• In guidance issued on October 16, 2020, the FDA announced that it had established a U.S. Agent Voluntary Identification System (VIS) in conjunction with their food facility registration database, the Food Facility Registration Module (FFRM), which will facilitate the expeditious verification of U.S. agents for foreign facilities
  •  By way of background, any U.S. or foreign food facility that is engaged in the manufacturing, processing, packing, or holding of food for consumption in the United States is required to register with the FDA under the Federal Food, Drug and Cosmetic Act. Furthermore, registered  foreign food facilities are required to appoint a U.S. agent to act as a liaison with the FDA and the FDA will not confirm registration or provide the foreign facility with a registration number until the U.S. agent has confirmed that it has agreed to serve as the U.S. agent for that facility.
  • Under the VIS system, when the U.S. agent adds the facility name and address to their profile and the foreign facility lists the U.S. agent identification number in their registration submission, a registration number will be automatically assigned and the FDA will not take additional steps to verify the U.S. agent. While the speed of verification of the new system incentivizes foreign facilities to use U.S. agents with VIS accounts, it also incentivizes U.S. agents to use the VIS program because it allows them to view any foreign facilities that have named them as their U.S. agent, thus allowing for quick identification of unauthorized or fraudulent registrations.
  • Keller and Heckman will continue to monitor and report on updates to the process for registering food facilities.

 

  • The U.S. Food and Drug Administration (FDA) released a draft guidance on April 18, 2019 (as discussed here) for the exclusion of allulose, a monosaccharide used as a sugar substitute, from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition and Supplemental Facts labels of conventional foods and dietary supplements made with allulose.  On October 19, 2020, FDA announced it has finalized The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels guidance document with no substantive changes and will continue to exercise enforcement discretion pending review of the issues in a rulemaking.
  • In an October 19, 2020 Federal Register notice, FDA solicited comments and information to inform potential amendments to the nutrition labeling rules for allulose and other sugars that are metabolized differently than traditional sugars.  Scientific data and other evidence are invited on topics pertinent to such sugars as follows:
    • The chemical properties or physiological effects of other such sugars, besides allulose, D-tagatose, and isomaltulose, which are already well known to FDA;
    • Consumer awareness or understanding of the differences between such sugars traditional sugars;
    • Potential regulatory approaches for the declaration of such sugars in ‘‘Total Sugars,’’ e.g., declaring the full amount, excluding the full amount, or declaring an adjusted gram amount;
    • Any factors aside from pH of dental plaque after consumption, caloric value, and glycemic and insulinemic response that may impact whether such a sugar should be excluded from the declaration of ‘‘Total Sugars;’’
    • Potential regulatory approaches for such sugars in the declaration of ‘‘Added Sugars,’’ e.g., declaring the full amount, excluding the full amount, or adjusting the gram amount of the ‘‘Added Sugars’’ or the percent daily value (%DV) declaration based on their caloric contribution to the diet;
    • Adjusting the %DV for ‘‘Added Sugars’’ for the U.S. population 4 years of age and older based on the caloric contribution of the sugar; and
    • Potential regulatory approaches to the label declaration of such sugars in the ingredient statement;
  • FDA has provided additional questions in subparts for certain of the above topics and has requested an explanation of the reasoning for each comment that is submitted, along with studies, data, and other supporting evidence as applicable to the topic that is being addressed.  The solicitation period for comments is scheduled to close on December 18, 2020.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • On October 13, 2020, a plaintiff filed a proposed class action in the United States District Court Southern District of New York alleging that Froneri US, Inc.’s Haagen-Dazs ice cream bars are falsely advertised as being dipped in milk chocolate despite the presence of vegetable oil among their ingredients.
  • In the lawsuit, plaintiff argues that “the unqualified, prominent and conspicuous representation” that the ice cream bar product is dipped in “milk chocolate” is false, deceptive, and misleading because the purported chocolate contains ingredients consumers do not expect in chocolate – vegetable oils.  Moreover, the plaintiff claims that the Haagen-Dazs ice cream bar products bear false advertisement, as the ice cream bars do not designate the chocolate as “milk chocolate and vegetable oil coating” on the front label.
  • By way of background, Congress directed the Food and Drug Administration to establish standards and rules to combat the marketing of foods from which traditional constituents are removed or new or different (often cheaper and artificial) ingredients are substituted.  In terms of chocolate products, this may entail the substitution of more valuable ingredients like cacao fat and replacement with less valuable, lower quality ingredients like vegetable oils.  Pursuant to 21 C.F.R. section 163.124(b), the optional ingredients in milk chocolate include cacao fat, nutritive carbohydrate sweeteners, spices, natural and artificial flavorings, dairy ingredients, and emulsifying agents, but not vegetable oils.
  • Plaintiff claims that the “chocolate (from cacao beans) provides greater satiety and a creamy and smooth mouthfeel compared to other ingredients which substitute for chocolate, like vegetable oils, that provide less satiety, a waxy and oily mouthfeel and leave an aftertaste.”   We will continue to monitor any developments.
  • On October 6, 2020, a California judge dismissed an amended complaint alleging that apple juice and applesauce products sold by Mott’s, LLP (a subsidiary of Dr. Pepper Snapple Group, Inc.) were falsely advertised as “Natural” and/or “All Natural Ingredients” where they contained trace amounts of the acetamiprid, a neonicotinoid pesticide.
  • The amended complaint was virtually identical to the original complaint (which was dismissed), but for the addition of two generic surveys which Plaintiff alleged demonstrated that consumers did not expect “natural” products to contain trace amounts of pesticides. One 2019 study reported that 68.1% of consumers did not believe that crops sprayed with synthetic pesticides were natural, while a 2015 study reported that 63% of respondents thought that natural labeling meant that “no toxic pesticides were used.”
  • Relying on precedent dealing with nearly identical issues (even the same two surveys were involved), the Court rejected Plaintiff’s argument and held that the surveys were not enough to demonstrate that a reasonable consumer would believe that a “natural” food product would contain no residual pesticides, even in trace amounts. Specifically, the Court found that the 2019 study was not persuasive because it related to crop production and not food labeling, while the 2015 study did not define important terms like “natural” and “toxic,” and arguably undermined Plaintiff’s claims by suggesting that the term “natural”  was “essentially meaningless.”
  • The case is a part of a continuing trend of litigation targeting “natural” claims even amidst the regulatory uncertainty regarding the use of the term. (In 2015, the FDA solicited comments regarding the use of the term, but has yet to take any action.) Keller and Heckman will continue to monitor and report on “natural” litigation and regulatory efforts to define the term.

