• The U.S. Government Accountability Office (GAO) recently released a report (the “Report”) which issues recommendations regarding FDA and USDA cooperation on regulatory oversight of cell-cultured meat and details the challenges of commercialization where much of the technology for commercial production is either still in development or being safeguarded as a proprietary technology.
  • In March 2019, the FDA and USDA announced that the FDA would oversee the early phases of cell-cultured meat production (including obtaining cell samples, cell selection and storage, and cell growth) through the point of harvest, at which point oversight would transfer to USDA to regulate food processing, including labeling.
  • The Report issues a number of recommendations for increased interagency cooperation to prepare for regulation of cell-cultured meat and also identifies a plethora of open questions which pose challenges for commercialization:
    • Tissue Collection – What animals will be used collect biopsy samples and how often will biopsies be required?
    • Genetic Engineering – Will selection of desirable traits in cells use genetic engineering?
    • Antibiotics – Will antibiotics be used, and if so, in what amounts and at what stages of production?
    • Growth Medium – What type will be used?
    • Scaffold – Will cells need to be attached to scaffolding structure during the growth stage, and if so, will the scaffold be edible?
    • Point of Harvest – How will this be defined by FDA and USDA and how will jurisdiction be transferred?
    • Scaling up Production – Do firms have the necessary equipment for production at a commercial scale?
    • Production Cost – Can firms make an affordable product, in particular where the growth medium represents a significant cost?
    • Safety Consideration – Are there new safety hazards and to what degree will this depend on the method of production?
    • Production Composition – What will the composition of the eventual products be, including any binding, flavoring ingredients, and plant-based materials?
    • Environmental, animal welfare, and health impact – There exists disagreement as to the advantages of cell-cultured meat over traditional meat products.
    • Timeline to Market – When will cell-cultured meat be available to consumers?
    • Labeling –  How will cell-cultured meat be labeled, and will federal requirements preempt any requirements in place at the state level?  
    • Consumer Acceptance – Will consumers purchase cell-cultured meat products?
  • While cell-cultured meat holds much promise, given the many uncertainties the industry still faces, from both a technology and regulatory perspective, it may be some time before consumers find cell-grown meat in the store.  We will continue to monitor and report on developments that impact the development of he cell-cultured meat industry.

 

  • Food safety in restaurants is regulated at the state and local level.  Most states have fully or partially adopted the model Food Code published by the U.S. Food and Drug Administration (FDA) to address the safety and protection of food offered at retail and in food service.  The Food Code, however, does not address pandemics and special rules for reducing the potential spread of COVID-19 vary among the states that plan to or have already permitted restaurants to re-open for dine-in service.  For example, Alaska, which allowed restaurants to re-open for dine-in service on April 24th, limits restaurants to 50% capacity, and Missouri, which permitted restaurants to re-open on May 4th, requires 6-foot spacing between tables, with no strict limit on capacity except there are to be no more than 10 people at a single table.
  • On May 8, 2020, FDA issued two documents, a checklist and an infographic, to assist retail food establishments that were closed or partially closed during the COVID-19 pandemic in preparing to reopen.  Topic areas in FDA’s guidance include: Facility Operations, Water/Plumbing/Ice, Food Contact and Non-Food Contact Surfaces, Food Temperature Control, Product Inspection and Rotation, Dishwashing Equipment, Handwashing Stations, Employee Health Screening, and Social Distancing.  These new guidance documents supplement and expand upon FDA’s April 9, 2020 guidance document aimed more at carry-out and delivery food service during the pandemic, as discussed here.
  • FDA’s guidance is much more general than a previously shelved document prepared by the Centers for Disease Control and Prevention (CDC) that was reported to make very specific and detailed recommendations for restaurants to re-open safely.  For example, whereas the CDC would have specifically recommended installing sneeze guards at cash registers, the FDA document merely lists “partitions” as an example of a measure that that could help to minimize face-to-face contact.  Further, with respect to limiting dine-in capacity, FDA simply advises restaurants to take measures “to minimize face-to-face contact that allows, to the extent possible, at least a 6-foot distance between workers, customers, and visitors.”  Other interesting details of FDA’s guidance document include advice to contact suppliers to ensure deliveries are scheduled and able to be fulfilled; to clean, disinfect, and sanitize with products that meet EPA’s criteria; and to follow the CDC guidance and practices for employee health checks/screenings.
