• Food prepared and served in restaurants does not typically require the Nutrition Facts label that is mandated by FDA on food that is packaged for retail sale.  Due to the COVID-19 pandemic, restaurants and food manufacturers have large quantities of food on hand that is not labeled for retail sale but cannot be sold in restaurants and hotels in the manner initially intended.
  • FDA and USDA have issued temporary policies on nutrition labeling that will make it easier for restaurants and food manufacturers to sell food that was not originally intended for retail sale.
    • During the COVID-19 pandemic, FDA does not intend to object to the sale of packaged food (both perishable and non-perishable food) that lacks a Nutrition Facts label by restaurants, provided that the food does not have any nutrition claims and contains other required information on the label.
      • The restaurant may reuse original labels or provide allergen labeling and other information that is still required on labels it creates or that are provided by the manufacturer.
    • FDA does not intend to object to the sale of packaged food that lacks a Nutrition Facts label by food manufacturers, provided that the food does not have any nutrition claims and contains other required information on the label.
    • USDA’s Food Safety and Inspection Service (FSIS) will not object to the use of labels or require establishments to submit for temporary approval for modified labels applied by the federal establishment so that the products can now be sold at retail if lack of nutrition labeling is the only deficiency.
    • FSIS has also made provisions for the distribution of bulk product originally intended for schools or other institutions in a manner that is inconsistent with a statement of limited use on the outer box; e.g., a box labeled “for school foodservice use only” can now be distributed to a retail outlet for repackaging and labeling.
  • FDA’s enforcement policy will remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS).  The FSIS labeling provisions will remain in effect for the next 60 days starting on March 26, 2020.
  • Consistent with similar efforts by FDA, USDA’s Food Safety and Inspection Service (FSIS) is initiating rulemaking to update its regulations on the term “healthy” in line with FDA’s 2016 updates to its nutrition labeling rules.  The rulemaking seeks to amend both 9 CFR 317.363(b) and 381.463(b).
  • FDA, in response to a Citizen Petition filed in December 2015 by KIND LLC, issued guidance in 2016 stating that it will exercise enforcement discretion for foods labeled as “healthy,” even though they do not comply with the definition under 21 CFR 101.65, when such foods (1) have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or (2) that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
  • Both FDA’s and USDA’s initiatives seek to make its enforcement of the “healthy” definition more consistent with FDA’s 2016 changes to its nutrition labeling regulations.  Those changes refocused attention from lowering fat in the American diet to lowering sugar in the American diet.  The same changes replaced vitamins A and C with potassium and vitamin D as mandatory nutrients to be declared on food labels.
  • USDA is accepting comments until May 18, 2020.
  • On March 11, 2020, the Physicians Committee for Responsible Medicine (PCRM) filed a lawsuit against the State of California alleging government officials failed to include “cancer-causing processed meat” on California’s Proposition 65 list (“Prop 65”), which requires businesses to inform California residents about exposures to listed chemicals that can cause cancer or reproductive harm.  In its lawsuit, PCRM argues that California has neglected to follow a state law requiring the Office of Environmental Health Hazard Assessment (OEHHA) to include on its carcinogen list “[s]ubstances listed as human or animal carcinogens by the International Agency for Research on Cancer (IARC).”  In 2015, IARC classified consumption of processed meat as “carcinogenic to humans” based on the Agency’s determination that there is sufficient evidence of colorectal cancer after assessing more than 800 epidemiological studies.
  • PCRM has pressured OEHHA since 2018.  In 2018, PCRM backed SCR 100, a resolution introduced by Sen. Ricardo Lara (D-Bell Gardens) that urged OEHHA to add processed meat—such as hot dogs, bacon, and deli meat—to the Prop 65 list.  This resolution died in the California Senate Environmental Quality Committee.