 

  • As covered on this blog, on March 7, 2019 the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” whereby FDA will have regulatory oversight at the stages of collection, growth and differentiation of cells and USDA oversight will begin at cell harvest for food products derived from the cultured cells of livestock and poultry.  For food derived from cultured seafood cells, other than cells from Siluformes fish under USDA jurisdiction, FDA oversight will continue over the processing, packaging, and labeling stages.  In this regard, the 2019 agreement provides that FDA and USDA will develop joint principles for product labeling and claims to ensure that products under each agency’s jurisdiction are labeled consistently and transparently.
  • In an October 7, 2020 Federal Register notice, FDA solicited comments, studies, and relevant data or information on consumer understanding of terms pertaining to the labeling of foods comprised of or containing cultured seafood cells.  The 5 topics for which input is solicited are:

1. Whether the name or statement of identity of foods comprised of or containing cultured seafood cells should inform consumers about how the animal cells were produced;

2. What terms should be in the name or statement of identity of a food comprised of or containing cultured seafood cells to convey the nature or source of the food to consumers, e.g., “cell cultured” or “cell based” or “cell cultivated;”

3. Whether there is agreement with FDA’s view that foods comprised of or containing cultured seafood cells are not yet in the marketplace and, therefore, do not have common or usual names established by common usage;

4. Whether terms that specify a certain type of seafood (such as “fillet” or “steak”) should be included in or accompany the name or statement of identity of foods comprised of or containing cultured animal cells; and

5. What attributes (such as nutrition, taste, texture, or aroma) vary between conventionally produced seafood as compared to foods comprised of or containing cultured seafood cells, and should be considered material to consumers’ purchasing and consumption decisions.

