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YOUR SOURCE ON FOOD LITIGATION AND REGULATION

Harvard Law School’s Animal Law & Policy Clinic (Clinic) submitted a petition on June 9 to the USDA’s Food Safety and Inspection Service (FSIS), urging it to adopt a labeling approach for the emerging category of cell-based meat and poultry that “does not overly restrict speech and that respects the First Amendment.”[1] In its response of July 23, FSIS indicates that it considers the document a request for future rulemaking.[2]

The Mexican Ministry of Economy and Federal Commission for the Protection Against Sanitary Risks approved a project on January 24 to modify the mandatory “Official Mexican Standard NOM-051-SCFI/SSA1-2010, General Labeling Specifications for Pre-packaged, Non-alcoholic Foodstuffs and Beverages” (NOM-051). The updated NOM-051 standards establish mandatory rules for all prepackaged, nonalcoholic foodstuffs and beverages sold in Mexico, regardless of their country of origin.

Among the key amendments established by NOM-051, relevant provisions include:

  • Front of Label Warnings: In addition to the already existing nutritional information requirements for principal display panels, NOM-051 requires the inclusion of an additional frontal “stamp” warning aimed at preventing the risk of overconsuming "Critical Nutrients," which, when ingested in excess, are considered risk factors associated with chronic diseases. Such Critical Nutrients include added sugars, saturated fat, sodium, and other nutrients and ingredients determined by the Ministry of Health.

FDA issued a final rule on October 28 that revises the type size requirement for front-of-pack (FOP) calorie labeling for food sold from glass-front vending machines. This new rule amends FDA’s 2014 final rule, which requires vending machine operators that own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines.

The 2014 final rule requires calorie labeling to be clear, conspicuous, and easily read on the article of food while in the vending machine, in a type size at least 50% of the size of the largest printed matter on the label. Following objections due to technical challenges faced by industry, FDA revised the type size requirement to reduce the regulatory burden on and increase flexibility for industry while ensuring that calorie information remains visible to consumers.

FDA announced on October 24 that it does not intend to take enforcement action against manufacturers in the first six months following the January 1, 2020, deadline to update Nutrition Facts labels on food packaging. The enforcement discretion extension follows the May 2018 compliance date delay, which extended the compliance dates for manufacturers with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020, while compliance dates for manufacturers with less than $10 million in annual food sales moved from July 26, 2019, to January 1, 2021.

The US Department of Agriculture (USDA) issued a Notice of Availability and Request for Public Comment on a new guideline addressing multi-component food kits that contain meat or poultry items (Meal Kit Guideline). The Meal Kit Guideline provides industry with information on how to label a multi-component food kit that contains meat or poultry and whether it would need to be prepared under FSIS inspection.

The major takeaways include the following:

FDA released a consumer update stating that it supports industry’s effort to toss expiration dating terms on foods, such as “use before,” “sell by,” and “expires on,” for the more neutral date phrase “best if used by.”

Recent scientific advancements have revolutionized the way food and agricultural products are being grown, sold, and regulated. These advancements raise new regulatory issues and create unique challenges for companies in the industry. A rapidly growing population, combined with tremendous attention from investors, means animal cell-culture derived products are poised for entry into the global marketplace within 5 to 10 years.

FDA partner Bob Hibbert explored this topic in a webinar titled “Opportunities in Food and Agricultural Tech” as part of the 2019 Morgan Lewis Technology May-rathon. The Technology May-rathon, now in its ninth year, is a series of tailored webinars and in-person events designed to share tech-related current issues, trends, and developments.

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The US Department of Agriculture (USDA), through its Agricultural Marketing Service (AMS) published its final rule (NBFDS Final Rule) on December 21 establishing a nationwide labeling disclosure requirement for foods containing bioengineered (BE) ingredients, defined as foods or substances that contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or be found in nature. While a more thorough analysis is still being conducted, here we provide a summary of the major topics addressed in the NBFDS Final Rule.

On October 29, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that FDA is considering whether sesame should be disclosed on food labels as an allergen. Because sesame is not identified as a “major food allergen” under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the ingredient is not always required to be stated on the food label. Rather, in some cases, sesame can be listed generically as “spice,” “natural flavor,” “tahini,” or other nonspecific ingredient names, which can lead to consumer confusion and uncertainty.

The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient. Under current regulations, dietary supplement ingredients can only be quantified by weight in the Supplement Facts panel. However, the use of weight to measure live microbial dietary ingredients can be inaccurate or confusing because weight does not distinguish between live and dead microorganisms, and does not reflect the occurrence of cell death of live microorganisms over the course of a product’s shelf life.

However, CFUs describe the quantity of live microbial dietary ingredients, and can help consumers identify the amount of living microorganisms in each product and make comparisons across dietary supplement products on the basis of that information. Accordingly, while FDA considers whether to conduct rulemaking to formally change the unit of measure, it will allow use of CFUs in the Supplement Facts panel of probiotics under certain conditions. For more information on the circumstances in which CFUs may be used, as well as other information on the guidance, please read our LawFlash, FDA: Probiotic Products Can Use CFUs on Supplement Facts Panel.