• FDA issued final guidance regarding its decision to exercise enforcement discretion with respect to the sale and distribution of dietary supplements containing N-acetyl-L-cysteine (NAC). The final guidance is substantively identical to the draft guidance issued in April 2022.
  • As we have previously reported, FDA concluded that NAC was excluded from the definition of a dietary supplement because it was approved as a drug before being marketed as a dietary supplement and because no regulation authorizing its use in dietary supplements has been promulgated.
  • Nevertheless, the Agency determined that enforcement discretion is appropriate because (1) it has not identified any safety issues thus far in its (ongoing) review of the safety of NAC in dietary supplements, (2) NAC has been used in dietary supplements for over 30 years, and (3) a strong demand for such use continues. FDA intends to continue exercising enforcement discretion until it either completes notice-and-comment rulemaking authorizing the use of NAC in dietary supplements, determines that rulemaking is not appropriate, or identifies safety issues in its ongoing review. We will continue to monitor and report on any developments related to the regulatory status of NAC in dietary supplements.
  •  We reported on the June 29, 2022 decree (in French) that prohibits the use of “sector-specific terminology traditionally associated with meat and fish” to describe plant-based products made in France.  The law banning “meaty” language, such as “steak,” “sausage,” or “chicken,” for plant-based foods was passed two years ago.  Per the decree that made the law official, the ban was set to take effect on October 1, 2022.
  • On July 27, 2022, however, according to FoodNavigator.com, France’s highest administrative court granted a request from the plant-based and alternative protein-focused association Protéines France for a temporary reprieve based on arguments that the industry would not have enough time to change branding and marketing before the October 1 deadline and the “impossibility for vegetable foodstuffs to leave the lexical field which comes close or far from meat.”  Protéines France also disputes whether some of the terms in question even have origins in meat, as targeted by the ban.  For example,  while “Carpaccio” would be banned, this name comes from the Renaissance painter, Vittore Carpaccio, who is known for his use of red and white tones.
  • The French decree will remain suspended until the court reaches a final decision that could possibly overturn the ban.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements in France and other jurisdictions.
  • On July 15, 2022, the World Health Organization (WHO) issued a draft guideline titled “Use of Non-sugar Sweeteners.”  WHO is seeking public comments on the draft guideline. Those interested in submitting must do so by the August 14, 2022 deadline.
  • Based on what WHO describes as a “systematic review that assessed the health effects of higher compared to lower intake of non-sugar sweeteners,” the guideline document provides a “conditional” recommendation against using non-sugar sweeteners to achieve weight control or to reduce the risk of noncommunicable diseases. Notably, WHO prominently acknowledged  that the recommendation “is based on evidence of low certainty overall….”
  • The guideline’s target audience includes policymakers, health professionals, scientists, and food industry representatives.  However, any interested party may submit a comment at WHO’s website.  WHO notes that it particularly seeks comments on issues like potentially missing information, contextual issues, and implications for implementing the guideline.
  • On July 26, 2022, FDA announced that it would hold a webinar for stakeholders to discuss Food Facility Registration, Biennial Renewal, and obtaining an acceptable Unique Facility Identifier.
  • As previously reported, under FDA’s Food Safety Modernization Act, Food Facility Registration is required for U.S. and foreign human and animal food facilities. Facilities that are registered must renew their registration between October 1, 2022, and December 31, 2022. The webinar will discuss who needs to register or renew and how to do so, as well as how to obtain a unique facility identifier and the benefits of food facility registration.
  • The webinar will take place on August 11, 2022, at 1:00 pm EST. Registration is required by August 10 to attend the webinar.
  • On July 22, the FDA published a draft guidance on conducting Remote Regulatory Assessments. Remote Regulatory Assessments (RRAs) were originally developed during the COVID-19 health emergency and are a set of tools to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products.
  • Currently, requests for records or other information from drug establishments under section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), are RRAs that FDA conducts for which participation is mandatory. RRAs that are not conducted under statutory or regulatory authority are voluntary, meaning that an establishment can decline to participate, in which case the Agency would consider other tools for evaluating compliance with FDA requirements.
