• On December 7, 2018, the Food and Drug Administration (FDA) established a docket and requested data, information, and comments to “assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use.”  The request for information (RFI) “is part of FDA’s ongoing evaluation of the safety and effectiveness of OTC drug products marketed in the United States on or before May 11, 1972.”  Products not on the market before May 1972 must undergo drug review rather than taking advantage of the OTC monograph.  The comment period was reopened on April 24 and it closed on July 23.
  • FDA provided a list of questions in its RFI to direct comments.  These questions covered:
    • Definitions of food handler antiseptics (categories of workers who might use the products, settings in which used, limitations of use, types of products, and frequency of use);
    • Active ingredients (eligibility of ingredients for consideration in the OTC monograph, ingredients currently in use, history of availability);
    • Safety, including the risk of antimicrobial resistance caused by the products, the need for clinical studies on the products (showing reduced incidence of illness) and the potential for transfer of the products to food handled after use of the products; and
    • Effectiveness of the products.
  • The American Cleaning Institute (ACI) provided comments addressing many of the specific questions raised by FDA in its RFI.  Of particular interest, ACI indicated that because the use of the active ingredients will be “biocidal (not biostatic)” food handlers are unlikely to “be exposed to a theoretically selective environment of sub-cidal concentrations” and are thus unlikely to encounter risks of antimicrobial resistance.  Further, because of the many factors that would have to be controlled for an effective clinical study, ACI argues that demonstrating the effectiveness of the sanitizers in reducing or eliminating bacteria of concern should be a sufficient demonstration of effectiveness.  Finally, ACI argues that the quantity of active ingredient expected to transfer to food by use in a food handling facility is expected to be so low that there will not be a risk to consumers of the food.
  • The use of sanitizers has been recently addressed by FDA in the context of the Food Safety Modernization Act (FSMA).  For example, in Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry, see our blog post here, FDA states that there are times when hand sanitizers may not be used in lieu of soap and water.
  • Researchers with the U.S. Department of Agriculture’s Agricultural Marketing Service have isolated Escherichia (E.) coli O157:H7 from a variety of pest flies in leafy green fields planted up to 180 meters away from cattle feedlots.  Among most fly species captured on sticky traps at leafy green farms, 22.3-29 flies per 1,000 flies carried E. coli O157:H7.
  • In 2018, Shiga toxin-producing E. coli O157:H7 in romaine lettuce was responsible for an outbreak that sickened 62 people in 16 states, of whom 25 were hospitalized.
  • The researchers noted that more work is needed to determine the human health risk posed by these flies and whether they are capable of contaminating leafy greens and causing a foodborne illness outbreak.
  • On July 25, 2019, a United Kingdom parliamentary sub-committee found that words like “burger,” “sausage,” and “steak” to describe plant-based foods are not misleading to consumers. Indeed, the House of Lords EU Energy and Environment Sub-Committee have raised concerns that a ban on the use of such descriptors for plant-based foods would actually reduce consumer clarity, be a barrier to growth for the plant-based sector of the food industry, and ultimately make it more challenging for people to reduce the amount of meat in their diet.
  • As background, in April of 2019, the European Parliament’s Committee on Agriculture and Rural Development proposed to restrict the use of descriptors like “burger,” “steak,” and “sausage” to apply only to products containing meat and not to vegetarian alternatives. Supporters of the restriction argued that the change is needed to make sure consumers have access to clear information. In light of this proposal, the Sub-Committee held a stakeholder meeting on June 19 to discuss the potential impact of the ban on consumers and the food industry.
  • As a result of the June 19 meeting, the Sub-Committee found no evidence that use of such descriptors would be misleading to consumers. In a letter to the Minister of State for Agriculture, Fisheries and Food, the Sub-Committee stated that they heard no evidence that consumers were misled by meat-free products and that less than 4% of consumers had ever unintentionally purchased a vegetarian product instead of a meat-based version, and vice versa. Further, the Sub-Committee found that the current naming conventions for meat-free products were actually clear and easy to understand for consumers. Therefore, in light of evidence to the contrary, the Sub-Committee challenged the stated justification of the proposed ban – that consumers are misled by such descriptors on plant-based products – and argued that without evidence of a problem, legislative action is unnecessary.
