• On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make cannabidiol (CBD) derived from hemp a legal dietary ingredient for use in dietary supplements.

 

  • The letter requests that Congress carve out a statutory pathway for the lawful introduction of CBD-containing supplements into the marketplace. Specifically, the proposed law would create a limited waiver of § 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FDCA), which FDA has previously used to support its position that CBD may not be used in dietary supplements because it is an active ingredient in an FDA-approved drug and has been the subject of substantial clinical investigations. CBD derived from hemp would be exempt from this section, provided that the products meet established safety and quality criteria and comply with all other provisions of the FDCA. The letter also calls for increased funding on top of the $2 billion provided to FDA to address the issue of hemp-derived CBD in the FY 2020 Agriculture and Related Agencies Appropriations bills.

 

  • In the wake of rapidly increasing sales of hemp-derived CBD products, Congress has repeatedly pressured FDA to act quickly in establishing a regulatory framework for CBD. Thus far, FDA has stated that it is exploring additional regulatory pathways for CBD products, but that this process is likely to take 3 to 5 years. FDA maintains that dietary supplements containing hemp-derived CBD are illegal under the FDCA. Meanwhile, the Federal Trade Commission has stepped up enforcement against CBD products that are promoted via health-related claims.
  • On October 7, 2019, the California Chamber of Commerce (“CalChamber”) filed suit in federal court against the California Attorney General, Xavier Becerra, to block the state from enforcing Proposition 65 warning requirements on foods containing acrylamide.  Acrylamide is a naturally occurring compound that develops when starches and sugars are cooked at high temperatures.  According to California’s Office of Environmental Health Hazard Assessment (OEHHA), it is present in foods including “French fries, potato chips, fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, some cookies, bread crusts, and toast.”
  • CalChamber is arguing that warnings for acrylamide constitute false and misleading compelled speech that violates the First Amendment of the United States Constitution because there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food products and cancer risk.  CalChamber also argues that Proposition 65 warnings for acrylamide will result in over-warning, which will dilute the effectiveness of warnings on other products that do pose a risk of harm to consumers.
  • Acrylamide has been on the Proposition 65 chemicals list since 1990 but was not a focus for enforcement in food products until recent years.  CalChamber hopes that this lawsuit will reduce unnecessary fear for consumers and reduce litigation threats for businesses.
  • As our readers may know, in November 2018, California voters passed a ballot initiative known as Proposition 12, which establishes new standards for confinement of certain farm animals and bans the sale of products that do not comply with the new confinement standards. Specifically, Proposition 12 requires that all eggs sold in the state come from cage-free hens by 2022, and it also bans the sale of pork and veal in California from farm animals raised in cages that do not meet new minimum size requirements. Therefore, farmers across the country who sell eggs, veal, and pork in California will be required to comply with Proposition 12.
  • In a lawsuit filed on October 4, 2019, the North American Meat Institute (NAMI) argues that Proposition 12 impedes interstate commerce and violates the Constitution’s commerce clause by banning the sale of pork and veal imported from other States unless they comply with Proposition 12’s animal-confinement standards. “This case is about whether California can insulate its farmers from out-of-state competition and project is agricultural regulations beyond its borders…” NAMI requests the U.S. District Court for the Central District of California stop implementation and enforcement of the law and issue a declaration that these requirements are unlawful under federal law.
  • We will continue to monitor developments in this challenge to California’s Proposition 12.
  • As our readers may know, the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however there are a range of compliance dates according to a number of considerations.
  • Under the program, importers are required to develop, implement, and maintain a FSVP which includes verification activities and records of those activities for each imported food from each foreign supplier. During an FSVP inspection, the FDA investigator will review the importer’s records to determine their compliance with the FSVP regulation.
  • To help importers determine the FSVP records they should develop and maintain, the FDA has made available a list of records required by the FSVP regulation. The list of records is organized based on the sections of the FSVP regulation so that importers can readily determine the required records for the sections that apply to them.  

