• As previously reported, on July 30, 2020, FDA worked with EPA to release a protocol to evaluate the efficacy of antimicrobial pesticides in agricultural water. The protocol established an agricultural water panel assay that companies could use to test the capability of their water treatment processes to combat strains of Listeria, Salmonella and E. coli frequently responsible for foodborne illnesses.
  • On May 17, 2022, FDA announced that it had formally updated its protocol to reflect two earlier changes that had been made since the protocol was first released.  In April 2021, FDA updated the protocol to allow companies and other agricultural water stakeholders to use data that did not comply with good laboratory practices (non-GLP) in their submissions, provided that the submissions accurately represented how the study differed from GLP standards. This change was intended to give companies and agricultural stakeholders access to more laboratories.  In April 2022, FDA amended the contact time in the protocol, changing the maximum from 1 minute to “up to 5 minutes.” This change was intended to meet current practical and scientific needs.
  • The changes are now reflected in the Efficacy Protocol and EPA Protocol Review although this document continues to be dated April 29, 2020.
  • On May 17, House Appropriations Committee Chair Rosa DeLauro (D-CT) introduced H.R. 7790, a supplemental appropriations bill to provide $28 million in emergency funding to address the shortage of infant formula in the US for the fiscal year ending September 30, 2022. The bill is intended to provide the FDA with needed resources to address the shortage, prevent fraudulent products from being sold, acquire better data on the infant formula marketplace, and to help prevent a future recurrence.
  • Representative DeLauro stated that FDA does not currently have an adequate inspection force to inspect more plants if it approves additional applications to sell formula in the US. Thus, the supplemental appropriations are intended for “salaries and expenses.”
  • Relatedly, the House Appropriations Committee will hold two hearings this week to examine the recent recall of infant formula, the FDA’s handling of the recall, and the nationwide infant formula shortage.
  • Yesterday FDA released a guidance document which lays out the Agency’s plan to help increase the supply of infant formula in the U.S through the exercise of its enforcement discretion for certain non-compliant infant formula. FDA will consider exercising enforcement discretion on a case-by-case basis and will ensure that any non-compliant infant formula that it allows to be introduced into interstate commerce under this policy will be safe and nutritionally adequate.
  • Infant formula manufacturers (both domestic and foreign) who would like FDA to exercise enforcement discretion should provide FDA with the following information:

Product Information

    • Product name and other identifying information (e.g., batch numbers, UPCs).
    • Countries in which product currently is being marketed and length of time marketed.
    • Quantity of product intended to be introduced into the U.S. (in weight at least).
    • Whether product is in current inventory. If yes, then provide “use by” date, and if not, provide date of import or introduction into interstate commerce.
    • Name/location of facilities where the specified batches are made.
    • Distribution plans (if available).
    • List of all ingredients (by weight).
    • Copy of product label.
    • Description of all packaging.
    • Test results for nutrients levels from the most recent batches produced at each facility.
    • Cronbacter and salmonella spp. test results for the most recent batches produced at each facility.

