• FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety Modernization Act (FSMA). As our readers may know, the Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption.
  • Part of the Produce Safety Rule requires that at least one supervisor or responsible party from a covered farm successfully complete food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA. The draft guidance recognizes version 1.1 of the standardized curriculum developed by the Produce Safety Alliance (PSA) as adequate for the standardized curriculum in 21 CFR 112.22(c) – Subpart C, Personnel Qualifications and Training of the Produce Safety Rule.
  • Covered farms, however, are not required to use the standardized curriculum and may use alternate curricula. The draft guidance provides recommendations on the factors that should be considered when developing or selecting an alternate curriculum training.
  • Stakeholders may submit comments on the draft guidance until October 2, 2019. Keller and Heckman attorneys are well-versed in FSMA and the Produce Safety Rule requirements and are available to assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com
  • Under current law, cannabidiol (CBD) cannot lawfully be added to a food or marketed as a dietary supplement, Acting FDA Commissioner, Ned Sharpless, MD, emphasized during remarks he made at a public hearing on products containing cannabis or cannabis-derived compounds. FDA held the meeting on May 31, 2019, to obtain scientific data and information about the safety of FDA-regulated products containing these compounds.
  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug EPIDIOLEX, the Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits adding it to a food or a dietary supplement.
  • Dr. Sharpless pointed out that while the law allows FDA to issue regulations to create exceptions to the statutory provisions, “FDA has never issued a regulation like that for any substance.” He added that if the Agency were to pursue this course “it would be new terrain for the FDA.” He also expressed concern about the lack of research to support CBD’s broader use in FDA-regulated products, including food and dietary supplements. Dr. Sharpless suggested that this lack of research has resulted in unique complexities for its regulation, including many unanswered questions related to its safety, such as how much CBD is safe to consume in a day or if it will interact with other drugs that a person is taking.
  • Industry suggested that FDA could either issue a regulation permitting CBD as a lawful ingredient in foods and supplements or issue guidance stating that it intends to exercise “formal enforcement discretion with respect to the provisions of the FD&C Act on which FDA bases its position that CBD-containing supplements and foods are unlawful.” (See comments by American Herbal Products Association President Michael McGuffin.) However, Dr. Sharpless noted that FDA “does not have a policy of enforcement discretion with respect to any CBD products.”
  • For more information on the public hearing and to learn about the current legal status of cannabis and cannabis-based compounds in FDA-regulated products, sign up for Keller and Heckman webinar, “FDA’s Regulation of Cannabis-Based Compound,” to be held Tuesday, June 11, 2019, at 1:00 PM EST. Also, speakers during the webinar will provide practical tips on how to navigate this space given the legal and regulatory uncertainties that exist. Click here to register.

 

  • Cyclosporiasis is an intestinal illness caused by the microscopic parasite Cyclospora cayetanensis. People can become infected with Cyclospora by consuming contaminated food or water. Past cyclosporiasis outbreaks in the U.S. have been mainly linked to consuming imported fresh produce like cilantro. C. cayetanensis, however, may be an emerging pathogen with an increasing incidence of occurrence and infection.
  • FDA’s investigation of multiple large foodborne outbreaks of cyclosporiasis in 2018 (reported on here) found C. cayetanensis in various domestic and imported fresh produce.  And earlier this year, we reported that FDA found Cyclospora in 2 of 141 samples of domestically grown fresh herbs and 4 of 74 samples of imported fresh herbs tested under FDA’s microbial surveillance sampling program.
  • A June 13, 2019 webcast lecture by FDA’s Center for Food Safety and Applied Nutrition’s Lead Parasitologist, Dr. Alexandre da Silva, will explore Cyclospora cayetanensis: The crossroads between scientific advances and knowledge gaps. Scientific gaps that remain major public health and regulatory challenges for FDA will be discussed in the context of the 2018 cyclosporiasis outbreak investigations. Dr. da Silva’s presentation will also discuss FDA’s use of a validated method to detect C. cayetanensis in foods in support of surveillance assignments and outbreak investigations.