 

  • As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive Controls for Human Food.  These rules, found in 21 Code of Federal Regulations (CFR) part 117, implement the hazard analysis and risk-based preventive control (HARPC) provisions for human food under the FDA Food Safety Modernization Act (FSMA).  Most human food facilities were required to comply with the human HARPC rules by September 2016.
  • FDA’s Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food will provide a comprehensive resource for understanding how to comply with all requirements of the human HARPC rule.  With the October 4, 2019 announcement of the most recent guidance document, Chapter 14: Recall Plan, the multi-chapter draft guidance is about half-completed.  Previously released documents are Chapters 1 (The Food Safety Plan), 2 (Conducting a Hazard Analysis), 3 ( Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food), 4 (Preventive Controls), 5 (Application of Preventive Controls and Preventive Controls Management Components), 6 (Use of Heat Treatments), and 15 (Supply-Chain Program for Human Food Products), as well an Introduction and Appendices 1 (Potential Hazards for Foods and Processes), 2 (Food Safety Plan Forms), and 3 (Bacterial Pathogen Growth and Inactivation).
  • Additional draft guidance yet to be completed for the human HARPC rule are Chapters 7 (Use of Time/Temperature Control as a Process Control), 8 (Use of Formulation as a Process Control), 9 (Use of Dehydration/Drying as a Process Control), 10 (Sanitation Controls), 11 (Food Allergen Controls), 12 (Preventive Controls for Chemical Hazards), 13 (Preventive Controls for Physical Hazards), and 16 (Validation of a Process Control), and Appendix 4 (Sanitation and Hygiene Zoning).  FDA indicates the remaining chapters and appendix are “coming soon.”
  • On September 13, deputy administrator of USDA’s National Organics Program (NOP), Jennifer Tucker, announced at the Natural Products Expo East in Baltimore, Maryland that the agency will soon release its new organic enforcement rule with the goal of protecting consumers from food products fraudulently labeled as “organic.” The new rule, which Tucker asserted would have a “profound impact” on both domestic and international markets, would establish tougher accreditation and certification requirements, as well as create a new electronic import certificate system.
  • Specifically, the new rule will authorize NOP to conduct unannounced inspections and will strengthen the criteria for inspection qualifications, minimum training requirements for inspectors, non-retail labeling, standardized organic certificates, and other data reporting. In addition, companies importing organic food products will be required to submit electronic import certificates through the U.S. Customs and Border Protection’s Automated Commercial Environment portal.
  • The new rule comes after Congress included a mandate in the 2018 Farm Bill requiring USDA to issue a rule on organic enforcement, following reports of fraudulently labeled imports of corn and soybeans. NOP plans to hire over a dozen new staffers to help implement the rule and keep pace with growing challenges in the organic space.
  • The Centers for Disease Control (CDC) has released its Surveillance for Food-borne Disease Outbreaks Annual Report, which includes an analysis of all foodborne illness outbreaks reported in 2017.   CDC found that 841 foodborne disease outbreaks were reported in 2017, resulting in 14,481 illnesses, 827 hospitalizations, 20 deaths, and 14 food product recalls.  These recent statistics show that the number of foodborne disease outbreaks has decreased as compared to 2015.  The CDC report summarizes data from the National Outbreak Reporting System (NORS), which local, state, and territorial health departments use to report all waterborne, foodborne, and enteric disease outbreaks to the CDC.
  • Norovirus was the cause of 35 percent of the outbreaks, followed by Salmonella, which caused 29 percent of the outbreaks, and shiga toxin-producing Escherichia coli, which caused 5 percent. Moreover, the highest number of outbreak-associated illnesses were from turkey (609 illnesses); fruit (521 illnesses); chicken (487 illnesses); and pork (376 illnesses).
  • CDC uses its annual report to acquire information on foods associated with outbreaks, which helps CDC identify foods most commonly reported in outbreaks and track how frequently certain foods are implicated.  The report also offers the agency insight into how well prevention measures are working, which can lead to new policies and practices.
  • Food manufacturers, including Nestle USA and Kraft Heinz, have submitted public comments on FDA’s draft guidance regarding the use of “potassium chloride salt” as an alternative common or usual name for potassium chloride. The comments opposed the use of “potassium chloride salt” and urged the agency to choose “potassium salt,” asserting that the term meets the common or usual name requirements at 21 CFR 102.5 and is better received by consumers.
