soy milk) and soy yogurt as part of the dairy group because they are similar to milk and yogurt in nutrient composition and use in meals. In contrast, other plant-based products sold as “milks” (e.g., almond, rice , coconut, oat, and hemp “milks”), while they may contain calcium and be consumed as a source of calcium, are not included as part of the dairy group because their overall nutritional profile is not similar to dairy milk and fortified soy beverages.
  • While the Dietary Guidelines are intended as guidance for all Americans and the scientific evidence that was reviewed is representative of both those who are healthy and those who are at risk of diet-related chronic conditions and diseases, they emphasize that individuals, especially those with chronic diseases, must adapt the Dietary Guidelines to meet their specific needs.
  •  As our readership is aware, FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact on the food industry of having to respond separately to each change.  When necessary, however, FDA also sets specific compliance dates outside the uniform compliance date.  When FDA sets a compliance date outside the uniform compliance date, it is typically to provide industry with more time than would have otherwise been permitted under a uniform compliance date.
  • Today, FDA released a prepublication copy of a January 6, 2021 Federal Register notice that will set January 1, 2024 as the uniform compliance date for final food labeling regulations that require changes in the labeling of food products and that publish on or after January 1, 2021 and on or before December 31, 2022.  As in the past, FDA has noted that special circumstances may justify a different compliance date in some cases.  The uniform compliance date, January 1, 2024, or a different specified date, if applicable, will always be identified in any final food labeling regulation.
  • All food products subject to the January 1, 2024 compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2024.

 

  • On December 22, the FDA issued a Warning Letter to Whole Foods Market “for a pattern of receiving and offering for sale misbranded food products necessitating a series of food recalls for allergens.” This is the first time the FDA has warned a retailer for engaging in such a pattern of selling misbranded food products containing undeclared allergens.
  • From October 2019 to November 2020, Whole Foods recalled 32 food products because the presence of major food allergens was not listed on the finished product labels. The FDA noticed similar patterns of recalls for undeclared allergens in previous years as well. The recalled products included a variety of foods sold under the Whole Foods in-house brand, although the foods were primarily from the deli and bakery sections of the store. For example, products were misbranded for failure to declare the presence of milk, eggs, and almonds, among other examples.
  • As our readers know, food or ingredients that contain one of the eight major allergens must be specifically labeled with the names of the allergen source. The eight major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. According to the FDA, undeclared food allergens have been the number one leading cause of Class I food recalls for at least the last three years. Thus, FDA has ongoing efforts to address undeclared allergens by analyzing patterns of recalls and have begun several initiatives to improve industry’s compliance with allergen labeling. For instance, in 2020, the FDA sent 8 warning letters to companies for issues related to undeclared allergens.
  • While the Warning Letter is unprecedented it reconfirms FDA’s attention and efforts to reduce the prevalence of allergen recalls. In an FDA press release, William A. Correll, Jr., Director of the Office of Compliance at CFSAN, stated that “[t]he entire food supply chain can and must do better to prevent exposing consumers to incorrectly labeled packaged food […] Manufacturers should also ensure they have controls in place to prevent unintentionally adding allergens during their manufacturing processes. When they fail to follow the law, we will take the necessary action.”

The next issue of The Daily Intake will publish on January 4, 2021. Keller and Heckman LLP wishes everyone a wonderful holiday season.