 

  • The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months.
  • The agenda includes significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of particular note for USDA is the hemp production program rule, which the Unified Agenda indicates will be released as an interim final rule in August 2019.  As readers of this blog may recall, the 2018 Farm Bill removed hemp from the Controlled Substances Act, and assigned regulation of the growth of hemp to the states with oversight by USDA.  The Secretary of USDA, Sonny Purdue announced in March his intent to have a final rule in place in late 2019 in time for the 2020 growing season.  Though many were skeptical due to the time generally required to promulgate a regulation, if USDA adheres to its estimated completion date of August 2019 (estimated completion dates for regulations published in the Unified Agenda are often inaccurate), Mr. Purdue’s promise may be fulfilled.   Other USDA regulatory priorities include USDA’s National Organic Program plan to strengthen oversight of organic imports to deter fraud, enhance enforcement and protect organic integrity and swine slaughter inspection.
  • Interim FDA commissioner Sharpless, in an FDA Voice blog, highlighted several of the agency’s proposed regulatory actions related to tobacco and standards of identity for food. The Unified Agenda includes several actions related to tobacco products, including implementing safety standards for Electronic Nicotine Delivery Systems, product standards for characterizing flavors in cigars and nicotine levels in products.  As was also the case in the Fall 2018 Unified Agenda, FDA still plans to update the definition of the claim “healthy” on food labels, to revoke outdated standards of identity for French salad dressing and frozen cherry pie, and to reopen the comment period (expected September 2019) on the proposed rule establishing general principles to update the framework for standards of identity.  FDA also continues to state that they will issue a proposed rule on the revocation of uses of partially hydrogenated oils in food, a final rule on gluten-free labeling of fermented, hydrolyzed, or distilled foods, and a final rule regarding the soy protein and coronary heart disease health claim.  A new item on the Spring 2019 Unified Agenda includes a final rule regarding calorie labeling for foods sold from certain vending machines and front of package type size.
  • NuTek Food Science—the company that filed a 2016 citizen petition to obtain FDA permission to label potassium chloride as “potassium salt”—has withdrawn its citizen petition.  The company made its decision based on FDA’s recent issuance of draft guidance authorizing the term “potassium chloride salt” as an alternative name for “potassium chloride” on food labels.
  • NuTek’s petition had requested that FDA permit “potassium salt” as a common or usual name for potassium chloride because consumers have negative associations with the word “chloride.”  In a press release, NuTek’s Chief Strategy Officer, Brian Boor, stated, “Although the FDA’s initial draft guidance fails to address the problematic use of the word ‘chloride,’ we are confident that the food industry and the health community can make a compelling argument for its removal during the 60-day comment period.”
  • NuTek’s citizen petition received support from members of the food industry and seems to have started a dialogue in other countries, such as Canada, that also may consider allowing potassium chloride to be declared as “potassium salt” on food labels.
  • On May 28, 2019, FDA announced a partnership with the American Chemical Society (ACS) to provide a series of biannual training sessions focusing on chemical science related to food safety. The half-day training sessions are continuing education opportunities for FDA employees, but are open to the public and offer participants the opportunity to interact with leading technical experts in chemistry. However, FDA emphasized the training sessions are not intended as a forum to discuss regulatory issues or make recommendations to the agency or agency employees.
  • The colloquia sessions will focus on various aspects of chemistry, including flavor modifiers, manufacturing processes, specifications and analytical methods. The first session titled “Frontiers in Flavor Chemistry,” will be held on Tuesday, June 4 and will cover a range of flavor-related topics, including taste perception in humans and its impact on nutrient intake, recent advances in food flavors, and the discovery of new flavors. Based on the invited panel of experts, it appears the training session will focus on the chemistry and development of flavors, versus the regulation of flavors and flavor labeling.
  • Only registered participants are allowed to attend the trainings, and there will be no onsite registration. More information can be found on the ACS event registration site.
  • As previously reported on this blog earlier this month, the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) posted Frequently Asked Questions (FAQs) and responses for manufacturers concerning its bioengineered (BE) food labeling rule (formally known as the National Bioengineered Food Disclosure Standard (NBFDS)). We pointed out in that blog that the FAQs were not very helpful in answering the questions being raised by manufacturers regarding their obligations under the rule but noted that further guidance would provide further  clarity.
  • On May 24, AMS announced that new FAQs on the BE food labeling rule were now available. The new questions include two on validation of processes for highly refined ingredients. There is also a question on the types of records that are required to show that the presence of a BE substance is inadvertent or technically unavoidable. Other new questions concern disclosure statements, and compliance and enforcement issues.  It is not clear whether AMS will continue to update the FAQs with new questions and responses.
  • The implementation date of the NBFDS is January 1, 2020, except for small food manufacturers, which have until January 1, 2021 to implement the standard. The mandatory compliance date is January 1, 2022.
  • Packaged food and beverage products for retail sale contain an array of date labels, such as “Use by,” “Best If Used By,” “Expires On,” etc. Ultimately, with few exceptions, such as labels for infant formula, data labels are not required on packaged foods. While manufacturers are prohibited from placing false or misleading information on a label, they are not required to obtain agency approval of the voluntary quality-based date labels they use or specify how they arrived at the date they’ve applied.
  • There have been a number of initiatives, both by industry and by government, to standardize date marking on foods, which this blog has covered here and here. Most recently, USDA’s FSIS announced an updated fact sheet on food product labeling, encouraging food manufacturers and retailers that apply product dating to use a “Best if Used By” date label. Our coverage of FSIS’ action can be found here.
  • FDA has followed suit, announcing in a letter to food companies that the agency “strongly supports” the voluntary industry-wide efforts to use the “Best if Used By” phrase when choosing to include a quality-based date label to indicate when a product will be at its best flavor and quality. In the letter, Deputy Commissioner Frank Yiannas notes that while industry has recommended the phrase “Use By” to apply to perishable products that should be consumed by the date on the package, “FDA is not addressing the use of a “Use by” product date label for safety reasons at this time.”

