• On June 18, 2019, FDA issued a final guidance to provide clarity on the labeling of added sugars for single-ingredient packages or containers of pure honey, maple syrup and other single ingredient sugars and syrups as a result of a requirement contained in the Agriculture Improvement Act of 2018 (Pub. L. 115-334), known as the “Farm Bill.”  We reported on the draft guidance and comments submitted on the draft guidance here.
  • Single-ingredient products, such as pure honey and maple sugar, are not required to declare the number of grams of added sugars in a serving of the product on the Nutrition Facts label but must still include the percent Daily Value (DV) for added sugars. In the guidance, FDA states its intent to exercise enforcement discretion by permitting the use of the “†” symbol immediately following the added sugars percent DV declaration, which leads to a footnote inside the Nutrition Facts label explaining the amount of added sugars that one serving of the product contributes to the diet as well as the contribution of a serving of the product toward the percent DV for added sugars.
  • With respect to certain dried cranberry products and cranberry beverage products, these products must still declare added sugars in grams and declare the percent Daily Value for added sugars.  However, in the guidance, FDA states it intent to exercise enforcement discretion by allowing the use of a symbol immediately following the added sugars percent Daily Value declaration leading to a statement outside the Nutrition Facts label explaining that sugars are added to improve the palatability of naturally tart cranberries.
  • Overall, FDA is giving manufacturers of single ingredient packages/containers of pure honey, maple syrup, other pure sugars and syrups, and cranberry products enforcement discretion until July 1, 2021 to comply with the new nutrition labeling requirements. FDA states that the extra 6 months is needed to give these manufacturers additional time to make label changes consistent with the Farm Bill and this final guidance.

 

 

  • On June 14, President Trump issued an Executive Order on Federal Advisory Committees. The Executive Order (EO) directs executive departments and federal agencies to evaluate their current advisory committees established under section 9(a)(2) of the Federal Advisory Committee Act (FACA). As part of the review, each agency “shall, by September 30, 2019, terminate at least one-third of its current committees.” Although, agencies may request a waiver. The Order also imposes limitations on new Advisory Committees.
  • The EO states that agencies may count committees discontinued since January 20, 2017, towards the termination requirement. This will allow FDA to count the termination of its Food Advisory Committee since that committee was discontinued effective December 12, 2017. (For information on why that committee was discontinued, see our blog, FDA Discontinues Food Advisory Committee.)
  • Reporting requirements are also included in the EO. On or before August 1, 2019, the head of each agency is required to submit to the Director of the Office of Management and Budget: 1) a recommendation on whether each of the agency’s current advisory committees should be continued and 2) a detailed plan for either continuing or terminating each committee.
  • We will report on the impact that this EO will have on FDA’s and USDA’s Food Advisory Committees.

 

  • Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to create an exception by regulation to the FD&C Act prohibition that currently makes it illegal to add CBD to a food or market CBD as a dietary supplement.  Some would alternatively be satisfied with a formal nonenforcement policy from FDA on the statutory prohibition.
  • At a May 31, 2019 meeting, discussed in this blog, FDA pointed out that it has never issued a regulation to create an exception to the statutory prohibition against the use in food of a substance that has been approved as a drug.  Confirming there is no policy of enforcement discretion with respect to the use of CBD, FDA also remarked on a lack of research to support the safety of CBD for use in food and dietary supplements.  The docket, FDA-2019-N-1482, solicits information on safety (including whether there is a threshold level that could appropriately be considered safe for), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
  • A June 14, 2019 statement by Dr. Amy Abernethy, FDA’s Principal Associate Commissioner for Policy, reiterates that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD.  Dr. Abernathy indicated that upon review of the docket (which she indicated may remain open past the current July 2, 2019 deadline for comments), FDA will identify gaps and examine “how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD.”