  • As our readers may know, the United States is facing similar issues, as evidenced by FDA’s review of the use of dairy terms in the labeling of plant-based foods, as well as with many states passing meat labeling laws that have been challenged by the plant-based food industry.
  • In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory pathways available to hemp products such as those containing cannabidiol (CBD).” However, she did not provide any details on those pathways.
  • While any CBD food or purported dietary supplement products in interstate commerce is a violation of the Food, Drug, and Cosmetic Act (FD&C Act), FDA’s biggest concern in the marketing of CBD products is with unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, Dr. Abernethy told the Senate Committee. She noted several additional concerns, which are described below.
    • Lack of good manufacturing practices (GMPs) in the production of these products since laboratory analysis have shown that some of the CBD products on the market do not contain the amount of CBD that was listed on the label and confirm the presence of substances, such as THC, not listed on the label.
    • The use of CBD in non-drug products will have wider distribution than its use in drugs, to include sensitive populations.
    • The possibility that allowing CBDS to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds.
  • As previously reported on this blog, FDA held a public hearing on May 31, 2019, to obtain scientific data and information about the safety of FDA-regulated products containing CBD. FDA opened a public docket to collect comments as part of that hearing. The Agency received 4,492 comments by the time the docket closed on July 16, 2019. In a July 23 press release concerning a warning letter that FDA sent to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, Dr. Abernethy explained that FDA remains committed to evaluating the Agency’s regulatory policies related to other types of CBD products. With respect to a timeline, she stated, “We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD.”  Keller and Heckman attorneys are well versed on the regulation of CBD and other cannabis-derived products.
  • The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs.  See Sections 743(a)(1)(A), (B), and (D), respectively, of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Every year since Fiscal Year (FY) 2012, FDA has published the established rates for assessing fees for food facility reinspections, recall orders, and importer reinspections.  These FSMA authorized fees have not been collected, however, because guidelines mandated under Section 743(b)(2)(B)(iii) of the FD&C Act, for considering the burden of such fees on small businesses, are not yet available, and FDA is also still considering various issues associated with the assessment and collection of importer reinspection fees.  Additionally, guidance is also pending regarding the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement of the FD&C Act.  It is food safety related noncompliance issues that trigger a reinspection (subject to a fee assessment) to evaluate corrective actions.
  • In the July 25, 2019 Federal Register, FDA announced its FY 2020 rate of $240/hour, exclusive of travel, that will be assessed for FDA staff working on certain food facility reinspections, recall orders, and importer reinspections.  FDA’s rates where domestic travel or foreign travel are required are $258/hour and $301/hour, respectively, and are both increased as compared to the rates of $253/hour and $282/hour, respectively, for FY 2019, which ends September 30, 2019.  It does not appear as though any of these FSMA authorized fees will be collected for FY 2020 because FDA simultaneously announced (as it has in the past) that it does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees and that importer reinspection fee issues are still under consideration.
  • The American Civil Liberties Union (ACLU), the Good Food Institute, the Animal Legal Defense Fund, and the ACLU of Arkansas recently filed a complaint on behalf of Turtle Island Foods (Tofurkey brand), challenging an Arkansas law that prohibits the representation of plant-based and insect-based products as “meat” or related terms (e.g., “beef,” “roast,” and “sausage”). The law covers all synthetic products derived from plants, insects, or any other source, as well as products grown in a laboratory from animal cells. In addition to these specific provisions, the law amends Arkansas Code Title 2, Chapter 1 to include a broad prohibition on “utilizing a term that is the same as or similar to a term that has been used or defined historically in reference to a specific agricultural product.”
  • The lawsuit was filed on July 22, 2019—two days before the Arkansas law came into effect. In the complaint, Tofurkey claims that the law creates consumer confusion and violates the Free Speech Clause of the First Amendment, the Due Process Clause of the Fourteenth Amendment, and the dormant Commerce Clause.
