• On July 1, the Federal Trade Commission (FTC) voted to adopt a final “Made in USA” (MUSA) rule, which incorporates guidance set forth in the FTC’s previous Decisions and Orders and its 1997 Enforcement Policy Statement on U.S. Origin Claims. The final rule applies to all labels, whether they appear on product packaging or online, and includes mail order catalogs or mail order promotional materials that include a seal, mark, tag, or stamp declaring goods are “Made in the USA,” “Made in America,” or the equivalent thereof.
  • Consistent with the guidance, the rule will prohibit marketers from including unqualified MUSA claims on labels unless:
    • Final assembly or processing of the product occurs in the United States;
    • Significant processing that goes into the product occurs in the United States; and
    • All or virtually all ingredients or components of the product are made and sourced in the United States.
  • The FTC received hundreds of comments regarding the applicability of the Rule to products like beef and shrimp. The FTC shares jurisdiction over country-of-origin claims for food and agricultural products with the USDA and, in some instances, the FDA. As stated in the Rule, the USDA and FDA have primary jurisdiction over labeling issues for food products within their purview, and the Rule does not supersede, alter, or affect the application of any federal statute or regulation relating to country-of-origin labeling requirements, including but not limited to regulations issued under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. Notably, however, the USDA announced the initiation of a top-to-bottom review of the voluntary “Product of USA” claim which is currently permitted on imported products under FSIS’s jurisdiction, including beef products, that are processed in the US. The review is intended to complement the FTC’s Rule and alleviate any potential confusion in the marketplace.
  • As our readers are aware, there have been numerous class action lawsuits related to the use of unqualified MUSA claims on food products. For past blog posts, see here and here. In addition to risk of potential lawsuits, manufacturers making unqualified MUSA claims may also face the FTC’s now broader legal authority and range of remedies, including the ability to seek redress, damages, and civil penalties, if such labeling claims are found to be false.

The final rule and adoption process is also covered in our Consumer Protection Connection blog post.

  • As we have previously reported on, the FDA issued a final rule regarding gluten-free labeling of fermented and hydrolyzed foods on August 12, 2020. The rule established a compliance date of August 13, 2021.
  • The rule does not alter the definition of gluten-free that was established in a 2013 final rule, which essentially requires foods bearing gluten-free claims to be made without gluten containing ingredients or processed such that no more than 20 ppm of gluten remain in the final food product. However, the FDA determined that additional regulation of fermented and hydrolyzed foods was required to ensure compliance with the 2013 final rule because currently the “FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins.”
  • Therefore, the 2020 rule established a records-based system to ensure that fermented and hydrolyzed foods are gluten-free consistent with the definition established in 2013. Specifically, food manufacturers of foods that bear gluten-free claims are required to keep records that demonstrate that (1) the food is gluten-free before fermentation or hydrolysis; (2) the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and (3) if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process. The records requirement only applies to food ingredients for which adequate analytical methods to test for gluten content are not available (i.e., hydrolyzed and fermented foods) and the records must be kept for at least 2 years after introduction of the food into interstate commerce and must be reasonably accessible to FDA during inspection at each manufacturing facility. We also note that the rule applies to enzymes that are grown on growth media containing gluten (e.g., wheat) because gluten from the growth media may be carried over and may be hydrolyzed due to fermentation, thus making it undetectable based on current methodologies.
  • As the compliance date approaches, food manufacturers of gluten-free products should be collecting and reviewing documentation from suppliers of any hydrolyzed or fermented food ingredients to ensure compliance with the rule.

FDA Releases Draft Guidance on Oversight of Food Products Covered by Systems Recognition Arrangements

  • On July 12, 2021, the U.S. Food and Drug Administration (FDA) published notice of a new draft guidance document for industry: FDA Oversight of Food Products Covered by Systems Recognition Arrangements.  A Systems Recognition Arrangement (SRA) establishes a regulatory partnership between FDA and another food safety authority in countries with systems FDA has concluded have similar elements and similar levels of oversight that lead to similar food safety outcomes.
  • The new draft guidance details adjustments to FDA’s regulatory oversight activities for food products covered by an SRA and imported from a country with an active SRA.  The draft guidance does not impact activities for food exported from a country whose food safety system is covered by an SRA but the specific type of food is not covered by the SRA or “for-cause” activities concerning food products covered by an SRA.  Otherwise, regulatory adjustments include:
    • In-country food establishment inspections will be rare in countries with an SRA (currently Australia, Canada, and New Zealand);
    • Automated screening and risk-targeting and review of imported food will be adjusted, although foods subject to Detention Without Physical Examination (DWPE) under an existing Import Alert (IA) will not be automatically removed from the IA when an SRA is signed;
    • Imported food covered by an SRA will generally not be prioritized for examination and sampling unless it is a commodity subject to routine surveillance sampling that targets both domestic and import samples;
    • FDA does not intend to prioritize inspections of importers for Foreign Supplier Verification Program (FSVP) compliance or compliance with juice and seafood Hazard Analysis Critical Control Point (HACCP) importer requirements with respect to imported foods covered by an SRA; and
    • With respect to regulatory compliance actions, FDA may issue warning letters, add establishments or food products to DWPE, refuse products offered for import, or take other regulatory actions as appropriate when food covered by an SRA that appears violative is offered for import and/or is intended for use in the United States.
  • Stakeholders are invited to submit comments on the new draft guidance by September 10, 2021 to ensure consideration before FDA begins work on the final version of the guidance.  Keller and Heckman attorneys are available to assist interested parties with submitting comments or helping with other food import issues.  For assistance, please email: fooddrug@khlaw.com.