  • The draft guidance describes the FDA’s current thinking on its use of RRAs and is intended to increase the industry’s understanding of RRAs and the FDA’s process for conducting RRAs. The draft guidance provides answers to frequently asked questions about what RRAs are, when and why FDA may use them, and how they are conducted, among other FAQs.
  • Stakeholders may submit comments on the draft guidance until September 23. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • A class action lawsuit which asserted various false advertisement claims related to the vegetable oil content of Costco’s chocolate almond dipped vanilla ice cream bars (the “product”) has been dismissed.
  • The Plaintiff alleged that the product was misleadingly advertised as chocolate because the product’s coating contained more vegetable oils than chocolate and the inclusion of vegetable oil was not “prominently disclosed on the product’s front label” as required by 21 CFR 163.155(c). Plaintiff also alleged that the vegetable oil content reduced the chocolate’s quality. In support of his claims, Plaintiff cited to a study which found that 64% of the 6400 respondents who viewed the product label “expected that it would contain more cacao bean ingredients than it did and would not be made with chocolate substitutes.”
  • The Court rejected each of these arguments. It found that the product label did not claim that the coating was made of mostly or entirely cacao bean ingredients and that any alleged violation of FDA regulations was largely irrelevant because there was no evidence that consumers were “aware of the nuances of the FDA’s regulations.” Furthermore, it found that sugar and milk should be considered in the calculation of the proportion of chocolate in the product’s coating, and that when considering these ingredients, the product’s coating contained more chocolate than vegetable oil.  The Court found the cited study similarly unpersuasive because it did not answer the precise question at issue and the complaint was devoid of important details such as the questions asked and the methodology used. Finally, the Court found that there were insufficient allegations to support the claim that the chocolate was of an inferior quality.
  • This case is the latest in a string of recent dismissals of similar lawsuits. Notably, in this case, the court took the unusual step of dismissing with prejudice (i.e., without leave to amend) because “Plaintiff alleged an unreasonable interpretation of what ‘chocolate’ includes, and no set of alleged facts could change the Court’s ruling.”
  •  As covered on this blog, on July 24, 2020, the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) recommended the addition of a new crop, ‘‘Sugarcane (insect-resistant),’’ to the List of Bioengineered Foods (the List).  AMS also recommended amending the existing listing for “squash (summer)” to “squash (summer, virus-resistant),” and sought information about bioengineered (BE) versions of cowpea and rice.  As of January 1, 2022, the date when all regulated entities were required to comply with the National Bioengineered Food Disclosure Standard (NBFDS; discussed here), the use of a listed food or ingredient produced from an item on the List would require a BE food disclosure unless a regulated entity has records demonstrating that the food or ingredient they are using is not BE.  When a crop is not on the List (as is currently the case for sugarcane), a BE disclosure is required only if the entity has actual knowledge that a food or food ingredient that it uses is BE.
  • On July 21, 2022, AMS announced a proposed rule that would update the List to add “sugarcane (Bt insect-resistant varieties)” and amend “squash (summer)” to “squash (summer, mosaic virus-resistant varieties).”  Both proposed listings would contain more precise language than previously recommended.  AMS noted in the July 22, 2022 Federal Register notice of the proposed rule that it did not receive any comments on cowpea or rice and is not proposing any action related to those two crops at this time, and addressed comments opposed to the previously recommended updates on sugarcane or wanting additional changes to the amendment for squash (summer) as follows:
    • On a comment acknowledging that BE sugarcane is authorized in Brazil, but arguing that sugarcane (Bt insect-resistant varieties) should not be added to the List because the BE sugarcane is in production in Brazil primarily for seedling bulk up, and not for human consumption, AMS found that sugarcane (Bt insect-resistant varieties) could be used for human food and requested data or evidence that would support or refute the conclusion that seedling bulk up is the only current use for sugarcane (Bt insect-resistant varieties).
    • In answer to a comment that BE sugarcane produced in Brazil is unlikely to end up in the United States, AMS noted that the List reflects production of BE foods on a global level and does not consider whether such foods are likely to end up in the U.S.
