• The European Food Safety Authority (EFSA) released a scientific opinion in the EFSA Journal on January 13, 2021 evaluating the safety of dried yellow mealworm (Tenebrio molitor larva) and finding in the affirmative. This is EFSA’s first opinion on insects as a novel food.
  • The opinion, adopted November 24, 2020, considered the uses listed in the novel food application submitted by SAS EAP Group – Micronutris, which included using whole, dried mealworms as snack products and ground, powdered mealworm in various other food products, such as baked goods, energy bars, and pasta. EFSA found that the food is not nutritionally disadvantageous under the proposed conditions and that the toxicity studies it considered did not raise safety concerns. The opinion did note that the mealworm proteins may cause allergic reactions in people allergic to crustaceans and dust mites.
  • The European Commission requested EFSA’s review of the food under Regulation (EU) 2015/2283, the Novel Foods regulation. The Novel Foods regulation simplifies the authorization procedure for categories of certain foods to allow food businesses to more quickly bring innovative foods to the EU market. The opinion must still be confirmed by the European Commission’s Health Directorate General before mealworms officially become an approved novel food.
  • On January 8, 2021, a plaintiff filed a proposed class action lawsuit against Ferrara Candy Co. (“defendant”) alleging that its Keebler Fudge Stripes cookies do not contain “real fudge.”  The labels of the Keebler product state that the product is “made with real Keebler fudge” and bear a picture of chocolate fudge.
  • Fudge is not the subject of a formal standard of identity under Food and Drug Administration regulations.  In the complaint, the plaintiff relies on dictionary definitions of fudge to argue that the defendant’s product is not fudge because it does not contain sugar, butter, and milk.   Instead, the plaintiff notes that the fudge in the defendant’s cookies contains vegetable oil, invert syrup, and whey.  The plaintiff also claims that the company is masking the fudge’s ingredients by combining the ingredients for both the cookie and fudge in a single ingredient listing, as opposed to having separate compound ingredient listings for the cookie and fudge components.
  • The plaintiff’s counsel in this case is Sheehan & Associates, which has been prolific in pursuing cases against allegedly misleading vanilla products in recent years.  It remains to be seen whether the Keebler case is the beginning of a flood of cases against other foods claiming to contain fudge.
  1. The Agency made clarifying edits to the Food Traceability List (FTL), which lists the foods for which additional traceability recordkeeping requirements in the proposed rule would apply. Edits to certain commodity descriptions were made for clarity, but do not change which foods are on the FTL. For example, the word “fresh” was added to certain fruit and vegetable commodities to clarify the scope. Similarly, the description for “cheeses, other than hard cheeses” was revised to clarify which cheeses apply, and included examples of such cheeses. A description of the edits is available in the memo “Food Traceability List of ‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule – Clarified Language.”
  2. The Agency published an FAQ on the proposed rule to assist stakeholders in providing feedback during the comment period, which was extended until February 22, 2021. Comments can be submitted at https://www.regulations.gov/ Docket ID: FDA-2014-N-0053. Those submitting comments to the proposed rule are encouraged to provide real life examples and details about specific arrangements for consideration.
  • As previously discussed on this blog here and here, FDA’s proposed rule would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain foods designated on the FTL. The proposed requirements would apply to foods listed on the FTL, including certain cheeses, shell eggs, nut butter, various fruits and vegetables, finfish, Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing FTL foods. At the core of the proposed rule is a requirement for those who manufacture, process, pack or hold foods on the FTL to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA encourages the voluntary adoption of these practices industry-wide.
  • As mentioned above, the proposed rule is available for public comment until February 22, 2021. Keller and Heckman attorneys are well-versed in food safety and traceability-related issues and are available to assist interested parties in preparing comments for submission. For assistance, please email: fooddrug@khlaw.com.
  • On January 8, 2021, FDA commissioner Stephen M. Hahn, M.D. released a statement entitled “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products”, which details the “knowledge gaps” that remain as the FDA works to develop a framework for the regulation of CBD products.
