• On April 9, 2020, the FDA issued Best Practices for Retail Food Stores, Restaurants, and Food Pick-Up/Delivery Services During the Covid-19 Pandemic. The publication provides measures intended to promote employee health and safe handling of food during the pandemic. It is available as a one-page summary chart here.
  • In particular, it outlines suggestions for both employers and employees to ensure that sick workers are quickly identified and that their exposure to other workers is minimized. The recommendations for employers include: (1) instructing sick employees to stay at home and immediately sending home any employees identified as sick; (2) informing employees of their possible exposure to Covid-19 while maintaining confidentiality; and (3) implementing controls to reduce transmission among employees, including screening for symptoms prior to work and regularly disinfecting work spaces and equipment.
  • The publication also provides guidance for management of foodservice establishments in retail food stores including ensuring that foods are heated prior to service and rapidly cooled after, and discontinuing service stations that require common use of utensils or dispensers. Similarly, the publication provides guidance for management of food pick-up and delivery services including cleaning and sanitizing receptacles used to deliver foods and establishing procedures to ensure appropriate social distancing, such as no-contact alerts for deliveries and designated zones for pick-up.
  • The publication draws from other previously issued guidance documents and serves as both a condensed guide to best practices during the pandemic, as well as a resource for those seeking more detailed guidance. Keller and Heckman will continue to monitor and report on Covid-19 developments that impact the food industry.
  • FDA has issued warning letters to companies selling allegedly fraudulent products with claims to prevent, cure, treat, or diagnose COVID-19. Companies that sell products with unapproved claims regarding COVID-19 may be subject to enforcement actions that may include seizure or injunction.
  • On April 8, FDA announced that it had issued a joint warning letter with the Federal Trade Commission (FTC) to the Genesis 2 Church of Health and Healing for selling “Miracle Mineral Solution,” a chlorine dioxide product marketed for the prevention and treatment of COVID-19.
  • FDA previously warned consumers not to purchase or drink chlorine dioxide products sold online as medical treatments.  Chlorine dioxide products have not been shown to be safe and effective for any use.  Rather, FDA has received reports of people experiencing serious adverse effects after consuming chlorine dioxide, which FDA describes as “a powerful bleaching agent.”
  • FDA and FTC have asked that Genesis 2 Church of Health and Healing respond within 48 hours to describe steps that have been taken to correct violations.
  • On April 3, 2020, U.S. District Judge James Donato dismissed the sugar-related claims in the putative consumer class action lawsuit against O Organics LLC (“O Organics”), a kombucha drink maker owned by Safeway Inc.  In the court’s order, Judge Donato stated that plaintiffs’ counsel would have the opportunity to amend the complaint and offer more than the “glancing” assertions that O Organics’ Kombucha drinks are misleading about their sugar content.  However, Judge Donato noted that the complaint adequately pleads that the labels mislead consumers about their alcohol content.  Plaintiffs claimed that O Organics did not identify its kombucha as an alcoholic beverage even though the products contained more than 0.5% ABV
  • The complaint alleged that the Kombucha maker mislabeled its Kombucha products as nonalcoholic products when testing showed that the products actually contained up to 2.63% alcohol by volume (ABV), which is above the 0.5% threshold for federal regulation to consider them alcoholic drinks.  According to the Alcohol and Tobacco Tax and Trade Bureau (TTB), “kombucha” generally refers to a fermented beverage produced from a mixture of steeped tea and sugar, combined with a culture of yeast strains and bacteria.  Moreover, the combination of sugar and yeast triggers fermentation, which may produce a kombucha with an alcohol content of 0.5% or more alcohol by volume.  Under federal law, if the alcohol content of kombucha is 0.5% or more alcohol by volume, at any time during production, when bottled, or at any time after bottling, the kombucha is an alcohol beverage and is subject to TTB regulations.  Also, TTB regulations on alcohol beverages apply to any kombucha that has less than 0.5% alcohol by volume when bottled, but the alcohol content increases to 0.5% or more alcohol by volume at any point afterwards as a result of continued fermentation in the bottle.  Any Kombucha product below 0.5% ABV is subject to the U.S. Food and Drug Administration’s jurisdiction.
  • TTB and FDA have launched investigations into the alcohol content of kombucha in the past, and have found that “many” kombucha drinks in the market were above the ABV threshold.  We will continue to monitor any developments.
  • On March 26, the USDA responded to two petitions that requested FSIS amend the Agency’s Food Standards and Labeling Policy Book to provide that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA Beef,” or in any similar manner be derived from cattle that have been born, raised, and slaughtered in the US. The two petitions were submitted by the Organization for Competitive Markets (OCM) and the American Grassfed Association (AGA) on June 17, 2018, and the United States Cattlemen’s Association (USCA) on October 23, 2019. The response letters for OCM/AGA can be found here and here for USCA.
  • The petitions alleged that since the repeal of country of origin labeling (COOL) requirements in 2015, there has been no official definition of US beef, nor any specific “Made in USA” labeling requirements for beef products that are so labeled. Petitioners argued that the lack of a clear definition of what constitutes “Made in USA” or “Product of USA” or other similar designations leads to consumer confusion.
