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The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient.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.
The US Department of Agriculture issued a proposed rule requiring that foods containing bioengineered (i.e., genetically modified organisms or “GMO”) ingredients display a food label to indicate to consumers that it is a “bioengineered food.” The proposed rule is far-reaching and, if adopted, would impact labeling obligations for a substantial percentage of food products offered for sale in the United States. This includes, but is not limited to, raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks. As explained in greater detail in the preamble, it also applies to some of the meat, poultry, and egg products independently regulated by the USDA, but only if an ingredient regulated by the US Food and Drug Administration (FDA) predominates. Read the full LawFlash.
The Food and Drug Administrant (FDA) on Thursday announced the details of its planned delay to require manufactures to update Nutrition Facts and Supplement Facts labels on food packaging. The finalized rule extends the compliance dates for manufactures with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020, while compliance dates for manufactures with less than $10 million in annual food sales will move from July 26, 2019, to January 1, 2021. As we previously discussed, FDA had announced last year that it was extending the compliance date to an undetermined time around the same time FSIS’s Nutrition Facts Panel proposed rule was placed on the list of “inactive” regulations by the White House Office of Management and Budget.
FDA explains in the final rule that the additional time will “help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions [FDA] received after publication of the final rules, and that [manufacturers] have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expended to be in compliance with the final rules.” Notably, FDA’s announcement came on the same day the US Department of Agriculture (USDA) published its much-awaited proposed rule establishing a National Bioengineered Food Disclosure Standard. UDSA’s labeling disclosure requirements will potentially require additional modifications to some types of labels. Therefore, FDA’s extension of the Nutrition Facts labels may more closely align the two compliance dates and possibly eliminate the need to change the labels twice.
The US Food and Drug Administration (FDA) opened a public comment period on November 12, 2015, seeking information and comments on use of the term “natural” on food labeling. The comment period was open until May 10, 2016. FDA received over 7,600 comments but has not yet issued any “natural” definition.
Anticipating FDA guidance, many courts stayed class actions involving allegations of the use of “natural” in food products under the primary jurisdiction doctrine, which permits a court to stay a lawsuit if doing so would give an administrative agency the opportunity to resolve the question at issue in the case. Now that it’s been more than a year since the comment period closed, some courts and parties are evaluating whether these cases should remain stayed. Plaintiffs argue that lack of FDA guidance weighs against a continued stay. But the US Congress and FDA made several statements over the past few months supporting food and beverage manufacturers’ requests for extending litigation stays.
After years of compliance date delays, New York City and FDA appear to have agreed to begin enforcing rules that would require chain restaurants and other establishments to post certain calorie and nutrition information in their stores on May 7, 2018. FDA has delayed enforcement of its federal menu labeling rule since 2015, and in response to the latest postponement, NYC announced that the city would begin to enforce its own similar menu labeling rules in the interim. However, the city and federal authorities came to an agreement on August 25 when NYC and FDA both agreed to the May 7, 2018 compliance date.
NYC began requiring calorie labeling disclosures in chain establishments when it promulgated its original menu labeling rule in 2008. The city updated the rule, yet deferred its enforcement in anticipation of an impending 2015 compliance date for the federal menu labeling regulation. However, FDA postponed the compliance date of the federal rule three times— first to December 2016, then to May 2017, and finally to May 2018.
On August 14, the federal government, through the Department of Justice (DOJ), filed a Statement of Interest in a lawsuit between a group of food industry trade associations and New York City regarding the city’s food chain menu labeling rule, which requires certain food establishments to post calorie information and other nutritional information. The lawsuit arose following NYC’s announcement in May that it would begin to enforce its own local menu labeling rule after FDA delayed the enforcement date of a similar federal menu labeling regulation for the third time. The trade associations sought an injunction to block NYC from enforcing its rule, and in its recent filing, the DOJ stated its agreement that the NYC rule should be barred on preemption grounds.
Last week FSIS’s Revised Nutrition Facts Panel proposed rule was placed on the list of “inactive” regulations, indicating that the rule is no longer a priority and will be reconsidered at an unspecified time in the future. This notice comes after FDA announced last month that it would be postponing the compliance date for its Nutrition and Supplement Facts Label rule and Serving Size rule from July 2018 to an undetermined implementation date.
The current unsettled status of restaurant menu labeling rules may be headed toward some form of resolution. FDA first promulgated a final federal menu labeling rule in December 2014 requiring that calorie information be posted on menu labeling boards in covered food retailers. The agency subsequently delayed the compliance date to December 2016, and again to May 2017. On May 4, 2017, the day before the rule was to take effect, FDA delayed the rule again, this time to May 7, 2018. In response, on May 18, New York City announced it would begin to enforce its own local menu labeling rule. Current circumstances have left retailers uncertain about how to proceed. Can a federal agency delay a final federal regulation for an indefinite period? Does a delayed federal regulation have preemptive effect over a local or state rule?