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  • The USDA’s Agricultural Marketing Service (AMS) issued final guidance to assist regulated entities in complying with the National Bioengineered Food Disclosure Standard (NBFDS). By the mandatory compliance date of January 1, 2022, regulated entities will need to disclose whether food offered for retail sale is bioengineered (BE) or contains BE ingredients. The final guidance discusses two possible ways entities can show their products do not contain BE material and thus avoid disclosure: (1) verifying that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable (7 CFR 66.9(b)), and (2) utilizing acceptable testing methods to confirm the absence of modified genetic material (7 CFR 66.9(c)).
  • The Guidance to Ensure Acceptable Validation of a Refining Process outlines eight general steps: (1) identify raw materials, ingredients, and product-contact materials; (2) define characteristics and intended use of end product; (3) define the sequence and interaction of all processing steps used to arrive at the end product; (4) identify key step(s) in the refinement process that may influence the end product’s characteristics and its ability to meet specified requirements; (5) assemble relevant validation information that demonstrates the refinement process operates as intended to meet specified requirements (end product characteristics), conducting studies as needed; (6) continually verify the refinement process is operating as validated; (7) revalidate the refinement process, as applicable, if significant changes are made to the process; and (8) maintain record(s) of the validation and ongoing verification.
  • As our readers may recall, we previously covered the draft instructions for acceptable testing methods to confirm the absence of detectable modified genetic material. The final Guidance on Testing Methods is largely similar, and addresses five main topics: (1) general considerations in selecting a test method; (2) DNA-based methods; (3) emerging technologies and other methods; (4) general considerations in selecting a laboratory; and (5) recordkeeping requirements.
  • Keller and Heckman attorneys are well-versed in the NBFDS requirements and would be happy to assist with any questions about compliance with the final validity and detectability guidance documents.
  • In 2011, USDA’s Food Safety Inspection Service (FSIS) announced that raw, non-intact beef products and raw, intact beef products intended for use in raw, non-intact beef products are adulterated if they contain the following six non-O157 Shiga toxin-producing Escherichia coli (STEC): 026, O45, O103, O111, O121, and O-145. FSIS identified these pathogens as adulterants because of their high pathogenicity, low infectious dose, transmissibility from person to person, and their thermal resistance being high enough to survive cooking. Despite these concerns, FSIS testing for these pathogens has lagged behind testing for E. coli O157:H7, and currently FSIS only tests beef manufacturing trimmings samples for these non-0157 STEC.
  • In order to reduce the risk of food borne illness, FSIS recently announced that it is expanding its routine verification testing for these six non-O157 STEC to ground beef, bench trim, and other raw ground beef components (all of which are also currently tested for E. coli O157:H7). FSIS also intends to test for the six non-0157 STEC in ground beef samples that it collects at retail stores and in samples it collects from imported raw beef products.
  • Raw ground beef containing these non-0157 STEC has been linked to a number of serious foodborne outbreaks, and the changes are intended to both improve public health and reduce the costs associated with outbreak-related recalls. Comments on the proposed expanded testing are due August 3, 2020. Keller & Heckman will continue to monitor for any updates.
  • On May 27, 2020, U.S. District Judge Edgardo Ramos in the U.S. District Court for the Southern District of New York entered an order of permanent injunction against two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs, including their Organic Hemp Seed Oil and Cassava Meal. The complaint was filed by the U.S. Department of Justice on behalf of the FDA. See FDA’s news release regarding the injunction here.
  • The court concluded that Sundial’s products have no published adequate and well-controlled studies to support their claims, and that the FDA has not approved any application for any of Sundial’s drugs, despite Sundial claiming that their products can cure, treat, or prevent a wide variety of disease such as syphilis, cancer, and HIV/AIDS. For example, Sundial claims that the hemp seed oil “suppresses the growth of cancer” and the cassava meal “prevents heart disease.”
  • Under the injunction, Sundial and the named individuals cannot directly or indirectly receive, label, hold, or distribute drugs at or from their facility until steps are taken to ensure all products comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the injunction, including recalling their drugs, hiring qualified experts to ensure conformity with the FD&C Act, and receiving written permission from the FDA to resume operations.
  • Sundial had received previous warnings from the FDA and, according to the federal complaint, repeatedly promised to correct any violations. For example, FDA conducted multiple inspections at Sundial between 2012 and 2017, as well as issued a warning letter to Sundial in 2013. According to the FDA, Sundial did not make any of the necessary corrections.