  • A federal court has dismissed a suit brought by Rural Community Workers Alliance, alleging unsafe working conditions due to COVID-19 for workers at a Smithfield pork processing plant in Missouri.
  • The judge cited in part the Trump administration’s April 28 executive order that requires meat processing plants to continue operating during the pandemic and noted that the federal government (i.e., the Occupational Safety and Health Administration and other agencies) has responsibility for ensuring worker safety, rather than the courts.
  • After the suit had been filed in April and as reported on this blog, federal agencies took action to respond to the outbreaks at meat processing plants, and Smithfield implemented changes in its plant, including screening workers for symptoms and installing barriers between workers.  It remains to be seen whether the Missouri decision will chill future actions from being brought for worker safety concerns at food processing plants.
  • In a complaint filed in the U.S. District Court Southern District of California, the plaintiff alleges unlawful, unfair, and deceptive business practices in violation of California law because the defendant, Folger Coffee Company (“Folgers”), “willfully misrepresents and omits from its labeling of the Coffee Products material information to consumers’ purchasing decision” through the number of coffee servings that each coffee Product will produce.  The plaintiff seeks to represent a California class of individuals who purchased a Folgers product that advertised an incorrect number of servings and did not receive a refund.
  • In the complaint, plaintiff alleges that Folgers engaged in a “classic bait-and-switch scheme that causes unsuspecting consumers to spend more money for less than the advertised amount of coffee they believe they are purchasing.”  Plaintiff claims that the packaging and labeling of many Folgers coffee product cannisters prominently advertise that they will produce an amount of six fluid ounce cups when, they do not, and the “label’s advertised cup yield is completely arbitrary.”
  • Folgers products that purportedly mislead consumers include its Colombian, Brazilian, house blend, classic roast, decaf and breakfast blends, among others.  The plaintiff added that the defendant prominently advertised on its front label that it “Makes up to 210 6 Fl oz Cups.”  However, plaintiff claims that when he followed the instructions on the back panel of the coffee canister, the cannister only produced approximately 156 six fluid-ounce servings, which is 54 short of what is advertised on the front panel.  The plaintiff also claims that the same cannister also comes up short if the coffee is brewed in bulk.  We will continue to monitor any developments.
  • On April 27, a federal judge dismissed a lawsuit challenging California’s Proposition 12, which established new standards for confinement of certain farm animals and bans the sale of products that do not comply. Specifically, Proposition 12 requires that all eggs sold in the state come from cage-free hens by 2022, and it also bans the sale of pork and veal in California from farm animals raised in cages that do not meet new minimum size requirements. The court rejected claims by the National Pork Producers Council (NPPC) and the American Farm Bureau Federation (Farm Bureau) that the animal welfare standards set by Prop 12 are unconstitutional.
  • In the lawsuit, the NPPC and Farm Bureau argued that Proposition 12 violates the Commerce Clause of the U.S. Constitution because it would force out-of-state hog farmers who sell pork to California to meet the new space requirements, thus violating the extraterritorial principle by regulating wholly out-of-state conduct and imposing a substantial burden on interstate commerce. Iowa, Ohio, Texas, and several other states and industry groups, including the National Cattlemen’s Beef Association, backed the complaint, which was filed in December 2019.
  • U.S. District Judge Thomas J. Whelan disagreed with the NPPC and Farm Bureau stating that “a statute that applies both to California entities and out-of-state entities does not target wholly extraterritorial activity.” He further held that even when a statute has extraterritorial effects it passes Commerce Clause muster when those effects result from the regulation of in-state conduct. A statute violates the extraterritorial principle when it is directed at interstate commerce only, which was not the case here. Proposition 12 does not require uniform practices throughout the entire country, but rather only requires that producers who sell directly to California follow the regulations.
  • Judge Whelan also rejected the claim that Proposition 12 places a substantial burden on interstate commerce: “[a]lthough Proposition 12’s regulations may burden pork producers and result in a less efficient mode of operation, there is no burden on interstate commerce merely because it is less profitable than a preferred method of operation.”
  • The court granted defendants’ motion to dismiss. The NPPC and Farm Bureau have 14 days to file an amended pleading.
  • On May 1st the Centers for Disease Control and Prevention (CDC) issued a report on COVID-19 in meat and poultry processing facilities in the United States. The report provides a summary of the available data, an analysis of the risk factors, and a suggested approach to mitigate them.