 

  • According to the Center for Science in the Public Interest (CSPI), a new statewide poll suggests that over 75% of New York residents support including a warning icon on chain restaurant menu items that exceed the total daily recommended serving of added sugars.  CSPI has stated that the results were consistent across all demographic and political groups. CSPI also claims that the survey suggests that New Yorkers struggle to identify menu items that may contain significant added sugars.
  • The triangle icon suggested in the survey featured a proposed warning that would appear at the bottom of the menu stating, “Item exceeds the total daily recommended limit for added sugars (50g) based on a 2,000-calorie diet. The U.S. Dietary Guidelines advises limiting added sugars.” The New York City Council considered but did not pass a bill in 2019 that would have required a similar warning for added sugars.
  • The New York City Council recently passed a bill that requires food service establishments to display public information messaging created by the Department of Health about healthy eating topics, including risks of excessive sugar and carbohydrate intake. New York City currently requires restaurants to display a salt shaker icon on menus next to food items that have a high sodium content (>2,300 mg). If a menu has an icon, the following warning must also appear on the menu: “Warning: [salt shaker icon] indicates that the sodium (salt) content of this item is higher than the total daily recommended limit (2300 mg).  High sodium intake can increase blood pressure and risk of heart disease and stroke.”
  • On Friday, July 2, three California residents filed a class action lawsuit (subscription to Law360 required) against Nature’s Path Foods Inc., claiming that Nature’s Path deceived customers by overstating the amount of protein present in its hemp granola and other products.
  • The consumers allege that the company’s Hemp Hearts Granola product bears claims stating that the product offers 10 grams of protein per serving but that, based on testing, the product contains only 7.87 grams protein per serving.  According to the plaintiffs, the Hemp Hearts Granola packaging indicates in a “small font that is barely legible to consumers” that the 10 grams of protein refers to the protein content “per serving with milk.” The nutrition facts panel indicates that without milk, the product only provides 6 grams of protein.
  • The plaintiffs allege that the company’s false and misleading advertising and labeling of its products is intended to induce consumers to purchase the products at a premium price and that they would not have purchased the granola, or at least would have paid less for it, if they had known the truth about its protein content.
  • The suit against Nature’s Path is the latest in a series of cases, challenging the accuracy of protein information on food labels.
  • On June 30, the House Committee on Appropriations approved the Fiscal Year 2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Funding Bill. In a report accompanying the bill, the Committee specifically encouraged the FDA to provide clarity around the labeling of plant-based foods that use traditional meat, dairy, and egg terminology.
  • The Committee stated that they are “aware of the ongoing debate around plant-based product labels and the use of traditional meat, dairy, and egg terminology. However, the Committee is concerned by the assertions being made that labeling of these products are misleading, deceptive, and confusing to consumers.” For instance, the Committee pointed out the certain foods are labeled as a fish or seafood product, but are instead “highly-processed plant-based foods rather than derived from actual fish or seafood.” Thus, the Committee directed the FDA to assess the products on the market to determine whether any action is needed to ensure that consumers are not misled.
  • The Committee also stated that they will provide $5,000,000 to support alternative protein research encompassing all stages of the production process, including optimizing ingredient processing techniques and developing new manufacturing methods.
  • Relatedly, on June 29, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics to be completed within the next 12 months. One of the documents that the Agency plans to issue is a draft guidance on the labeling of plant-based milks. However, as per FoodNavigator-USA, the FDA would not state whether it plans to also issue guidance on the labeling of cheese, yogurt, meat, seafood, and/or egg alternatives.
    • As we have previously blogged about, Champion Petfoods faced a consumer class action alleging fraud, negligence, and violations of the Wisconsin Deceptive Trade Practices Act for allegedly misleadingly representing its petfood products as “biologically appropriate,” “fresh” and “made with regional ingredients,” and “never outsourced.”
    • On June 30, 2021, the U.S. District Court for the 7th Circuit affirmed a district court’s grant of summary judgment in favor of Champion Petfoods on all three of the claims.  The court affirmed summary judgment in favor of Champion Petfoods because, apart from his own testimony, Plaintiff offered no evidence that a reasonable consumer would be deceived. Citing to prior 7th Circuit precedent, the Court held that extrinsic evidence of consumer deception such as consumer surveys or market research are necessary to survive summary judgment where the advertising is not clearly misleading on its face and materiality is in doubt.