  • FDA has provided additional questions in subparts for certain of the above topics and has requested an explanation of the reasoning for each comment that is submitted, along with studies, data, and other supporting evidence as applicable to the topic that is being addressed.  The solicitation period for comments is scheduled to close on March 8, 2021.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • The Canadian Food Inspection Agency (CFIA) announced  that it is temporarily imposing import restrictions on romaine lettuce grown in the U.S.  CFIA specifies a number of ways to demonstrate that the romaine is suitable for importation, such as documenting that the romaine does not originate from the Salinas Valley of California or providing a certificate from an accredited laboratory confirming that the lettuce does not contain detectable levels of E.coli.
  • The requirements follow several outbreaks of foodborne E.coli illnesses in Canada and the United States that have been traced to romaine lettuce.  Investigations conducted by American and Canadian authorities identified the California counties of Santa Cruz, Santa Clara, San Benito and Monterey—where the Salinas Valley is located—as recurring sources of the outbreaks.
  • CFIA’s temporary import conditions are in effect from October 7, 2020 through December 31, 2020 and apply to all shipments of romaine lettuce from the U.S.
  • A coalition of organic farmers and the Center for Food Safety recently filed for summary judgment in their challenge of the U.S. Department of Agriculture’s (USDA) denial of a petition calling on the Agency to bar soil-less operations from using the organic label.  The groups noted that USDA’s refusal to stop hydroponic operations from making organic claims ignores the “principles of organic farming” and violates the Organic Foods Product Act (OFPA).
  • By way of background, in 2010, the National Organic Standards Board declared that hydroponic systems do not appear consistent with the organic label as the operations do not enrich the soil or protect the environment.  USDA, however, ignored the National Organic Standards Board’s recommendation and noted that hydroponic operations can make organic claims if they demonstrate compliance with federal organic rules.
  • In 2018, USDA issued a statement reaffirming its policy, which prompted the Center for Food Safety and others to file a petition calling for the agency to reverse course.  The petitioners argued that hydroponic operations cannot be certified as organic because they do not accomplish the statutory mandate of the OFPA to foster soil fertility and improve the organic matter content of the soil; however, USDA denied the petition in 2019.  In its denial, USDA argued that the soil fertility requirements cited by the petitioners only apply to production systems that use soil.  In response to USDA’s denial of the petition, the Center for Food Safety, along with several organic farmers and certifiers, filed their lawsuit in March 2020 challenging the Agency’s petition denial.
  • In the groups’ motion for summary judgment, plaintiffs contend that USDA’s interpretation that hydroponic production systems and other soil-less production systems are exempt from OFPA’s statutory requirement that organic crop productions foster soil fertility “is contrary to the statute’s plain language.”   However, plaintiffs argue that the organic law requires that organic certification plans must contain management practices to promote the growth and development of fertile soil.  Plaintiffs also allege USDA’s conclusion violates the OFPA regulations, which require organic producers to maintain or improve the natural resource and biodiversity of the operation, including soil and water quality.
  • A hearing on the motion has been set for January 21, 2020 and USDA is expected to file a competing motion for summary judgment. We will continue to monitor any developments.
  • The FDA and two Mexican regulatory agencies, the National Service of Agro-Alimentary Public Health Safety and Quality (SENASICA) and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), have signed a statement of intent (SOI) that strengthens and expands upon their 2014 Produce SOI.
  • The most recent SOI broadens the scope of the partnership to cover all foods that are traded between the U.S. and Mexico. Furthermore, it encourages the development and use of new technologies to prevent and respond to foodborne illness outbreaks and also encourages collaboration with other governmental agencies and non-governmental entities including industry, consumer groups, and academia.
  • This partnership, including its emphasis on the development new technologies, is an important step in furthering the goals laid out this past summer by the FDA in their New Era of Smarter Food Safety Blueprint. And, it is an impactful one for U.S. consumers, as approximately one third of all food and sixty percent of produce in the U.S. is imported from Mexico. Keller and Heckman will continue to monitor and report on food safety issues.