  • The CDC’s report comes as the government and the meat and poultry processing industry grapple to keep workers safe while ensuring that the U.S. food supply chain remains stable. Despite the Food and Drug Administration’s (FDA’s) assurances that the food supply is secure (blogged about here), the spread of COVID-19 has closed meat and poultry processing facilities, resulted in the culling of food production animals due to worker shortages and facility closures, and prompted fears of meat and poultry shortages. In response to these concerns, on April 26th the CDC and the Occupational Safety and Health Administration (OSHA) issued guidance which provided recommendations for employers to keep their meat and poultry facilities safe during the pandemic. Further, on April 28th the President signed an executive order invoking the Defense Production Act to ensure that meat and poultry processors continue operations and delegating the authority to oversee the process to the Secretary of Agriculture.
  • According to the report (which analyzes data from 19 of the 23 states that have reported COVID-19 in the meat and poultry processing industry), 115 processing facilities have been affected, 4,913 COVID-19 cases have been confirmed among workers (representing approximately 3.0% of workers), and 20 workers have died of COVID-19. The report identified the following as factors contributing to the spread of COVID-19 in the processing facilities: (1) structural and operational challenges to implementing 6-foot social distancing, (2) difficulty in wearing face coverings given the pace and demands of processing work, (3) failure to implement heightened cleaning guidelines, and (4) social and economic challenges, including education of a diverse workforce, work policies incentivizing attendance of sick employees, crowded living conditions of workers, and shared transportation among workers.
  • The report calls for “prompt action to decrease risk to workers” and suggests corrective measures that largely track the risk factors identified. Namely, the report encourages employers to (1) increase screening procedures, (2) organize the work space to maximize social distancing, (3) implement engineering controls—such as positioning fans so they blow air away from workers, (4) increase sanitization of facilities, and (5) make administrative changes that encourage sick workers to stay home. Keller and Heckman will continue to monitor and report on the impact of the pandemic on the food industry.

 

  • A multi-state listeriosis outbreak linked to consumption of Blue Bell Creameries’ ice cream products in 2015 lead to state regulatory enforcement actions (discussed here) and multiple civil lawsuits.  As our readers may recall, Blue Bell did not recall any products that had tested positive for Listeria monocytogenes until after hospitalizations and deaths had occurred.  FDA later published inspectional observations for Blue Bell production facilities indicating the company was aware of food safety violations in facilities dating back to 2007 and positive tests for Listeria monocytogenes in one plant as far back as 2013.  Thus, criminal charges may have been expected to follow.
  • According to its May 1, 2020 Press Release, the U.S. Department of Justice filed a plea agreement in a Texas federal court whereby Blue Bell has plead guilty to two misdemeanor counts of distributing adulterated ice cream products and has agreed to pay a criminal fine and forfeiture of $17.25 million.  Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities.  The total $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food-safety matter.
  • In a related federal action, Blue Bell’s former president, Paul Kruse, was charged with seven felony counts for his alleged efforts to conceal from customers what the company knew about the listeria contamination.  Kruse allegedly directed other Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason and directed employees to tell customers who asked that there had been an unspecified issue with a manufacturing machine instead of that samples of the products had tested positive for listeria.
  • On March 13, 2020, Ultimate Brain Nutrients, LLC (“UBN”) submitted a Petition (which FDA filed and posted for comprehensive review on April 30, 2020), seeking FDA’s authorization of a qualified health claim for Caprylic and Capric Acid in connection with their use in the management of migraine headaches.
  • The claims pursued by UBN’s Petition, if approved, would apply only to products containing a minimum of 5 grams of Caprylic Acid at the “Effective Level” of 80% concentration. The active ingredient is identified as Caprylic Acid (with Capric Acid present at a “less ketogenic” level), in medium chain triglycerides (MCTs) that are fatty acid molecules with 6-12 carbon atom aliphatic chains. The Petition also indicates that foods and beverages that are eligible for the proposed claims would comply with FDA’s regulations regarding health claims at 21 C.F.R. § 101.14, with the exception (via FDA waiver) of the total fat and saturated fat disqualifying levels set forth in 21 C.F.R. § 101.14(a)(4).