  • The Arkansas law is one of many state laws aimed at restricting the ability of companies to use “meat” and similar terms on the label of their plant-based, insect-based, or cell-based products. This challenge is Tofurkey’s second labeling lawsuit, after the company filed suit in Missouri over a similar meat labeling law. A group of plant-based food producers also recently challenged a Mississippi labeling law with similar provisions. In addition to state activity, the Food and Drug Administration (FDA) has taken steps to formulate a path forward on plant-based products, and recently sought comments on the use of dairy terms—such as milk, yogurt, and cheese—in the labeling of plant-based products. We will continue to monitor this active area of legislation and regulation and report on significant developments.
  • On July 22, 2019 the Food and Drug Administration (FDA) announced that it had suspended the food facility registration of Topway Enterprises, Inc, doing business as Kazy’s Gourmet of Houston, Texas.
  • The suspension follows inspections conducted by the FDA and the Texas Department of State Health Services earlier this year, where sanitation issues were noted, including the presence of listeria
  • FDA issued a safety alert on July 18, advising restaurants and retailers to stop selling to Topway and to discard recent shipments of Topway’s seafood products.
  • This is the sixth time the FDA has suspended a facility’s registration since getting the authority to do so from the FDA Food Safety Modernization Act in 2011.
  • FDA is working with the company to address violations. It notes that after a corrective plan has been established and implemented, the FDA will consider allowing the company to resume operations.
  • On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA).
  • Under FSMA, FDA 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 and that meet applicable FDA food safety requirements. As previously covered on this blog, the accreditation process includes a web-based application and user fee.
  • In fiscal year 2020, FDA will collect an initial application fee for accreditation bodies seeking recognition of $41,328, an annual fee for recognized accreditation bodies of $1,945, an annual fee for certification bodies accredited by a recognized accreditation body of $2,432, and an initial application fee for a certification body seeking direct accreditation from FDA of $41,328. The fee rates are effective October 1, 2019, and will remain in effect through September 30, 2020.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA or the Accredited Third-Party Certification Program.

  • Many, including state regulators, are closely watching the U.S. Food and Drug Administration (FDA) as it works through the challenges associated with regulating cannabidiol (CBD) products.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD cannot lawfully be added to a food or marketed as a dietary supplement; however, industry has been pressuring the Agency to create a pathway for the lawful use of CBD in food and dietary supplements through either an exception by regulation to the FD&C Act or through a nonenforcement policy.
  • As previously reported on this blog, FDA held a public meeting on May 31, 2019 to obtain scientific data and information about the safety of FDA-regulated products containing cannabis or cannabis-derived compounds.  The Agency has made clear that outstanding questions related to the safety of CBD products must first be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD.
  • In response to FDA’s request for safety data and information, on July 16, 2019, a coalition of 37 Attorneys Generals submitted a letter to FDA, urging the Agency to cooperate with the states to protect consumer from false advertising and potential harms to their health from products containing cannabis or cannabis-derived compounds, including CBD.  The letter also urged the Agency to develop ongoing assessments of potential risk and benefits of these products, including how they interact with other dietary or pharmaceutical products.  Ultimately, the letter requests that FDA “ensure that states maintain a role as regulators in this emerging market.”
  • Meat, poultry, and egg product establishments are responsible for accurately labeling their products in conformance with regulations, guidance and policy enforced by the United States Department of Agriculture (USDA)’s Food Safety and Inspection Service (FSIS). FSIS has published a number of resources to help regulated entities navigate labeling requirements for FSIS-regulated products, including guidance documents related to labeling procedures, ingredients, claims, etc., and a number of policy memoranda and resources.
  • In addition to guidance documents and policy memoranda, FSIS regularly publishes its Constituent Updates, where the Agency updates readers on its current backlog in evaluations for labels that require review and provides submission “tips” for industry to help with label application submissions. In its July 12, 2019 Constituent Update, FSIS provided guidance on voluntary modification of nutrition facts for meat and poultry establishments to meet the Food and Drug Administration’s format requirements. More recent “tips” include ensuring the application includes a label with all of the required features and documentation necessary to support any statements or claims on the label, and identifying all special statements and claims in the “Special Claims Information” section of the label application to help streamline the evaluation process.
  • FSIS has put out a flurry of new policy guidelines and changes to meat and poultry labeling in recent months, including the recent guideline on labeling of “kit” products and the proposal to change net weight/net contents for meat and poultry packages. This blog will continue to monitor such developments.