YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient.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

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.”

What is currently unfolding in Texas and Florida is both tragic and unprecedented. Early reports have estimated the reconstruction costs in Texas alone to be around $40 billion dollars. As Texas continues to grapple with the effects of Hurricane Harvey and Florida begins the recovery process, we thought it would be helpful to supply our clients and friends in the food and agricultural sectors with some relevant regulatory information and potential sources of assistance.

Food Safety

Producers and Manufacturers

As a result of the unprecedented rainfall, storm surges, and wind gusts, food production and manufacturing facilities may have been flooded or lost power. In some areas crops as well as processed food may have been submerged in floodwater. Such flooding potentially exposes food products to certain harmful contaminants (e.g., sewage, chemicals, heavy metals, pathogenic microorganisms). As a result, the Food and Drug Administration (FDA) advises that foods exposed to floodwater and perishable foods that are not adequately refrigerated are generally considered adulterated within the meaning of Section 402(a) of the Federal Food, Drug and Cosmetic Act (FDCA) and thus should not enter the human food supply. Individual/case-by-case evaluations are suggested for foods that may not have been completely submerged (e.g., crops as well as grains or similar products stored in bulk containers). Many of you have likely provided a certain level of assurances concerning the regulatory status of your products (i.e., not adulterated) in your contracts. Thus, we take this opportunity to encourage you to be mindful of the impact this aforementioned presumption of adulteration may have on your contracts. We encourage you to conduct additional due diligence and review your standard operating procedures as well as follow current good manufacturing practices for guidance. However, when in doubt, throw it out. The premise behind such an assumption is that both exposure to floodwater and inadequate refrigeration compromise food safety—thus the introduction of an adulterated product into commerce constitutes a violative offense under the FDCA. However, we also note that not all potentially exposed foods are presumed adulterated. FDA has indicated that hermetically sealed (top and bottom double-seam) cans may be reconditioned and relabeled under certain conditions.[1]

For additional FDA information on food safety, please visit FDA’s emergencies website. In a similar vein, owners of meat and poultry producing businesses who have questions or concerns should contact the Food Safety and Inspection Service (FSIS) Small Plant Help Desk by phone at +1.877.FSIS.HELP (+1.877.374.7435) or by email at infosource@fsis.usda.gov. In addition, the US Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) is providing information on its website for farmers, ranchers, and businesses that have been affected by the recent hurricanes.

If you have any specific questions concerning Hurricane Harvey’s impact on your business (e.g., regulatory compliance, cGMP issues), please do not hesitate to contact Kathleen Sanzo or Bob Hibbert from Morgan Lewis’s FDA practice.

Restaurants and Food Retail Establishments

Similarly, FDA advises that restaurants and food retail establishments that have resumed activities do the following:

  • Ensure that any rodents/pests that may have entered the facility are no longer present.
  • Discard all food and packaging materials that have been submerged in floodwater, unless the food is sealed in a hermetically sealed can that has not been damaged and has its label intact.
  • Inspect physical facilities for possible water damage and consult professional service technicians, as needed.
  • Verify that all equipment used for food preparation (e.g., cooking, cooling, and reheating) is clearly functioning and properly calibrated prior to use.
  • All foods, including raw, fresh, frozen, prepackaged, shelf-stable, and ready-to-eat foods, should only be received from licensed and approved food sources. This includes food distributors and vendors licensed by local or state regulatory food authorities.

It is important to understand that your food supply chain will likely be disrupted. As a result, additional due diligence is necessary to identify existing new sources and these efforts should be documented.

For a complete listing of FDA’s advice for restaurants and food retail establishments and retail food protection, please see FDA’s publication on this topic.

Livestock

Reports have indicated that more than 1.2 million beef cows may have been affected by Hurricane Harvey. APHIS, working alongside the Texas Animal Health Commission (TAHC), is providing emergency assistance in caring for animals. The TAHC has advised the public to call 211 or to contact the area emergency management department for assistance in finding large or small animal shelter/holding facilities in your area or evacuation area.

If cattle have strayed onto your property, property owners are encouraged to contact the Texas Southwestern Cattle Raisers Association (TSCRA) at +1.817.332.7064 or the TAHC at +1.512.719.0733 or +1.806.354.9335. Under Texas law[2] you may be eligible for reasonable payment for maintenance of or damages caused by the stray livestock. For additional information, contact your local Sheriff’s department.

Disaster Assistance Programs

To assist businesses in their recovery efforts, please find a few federal disaster assistance programs below.

Small Business Administration

The US Small Business Administration (SBA) offers low-interest, long-term loans for losses not fully covered by insurance or other means. Additional information can be found on the SBA website.

USDA

The USDA Farm Service Agency (FSA) administers many disaster assistance programs to help producers recover from eligible losses, including the following:

USDA encourages farmers and ranchers to contact their local FSA office to learn what documents they can produce to help the local office expedite assistance, such as farm records, receipts, and pictures of damages or losses.

We hope these materials are helpful, and we will continue to monitor ongoing government response to these events.


[1] See FDA, Investigations Operations Manual 2017, Ch. 8, § 8.5.7.9, p. 431, c (2017).

[2] Tex. Agri. Code Ch. 142.