  • PCRM argues that adding processed meat to the Prop 65 list will provide first line defense against colorectal cancer.  Allan Hirsch, deputy director at OEHHA noted that IARC did not conclude that any specific types of processed meat are known to be carcinogenic.  Hirsch also stated that Prop 65 is a right to know statute that entitles Californians to clear and reasonable warnings about specific substances that can cause cancer, and that listing “processed meat (consumption of)” would not provide adequate guidance to consumers or businesses, as the listing would include meat products that have not been shown to cause cancer.  OEHHA concluded that adding “processed meat” to the Prop 65 list would ultimately result in an “overinclusive warning.”  We will continue to monitor any developments.
  • In Amos v. Brew Dr. Kombucha, LLC, Case No. 3:19-cv-01663-JR, an Oregon magistrate judge recommended the dismissal of a class action lawsuit which alleged that Defendant Brew Dr. Kombucha, LLC, had breached express and implied warranties and unjustly enriched itself through the sale of kombucha drinks that allegedly were falsely advertised as containing a significantly higher concentration of probiotic bacteria than they actually contained.
  • Applying the conflict of law provision of Oregon (the forum state), the judge found that her task was to determine “in what state the injurious conduct and resulting injury occurred.” Plaintiff argued that the injurious conduct occurred in Oregon because the Defendant was headquartered there and the labelling containing the alleged misrepresentation occurred there. The judge rejected this argument and found that the injury occurred in Idaho, where the product was sold. Therefore, applying Idaho law, the judge found that: 1) the warranty claims must be dismissed because Plaintiff had failed to give notice to the seller, and 2) the unjust enrichment claim must be dismissed because there was no evidence that any benefit was conferred directly upon the Defendant as opposed to the retail seller.
  • This decision is a reminder of the significance of the forum and of the characteristics of the class representative in class action lawsuits, and food companies should be mindful of the different liabilities to which they may be exposed to depending on where their product is sold.
  • On January 19, 2020, a Citizen Petition was submitted to the USDA on behalf of Food & Water Watch, Consumer Federation of America, Consumer Reports, and others, requesting that the Food Safety and Inspection Service (FSIS) declare the following Salmonella serotypes as per se adulterants in meat and poultry products:
    • Salmonella Agona, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium.
  • According to the petitioners, each of the serotypes has a “history associated with either an illness outbreak or a product recall and is proven to be injurious to human health.” Thus, they requested that FSIS take action through interpretive rulemaking on all serotypes jointly or individually, declaring the serotypes to be adulterants within the meaning of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). The original deadline to submit a comment on the Citizen Petition was March 23.
  • However, in response to a March 16 request for extension from the North American Meat Institute (NAMI), the FSIS agreed to make an additional 60 days available for public comments on the petition. In light of the current COVID-19 pandemic, NAMI asked the agency for more time to comment on the petition that “would be one of the most significant policy changes affecting the meat and poultry industry in decades.” Stakeholders may now submit comments until May 22, 2020. As of the date of this blog post, there are approximately 350 comments on the Citizen Petition. Keller and Heckman attorneys are well-versed in FMIA and PPIA requirements and are available to assist interested parties in preparing comments for submission to the USDA. For assistance, please email: fooddrug@khlaw.com.
  • The federal government has taken a supporting role as state and local governments and private companies institute an evolving patchwork of responses to the COVID-19 pandemic.  On March 19, 2020, the Cybersecurity and Infrastructure Security Agency (CISA), operating under the Homeland Security Act of 2002, issued guidance and an accompanying list of “Essential Critical Infrastructure Workers.”  CISA’s list is intended to promote the ability of essential workers to continue to work during periods of community restriction, access management, social distancing, and closure orders or directives.