 

  • On June 11, President Trump issued an Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products.  The purpose of the Executive Order (EO) is to employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment with an ultimate goal of facilitating innovation, ensuring coordination across regulatory agencies (the United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA)), and fostering public confidence in the oversight of such products.
  • Six specific policy objectives are listed, with additional elaboration on each:
    • Base regulatory decisions on science and, as appropriate and consistent with law, economic factors;
    • Review applications for products of agricultural biotechnology quickly and efficiently;
    • Ensure transparency, predictability, and consistency in the regulation of products;
    • Involve the public in guidance and regulation development;
    • Use a risk-based decision-making process; and
    • Promote a science- and risk-based regulatory approach with trade partners.
  • The heads of USDA and the Department of Health and Human Services (HHS; the Department in which FDA sits) have issued press releases regarding the EO.  Both Agencies applauded the EO and both indicated that currently ongoing efforts at each Agency would continue in support of the EO.  These ongoing efforts include FDA’s Plant and Animal Biotechnology Innovation Action Plan, Veterinary Innovation Program, and Plant Biotechnology Consultation Program and USDA’s non-regulation of plants that could otherwise have been developed through conventional breeding techniques (consistent with the Bioengineered Food Labeling Rule).
  • The EO’s push for streamlined regulation of genetically modified organisms can be contrasted with recent increases in regulation in Europe.
  • On June 11, Acting FDA Commissioner Ned Sharpless released a statement highlighting recent agency efforts to better understand the impact of per- and polyfluoroalkyl substances (PFAS) in food and providing findings from recent tests of food samples in the United States.  In presenting the initial results of the testing, which focused on foods from specific geographic areas with known environmental contamination, Sharpless affirmed that FDA “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”
  • PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.  PFAS have been the subject of increased scrutiny among environmental groups and certain states.
  • Of the 91 samples evaluated from the 2017 FDA Total Diet Study (TDS), 14 contained PFAS. The safety assessments undertaken for these 14 samples indicated no human health concern, based on analysis of the level of PFAS found in that food, consumption of that food, and the most current toxicological information available for PFAS.  Sharpless’ announcement comes one week after FDA updated its website to include information on PFAS in the food supply and the agency’s newly formed PFAS working group.  The agency plans to continue to work with states to develop testing methods and capacities and to increase the baseline knowledge of PFAS levels in foods.
  • On June 11, 2019, FDA updated its Frequently Asked Questions (FAQ) on FSMA to include additional questions and answers related to the Produce Safety Rule that the Agency received through the FSMA Technical Assistance Network (TAN).
  • The FAQ covers a wide range of topics, from defined terms (e.g., “qualified end-use” and “retail food establishment”) to training of personnel requirements, health and hygiene, agricultural water requirements, and recordkeeping.  For example, the FAQ clarifies the status of the agricultural water requirements and stated that “FDA will be engaging with stakeholders to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used to ensure that the standards will be as practical and effective as possible for all farming operations. As [they] continue to meet with stakeholders and review new data and information, [they] will be assessing not only which aspects of the agricultural water standards are proving most challenging for growers, but also the appropriate mechanism for addressing those concerns.”
  • FDA finalized the Produce Safety Rule in 2015, which established science-and risk-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables. Since then, the FDA has been working to provide farms with training to comply with the rule’s requirements. Most recently, FDA published draft guidance to assist in developing alternate curricula to satisfy rule training requirements. You can find out more about the alternate curricula requirements here.
  • The Food Safety Modernization Act (FSMA), enacted on January 4, 2011, set deadlines for the U.S. Food and Drug Administration (FDA) to (1) designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health; and (2) publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold such foods. The FSMA also required FDA to publish the list of foods designated as high-risk on FDA’s website at the time the Agency promulgates the final rule establishing recordkeeping requirements.
  • On October 15, 2018, the Center for Food Safety (CFS) and the Center for Environmental Health sued FDA alleging that the Agency violated the FSMA and the Administrative Procedure Act by failing to meet the statutory deadlines and to publish the list of foods as described above. The complaint sought a judgement requiring FDA to take actions described in the statute pursuant to a court-ordered timeline.
  • In a Consent Decree, filed on June 7, 2019, FDA agreed to a schedule for FDA action, including:
    • Sept. 8, 2020 – Deadline for FDA to designate the list of “high risk” foods as required by the FSMA Section 204(d)(2)(A).
    • Sept. 8, 2020 – Deadline for FDA to publish a proposed rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
    • Nov.7, 2022 – Deadline for FDA to issue a final rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
  • In February 2014, FDA previously put out a Draft Approach for Designating High-Risk Foods, which outlined several criteria for designating a food as high-risk: (1) outbreak frequency and illness occurrence, (2) severity of illness, (3) likelihood of microbial or chemical contamination, (4) microbial growth potential/shelf life, (5) the probability of contamination and steps taken during manufacturing to reduce contamination, (6) food consumption patterns, and (7) economic impact. Whether the Agency will utilize its draft approach to develop its list of “high risk” foods remains to be seen.
  • June 7 marked the first ever celebration of the United Nations’ World Food Safety Day.  The theme for 2019 is that food safety is everyone’s business.   The United Nations has designated two of its agencies, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), to lead efforts in promoting food safety around the world.
  • In late 2018, Frank Yiannis assumed the role of the U.S. Food and Drug Administration’s (FDA) Deputy Commissioner for Food Policy and Response, focusing his efforts on food safety issues.  In Remarks on World Food Safety Day, Deputy Commissioner Yiannis highlighted the global nature of food safety, “foodborne pathogens do not recognize boundaries or borders, so when it comes to protecting consumers, neither should we” and the role FDA plays in ensuring that consumers are confident in the safety of the food supply.
  • In the spirit of World Food Safety Day, Mr. Yiannis highlighted three key FDA initiatives: (1) the Food Safety Modernization Act; (2) the announcement of an initiative called the New Era of Smarter Food Safety, leveraging new and emerging technologies to further food safety goals; and (3) FDA’s Nutrition Innovation Strategy, specifically highlighting the implementation of the Nutrition Facts label and requiring that certain menus and vending machine labels include calorie information.

