YOUR SOURCE ON FOOD LITIGATION AND REGULATION

Sonic Drive-In reached a $4.3 million settlement on October 10 with its customers over the chain’s data security breach in 2017 that exposed customer credit and debit card information at 325 Sonic Drive-In locations.[1] The attack followed a pattern familiar in the retail and restaurant context, where hackers infect the point-of-sale system with malware that copied and transmitted the information from consumers payments cards when used to make a purchase. Plaintiffs filed several class action lawsuits for violations of state consumer protection laws and data breach notification statutes, along with various common law causes of action. The lawsuits were consolidated into a multidistrict litigation proceeding in the Northern District of Ohio in early 2018.

The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient.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.

In recent months, questions about the potential future marketing of what will be termed herein “cell-cultured meat” (CCM) have moved outside the confines of biotech laboratories and tech funders’ boardrooms and caught the attention of both regulators and a much broader segment within the general public. As the regulatory future of such products starts to come into focus, debates and discussions have been generated within the food industry over three interlocking issues:

  1. Jurisdiction: What federal agency should be responsible for overseeing such products?
  2. Oversight: How should such products be regulated?
  3. Labeling: How are they to be identified to the consumer?

For a more comprehensive discussion of the emerging regulatory landscape for CCM read the article by Morgan Lewis lawyers Robert Hibbert and Amaru Sanchez in Food Quality & Safety magazine.

As always, if you have any questions, please do not hesitate to contact us.

The Food and Drug Administration (FDA) held a public meeting July 12 on “Foods Produced Using Animal Cell Culture Technology” to give the public an opportunity to provide comments on federal regulation of the future production of foods using animal cell culture technology. While a thorough account of the all-day meeting is beyond the scope of this article, we wanted to share with you our main takeaways from the meeting, which can be lumped into three categories: jurisdiction, regulatory oversight, and labeling.

The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Draft Guidance). The IA Draft Guidance is intended to assist industry in developing and implementing a “food defense plan” (FDP) in accordance with the “Mitigation Strategies to Protect Food Against Intentional Adulteration” Final Rule (IA Rule).[1] The IA Rule requires domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide-scale public health harm by developing said FDP.[2]

Three years after FDA’s final rule on menu labeling was published,[1] the compliance date for the rule finally went into effect on May 7.[2] The federal menu labeling rule requires that calorie information—which is already included on most packaged foods—must be posted on menus and menu boards in chain restaurants.

The menu labeling requirements apply to retail food establishments that are part of chains with 20 or more locations. “Covered establishments” must post the following on menus and menu boards:

  • The number of calories contained in standard menu items
  • The statement: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.”
  • The statement: “Additional nutrition information available upon request.”

The Food and Drug Administration (FDA) on Thursday announced the details of its planned delay to require manufactures to update Nutrition Facts and Supplement Facts labels on food packaging.[1] 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.[2] 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.[3] 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.

Since our last post, more than 41 comments have been submitted in response to the US Cattlemen’s Association’s petition (USCA Petition) requesting that the USDA FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM). While an exhaustive analysis of the submitted comments is beyond the scope of this article, we would like to highlight two comments we found interesting. We also would also like to highlight a separate but related approach taken by Rep. Rosa DeLauro (D-Connecticut), to understand how best to regulate these innovative food products.

In a petition (USCA Petition) submitted to the Food Safety and Inspection Service (FSIS) on February 9, the US Cattlemen’s Association requests that FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM)—meat grown in a cell culture instead of culled from an animal (jointly, Alternative Products). The USCA Petition presents the following assertions to support such exclusions:

  • Alternative Products, it maintains, do not meet the common dictionary or statutory/regulatory definitions of “meat,” “beef,” and related terms because the definitions contemplate products derived naturally from animals.
  • The marketing of Alternative Products is potentially misleading because consumers would reasonably expect products labeled as “meat” and “beef” to be derived from animals slaughtered in the traditional manner.

In almost any area where an emerging technology intersects with a highly regulated industry, there is a dynamic of entrepreneurial spirit facing the realities of existing regulatory frameworks. One novel product facing this dilemma is “cell-cultured meat” (CCM)—meat grown in a cell culture instead of culled from an animal.

CCM is part of a new and emerging area of biotechnology known as “cellular agriculture” through which agricultural products are produced from the cellular level rather than taken from the whole plant or animal. Proponents of cellular agriculture highlight the process as creating a more sustainable, efficient, and predictable food supply, and the National Academy of Sciences estimates products of cellular agriculture will be in the marketplace within the next five years.