  • CISA identifies Food & Agriculture as a critical industry and describes essential workers in this industry as follows:
    • Workers supporting groceries, pharmacies and other retail that sells food and beverage products
    • Restaurant carry-out and quick serve food operations – Carry-out and delivery food employees
    • Food manufacturer employees and their supplier employees—to include those employed in food processing (packers, meat processing, cheese plants, milk plants, produce, etc.) facilities; livestock, poultry, seafood slaughter facilities; pet and animal feed processing facilities; human food facilities producing by-products for animal food; beverage production facilities; and the production of food packaging
    • Farm workers to include those employed in animal food, feed, and ingredient production, packaging, and distribution; manufacturing, packaging, and distribution of veterinary drugs; truck delivery and transport; farm and fishery labor needed to produce our food supply domestically
    • Farm workers and support service workers to include those who field crops; commodity inspection; fuel ethanol facilities; storage facilities; and other agricultural inputs
    • Employees and firms supporting food, feed, and beverage distribution, including warehouse workers, vendor-managed inventory controllers and blockchain managers
    • Workers supporting the sanitation of all food manufacturing processes and operations from wholesale to retail
    • Company cafeterias – in-plant cafeterias used to feed employees
    • Workers in food testing labs in private industries and in institutions of higher education
    • Workers essential for assistance programs and government payments
    • Employees of companies engaged in the production of chemicals, medicines, vaccines, and other substances used by the food and agriculture industry, including pesticides, herbicides, fertilizers, minerals, enrichments, and other agricultural production aids
    • Animal agriculture workers to include those employed in veterinary health; manufacturing and distribution of animal medical materials, animal vaccines, animal drugs, feed ingredients, feed, and bedding, etc.; transportation of live animals, animal medical materials; transportation of deceased animals for disposal; raising of animals for food; animal production operations; slaughter and packing plants and associated regulatory and government workforce
    • Workers who support the manufacture and distribution of forest products, including, but not limited to timber, paper, and other wood products
    • Employees engaged in the manufacture and maintenance of equipment and other infrastructure necessary to agricultural production and distribution
  • The CISA list above identifies food packaging and other examples of products that people may not generally recognize as being regulated by FDA as “food,” such as pet food and animal feed, but it does not explicitly recognize dietary supplements as food.  An industry report indicates that dietary supplement manufactures have urged that plants and their sales channels remain open during the COVID-19 pandemic.  The CISA guidance ultimately leaves the issue for state and local governments to decide, although it suggests a broad interpretation, noting “these identified sectors and workers are not intended to be the authoritative or exhaustive list of critical infrastructure sectors and functions that should continue during the COVID-19 response.”
  • While agriculture workers are explicitly identified on CISA’s list of critical infrastructure workers, it is not clear how other arms of the federal government will support CISA’s efforts.  For example, the Wall Street Journal and others have reported that the State Department has stopped processing visas in Mexico for seasonal workers to enter the U.S.
  • On March 18, 2020, the U.S. Food and Drug Administration (FDA) announced that it has temporarily postponed all domestic routine surveillance facility inspections, which include facility inspections that the FDA traditionally conducts every few years based on a risk analysis. FDA noted that all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.  FDA made this announcement in order to protect the health and well-being of its staff and those who conduct inspections for the agency under contract at the state level.
  • In order to help slow the spread of the virus, help flatten the curve of the COVID-19 pandemic, and ensure that its workforce remains healthy to carry out the FDA’s critical public health mission, FDA directed all eligible FDA employees to begin teleworking.  However, FDA noted that this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products.  In its announcement, FDA mentioned that it is evaluating additional ways to conduct its inspection work that would not jeopardize public safety.  For example, FDA may evaluate records instead of conducting an onsite inspection on an interim basis when travel is not permissible.
  • A few weeks ago, FDA also announced that it is postponing most foreign facility inspections through April, and that only inspections that are deemed mission-critical outside the U.S. will be considered on a case-by-case basis.  We will continue to monitor any developments.

On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued its “Temporary Policy Regarding Preventive Controls and FSVP [Foreign Supplier Verification Food Program] Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry.” As previously reported in this blog, FDA had recently announced it would postpone most foreign inspections until April 2020, cancel all foreign travel by agency officials, and limit domestic travel to “mission critical only” through April. Also as reported in this blog, FDA announced it would scale back domestic inspections in response to COVID-19.