 

 

 

 

  • On May 29, 2019, the USDA Food Safety and Inspection Service (FSIS) announced in a letter that it will remove the entry for Jambalaya from the Food Standards and Labeling Policy Book (Policy Book).  The change came in response to a 2013 petition from Zatarain’s, a Louisiana-based food company owned by McCormick & Company, Inc., that requested FSIS revise the entry for Jambalaya in the Food Standards and Labeling Policy Book.  The previous Policy Book entry for Jambalaya stated “[p]roduct must contain at least 25 percent cooked ham and one other meat or seafood must be included.  A New Orleans dish involving rice and ham and usually tomatoes (shrimp or other shellfish, other meat or poultry), together with seasonings.  Must show true product name, e.g., ‘Ham and Shrimp Jambalaya.’”
  • Zatarain’s petition stated Jambalaya is a dish with ingredients that vary greatly, and consumers do not always expect Jambalaya to contain ham and tomatoes.  It went on to say Creole Jambalaya recipes usually have tomatoes but Cajun recipes usually do not, and some Jambalayas contain chicken and shrimp while others have sausage and onions.  The petition included Jambalaya recipes and statements from several New Orleans chefs, all of which indicated Jambalaya includes a heavy portion of rice, but the chef can choose what kind of protein to include, if any.  The petition proposed FSIS revise the Petition Book entry to say the dish can contain meat, seafood, and/or vegetables, but that it must be comprised of at least 50% rice.  The New Food Economy  published an article with more on the chefs that supported the petition and the history of Jambalaya.
  • Instead of revising the entry, FSIS removed it from the Policy Book entirely.  FSIS states that for a product to now be labeled as Jambalaya, it must have “amenable levels” of meat or poultry and must state the common or usual name on the label.  Removing the entry from the Policy Book is in keeping with a general movement away from standards that restrict innovation and will accommodate the many variations of Jambalaya in the marketplace, including those without any ham.  The final policy is included in the May 31, 2019 Constituent Update.
  • In a tweet published on June 3, 2019 California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that its draft Proposition 65 regulation regarding listed carcinogens in coffee had been finalized and will become effective on October 1, 2019.  The regulation states that exposures to Proposition 65 carcinogens listed on or before March 15, 2019, which are produced by roasting or brewing coffee, do not pose a significant cancer risk.  OEHHA has yet to publish a formal notice on its website.
  • OEHHA initially proposed the regulation on June 15, 2018, stating in support that extensive scientific research showed not only that drinking coffee did not increase the risk of cancer but that it may reduce the risk of certain types of cancer.
  • A statement by former FDA Commissioner Scott Gottlieb, published after OEHHA’s proposed regulation, communicated FDA’s support for exempting coffee from bearing a Proposition 65 warning.  Gottlieb noted that placing a cancer warning on coffee could potentially mislead consumers, as the scientific evidence supports that coffee consumption does not pose a significant risk of cancer.
  • OEHHA initiated this rulemaking immediately after a ruling in the Los Angeles Superior Court that coffee sellers, including Starbucks, must warn consumers of the presence of acrylamide, a listed carcinogen.  The judge held that coffee retailers had not sufficiently demonstrated that the benefits of drinking coffee outweighed the risk from consuming acrylamide, a potentially cancer-causing chemical.  It remains to be seen how the final rule will impact the ongoing Starbucks litigation.