Information for each Manufacturing Facility

    • Certification that the manufacturer has established CGMP to prevent adulteration.
    • Process flow diagram and written narrative which includes heating and processing conditions and critical control points.
    • FDA food facility registration number (as applicable).
    • If the facility has not received an FDA inspection, information regarding inspections by other government authorities or auditors.
  • FDA states that requests for enforcement discretion relating to items that may pose a safety concern (e.g., low levels of a critical nutrient or a failure to clearly identity food allergens) will be scrutinized and may not be appropriate candidates for enforcement discretion. In contrast, FDA cites a label that provides nutrients in the wrong order as a type of deficiency that would be a good candidate for enforcement discretion.
  • The guidance is in effect until November 14, 2022, but FDA will evaluate whether an extension is necessary. Requests for enforcement discretion should be sent to infant_formula_flexibility@fda.hhs.gov.
  •  As covered on this blog, FDA announced a draft guidance on June 25, 2019 for the seed sprouting industry that provides recommended steps to prevent adulteration for firms involved in the growing, conditioning, and distribution of seed for sprouting.  Possible sources of contamination of seeds implicated in foodborne disease outbreaks include rodent and bird activity within the seed conditioning operation, use of chicken manure to fertilize fields where seed was grown, transport in unclean vehicles, and use of irrigation water impacted by drainage from neighboring fields where manure was applied as a soil amendment.
  • On May 13, 2022, FDA issued a final guidance titled “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry.”  While the Produce Safety Rule (PSR) implemented under the FDA Food Safety Modernization Act (FSMA) includes provisions to prevent the introduction of known or reasonably foreseeable hazards once seeds have been received at the sprout operation, FDA considers seeds for sprouting to be outside the definition of “covered produce” in the PSR.  Reduction of the incoming microbial load, however, is considered a key step in ensuring the safety of seeds and sprouts.  Thus, FDA recommends that seeds for sprout production be grown using good agricultural practices (GAPs) in seed production or in conformance with international standards such as the Codex Alimentarius International Code of Hygienic Practice for Fresh Fruits and Vegetables.  In response to comments, FDA’s final guidance for preventing the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed for sprouting includes changes as follows:
    • The addition of examples relevant to storing seed, cleaning equipment, and following up after the discovery of contamination;
    • More information about when to use wet cleaning and sanitizing versus dry cleaning of food contact surfaces;
    • Clarification that testing seed is not a substitute for implementing GAPs and that a positive test result is not negated by a subsequent negative test result;
    • Research from FDA’s analysis of 14 sprout outbreaks that occurred in the US between 2012 and 2020, which showed that contaminated seed was the likely cause of most sprout-related outbreaks; and
    • Updated recommendations related to proximity of seed growing operations to a domestic animal raising farm.
  • The final guidance recommends that everyone in the sprout seed supply chain become as informed as reasonably possible about the food safety practices, processes, and procedures followed by the firm(s) from which they source their seed, where the seed will go after it leaves their firm, and whether their seed is reasonably likely to be used to produce sprouts for human consumption.
  • Keller and Heckman attorneys and scientists are experienced with advising on FSMA, the PSR and sprout seed, and related regulatory issues, and would be happy to answer any questions.
  • On May 10, 2022, FDA published a news release in which it highlighted its efforts to improve the supply of infant and specialty formula products.  This follows a warning from FDA to not use certain powdered infant formulas and a voluntary recall of those products.
  • FDA acknowledged that many consumers have not been able to access the infant formulas and medical foods that they were accustomed to using. FDA stated that it is working to ensure there is adequate product available where and when it is needed. In this regard, FDA states that it is “leveraging all the tools at its disposal” to support the infant formula product supply, including:
    • Expediting the review of notifications and manufacturing changes to help manufacturers bring safe products to market;
    • Monitoring the infant formula supply by using the 21 Forward food supply chain continuity system;
    • Expediting certificates for imports to allow for flexibility in the movement of already-permitted products into the U.S. and offering a streamlined import entry review process; and
    • Exercising enforcement discretion on minor labeling issues.
  • FDA emphasized that only facilities that are “experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risk to consumers” and continues to advise against making infant formulas at home.

 