  • As many of our readers know, the 2018 Farm Bill removed “hemp” from the definition of “marijuana” under the Controlled Substance Act, thus removing one legal obstacle from marketing CBD commercially. However, CBD still needs an appropriate regulatory status for its use in conventional foods and dietary supplements. FDA has taken the position that CBD is not a lawful dietary ingredient or food ingredient based on two timing provisions found in the Federal Food, Drug, and Cosmetic Act.  While a regulatory pathway for CBD is under consideration and safety data is generated, FDA has focused its efforts on Warning Letters against companies making unsubstantiated health claims.
  • Dr. Hahn’s statement declared that the FDA still has a “limited understanding of the safety profile of CBD” and that important questions remain, including the risks associated with long-term use of CBD products. While acknowledging industry’s efforts to engage with and provide information to FDA, Dr. Hahn cautioned that filling the gaps “will not be a trivial exercise.” The statement describes a framework in which real-world data (RWD) can be used to answer outstanding questions on CBD products including how to understand the safety profile of CBD in the general population and potentially in specific populations. In particular, Dr. Hahn announced the following principles and goals that will guide FDA work in this area:
    • Research projects should contribute to development of more sophisticated data infrastructure for understanding the safety and quality of CBD products;
    • Research projects should yield information to help refine future studies, such as subpopulations that are most important to study;
    • Research projects should be designed to complement the existing work of other stakeholders;
    • More systematic data is needed as existing data largely comes from spontaneously reported adverse events;
    • The development of specific codes in data sets is needed to identify specific CBD products;
    • Longitudinal studies are needed to learn more about the long-term health effects of CBD use.
  • The latest statement from FDA makes clear that a lawful regulatory position for CBD will still take some time to develop and that FDA believes there are substantial safety gaps that need to be addressed. We are also awaiting FDA’s draft enforcement guidance that has been at OMB since July. Keller and Heckman will continue to monitor and report on developments that impact the use of CBD in FDA regulated products.
  • On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed Proposition 65 rulemaking that would limit use of the short-form version of the safe harbor warning.  Since it became an option in 2016, manufacturers have gravitated toward the short-form warning, which does not require the disclosure of chemical name(s) in the warning.
  • OEHHA is seeking to limit the use of short-form warnings by proposing various changes, including:
    • Only allowing the short-form warning (a) on products with 5 square inches or less of “label space” (which is not defined) and (b) when the standard warning will not fit.
    • Prohibiting the short-form warning for internet and catalog sales (even if the short-form warning is provided on the product itself in compliance with the regulations).
    • Requiring that the name of at least one chemical per relevant toxicity endpoint be included in the short-form warning; and
    • Including the words “Risk” and “Exposure” in the warning.

Under the proposal, the new warning would read (when warning for both toxicity endpoints), “ WARNING: Cancer Risk from [insert chemical name] and Reproductive Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”  (The existing minimum type size requirements under the current regulations would not change.)  In addition to requiring more transparency concerning the identity of chemicals in the warning, OEHHA intends the proposed changes to dissuade businesses from over-warning.

  • OEHHA is accepting comments on the proposal through March 8, 2021.  Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions under Proposition 65.  If you have any questions concerning the proposed rulemaking or other Proposition 65 matters, please email prop65@khlaw.com.
  • Effective January 1, 2021, a new US-UK equivalence agreement ensures that organic products certified to either USDA or UK standards may be labelled and sold as organic in both countries. The agreement provides continuity for US-UK exports that were covered by the US-EU equivalence agreement, effective in 2012, following the UK’s departure from the EU.
  • Like the US-EU agreement, the US-UK agreement covers only certified organic products that have been grown or raised in the US or UK and products where the final processing or packaging occurs in these countries, including where organic ingredients from other countries have been certified to USDA or UK standards. Crops, wild crops, livestock, and processed products are all eligible for equivalency under the agreement, but aquatic animals (fish, shellfish) and agricultural products derived from animals treated with antibiotics will not be certified organic when exported to the US.
  • The UK has established a new import process for all USDA organic products traded under the agreement, with different documentation required depending on whether the product is exported to Great Britain (England, Scotland, Wales) or Northern Ireland. As is the case under the US-EU agreement, exported organic products under the US-UK agreement must meet the labeling requirements of the destination country. Keller and Heckman is experienced in assisting with certification and labeling regulations under USDA’s National Organic Program.
  • 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.