  • For the second time this week, FDA has proposed to revoke a standard of identity (SOI), this time for French dressing. (For our blog post on the proposed revocation of the frozen cherry pie standard of identity, see here.) FDA’s action is in part a response to a citizen petition submitted by the Association for Dressing and Sauces (ADS) in 1998.
  • The SOI for French dressing, which is codified in 21 C.F.R 169.115 (“French dressing”) was established in 1950 and most recently amended in 1974. FDA’s proposed withdrawal stems from its understanding that the market for salad dressing has significantly changed and that the standard of identity no longer serves to protect consumer’s expectations. Rather, FDA believe that consumers have come to expect a French dressing that no longer exactly conforms to the regulation. For example, while tomatoes or tomato derived ingredients are optional according to the French dressing SOI, FDA believes that the majority of consumers expect these ingredients to be present in a French dressing. Further, French dressing is sold in lower-fat varieties that contain less than the 35% by weight of vegetable oil required by the French dressing SOI.
  • As a result of these changes in the market, the FDA has tentatively concluded that revocation of the French dressing SOI would provide additional flexibility to the industry and encourage further innovation to produce dressings that align with consumer expectations. Comments on the proposed rule are due by March 22, 2021.
  • Our readers may recall a 2016 citizen’s petition filed by NuTek Food Science that requested FDA to permit “potassium salt” as a common or usual name for potassium chloride because of consumers’ negative associations with the word “chloride.”  While NuTek withdrew the petition following FDA’s release of a 2019 draft guidance authorizing the term “potassium chloride salt,” which FDA framed as a compromise, the case was made in numerous food industry comments, as discussed here, for removal of the word “chloride” as requested in NuTek’s petition.  Several health advocacy groups also supported this position.  Morton Salt, the manufacturer of salt (the common name for sodium chloride), was alone in urging FDA to permit only “potassium chloride” as a common name.
  • With a December 18, 2020 notice, FDA released its final guidance to advise food manufacturers of the Agency’s intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”  In support of this change from the draft guidance, FDA cited consistency with activities to encourage manufacturers to reduce the sodium levels in food products and FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options.
  • Keller and Heckman will continue to follow a request, discussed here, for Health Canada to likewise allow “potassium salt” as an alternate name for “potassium chloride” in food labeling in Canada.
  • On December 18, 2020, FDA published a proposed rule to revoke the standard of identity and the standard of quality for frozen cherry pie. The standards of identity and quality for frozen cherry pie are found at 21 CFR § 152.126 and require, in relevant part, that the cherries comprise not less than 25% of the pie’s weight and that not more than 15% of the cherries be blemished. The proposed rule would revoke 21 CFR part 152 in its entirety, as the standards for frozen cherry pie are the part’s only contents.
  • FDA’s action regarding this standard of identity was prompted by a 2005 citizen petition from the American Bakers Association (ABA) that claimed that the only purpose of the regulations was to establish a standard of quality, not identity, for frozen cherry pies. The petition also noted that other fruit pies, frozen or not, including non-frozen cherry pies, do not have standards of identity or quality, and there was no evidence of public confusion with nonstandardized fruit pies. FDA agreed with these conclusions in its proposed rule, “tentatively conclud[ing]” that the frozen cherry pie standards of identity and quality are not necessary for honesty and fair dealing in the marketplace. However, FDA disagreed with a stronger stance in the petition that stated all food quality standards were unnecessary because manufacturers and consumer spending choices sufficiently regulate food quality.
  • FDA has planned to revoke the frozen cherry pie and French salad dressing standards of identity for some time and included these goals its Unified Agendas in 2018 and 2019. Comments on the proposed rule are due by March 18, 2021.
  • The Bee Better Certified™ program works with farmers to develop habitat and mitigate impacts from the use of pesticides, which presents an opportunity for companies to incorporate ingredients sourced from these farms into their supply chain.  Food companies like Haagen-Dazs, California Giant Berry Farms, and others now offer products that carry the Bee Better Certified Seal™, which denotes that they source from farms that provide habitat, protect bees from pesticides, and responsibly manage commercially bred bumble bees.
  • By way of background, in 2016, the Xerces Society and Oregon Tilth were awarded a Conservation Innovation Grant (CIG) from the Natural Resources Conservation Service (NRCS), an agency of the United States Department of Agriculture (USDA). The CIG awarded funds and provided the opportunity to trial Bee Better certification on a diverse array of farms across the US.
  • The Bee Better Certified™ Seal ensures that certified ingredients were grown in ways that support pollinators, including bees, butterflies, and other beneficial insects.  Farmers who participate in the certification program commit to provide habitat and mitigate impacts from pesticides use in accordance with standards developed by the Xerces Society.  Certification is verified by Oregon Tilth, a third-party certifier.
  • To date, the Bee Better Certified Production Standards have been adopted on nearly 20,000 acres of land, and companies like Haagen-Dazs are incorporating ingredients that are Bee Better Certified™ into their products.  For example, Haagen-Dazs has recently committed to adopting Bee Better standards for their entire almond supply, adding nearly a half dozen Bee Better Certified™ ice cream flavors to their menu.  Additionally, many west-coast blueberry and cherry companies and wine grape vineyards in Washington, Oregon and California have expressed interest in the Bee Better Standards.
  • A proposed class of cheese buyers is suing Dietz & Watson Inc. in New York federal court, claiming that its smoked provolone cheese is falsely advertised because the cheese is made with “smoke flavor” instead of actually smoking the cheese in burning wood chips. Plaintiffs allege that the Dietz & Watson labels are not in compliance with FDA’s flavor labeling regulations, which state the following:
    • If the food is commonly expected to contain a characterizing food ingredient and the ingredient is present in a sufficient amount to independently characterize the flavor of the product (regardless of whether the food contains any added natural flavors), the name of the ingredient should simply accompany the product name.
    • However, if the product contains any artificial flavors simulating, resembling or reinforcing the characterizing flavor, the name of the food on the PDP must also be accompanied by the words “artificial” or “artificially flavored.”
    • If, on the other hand, the food contains only added natural flavor derived from the characterizing ingredient, the product identity statement must include the name of the characterizing flavor and the word “flavored,” and may include a description of the flavor as “natural.”
    • If none of the natural flavor used in the food is derived from the product whose flavor is simulated (i.e., if all of the natural flavor is from another source), the food in which the flavor is used must either be labeled with the name of the product from which the flavor is derived or be described as “artificially flavored.”  21 CFR 101.22.
  • The Dietz & Watson label states that the product is “piquant & full flavor,” but does not appear to disclose that flavoring is used in the product to provide the smokey flavor. The class pointed to a 2017 FDA Warning Letter that stated foods using added flavors instead of the smoking process must declare that fact on the front label, while descriptions of the smoking process should not be in the ingredient list.
  • The proposed class intends to represent buyers from New York and the other 49 states who bought the cheese. The suit brings claims under New York’s consumer protection statutes, as well as for negligent misrepresentation, breach of express and implied warranty, fraud and unjust enrichment. The complaint seeks unspecified money damages and an injunction barring Dietz & Watson from continuing to label its smoked provolone as it currently does.