    • As for comments that sugar produced from BE sugarcane is not a BE food because it is highly refined and does not contain detectable modified genetic material, AMS noted that the BE presumption established by listing applies here because the BE sugarcane meets the only two applicable criteria for inclusion (i.e., it is authorized for commercial production and currently in legal commercial production somewhere in the world), and that the presumption could potentially be rebutted, and the associated BE disclosure requirement could be avoided, by demonstrating that modified genetic material is not detectable in sugar.
    • AMS declined to add a trade name to the more specific listing for “squash (summer, mosaic virus-resistant varieties),” in response to comments suggesting this would help distinguish BE versions from their non-BE counterparts, because there is more than one variety of squash (summer) that meets the listing criteria and it is an AMS policy to list crops generically where there is more than one BE variety being marketed.
  • As we noted previously when AMS recommended adding ‘‘Sugarcane (insect-resistant)’’ to the List, the addition of “Sugarcane (Bt insect-resistant varieties)” may complicate the strategy of regulated entities wishing to alleviate NBFDS burdens by avoiding “Sugarbeet,” which is currently listed generically based on availability of more than one BE version.  Comments on the proposed rule are due by September 20, 2022.

 

  • Following an Advance Notice of Proposed Rulemaking (ANPR) for labeling cell-based meat products issued in September, the issue has been placed on the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service’s (FSIS) list of “long-term actions” – meaning the agency does not intend to have a regulatory action within the next 12 months.
  • This is despite food tech companies’ eagerness to bring cell-cultured meat to the market. A California-based company recently developed what it claims to be a significantly less expensive method to produce edible beef cells and anticipates lowering that cost further at scale.
  • Through the ANPR, FSIS received more than 1,200 comments on an array of questions, including whether labeling should differentiate cell-cultured products from products made from traditionally slaughtered animals.
  • Keller and Heckman will continue to monitor FSIS’s plans regarding regulating cell-based meat products.
  • On July 19, 2022, FDA Commissioner Robert Califf published a statement regarding FDA’s evaluation of agency activities. In his statement, Califf acknowledged that the agency has recently confronted challenges that have tested its regulatory frameworks. As a result, Califf commissioned external agency experts to conduct evaluations for the agency’s Human Foods Program and Center for Tobacco Products.
  • The evaluation of the Human Foods Program will include the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). Califf noted that the program has been stressed by complexity of the nation’s food systems and supply chain, and that fundamental questions regarding the structure, funding and leadership of the program must be addressed. The evaluation of the Center for Tobacco Products (CTP) will focus on how the agency will address policy issues and enforcement activities for an increasing number of novel products.
  • The Reagan-Udall Foundation, an independent partner organization for FDA, will work with the external group of experts on the evaluation and will report its findings to FDA within 60 days of initiation. Califf stated that he was committed to addressing the findings and communicating them to the public and believes that the evaluation will support the agency in addressing immediate and future public health matters.
  • On July 13, Chair of the House Appropriations Committee Rosa DeLauro (D-CT-03) and Senator Dick Durbin (D-IL) introduced the Food Safety Administration Act, which is legislation that would establish the Food Safety Administration, a single food safety agency that would incorporate FDA’s food safety and veterinary medicine centers and the Office of Regulatory Affairs’ food operations. The Food Safety Administration would be led by a Senate-confirmed food safety expert.
  • In a Fact Sheet about the bill, DeLauro and Durbin state that, because most FDA commissioners have been medical specialists, the food program “has second-class status within FDA and we have not had sufficient strategic leadership and management accountability for the programs that regulate our food supply.” Further, DeLauro and Durbin state that “[i]n addition to bringing focused leadership and more accountability, a unified structure and full-time senior leader will strengthen oversight of the food supply and enhance the industry’s ability to operate effectively.”
  • DeLauro, Durbin, and other lawmakers have tried to establish a new food safety administration numerous times over the past 20 years. For instance, lawmakers have repeatedly introduced the Safe Food Act which is aimed at transferring and consolidating food safety authorities for inspections, enforcement, and labelling into a single food safety agency. In 2015, the White House’s fiscal 2016 budget proposed consolidating FDA food inspections and enforcement functions and the USDA’s FSIS into a single new food agency within HHS. Of note, DeLauro and Durbin’s current legislation would not apply to the USDA and would only affect FDA.
  • Keller and Heckman will continue to monitor the status of the legislation and provide updates.