• On October 26, 2020, the FDA held a webinar in which it discussed its progress in implementing the blueprint for the New Era of Smarter Food Safety and its vision for the path forward. The webinar focused on the four Core Elements of the blueprint with leaders of the teams assigned to each Core Element addressing their respective contributions and visions. Additionally, Frank Yiannas, the Deputy Commissioner for Food Policy and Response at the FDA, delivered the opening and closing remarks in which he discussed the need to build upon the Food Safety Modernization Act (FSMA) and leverage new technologies to improve food safety and adapt to changes in the industry. He stressed that while the FDA was leading the charge, it was a collaborative effort that could not be done without the assistance of a wide variety of stakeholders, and that the FDA was committed to transparency throughout the process.
  • Kari Irvin, Deputy Director of the Office of Coordinated Outbreak Response and Evaluation, in the Center for Food Safety and Applied Nutrition (CFSAN) addressing Core Element 1: Tech Traceability, discussed the importance of creating a foundational language in this space. She stated that the Proposed Rule for Food Traceability is an effort to establish the common language and encouraged all stakeholders to comment on the proposed rule and participate in the coming public meetings on the proposed rule. Comments on this proposed rule are due on January 21, 2021.  She further stated that the FDA is not looking at any single technology and stated that one goal of creating a common language is to allow multiple systems to operate together.
  • Mark Moorman, Director of the Office of Food Safety, CFSAN, addressing Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response, emphasized the importance of information sharing, both within industry and government, in order to learn from adverse effects. In particular, he discussed the importance of data analysis to predict future outbreaks, the need to conduct root cause analysis of outbreaks, and the importance of clear communication to consumers.
  • Andreas Keller, director, Multi-Commodity Foods, Office of Food Safety, CFSAN, addressing Core Element 3: New Business Models and Retail Modernization, discussed the FDA’s efforts to evaluate the effectiveness of retail food regulatory programs, encourage the development and implementation of new systems and technologies to promote food safety, and study the impact of changing consumer behaviors, especially in light of the COVID-19 pandemic.
  • Conrad Choiniere, Director, Office of Analytics and Outreach, CFSAN, addressing Core Element 4: Food Safety Culture, stated that the blueprint seeks to develop a food safety culture within the FDA and among industry and consumers. Furthermore, he stated that the FDA’s role is not to mandate a predetermined food safety culture, but rather to study the issues and provide advice so that industry, and other stakeholders, can each develop their own unique food safety culture tailored their particular needs. He also noted that the Global Food Safety Initiative (GSFI) food culture safety standard is among the sources of information that the FDA was considering in developing its approach.
  • Keller and Heckman will continue to monitor and report on developments related to the New Era of Smarter Food Safety.

 

  • FDA’s regulations implementing the FDA Food Safety Modernization Act (FSMA) requirements for Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), and Foreign Supplier Verification Programs (FSVP) permit the use of third-party audits as supplier verification activities.  Additionally, FDA’s July 13, 2020 New Era of Smarter Food Safety Blueprint (discussed on our blog) indicates that to the extent third-party audit data are reliable and align with FDA’s regulatory food safety standards, FDA may use such data in risk-prioritization for FDA regulatory activities, such as inspections of both imported and domestically produced foods.  In this regard, FDA has developed templates that may help determine how well third-party audit standards align with the requirements under the PCHF, PCAF, and FSVP rules.
  • On October 26, 2020, FDA published notice and invited requests for participation from owners of third-party human food safety standards and others interested in participating in a voluntary pilot program for assessing third-party food safety standards for alignment with FDA’s PCHF and/or FSVP rules.  Under the pilot program, FDA plans to select and assess up to five third-party food safety standards.  FDA will evaluate:
    • The resources required to review and assess third-party standards for alignment with the PCHF and FSVP;
    • The ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment; and
    • Whether the audit standard comparison templates that FDA developed are helpful in making alignment determinations.
  • The pilot program will run through October 26, 2021 or longer, as needed.  Applications to participate are due by November 25, 2020.  FDA will publish information on its website regarding the third-party standards that FDA determines to be in alignment with FDA regulations.
  • On September 18, 2020, California Governor Gavin Newsom signed Assembly Bill 3336 (“AB-3336”) into law.  AB-3336 (codified at Section 113930.5 to the Health and Safety Code) sets new safety standards for third-party delivery applications, including sanitation and temperature standards.
  • The standards set in AB-3336 are consistent with the requirements for restaurants and stores, but this is the first time that third-party delivery applications have expressly and independently been required to follow them as well.  AB-3336 defines a “third-party food delivery platform” as a “business engaged in the service of online food ordering and delivery from a food facility to a consumer.”
  • AB-3336 requires ready-to-eat food delivered through a third-party food delivery platform to be transported in a manner in which the ready-to-eat food is protected from contamination.  The law would require all bags or containers in which ready-to-eat foods are being transported or delivered, from a food facility to a customer through a third-party food delivery platform, to be closed by the food facility with a tamper-evident method prior to the food deliverer taking possession of the food.  Additionally, food holding areas must meet sanitation standards, and food must be maintained at a temperature necessary to prevent spoilage.
  • AB-3336 provides that enforcement officers may recover, from a third-party food delivery platform, reasonable costs that are associated with enforcement against food deliverers who transport and deliver ready-to-eat food for the platform.  The law also allows enforcement officers to penalize food delivery applications for violations of the law.  Additionally, a person who violates any provision of the code may be subject to criminal prosecution for a misdemeanor offense.
  • On October 19, 2019, organizations representing conventional and cell-based /cultured meat, poultry, and seafood companies, including the Alliance for Meat, Poultry and Seafood Innovation and the North American Meat Institute, wrote a letter to the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) stating that “although these products have not yet come to market in the United States, market entry is fast approaching, and there is significant interest in the regulation of these products, particularly regarding applicable labeling requirements.”
  • In their letter to USDA, the groups stated that they are committed to supporting and complying with principles that ensure labeling is truthful and not misleading, does not disparage cell-based/cultured or conventional products, enables consumers to distinguish between such products, and is consistent with the safety and nutritional qualities of the product.
  • By way of background, in 2019, USDA and the U.S. Food and Drug Administration (FDA) announced a formal agreement that stated that both agencies would jointly oversee the production of human food products derived from the cells of livestock and poultry.  The agreement stated that FSIS will have oversight of the labeling of cell-based/cultured meat and poultry while the FDA will oversee the labeling of cell-based/cultured seafood.  Moreover, on October 6, 2020, FDA issued a Request for Information on the labeling of foods comprised of or containing cell-based/cultured seafood, in which FDA notes that it intends to use the information and data resulting to determine what type(s) of action, if any, the Agency should take to ensure that these foods are labeled properly.
  • In the letter, the groups urged USDA to also solicit data to propose and establish an appropriate mandatory labeling requirement for cell-based meat and poultry products.  The groups recommended that FSIS issue an Advance Notice of Proposed Rulemaking (ANPR) to obtain more information and supporting data on finished product characteristics for cell-based/cultured meat and poultry products, mainly those that may require labeling, as this information will provide FSIS with substantive data needed to better inform the Agency’s decision-making process.  The groups added that FSIS has issued ANPRs to obtain information from industry, consumers, and other stakeholders in the past, and that it could do so for the labeling of cell-based/cultured products as well.
  • 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.