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Keeping Tabs on FDA’s Increased Guidance “Action Levels”

The areas where FDA issues guidance documents is an indicator of future regulatory focus. In April, FDA has issued four new guidance/draft guidance documents for the food industry – none of which should really be unexpected, as all were a continuation of areas on which FDA has put recent focus: heavy metals, imports, and allergens.

  • Action Level for Lead in Juice. Since the early 1990s, FDA has issued action level guidance for the levels of lead in juice having established an emergency action level of 80 ppb and above for lead in juice packed in lead soldered cans in 1993 while it undertook rulemaking to prohibit the use of lead solder cans for food. Since then, the action levels have been gradually reduced with FDA issuing guidance for 50 ppb as the recommended level not to be exceeded based on concurrence with the 2001 Codex maximum level (ML) for ready-to-drink fruit juices in international trade. Further work of the U.S. with Codex resulted in the reduction of the Codex lead ML for most fruit juices to 30 ppb in 2012 based on the achievability of lower MLs following review of international data on lead in fruit juices.

               Following FDA’s 2021 Closer to Zero action plan identifying actions it will take to reduce exposure to toxic elements from foods eaten by babies and young children, the agency has reevaluated the current 50 ppb lead level recommendation based on achievability, as well as FDA’s development of interim reference levels and the Closer to Zero plan. The result is the new draft guidance establishing an action level for lead of 10 ppb for apple juice on a single-strength (ready-to-drink) basis and 20 ppb for other single-strength juice types, including juice blends that contain apple juice. FDA set a lower action level for apple juice because it is the most consumed juice by young children in the U.S. Additionally, FDA considers the guidance action levels “to be achievable by industry when measures are taken to minimize the presence of lead.”

  • Imports. FDA issued two new documents focused on imports:
    • FSVP Unique Facility Identifier. This final guidance removes the ability for importers to use “UNK” (“unknown”) in lieu of a DUNS number in the Entity Number field for importer identification which was provided as a temporary measure in 2018 guidance.  With FSVP importers having now had ample time to familiarize themselves with the requirements, beginning on July 24, 2022, FSVP importers must enter their valid, nine-digit DUNS number in the Entity Number field, or the system will reject the entry. The guidance also provides information for importers with multiple DUNS numbers. So, if you don’t have a DUNS number, now is the time to get one if you are an importer.
    • Accredited Third-Party Certification Program. Set as a Q&A, this draft guidance focuses on questions commonly asked about the program, such as whether the certification is mandatory for imports (no, it is only needed to establish eligibility for participation in VQIP or when required by FDA to prevent potentially harmful food from reaching U.S. consumers). It also addresses the difference between consultative and regulatory audits – that is, consultative audits are conducted to help eligible entities prepare for a regulatory audit, which is the one that determines eligibility for issuing food or facility certification. Though the primary focus is on accreditation bodies, there is other general information that warrants at least a scanning of the document by importers interested in the program.
      NOTE: FDA has also just published a reminder that the VQIP application portal for fiscal year (FY) 2023 benefits will close at the end of this month. Importers have until May 31, 2022, at 11:59 pm EST to submit their online application to participate in VQIP for FY2023 benefits, beginning October 1, 2022. Application status also can be checked at
  • Evaluating the Public Health Importance of non-major Food Allergens. Intended for FDA staff who are responsible for the evaluation, stakeholders intending to submit a citizen petition on an allergen, and those interested in how the evaluation is conducted, the draft guidance describes FDA’s approach to evaluation. It includes the consideration of scientific factors and other information relevant to the labeling and production of food containing the allergen and recommendations for how to identify and evaluate evidence of the public health importance of a non-listed food allergen.

      While noting that food allergy can be broadly defined as an “adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food,” FDA limits the food allergies to be discussed in the guidance as those that are mediated by immunoglobulin E antibodies (IgE). These are recognized to be the most severe and immediately life-threatening because IgE-mediated food allergic reactions can trigger anaphylaxis, which can be fatal. Thus, the focus of guidance is IgE-mediated food allergy, and the four scientific factors (consistent with Codex, the ILSI-EU, and other scientific references) that FDA will consider when evaluating the public health importance:

  1. Evidence of IgE-mediated food allergy
  2. The prevalence of an IgE-mediated food allergy in the U.S. population
  3. The severity of IgE-mediated food allergic reactions
  4. The allergenic potency

As stated, none of the topics of the guidances should be a surprise as all are areas on which FDA has increased its focus. While guidance is not binding, it is a strong indication of what FDA expects from the food industry, and it is important to be as familiar with guidance documents as regulatory requirements. An increase in guidance publication be unexpected as the ebbing of the pandemic is enabling FDA to refocus on such essentials of food safety – and to spur industry to do so as well. Whether May, or any following months, will incite such a wealth of guidance – or regulation – is yet to be seen, but we do know that FDA is back on its inspection rounds and could be cuing up your facility or imports even now.


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