 

  • 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 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.
  • As our readers may recall, under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.
  • However, on February 10, the Trump administration proposed creating a new federal agency to regulate tobacco products and to remove that authority from the FDA. The administration’s plan is included in their 2021 budget proposal, but to take effect, the budget proposal must be passed by Congress, which appears unlikely given the current political landscape.
  • In sum, the budget proposes to move the Center for Tobacco Products out of the FDA and to create a new agency within HHS to focus solely on tobacco regulation. The new agency would be led by a Senate-confirmed Director. According to the proposal, a “new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity for new tobacco products. In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply.”
  • The proposal comes after the head of the White House Domestic Policy Council, Joe Grogan, told reporters last year that tobacco regulation was a “huge waste of time” for the FDA.  Grogan further stated that “tobacco has no redeeming qualities and it should not be regulated by a health agency like this.”  However, public health and policy experts have already criticized the proposal. For example, Matthew Myers, present of the Campaign for Tobacco-Free Kids state that “[i]t has taken a long time for the FDA Center for Tobacco Products to build up the staff, legal expertise and structure to do the job.” Myers elaborated further lamenting that the proposal is “yet another giveaway to the tobacco and e-cigarette industry.”
  • As our readers may recall, the California Office of Environmental Health Hazard Assessment (OEHHA) tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (Δ9-THC) have been shown to cause reproductive toxicity for purposes of listing under California’s Proposition 65 (“Prop. 65”). Marijuana smoke has been listed as a carcinogen since 2009. At a public meeting on December 11, 2019, DARTIC (in its official capacity as the “state’s qualified experts”) determined that cannabis (marijuana smoke) and Δ9-THC were shown to cause reproductive toxicity based on the developmental toxicity endpoint.
  • Effective January 3, 2020 (and subject to enforcement starting January 3, 2021), OEHHA finalized the listing of cannabis (marijuana) smoke and Δ9-THC as reproductive toxicants under Prop. 65. Due to the large volume of data received in response to its March 15, 2019 public request for information, however, OEHHA limited its review of evidence to the developmental toxicity of cannabis smoke and Δ9-THC, deferring evaluation of “[o]ther extracts of cannabis” for potential future consideration.
  • Due to the prior listing of marijuana smoke on Prop. 65 as a carcinogen, some marijuana smoke-based products may already bear Prop. 65 warnings addressing the cancer risk. The new listing, however, would require companies to reassess and consider expanding their warnings for cannabis (marijuana) smoke products to incorporate the reproductive toxicity endpoint. In addition, the new listing may reach cannabis products that contain Δ9-THC but do not expose individuals to smoke (such as edibles, cosmetics, beverages, vape cartridges, etc.), for potential warnings addressing reproductive toxicity.

Keller and Heckman attorneys routinely advise clients on compliance issues and enforcement actions related to California’s Prop. 65 and the evolving regulatory status of cannabis-related ingredients.