  • As a reminder, in 2013, the USDA implemented COOL rules, requiring meat labels to indicate where animals were born, raised, and slaughtered.  Meatpacking and livestock commodity groups in the U.S., Canada, and Mexico challenged the COOL requirements via appeal to the World Trade Organization (WTO) and a lawsuit filed in the U.S. (alleging that the requirements infringe First Amendment rights).  The controversy surrounding mandatory COOL rules for beef products ultimately culminated in: (1) a WTO ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL as of December 21, 2015.
  • In response to the two petitions, FSIS concluded that “its current labeling policy, which permits meat and poultry products that were derived from animals that may have been born, raised and slaughtered in another country but processed in the United States to be labeled as ‘Product of USA,’ may be causing confusion in the marketplace, particularly with respect to certain imported meat products.” Thus, FSIS decided to initiate a rulemaking to define the conditions under which the labeling of meat products would be permitted to bear voluntary statements that indicate US as the product origin. As indicated in the response letters, FSIS intends to propose that such labeling be limited to meat products derived from livestock that were slaughtered and processed in the US. The policy will focus on where the product is made (i.e., slaughtered and processed) without regard to where the animal was born and raised, meaning that cattle born and raised outside of the US, but slaughtered and processed in the US would be able to bear a “Made in the USA” label.
  • The COVID-19 pandemic has resulted in an increased consumer demand for shell eggs in the retail market and a reduced demand for further processed eggs. In response, and in order to facilitate the distribution of shell eggs to the retail market, the FDA has issued a pair of guidance documents that (i) relax food labelling requirements applicable to shell eggs and (ii) relax enforcement of the Egg Safety Rule (21 CFR Part 118).
  • The first of these guidance documents, issued on April 3, 2020, was directed to retail sellers of shell eggs and stated that the FDA would not object to the sale of shell eggs in cartons or flats that lack labels, provided that at the point of purchase no nutrition claims are made and the retailer displays in clear product-specific labeling:
    • a statement of identity;
    • the name and place of business of the manufacturer, packer, or distributor; and
    • safe handling instructions for shell eggs that have not been processed to destroy Salmonella Enteritidis (SE).
  • The second guidance document, issued on April 6, 2020, allows egg producers flexibility in compliance with the Egg Safety Rule when sending their eggs to the retail market. In particular, the guidance details modified requirements for compliance with the Egg Safety Rule for both poultry houses that are currently sending eggs to the retail market, and therefore would otherwise subject to more extensive regulation under the Egg Safety Rule, and for poultry houses that are not currently providing eggs to the retail market, and therefore would otherwise be subject to less extensive regulation under the Egg Safety Rule.
  • These recent guidance documents follow the FDA’s relaxation of food labeling requirements for restaurants and food manufacturers seeking to repurpose their food for retail sale (blogged about here) and the relaxation of nutrition information requirements in chain restaurants (blogged about here), and are yet another effort by the FDA to give the food industry flexibility as it adjusts to the changing market dynamics brought about by the pandemic. Keller and Heckman will continue to monitor and report on COVID-19 related developments that impact the food industry.
  • The Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) requires importers to perform certain risk-based activities to verify that their foreign supplier is producing food in accordance with U.S. food safety standards.  Inspections by the Food and Drug Administration (FDA) to review FSVP records are typically conducted at an importer’s place of business.
  • As previously reported on this blog, FDA announced a temporary halt of all domestic routine surveillance facility inspections on March 18, 2020 due to the COVID-19 public health emergency.  This followed the March 17, 2020 announcement, discussed here, of FDA’s temporary enforcement discretion policy regarding requirements for the importer to conduct onsite audits of food suppliers.
  • On April 3, 2020, FDA announced that it will temporarily conduct remote inspections under the FSVP, beginning with previously assigned routine and follow-up inspections falling in April as well as previously scheduled inspections that had been postponed due to COVID-19.  Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make a written request for records.  FDA reserves the option to conduct an onsite FSVP inspection in response to an outbreak of foodborne illness or where otherwise warranted.
  • FDA will continue to conduct FSVP inspections of importers’ records remotely until further notice and importers may continue to use others means of supplier verification in lieu of onsite audits until a reasonable time after social distancing recommendations and COVID-19 travel advisories are lifted.  Additionally, in another adjustment to the corona virus outbreak, FDA announced on April 3, 2020 a further extension of the comment period for the proposed rule to establish a laboratory accreditation program for the testing of human and animal food in certain circumstances by accredited laboratories.  See our previous blog on the laboratory accreditation program.