Pursuant to the Guidance, the Agency further announces its intention to exercise enforcement discretion regarding requirements in three food regulations to conduct onsite audits of food suppliers, if other supplier verification methods are used instead: (1) Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 C.F.R. part 117); (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 C.F.R. part 507); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 C.F.R. part 1 subpart L). The Guidance provides information regarding the specific circumstances under which FDA intends to refrain from enforcing the requirements for an onsite audit.

The Guidance notes that receiving facilities and FSVP importers should resume onsite audits within a reasonable period of time after it becomes practicable to do so, and should update their food safety plans and foreign supplier verification programs accordingly. The Agency states it will provide timely notice about the withdrawal of this temporary policy. We will continue to monitor the situation for any developments.

  • In a March 12 court order, the U.S. District Court for the District of Columbia agreed with the Organic Trade Association’s (OTA) lawsuit against the USDA that the withdrawal of the Organic Livestock and Poultry Practices (OLPP) final rule was based on a flawed analysis. As background, the OLPP Rule set standards for organic livestock practices, including requirements for the production, transportation, and slaughter of organic livestock and poultry. The Rule also added provisions for outdoor access and space for organic poultry production, which resolved prior ambiguities regarding outdoor poultry access. According to OTA, the final rule was broadly supported by the vast majority of the organic community, which submitted approximately 47,000 comments.
  • Over the course of two and a half years, OTA argued that the USDA violated the Administrative Procedures Act by delaying the OLPP Rule’s effective date three times, and ultimately issuing a Final Withdrawal Rule. OTA further challenged the Withdrawal Rule by arguing that the USDA incorrectly concluded that it lacked authority to publish the OLPP Rule and that the Withdrawal Rule contained errors in its economic analysis.
  • In what appears to be somewhat of an admission, the USDA asked the court for remand to correct “a series of admitted flaws in the cost/benefit analysis in the OLPP Rule that were carried over into the Withdrawal Rule.” The court ordered the USDA to publish a final rule, after notice and comment, fully explaining its updated cost/benefit analysis within 180 days, and noted that, “after these many efforts, the Department should move quickly.” We will continue to monitor the status of the OLPP Rule.

 

  • The world’s food regulatory authorities have had a more limited role in responding to the rapid spread of the coronavirus outbreak (COVID-19) than their counterparts involved with drugs and devices/diagnostic tests.  Related to food, the U.S. Food and Drug Administration (FDA), for example, has taken action against dietary supplements and other products under its jurisdiction for making fraudulent claims about preventing or curing COVID-19.  See our coverage of seven recent warning letters issued jointly by FDA and the Federal Trade Commission (FTC).
  • FDA also has addressed COVID-19 concerns for food products, among several other topics, on a Q&A website, updated on March 13, 2020.  FDA acknowledges it is possible that the virus that causes COVID-19 can survive on surfaces or objects but states there is currently no evidence of food or food packaging being associated with transmission of COVID-19.  While making no specific new recommendations, FDA’s Q&A points to the regulation of restaurants and retail food establishments at the state and local and notes that FDA-regulated food manufacturers are required to maintain clean facilities, including, as appropriate, clean and sanitized food contact surfaces, and to have food safety plans under the FSMA Final Rule for Preventive Controls for Human Food.
  • In Europe, where the full brunt of COVID-19 was felt earlier than in the United States, the European Food Safety Authority (EFSA) issued a statement on March 9, 2020 that is specifically aimed at calming consumer fears of potentially contracting the virus from food.  EFSA’s chief scientist noted that transmission through food consumption did not occur during previous outbreaks of related coronaviruses, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), and there is no evidence to suggest that the COVID-19 virus is any different in this respect.  Nevertheless, EFSA noted precautionary recommendations on good hygiene practices, including advice on food handling and preparation, outlined by the World Health Organization (WHO).