 

  • On September 23, 2020, the Food and Drug Administration (FDA) published a proposed rule under the Food Safety Modernization Act (FSMA) that would establish “Requirements for Additional Traceability Records for Certain Foods.”  As discussed here, FDA concurrently published a new “Food Traceability List” (FTL) designating the high risk foods that will subject persons who manufacture, process, pack, or hold such foods to the proposed additional traceability requirements.  FDA is required under FSMA to conduct not less than 3 public meetings in diverse geographical areas of the U.S. to provide persons in different regions an opportunity to comment on the new proposed traceability rule during the formal comment period, which closes January 21, 2020.
  • In the October 5, 2020 Federal Register, FDA published details for the 3 required public meetings on the proposed new traceability rule.  These meetings will be held virtually to protect the public during the ongoing COVID-19 pandemic.  All 3 public meetings will cover the same agenda items.  To accommodate persons in different time zones, the 3 meetings will occur with different time frames as follows:
    • November 6, 2020 at 8:30 am to 3:30 pm EST,
    • November 18, 2020 at 9:30 am to 4:30 pm EST, and
    • December 2, 2020 at 11:30 am to 6:30 pm EST.
  • At each meeting, FDA will present information on the various sections of the proposed rule.  Stakeholder panels will then provide discussion on the various issues.  There will also be an opportunity for questions, as well as an opportunity for open public comment.
  • Attendance may be limited to those who have registered in advance by October 28, 2020, November 6, 2020, and November 18, 2020 for the first, second, and third meetings, respectively.  A limited number of interested parties will be permitted to provide oral presentations upon request, which must be made in advance by October 9, 2020, October 16, 2020, and October 26, 2020 for the first, second, and third meetings, respectively.  Keller and Heckman will continue to monitor and report on any updates to the rule and is available to assist in drafting comments.  Meeting attendance is not required for submitting comments.
  • On October 1, 2020, the U.S. Food and Drug Administration (FDA) published the results of its sampling project on domestically manufactured dark chocolate bars and dark chocolate chips labeled with claims such as “dairy free.” FDA conducted the sampling assignment to better understand the extent to which these products contain potentially hazardous levels of milk and therefore may cause serious health consequences to consumers with an allergy to milk.
  • FDA’s sampling assignment focused on products that did not include milk as a disclosed ingredient; were manufactured in the U.S.; bore claims such as: “dairy free,” “milk free,” “100% milk free,” and “contains no milk,” on packaging or website (this sampling assignment did not target “lactose-free” or standalone “vegan” claims in the absence of “dairy free”-type claims); and consisted solely of dark chocolate, without other component ingredients such as fillings, candy shells, fruits, nuts, seeds, etc. From July 2018 to October 2019, FDA collected 119 samples (88 dark chocolate bars and 31 packages of dark chocolate chips), representing 52 products, at retail (including online).  FDA found that four of the products sampled (4 of 52 products; 12 of 119 samples) had milk levels ranging from 600-3,100 parts per million (ppm), and the potential to cause severe reactions in consumers with milk allergy.
  • Dark chocolate can be made with or without milk as an intentionally-added ingredient. Some dark chocolate is made without the addition of milk as an ingredient, but milk may nevertheless be found present in these products due to inadvertent cross-contact, or the fact that dark chocolate is often produced on equipment used to produce milk chocolate, and it can be very challenging to thoroughly clean the equipment between product runs.
  • Milk is one of the eight major allergens identified by FDA (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), and manufacturers are required to label products that contain these ingredients and/or proteins accordingly. Undisclosed allergens are a leading cause of FDA requests for food recalls.  FDA believes milk is the most common undeclared food allergen, and that milk has been observed to be the leading cause of consumer adverse reactions to foods recalled due to undeclared allergens.  Based on consumer surveys, millions of people in the U.S. (estimated at approx. 2% of the population) are believed to experience symptoms of milk allergy, ranging from mild to severe (including hives, facial swelling, upset stomach, vomiting, wheezing, and anaphylaxis).
  • In response to the findings of the sampling project, all four products were recalled by the three manufacturers involved. The Agency will continue to monitor the issue, and will conduct additional sampling of domestic and imported dark chocolate.