 

 

  • FDA has launched a social media toolkit to assist with consumer awareness of menu labeling information.  The toolkit features web badges that can be added to an organization’s website, a sample newsletter/blog, and social media messages for sharing on Facebook and Twitter.
  • The new consumer-focused materials refer to FDA’s www.fda.gov/caloriesonthemenu website, which provides consumers with additional resources for understanding menu labeling information and making restaurant choices based on “calorie needs.”
  • Having become effective just one year ago on May 7, 2018, the menu labeling rules remain relatively new, and the new social media toolkit is the latest in a series of FDA efforts to educate both industry and consumers on menu labeling.
  • Country of Origin Labeling (COOL) requirements at 7 CFR Part 60 and 7 CFR Part 65 require retailers to notify their customers of the country of origin of covered commodities, which include muscle cut and ground lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng. For example, seafood sold at grocery stores would be subject to the federal COOL requirements. However, a Louisiana bill would require those same requirements to extend to restaurant menus.
  • House Bill No. 335 would require Louisiana restaurants to label menus with the origins of shrimp and crawfish. The proposed law would require all restaurants that use a menu as a standard business practice and sell cooked or prepared crawfish or shrimp that originate outside of the U.S. to display on all menus the country of origin in letters no smaller than one-half inch in size, in English, immediately adjacent to the menu listing of the seafood item being sold. For restaurants that do not use a menu, a sign may be posted at the main entrance that notifies customers of the country of origin of the crawfish and shrimp. Any violation of the proposed law would constitute a violation of the state’s sanitary code. House Bill No. 335 has passed the Louisiana state house with unanimous support, and is currently under consideration by the Senate Health and Welfare Committee.
  • Louisiana is not the first state to use country of origin labeling laws in restaurants. Indeed, Alabama, Arkansas, Mississippi, Louisiana, and Tennessee all have state laws requiring origin labeling for catfish on restaurant menus.
  • House Bill No. 335 is not the only food labeling-related bill currently in the Louisiana state legislature. Senate Bill No. 39, if passed, would prohibit plant-based milks from being labeled as “milk” and Senate Bill No. 152 would ban plant-based and cell-cultured meats from using the term “meat” on labels and in labeling.