On November 6, the US Food and Drug Administration (FDA) announced that its final guidance on Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff (Mandatory Recall Guidance) is now available. The Mandatory Recall Guidance provides information on the implementation of the mandatory food recall provisions of the Food Safety Modernization Act (FSMA). The Mandatory Recall Guidance comes in the form of a Q&A on common topics about the FSMA’s mandatory recall provision.
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. 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The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient.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:
- Jurisdiction: What federal agency should be responsible for overseeing such products?
- Oversight: How should such products be regulated?
- Labeling: How are they to be identified to the consumer?
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). 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.
The US Department of Agriculture’s Food Safety Inspection Service (FSIS) recently released a new guideline in an effort to clarify whether or not a firm is exempt from the inspection requirements under the Federal Meat Inspection Act (FMIA). A copy of the guideline can be found here.
The guideline is effective immediately; however, FSIS provided the public 60 days to comment on the proposed rule, which closes on Monday, July 24, 2018. Anyone can submit their comments online here.
The new FSIS guideline specifies criteria and notes for familiar exemptions under traditional business models, such as livestock slaughtered for personal use, custom slaughtered or prepared livestock, retail stores, restaurants, central kitchen facilities, and caterers. As discussed in further detail below, the document essentially codifies established agency practice.
Three years after FDA’s final rule on menu labeling was published, the compliance date for the rule finally went into effect on May 7. 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 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.