  • On May 9, the FDA posted warning letters to 11 companies for selling adulterated dietary supplements that either contained new dietary ingredients (NDIs) for which the FDA had not received the required premarket NDI notifications, or contained unsafe food additives. FDA also determined some of the dietary supplements to be unapproved drugs because they were intended for use in the cure, mitigation, treatment, or prevention of disease. As noted in the warning letters, the FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
  • The dietary supplements at issue contained one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. Notably, the FDA has previously expressed concern over potential adverse effects from some of these ingredients, such as the potential effects that higenamine may have on the cardiovascular system.
  • The FDA requested the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law. Failure to adequately address could result in legal action, such as product seizure and/or injunction.
  • Health Canada and the Canadian Food Inspection Agency (CFIA) announced that they are seeking feedback on the development of voluntary guidance for providing information for foods that are sold to consumers through e-commerce. Although all information provided on e-commerce platforms must be truthful and not misleading, Canada’s Food and Drug Regulations and the Safe Food for Canadians Regulations only set out mandatory information for the physical labels of foods.
  • Those who wish to comment should read the consultation document which proposes that the following principles govern the development of the guidance:
    • Provision of the same information that would be provided on a food label [Section 4.1];
    • Provision of allergen information (including for foods prepared by a seller, such a take-out foods) [Section 4.2];
    • Provision of product images to help consumer recognition [Section 4.3];
    • Provision of food information and product images on the product information page, before the purchase is concluded [Section 4.4];
    • Indication of how the delivered food will differ from that offered for sale [Section 4.5]; and
    • Provision of information through various means intended to allow for easy access and understanding of the information (e.g., provision of information in both English and French and in a manner accessible to screen readers) [Sections 4.6 – 4.11].
  • The consultation document includes specific consultation questions (see Section 7), including solicitation of feedback on: (1) the above-listed guiding principles and (2) the challenges in obtaining, providing, and/or maintaining information about foods for sale through e-commerce. The comment period is open from May 9 to July 8, 2022. All comments should be emailed to nut.labelling-etiquetage@hc-sc.gc.ca with the subject line “Consultation on Online Food Labeling.” We would be happy to assist in drafting comments.

 9th Circ. Backs Calif.’s In-State Foie Gras Sales Ban (Law360 Subscription Required)

  • As we reported in 2017, the Ninth Circuit upheld a 2004 California law that prohibits force feeding a bird for the purpose of enlarging its liver beyond normal size and bans the in-state sale of foie gras produced by force feeding.  The court reasoned that even if U.S. Department of Agriculture (USDA) guidance defines foie gras to be the liver product of force-fed birds, the state law is not preempted by USDA’s Poultry Products Inspection Act (PPIA) because Congress intended for states to have extensive involvement in regulating poultry products and the ban does not dictate a method for foie gras production.
  • In a May 6, 2022 opinion, a split three-judge panel of the U.S. Court of Appeals for the Ninth Circuit upheld subsequent decisions in 2020 by a district court that rejected new constitutional claims by foie gras sellers on California’s in-state ban of foie gras from force feeding but awarded them declaratory relief on certain out-of-state sales.  Regarding the sellers’ preemption arguments, the panel majority said that California’s ban against the sale of foie gras from force fed birds is neither a command to market non-force-fed products as foie gras nor to call force-fed products something that would violate federal naming provisions.  Rejecting dormant Commerce Clause arguments, the panel majority found that California’s foie gras sales ban does not affect transactions outside the state and, as it is not discriminatory, the ban does not impose an undue burden on interstate commerce.  The court, however, upheld summary judgement for the plaintiffs that permits the sale of foie gras from force fed birds to individual California buyers from out-of-state companies by internet, phone or fax.
  • The plaintiffs have indicated they will request a rehearing en banc.  We will continue to monitor any developments.

 

  • On May 4, 2022, FDA announced that it had issued warning letters to five companies selling products (including gummies, capsules, tinctures, lotions, vaping products, pet products, and hand sanitizers) labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), as well as cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first time that FDA has issued warning letters for products labeled as containing delta-8 THC.
  • Delta-8 THC is an isomer of Delta-9 THC and is known to cause similar psychoactive and intoxicating effects. The warning letters follow reports of adverse events from consumers. The warning letters note the illegal marketing of delta-8 THC and CBD as unapproved treatments for medical conditions and therapeutic uses. The letters also cite to violations regarding drug misbranding, and the addition of delta-8 THC and CBD in foods.
  • The warning letters follow a consumer update from FDA in which the agency expressed its concerns regarding the potential health effects of delta-8 THC products. They also follow previous warning letters that were sent to CBD companies whose products claimed to cure, mitigate, treat or prevent various diseases.