•  We have reported on developments regarding toxic elements of concern that may be present in the food supply and, in particular, FDA’s “Closer to Zero” plan to reduce the levels of arsenic, lead, cadmium, and mercury in food for babies and young children.  These toxic elements cannot be completely avoided in the fruits, vegetables, or grains that are used in baby foods, juices, and infant cereals because they are present in the environment and may enter the food supply through soil, water, or air.
  • On July 15, 2022, FDA released the Fiscal Years 2018 – 2020 Total Diet Study (TDS) Elements Report on the analytical results for nutrients and toxic elements from 307 foods (including beverages and water), as well as 384 baby food (BF) products, that FDA sampled and analyzed over the 3-year period of the latest TDS and a Supplement (table) that summarizes the data.  Highlights from FDA’s report include:
    • Total arsenic, lead, and mercury were detected in less than half of the FY2018-FY2020 vegetable samples (35%, 10%, and 6% detects respectively); whereas cadmium was detected in 93% of vegetable samples (mean concentrations in vegetables range from: total arsenic, not detect (ND) – 15 ppb; cadmium, ND–222 ppb; lead, ND–12 ppb; mercury, ND – 1.8 ppb)
    • Among the foods with the highest mean concentrations of each analyte:
      • Arsenic (total) was ND in most of the foods tested (i.e., 57%), but was detected in all 27 samples of Baked cod, all 3 samples of Canned Tuna, all 3 samples of Fish sticks, all 27 samples of Baked salmon, and all 27 samples of Pre-cooked shrimp, with the highest reported level of 10,900 parts per billion (ppb) found in Baked cod;
        • Other than seafoods, Crisped rice cereal, BF Rice cereal, and Brown and White rice also had high mean total arsenic concentrations;
        • The results of the subset of samples that were further analyzed for inorganic arsenic ranged from 6.1 to 103 ppb and the highest mean concentration (i.e., 93 ppb) was found at in Crisped rice cereal;
      • Cadmium was ND in only 39% of the foods tested, and was detected in all 3 samples of Sunflower seeds, all 27 samples of Raw spinach, all 3 samples of Potato chips, all 27 samples of Leaf lettuce, and all 27 samples of French fries, with the highest reported level of 400 ppb found in both Raw Spinach and Sunflower seeds;
      • Lead was ND in most foods (86%) but was detected in all 8 samples of BF Sweet potatoes, all 8 samples of BF Teething biscuits, all 3 samples of Sandwich cookies, all 3 samples of White wine, and all 3 samples of Ranch salad dressing (low-calorie), with the highest reported level of 38 ppb found in BF Sweet potatoes; and
      • Mercury was ND in most foods (93%) but was detected in all 3 samples of Canned tuna, all 27 samples of Baked cod, all 27 samples of Baked salmon, all 27 samples of Pan-cooked catfish, and 27 samples of Pre-cooked shrimp, with the highest reported level of 250 ppb found in Canned tuna.
    • For TDS foods with FDA Action Levels, i.e., Apple juice (10 ppb lead, 10 ppb inorganic arsenic), Chocolate and Hard candy (100 ppb lead), and Infant rice cereal (100 ppb inorganic arsenic), or Standards, i.e., Bottled water standards (5 ppb lead, 10 ppb arsenic, 5 ppb cadmium, 2 ppb mercury), all results were below the levels/standards established by FDA.
  • While these new results add significantly to the analytical database for toxic elements of concern, especially for cadmium, which had been the most lacking, FDA has not posted any revisions to its Closer to Zero plan or otherwise provided any updates on establishing interim reference levels (IRLs) since the update in June that is discussed here.  Keller and Heckman will continue to monitor and report on developments impacting the Closer to Zero plan.
  • On August 3, 2022, FDA announced the establishment of the Laboratory Accreditation for Analyses of Foods (LAAF) program Dashboard. The LAAF Dashboard will serve as a public registry listing for information on LAAF participants. The LAAF Dashboard allows users to search, view, and export lists of recognized accreditation bodies and LAAF-accredited laboratories.
  • As previously reported, and as demonstrated in the LAAF Dashboard, FDA has recognized six accreditation bodies under the LAAF program. Accredited bodies under LAAF may, in turn, accredit laboratories to the standards established under the Food Safety Modernization Act of 2011 (FSMA).
  • Interested accreditation bodies can apply for recognition under the LAAF program through FDA’s electronic portal, and interested laboratories may apply to one of the recognized accreditation bodies to seek LAAF accreditation. The LAAF Dashboard will be updated as participants are added or changed.
  • On August 1, the USDA’s FSIS announced that it will declare Salmonella an adulterant in breaded and stuffed raw chicken products. Breaded and stuffed raw chicken products will be considered adulterated when they exceed 1 colony forming unit (CFU) of Salmonella per gram. Products that exceed the limit would be subject to regulatory action. FSIS believes the limit of 1 CFU/gram will significantly reduce the risk of illness from consuming such products.
  • Breaded and stuffed raw chicken products have been associated with up to 14 food safety outbreaks and approximately 200 illnesses since 1998. The products at issue are those found in the freezer section and that appear to be cooked, but are only heat-treated to set the batter or breading; the products contain raw poultry. FSIS has found that continual efforts to improve product labeling have not reduced consumer illnesses.
  • FSIS is expected to publish a notice in the Federal Register in the fall and will be seeking public comments on whether a different standard for adulteration (i.e., zero tolerance or one based on specific serotypes) would be more appropriate, an implementation plan, and a verification testing program.
  • This announcement is part of FSIS’ effort to reduce Salmonella illnesses associated with poultry. In October 2021, USDA announced that it was reevaluating its Salmonella control strategy. USDA plans to present a proposed framework for a new comprehensive strategy to reduce Salmonella illnesses attributable to poultry in October and convene a public meeting to discuss in November.
  • 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.