The National Advertising Division (NAD) of BBB National Programs, Inc. recently launched its new Fast-Track SWIFT (Single Well-defined Issue Fast Track) challenge process. NAD’s Fast-Track SWIFT offers an expedited process for resolving relatively simple and well-defined single-issue advertising disputes.

Three types of categories are currently eligible for a SWIFT challenge, although as the program develops, NAD indicates it may expand the scope of the matters that are deemed appropriate for SWIFT review:

  • The prominence or sufficiency of certain disclosures, such as:
    • Influencer disclosures;
    • Native advertising disclosures; or
    • Incentivized reviews, etc.
  • Pricing and sales claims.
  • Express claims that do not require review of complex evidence or claim substantiation (such as clinical studies, technical testing, or consumer perception evidence, etc.).

Additional differences between a SWIFT challenge and a standard track NAD challenge, include factors such as the following:

  • SWIFT challenges are limited to a single issue (claims that are worded slightly differently but convey the same message may be brought together as a single challenge).
  • Only one substantive submission per party is permitted (the challenger is only permitted to submit its initial challenge submission, and once the advertiser submits its response, the record is closed).
  • All challenges and supporting materials are submitted online.
  • SWIFT decisions will be issued within 20 business days from the day the advertiser receives notification of the challenge from NAD.
  • The advertiser has an opportunity to object to the issue being undertaken as a SWIFT challenge. If NAD agrees, the matter can be routed to the standard track process.

Keller and Heckman advises and represents clients in various stages and types of NAD proceedings. We will continue to monitor this new challenge mechanism as it develops.

  • In response to the COVID-19 pandemic, on April 1, 2020, the Food and Drug Administration (FDA) issued guidance to  chain restaurants and similar retail food establishments that sell standard menu items covered under the menu labeling provisions of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  The FD&C Act menu labeling requirements require restaurants and similar retail food establishments that “are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items” to provide nutrition information, including calorie information, for standard menu items on menus so that the information is available for customers.
  • In its guidance, FDA stated that this temporary flexibility may help food establishments that are temporarily changing business practices due to COVID-19 restrictions. For example, the FDA noted that some food establishments are switching to takeout only, which may require changes in online ordering portals and printed menus.  Moreover, the rapid transition to a takeout business practice may make it difficult for food establishments to provide nutrition information on standard menu items.  This guidance may also provide flexibility to those establishments that may be experiencing temporary disruptions in the food supply chain, which may lead to different menus, or substitutions that could affect the accuracy of the nutrition information.
  • Although the FDA encourages food establishments to comply with menu labeling regulations, the agency does not intend to object if food establishments do not meet menu labeling requirements.  However, the FDA noted that establishments will be required to comply with the menu labeling requirements upon conclusion of the public health emergency.
  • On March 31, an Ohio federal judge dismissed a proposed class action lawsuit which alleged that J.M. Smucker Co. misleadingly labeled peanut butter as “natural” even though it may have contained sugar derived from genetically modified beets.  The complaint was dismissed because the “consumers’ claims were too speculative and insufficient to show that a reasonable consumer would be misled.”
  • In the order, U.S. District Judge John R. Adams said that plaintiff Graham Forsher did not allege that the Jif brand natural peanut butter was actually genetically modified, but only that one of the product’s ingredients may have been. Forsher did not provide any facts showing that the Jif peanut butter contained sugar derived from genetically modified beets, but rather simply alleged that half of the sugar production in the US comes from sugar beets. He similarly did not show that sugar actually contains any bioengineered material. Forsher argued that where food is made with ingredients possibly derived from bioengineered food, it is misleading to label the product as “natural.”
  • Judge Adams also took issue with Forsher’s failure to state adequate facts to back his assertion that genetically modified sugar beets are unnatural: “Alleging that food is created in a lab ‘utilizing different modern scientific techniques’ is not the same as alleging that ingredients are unnatural. Plaintiff does not claim that GMO-derived sugar beets are chemically created. Plaintiff also does not point to a specific statute or regulation that would deem GMO-derived sugar beets as unnatural. Defendant has complied with the FDA’s policies and regulations regarding product labeling to the extent the sugar in the Products is derived from GMO sugar beets.”
  • The COVID-19 pandemic has caused a shift in the supply of food and has left both restaurants and restaurant suppliers looking for means to repurpose their food inventory. Where food cannot be distributed for human consumption because of supply-chain or food quality issues, but otherwise remains safe for consumption by animals, the food should be repurposed and distributed as animal food.
  • In order to encourage and facilitate the safe distribution of food to animals, the FDA’s Center for Veterinary Medicine has issued a Fact Sheet to guide restaurants and other suppliers of food.
    • Food can be sent to animal food manufacturers or their suppliers or directly to farmers or animal caretakers.
    • Animal specific toxicities must be accounted for. For example, the artificial sweetener xylitol is safe for humans, but can be toxic to dogs, although it may be safe for other species.
    • If the food is adulterated or contaminated, a diversion or reconditioning request must be submitted.
    • Caution is required for food containing meat. Several diseases can be spread through uncooked meat. In addition, any meat products fed to swine must comply with the Swine Health Protection Act (SHPA) and most mammalian protein is prohibited as food for ruminants, see 21 CFR 589.2000.
    • While animal food does not have to meet the requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA), it must have a statement of identity and list of ingredients.
    • State governments may also impose further regulation.
  • This Fact Sheet follows the FDA’s relaxation of nutrition labeling requirements for human foods not originally intended for retail sale and signals a clear intent to aid the food industry in minimizing disruption and loss of food during the COVID-19 pandemic.  Keller and Heckman will continue to monitor and report on COVID-19 related developments that impact the food industry.