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Year in review

i Infant formula shortage

In February 2022, in response to consumer complaints of infections among infants reported to have consumed certain infant formulas, the FDA launched an investigation and warned consumers not to use those formulas, which were also subject to recall. The recall, combined with ongoing supply chain issues due to the covid-19 pandemic, led to a shortage of infant formula in the US. In May 2022, as part of its efforts to address the shortage, the FDA issued guidance to infant formula manufacturers, announcing the agency's intention to temporarily exercise enforcement discretion, on a case-by-case basis, in respect of certain requirements that apply to infant formula. This guidance will remain in effect until 14 November 2022, after which the FDA will assess whether an extension is necessary.5 The FDA's website includes a list, which is updated on a regular basis, of foreign infant formula products subject to enforcement discretion for import into the US.6

ii Bioengineered food disclosure

The mandatory compliance date for the National Bioengineered Food Disclosure Standard (the Standard), which was promulgated in 2018 by the Agricultural Marketing Service, an agency of USDA, took effect on 1 January 2022. Accordingly, entities subject to the Standard must ensure that bioengineered food and bioengineered food ingredients are disclosed.7

iii Foods derived from animal cell culture technology

As was announced on 7 March 2019, the FDA and FSIS signed a formal agreement to jointly oversee the production of human food products derived from the cells of livestock or poultry. The agreement provides that, among other things, the agencies will 'develop joint principles for product labelling and claims to ensure that products are labelled consistently and transparently'.8 On 3 September 2021, FSIS published an Advance Notice of Proposed Rulemaking (ANPR) to solicit public comments regarding the labelling of meat and poultry products produced using animal cell culture technology.9 The ANPR followed a notice and request for information that the FDA issued on 7 October 2020 regarding the labelling of foods comprising or containing cultured seafood cells.10 Consistent with the 2019 formal agreement, FSIS indicated that it will consider comments submitted in response to the FDA's request for information in developing rules governing the labelling of cell culture products.

iv Per- and polyfluoroalkyl substances

In connection with the FDA's ongoing efforts to assess the presence of per- and polyfluoroalkyl substances (PFAS) in food, in June and August 2021, the FDA released results from the agency's testing for certain PFAS in foods from the general food supply and in nationally distributed processed foods, respectively.11 Because PFAS were detected in certain seafood samples, the FDA subsequently conducted a targeted survey of the most commonly consumed seafood in the US. The FDA concluded from the results of this survey, which were released in July 2022, that the estimated exposure to perfluorooctanoic acid (PFOA) (a type of PFAS) from certain samples of imported canned clams was likely a health concern. The agency is actively engaging with distributors of the sampled canned clam products to identify potential sources of contamination; the distributors of the canned clam samples with the two highest levels of PFOA have already issued voluntary recalls of the implicated products. In addition, the FDA is continuing to evaluate the extent of PFOA in imported canned clams, as well as PFAS in clams overall.12

In August 2021, the FDA issued a Letter to Industry emphasising that 'only certain fluorinated polyethylene containers [as specified in 21 CFR § 177.1615] are authorized for food contact use'. The letter was prompted by results from the Environmental Protection Agency's (EPA) testing of non-fluorinated high-density polyethylene containers for the presence of PFAS, which revealed that certain types of PFAS that are associated with adverse health effects can migrate from some fluorinated polyethylene containers used to hold pesticides. The FDA found that such PFAS can result from fluorination processes that are not approved for food contact. Therefore, to help ensure that these fluorinated processes are not used to produce food contact articles, the FDA issued the August 2021 Letter to Industry.13 The FDA also issued a request for information in July 2022 on the food contact uses of fluorinated polyethylene, as part of the agency's ongoing efforts to ensure that authorised food contact uses are safe.14

v Nutrition Innovation Strategy

As was first announced in 2018, the FDA has been pursuing its Nutrition Innovation Strategy, which seeks to modernise food label claims and standards of identity and implements the recently overhauled nutrition label and restaurant menu labelling requirements. In January 2022, the FDA revoked the standard of identity for French dressing, effective as of 14 February 2022.15 In June 2021, the FDA issued a Final Rule to revoke the standards of identity for low-fat and non-fat yogurt and amend the standard for yogurt, with an effective date of 12 July 2021 and a compliance date of 1 January 2024; however, certain provisions of the Final Rule have been stayed as a result of objections filed by industry stakeholders.16 In November 2021, the FDA issued guidance to industry regarding the Temporary Marketing Permit process, which allows manufacturers to market test products that deviate from established standards of identity.17

vi Closer to Zero action plan

In March 2021, the FDA issued a Letter to Industry on chemical hazards, including toxic elements, in foods for babies and young children.18 The FDA reminded manufacturers and processors of the agency's goal to 'reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders'. In April 2021, the FDA announced its Closer to Zero action plan19 for reducing exposure to toxic elements such as arsenic, cadmium and mercury in foods consumed by babies and young children. As part of the plan, in October 2021, the FDA, in coordination with the EPA, issued updated advice about eating fish.

vii Laboratory accreditation programme

In December 2021, the FDA issued a Final Rule establishing a Laboratory Accreditation for Analyses of Foods (LAAF) programme, as required by the FDA Food Safety Modernization Act (FSMA).20 The purpose of this programme is 'to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories'. Under the programme, the FDA recognises accreditation bodies that will evaluate and accredit laboratories (LAAF-accredited bodies) to the standards established in the Final Rule. The FDA will maintain on its website a public registry listing recognised accreditation bodies and LAAF-accredited laboratories. After the FDA has recognised a 'sufficient number' of accreditation bodies and a 'sufficient number' of laboratories have been LAAF-accredited, the agency will issue a notice in the Federal Register, with compliance required six months after such a notice. Separate Federal Register notices may be issued for the various types of food testing required under the Final Rule. Following implementation of the Final Rule, owners and consignees will be required to use an LAAF-accredited laboratory for certain food testing as required under the rule.21

viii Cosmetics

In October 2021, the FDA removed the stay of the Final Rule to repeal 21 CFR § 73.2396, which had provided for the use of lead acetate in cosmetics intended for colouring hair on the scalp. The rule went into effect on 6 January 2022, although the FDA intends to exercise enforcement discretion for 12 months from the effective date.22 In October 2021, the FDA also released the results of the agency's 2021 sampling assignment to test talc-containing cosmetics for the presence of asbestos. The results showed that all 50 samples were negative. The FDA has announced plans to test, in 2022, 50 additional samples of talc-containing cosmetics for the presence of asbestos.23 In January 2022, the FDA made available a white paper, developed by the Interagency Working Group on Asbestos in Consumer Products, which describes scientific opinions on testing methods to ensure reliable detection and identification of any asbestos particles.24