  • As our readers may recall, FDA held a public meeting on September 27, 2019, to discuss FDA’s efforts to modernize food Standards of Identity (SOI) and to provide information about changes the FDA could make to existing SOIs. Section 401 of the Federal Food, Drug, & Cosmetic Act gives FDA authority, whenever in its judgment it “will promote honesty and fair dealing in the interest of consumers, to promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a definition and standard of identity.” There are literally hundreds of food products for which standards of identity have been promulgated. These standards are set forth by product category in 21 C.F.R. Parts 131 through 169. The procedures for setting standards of identity, many of which were initiated by the food industry, are set forth at 21 C.F.R. Part 130.
  • On January 6, the Center for Science in the Public Interest (CSPI) sent Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) a letter urging the Agency not to make broadly conceived horizontal changes to SOIs, which as CSPI states, “could introduce unintended negative consequences and/or confuse consumers about the quality or nutritional value of foods.” Although CSPI supports the FDA’s efforts to re-examine the SOIs, CSPI urged the FDA to proceed with caution and ensure that any amendments to the SOIs are “targeted, clearly defined, and fully considered to support specific public health priorities.”
  • Overall, CSPI recommended the Agency review proposed amendments to SOIs in light of potential public health benefits and drawbacks, and also outlined 5 changes that the Agency should prioritize should the Agency wish to consider broad horizontal changes that cut across food categories:
    1. Issue regulations requiring the amount of key healthful ingredients to be declared
    2. Allow salt substitutes to be used in standardized foods where necessary to achieve sodium reduction targets.
    3. Maintain and expand key standards for enriched cereals.
    4. Require dairy substitutes to disclose when the product contains less of a key nutrient than the reference dairy food.
    5. Develop a streamlined process for reviewing other changes to standardized foods on a case-by-case basis.

We will continue to monitor updates on the FDA’s efforts to modernize SOIs.

  • On December 12, the U.S. Senate confirmed Dr. Stephen Hahn to be the next FDA Commissioner. Dr. Hahn will take over for Admiral Brett Giroir, Assistant Secretary for Health within the Department of Health and Human Services, who has been overseeing the FDA since Ned Sharpless’s tenure as “acting” FDA Commissioner expired in November 2019. Sharpless became acting FDA Commissioner following Scott Gottlieb’s resignation as FDA Commissioner in April 2019.
  • As our readers may recall, Dr. Hahn is a professor of radiation oncology and the current Chief Medical Officer of the University of Texas MD Anderson Cancer Center in Houston, Texas. While Hahn has never served in a government post, five previous FDA commissioners and several physician and research organizations, including the American Association for Cancer Research, supported Hahn’s nomination.
  • Dr. Hahn’s confirmation comes amidst a frenzy of activity relating to vaping and e-cigarette products. During his confirmation hearing, Hahn faced questions about whether he intended to finalize FDA’s proposed ban on the sale of flavored e-cigarettes. While Dr. Hahn did not commit to a ban, he acknowledged that “this is an important, urgent crisis in this country” and that “I very much agree and support that aggressive action needs to be taken to protect our children.” Other notable topics at Hahn’s confirmation hearing included opioids and drug pricing. The final senate vote was 72 to 18.
  • In addition to the regulation of flavored e-cigarettes, as FDA Commissioner, Dr. Hahn will face several other pressing public health issues, including the regulation of food and dietary supplements containing CBD, the production and labeling of cell-based meat and plant-based alternatives, and proposed revisions to current food Standards of Identity, among others.
  • As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling a variety of FDA-regulated products (for humans and animals) containing cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA emphasized that CBD lacks an appropriate regulatory status for use in these products, and in some cases they bear impermissible drug claims, thereby rendering them unapproved new drugs that are also deemed misbranded and adulterated.
  • FDA sent a warning letter to, among others, Koi CBD LLC (Koi), referencing products such as balms, vape oils, tinctures, lotions, gummies, and beverage shots (for humans), and pet sprays and soft chews (for pets). FDA cited claims on the company’s website that CBD could be used to treat diseases and medical conditions such as various cancers, diabetes, multiple sclerosis, post-traumatic stress disorder, schizophrenia, opioid addiction, and Crohn’s Disease.
  • On December 5, 2019, plaintiffs Calley Fausett and Leigh Good filed a putative class action complaint against Koi in California federal court (Central District), alleging the company intentionally marketed and sold illegal products containing CBD. Among other things, plaintiffs allege the marketing and sale of these products constitute false, deceptive, and misleading practices and advertising; that plaintiffs would not have purchased the products (or would have paid less) had they been fully informed; and that the products lack adequate directions for use. The lawsuit is one of a growing number of private actions filed as a result of FDA’s recent warning letters that allege the use of CBD as an ingredient runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.