• 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).

 

  • On March 16, 2020, the Consumer Brands Association (CBA) submitted a letter to the U.S. State Department and the Office of the U.S. Trade Representative asking for an increase in protections against other countries hoarding materials required to make products that keep American consumers healthy, such as food, hygiene, and cleaning materials.  Moreover, CBA also requested that the federal government exempt manufacturing facilities from Center for Disease Control and Prevention gathering limits, which ban the gathering of more than 50 people.
  • In the letter, CBA noted that it fears that countries may wish to restrict the export of base materials, nutritional and food inputs, chemicals and other essential manufacturing supplies and ingredients, which will prevent U.S. manufacturers from increasing production. Ultimately, CBA stated that this may lead to consumers being unable to obtain products that are vital to treating and stopping the spread of COVID-19.  CBA also highlighted that other counties, like India, Germany, France, the Czech Republic, Turkey, and Russia, have already implemented restrictions on exports of chemicals, medical supplies and other materials.
  • Last week, CBA also wrote a letter to Attorney General William Barr requesting that there be protections from price gouging of consumer packaged goods due to the coronavirus. We will continue to monitor this issue.
  • As previously  covered on this blog, FDA issued final rules in May 2016 to implement changes to the nutritional labeling and serving size regulations.  For manufacturers with $10 million or more in annual food sales, the compliance deadline was January 1, 2020.  Manufacturers with less than $10 million in annual food sales have until January 1, 2021 to comply.
  • On March 11, 2020, FDA launched an education campaign  to raise awareness concerning changes to the label and help consumers learn to use the nutrition labels as a tool for healthy dietary practices.
  • The campaign, titled “The New Nutrition Facts Label: What’s in it for You?”, includes outreach through social media, videos, downloadable educational material, and indoor/outdoor advertising.  This campaign is part of FDA’s Nutrition Innovation Strategy that seeks to reduce preventable death and disease associated with poor nutrition.
  • The ongoing spread of the novel coronavirus has prompted the U.S. Food and Drug Administration (FDA) to postpone most foreign inspections of manufacturing facilities.  On March 10, 2020, the FDA provided an update on the status of FDA inspections outside of the U.S. in response to the COVID-19 outbreak where it noted that it will immediately postpone most foreign inspections until April 2020.  Additionally, the FDA canceled all foreign travel by agency officials and said it is limiting domestic travel to “mission critical only” through April.  Last month, FDA stopped conducting inspections in China.
  • In its update, FDA stated that when it is not temporarily able to physically inspect foreign produced FDA-regulated products or manufacturers, it will employ additional measures to ensure the safety of products imported to the U.S., which include denying entry of unsafe products into the country, physical examinations and/or product sampling at borders, reviewing a company’s previous compliance history, and using information sharing from foreign governments as part of mutual recognition and confidentiality agreements.
  • The FDA also noted that it will continue to partner with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers who may be unfamiliar with regulatory requirements or repeat offenders trying to circumvent the law.
  • FDA mentioned that it will continue to assess and calibrate its approach as needed to help advance federal response efforts in the fight against COVID-19.  We will continue to monitor any developments.
  • The FDA and FTC issued joint warning letters to seven companies for selling fraudulent COVID-19 (Novel Coronavirus Disease 2019) products. The warning letters were sent to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC, and the Jim Bakker Show. The products cited in the warning letters range from teas, essential oils, tinctures, to colloidal silver.
  • The agencies asserted that the products pose significant health risks to patients and are unapproved drugs intended to mitigate, prevent, treat, cure, or diagnose COVID-19 in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(a). The FDA and FTC requested the companies respond in 48 hours describing the specific steps they have taken to correct the violations. In addition to following up with companies that fail to make adequate corrections, the agencies will monitor social media, online marketplaces, and incoming complaints to ensure fraudulent products are not on the market.
  • In regard to the warning letters, FTC Chairman Joe Simons stated “[t]here already is a high level of anxiety over the potential spread of coronavirus. What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
  • In their press release, the FDA reminds consumers to be cautious of websites and stores selling products that claim to prevent, mitigate, treat, diagnose, or cure COVID-19. There are currently no vaccines or drugs approved to treat or prevent COVID-19. An FDA cross-agency task force has been established to closely monitor for fraudulent products related to COVID-19. The task force has been in contact with major retailers asking for help in monitoring online marketplaces for fraudulent products claiming to combat coronavirus. The task force has already worked with some major retailers to remove more than three dozen listings of fraudulent COVID-19 products.