  • UBN requests FDA’s approval of the following proposed qualified health claims: (1) “Supportive, but inconclusive, scientific evidence suggests that consuming at least 1 serving of 5 grams of [Caprylic Acid] daily in a food or beverage containing an Effective Level [80% concentration] creates the ketogenic effect that may reduce the risk of a migraine headache”; and (2) “Daily consumption of a serving of a beverage as a source of [Caprylic Acid], containing at least 5 grams of [Caprylic Acid] at an 80% concentration may reduce the risk of migraines. Fuel for Thought® provides 5 grams of [Caprylic Acid] per serving that, when consumed, has a ketogenic effect per serving of the beverage.”
  • UBN’s Petition asserts that “ketones are the brain’s preferred alternative fuel source, if supplied in sufficient quantities. As people age or suffer from neurological decline, the brain becomes less able to utilize glucose, its usual source of fuel and brain cells will then begin to decline and die.” The Petition further states that UBN’s coconut oil-based product comprises a “unique formulation [that] provides [MCTs] to quickly increase ketone production to sufficient levels to help in keeping the brain supported in performing its many functions.”
  • FDA is accepting comments on the Petition until June 29, 2020 (Docket FDA-2020-Q-1295). We will continue to monitor the status of this Petition.
  • On October 14, 2019, Plaintiff filed an amended complaint in state court alleging that Bacardi USA Inc. and Winn-Dixie Supermarkets Inc. (“Defendants”) produced and sold a liquor which contained an additive known as “grains of paradise,” a peppery spice originally found in West Africa.  The lawsuit alleged that a 150-year-old Florida statute renders it illegal to produce, and or sell liquor, which contains grains of paradise.  The antiquated statute was passed during an era when some people believed the spice was a poisonous drug that could lead drinkers to suicide.
  • Defendants removed the case to the U.S. District Court for the Southern District of Florida where they argued that federal regulators explicitly categorize “grains of paradise,” as a spice that is safe for consumption.  The U.S. Food and Drug Administration has expressly found that grains of paradise are generally recognized as safe for human consumption as a spice and flavoring and has placed no limit on how much can be used.  Defendants also stated that the plaintiff did not show he had suffered any actual injury as a result of buying or drinking the liquor, which contained the grains of paradise.
  • U.S. District Judge Robert N. Scola Jr. stated that that because the Federal Food, Drug, and Cosmetic Act (FDCA) allows the “grains of paradise” that the plaintiff takes issue with, the 1868 Florida statute prohibiting them is preempted.  In its order, the Eleventh Circuit noted that plaintiff’s claims were preempted under the doctrine of conflict preemption” because the Florida statute prohibiting the adulteration of a liquor product with grains of paradise, “frustrates the purposes and objectives” of the FDCA, “and its implementing FDA regulations, which establish that grains of paradise is generally regarded as safe.” Moreover, the court concluded that the plaintiff did not allege any “actual damages.” As such, Judge Scuola dismissed the lawsuit on January 28, 2020, which the plaintiff appealed to the Eleventh Circuit.
  • In its appeal to the Eleventh Circuit, plaintiff argued that just because the additive has been deemed safe does not mean it must be legally permitted to be sold.  Plaintiff also claimed that the Food Additives Amendment to the FDCA, is meant to prohibit unsafe food additives from entering the market and is not meant to ensure that all food that is deemed safe enters the market.  We will continue to monitor any developments.
  • FSMA established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals.
  • On April 22, FDA issued a temporary policy guidance document to address current challenges in conducting Accredited Third-Party Certification Program-related onsite monitoring activities during the COVID-19 public health crisis. The guidance provides currently-recognized accreditation bodies (ABs) and accredited certification bodies (CBs) flexibility so that ABs can maintain the accreditations of CBs, and already-issued certifications need not lapse where certain safeguards are in place.
  • The guidance document provides flexibility specifically with regard to the following:
    • For ABs monitoring accredited CBs, FDA does not intend to enforce the requirement that recognized ABs must conduct onsite observations of regulatory audits and visit the CBs headquarters within 1 year after accreditation and every 2 years thereafter. The FDA provides this flexibility when the AB determines that it is impracticable to conduct the observations or visit the headquarters due to government travel restrictions or advisories related to COVID-19, and the AB conducts annual comprehensive assessments of a CBs performance in accordance with 21 CFR 1.621(a).
  • For already-issued certificates under the Program, FDA does not intend to enforce the requirement that the CBs issue certificates for a term only up to 12 months when the CB determines that it is impracticable to conduct regulatory audits due to government travel restrictions or advisories related to COVID-19, among other requirements.
  • According to the guidance, ABs should resume onsite observations and visits within a reasonable period of time after it becomes practicable to do so.