    • The court held that the marketing representations were not clearly misleading.  Specifically, trace amounts of BPA found in the petfood did not make the “biologically appropriate” representation misleading because BPA was not intentionally added, it is present at very low levels that would not harm the pets, and both animals and humans face ubiquitous exposure to BPA. The Court also held that the “fresh” and “made with regional ingredients” representations were not claims that the products contained only fresh and regional ingredients, and that “never outsourced” meant only that Champion Petfoods manufactured the food itself, not that it also produced every ingredient in the petfood.
    • The 7th Circuit’s holding provides a strong message to Plaintiffs asserting consumer deception causes of action that absent clearly misleading marketing, extrinsic evidence of consumer deception (i.e., something more than Plaintiff’s testimony) will be required to survive a motion for summary judgment. However, notably, the Court was careful to limit this standard to the summary judgment stage of litigation. A plaintiff still may survive a motion to dismiss without meeting this evidentiary standard since motions to dismiss are governed by a lower plausibility standard.
  • FDA released its Cyclospora Prevention, Response, and Research Action Plan on July 1 as part of FDA’s New Era of Smarter Food Safety initiative. The Action Plan is modeled after FDA’s Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan and seeks to improve food safety prevention practices, fill knowledge gaps, and quicken response activities to prevent Cyclospora contamination of foods and efficiently respond to future outbreaks.
  • While cyclosporiasis was historically associated with consumption of imported produce, Cyclospora contamination has become a domestic concern in recent years. The first known contamination in U.S. produce was in 2018. In addition to precautionary procedures of testing imported produce and inspecting foreign farms, FDA has helped develop new diagnostic and detection methods for Cyclospora to improve its response to domestic outbreaks.
  • Cyclospora cayetanesis causes cyclosporiasis in humans, a foodborne intestinal illness. The number of reported cases has risen in recent years, partly because of improved testing methods. Data from the Centers for Disease Control and Prevention show roughly 6,000 domestically-acquired cases of cyclosporiasis during the past three years, and actual numbers may be higher.
  • On June 30, the U.S. Food and Drug Administration (FDA) published a constituent update notifying the public of recent test results from a study it conducted to better understand the presence of per- and polyfluoroalkyl substances (PFAS) in the food supply.  PFAS are known for their grease, water, and oil-resistant properties and are used in a variety of consumer products, including food-contact materials.
  • FDA’s most recent testing detected PFAS in only one of 94 food samples.  FDA tested a variety of breads, cakes, fruits, dairy, vegetables, meats, poultry, fish, and bottled water and detected PFAS in a single sample of cod, which contained detectable levels of two PFAS compounds, perfluorooctane sulfonate (PFOS) and perfluorononanoic acid (PFNA).  Based on current and reliable food science, the Agency indicated that the PFAS levels detected in cod do not present a human health concern.
  • FDA’s testing was conducted as part of the Total Diet Study (TDS), a program the Agency began in 1961 to monitor the levels of nutrients, toxic elements, pesticide residues, and other chemicals in food. The Agency’s testing of TDS samples for PFAS is intended to determine if targeted sampling assignments are necessary for certain food items and to help inform its approach to future surveillance efforts.
  • The most recent testing is the third dataset released on PFAS in food.  Given that PFAS has been detected in past analysis of tilapia, FDA plans to conduct a targeted survey of PFAS in the most commonly consumed seafood items in the U.S.
  • On June 29, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority to complete during the next 12 months. The list covers food safety, allergens, food additives, and dietary supplements, among others, and includes the following guidance topics:
    • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;
    • Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;
    • Best Practices for Convening a GRAS Panel: Guidance for Industry;
    • Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; and
    • Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
  • The full list of guidance topics is available here. The list focuses on Level 1 draft and final guidances, which set forth the agency’s initial interpretations of new significant regulatory requirements, describe substantial changes in FDA’s earlier interpretation or policy, and deal with complex scientific or highly controversial issues.
  • The FDA anticipates publishing many of the documents by June 2022. In the future, the FDA intends to release the list of anticipated human food and cosmetic guidance topics at the beginning of each calendar year with updates scheduled for mid-year. Thus, FDA will update this list by the end of January 2022.
  • Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553. Please contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.