YOUR SOURCE ON FOOD LITIGATION AND REGULATION

As readers are undoubtedly aware, the Centers for Disease Control (CDC) issued a Food Safety Alert (Alert) on November 20 due to a multistate outbreak of E. coli-related infections linked to romaine lettuce. The CDC alert associated the product with 32 illnesses and 13 hospitalizations. Further, it advised consumers not to consume any romaine lettuce and advised retailers and restaurants not to serve or sell it. By rendering such products unsellable, the alert raised immediate questions concerning the identity of parties forced to bear the risk of loss. The issue has been addressed by the US Department of Agriculture’s (USDA) Perishable Agricultural Commodities Act (PACA) Division through FDA Advisory Alert on Romaine Lettuce and the PACA (PACA Announcement).

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.

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.[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.

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.”

An appellate court recently upheld the convictions of former employees of the now defunct Peanut Corporation of America (PCA),[1] affirming what is the longest criminal sentence in a food safety case.[2] Specifically, on January 23 the US Court of Appeals for the Eleventh Circuit unanimously denied the appeals of former PCA president Stewart Parnell, who was sentenced to serve 28 years in prison; his brother and peanut broker Michael Parnell, who was sentenced to serve 20 years; and PCA’s quality assurance director Mary Wilkerson, who was sentenced to serve 5 years.[3]

In 2009, the peanut processing company was identified as the source of a massive salmonella outbreak in the United States, which led to an extensive recall. More than 700 individuals were reported to have salmonella poisoning that was linked to the outbreak, and there were at least nine deaths. On February 13, 2009, PCA ceased all manufacturing and business operations, and filed for Chapter 7 bankruptcy liquidation.

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.[1] 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.