  • As our readers may remember, the issue of potassium chloride labeling arose in a 2016 citizen’s petition filed by NuTek Food Science. NuTek’s petition had requested that FDA permit “potassium salt” as a common or usual name for potassium chloride because of consumers negative associations with the word “chloride.”  FDA has acknowledged that wider use of potassium chloride as a salt replacement could help reduce sodium intake and increase potassium intake and therefore, in May 2019, responded to NuTek’s petition with draft guidance proposing the term “potassium chloride salt” as a compromise.
  • Many of the public comments noted consumer suspicion of the term “chloride.” Indeed, one consumer survey conducted by the International Food Information Council (IFIC) Foundation found that shoppers rated “potassium salt” as safer, healthier, and tastier than “potassium chloride salt.” Similarly, the survey found that names of ingredients that contained both potassium and chloride were perceived as least safe, with 47% of consumers ranking “potassium chloride” and 38% ranking “potassium chloride salt” as least safe.
  • At least one comment urged FDA to revise their guidance and require potassium chloride to be labeled as such. Morton Salt stated that “salt is the common or usual name for sodium chloride, and potassium chloride is the common or usual name for potassium chloride that consumers recognize on our food nutritional labels and that is accepted by industry.” The comment period closed on September 17, 2019. Keller and Heckman will continue to monitor this issue.
  • On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter Food Safety, continuing the successful implementation of FSMA will support the Agency’s goal of reducing illness and death due to preventable contamination of FDA-regulated human and animal food products, explained the Agency in a press release. (For more information on FDA’s New Era of Smarter Food Safety, see our September 28 blog.)
  • The initial metrics on the Food Safety Dashboard will begin to track outcomes for three FSMA rules in the areas of inspections and recalls. These are:
    • “Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls” rules for both human food and food for animals (preventive controls rules).
    • Imported food safety, including data relevant to the “Foreign Supplier Verification Program” (FSVP) rule.
  • “We plan to update the data for these three FSMA rules quarterly, with our goal being to ultimately publish metrics for all seven rules,” stated Acting FDA Commissioner Ned Sharpless and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a statement about the Dashboard. They added, “Many factors will influence these data over time, especially in the early phases of implementation.” FDA expects that it will take several years to establish meaningful trends from the data on the Dashboard.
  • The Food Safety Dashboard is available as part of the FDA-TRACK program, the FDA’s agency-wide performance management system.
  • The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) work jointly and with other federal agencies, as well as state, local, and tribal government agencies to develop and implement food defense strategies.  Food defense is the protection of food products from intentional contamination or adulteration intended to harm the public or cause economic disruption.  Food defense is a required component of food safety plans for all regulated food facilities.
  • USDA’s September 27, 2019 constituent update highlights the availability of resources on the agency’s Food Defense Tools, Resources, and Training webpage, which includes a link to FDA’s Food Defense Plan Builder.  Launched August 22, 2017 (as covered here), the Food Defense Plan Builder is software that may assist owners and operators of food facilities with developing personalized food defense plans for their facilities.  FDA updated the Food Defense Plan Builder on September 19, 2019 and is providing an informational webinar on October 10, 2019 (registration is required).
  • In addition to safeguarding the nation’s food supply against intentional contamination or adulteration that is perpetrated for the express purpose of causing public harm or economic disruption, food defense and recall plans also serve to protect the public from food that is tampered with through social media pranks.  As covered here, for example, a spurt of viral videos this summer of people licking or spitting on food prompted FDA to issue a reminder on strategies to prevent tampering and intentional adulteration of foods and cosmetics in grocery stores.

For help complying with regulatory requirements for food facilities, please email us at fooddrug@khlaw.com.