Food Ingredient Testing Requirements Under FDA Regulations

The US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) oversees the regulation of food ingredients,1, 2 and premarket approval is required before a food ingredient can be brought to market. Food ingredients include the following:

  1. Food additives
    • Food components are ingredients directly added to food.
    • Food contact substances are used in packaging or production processes that indirectly contact food.
  2. Food colour additives impart colour.

Manufacturers submit safety information on a food ingredient to CFSAN using one of three types of petition:3

  • For direct food additives (food components) or food colour additives, a Food or Color Additive Submission is used. Direct food additives may be exempt from the regulatory process if they are prior sanctioned substances or are generally recognized as safe (GRAS).4
  • For indirect food additives (food contact substances), a Food Contact Substance Submission is used.
  • Companies seeking voluntary GRAS status for direct food additives submit a GRAS Notice. GRAS status means that the direct food additive is safe under the conditions of intended use according to qualified scientific experts; however, this status can be reversed and may be revoked on the basis of new data indicating poor safety.

The FDA provides general guidelines5, 6 about tests that may be used to infer a reasonable certainty of no harm. In general, safety is determined largely using information reflecting chemical identity, exposure, and the results of a flexible battery of toxicology tests. While agency guidelines recommend animal tests, these are not required to achieve regulatory acceptance, as noted in the FDA Redbook:

FDA’s guidance for toxicity studies for food ingredients continue to emphasize that there is no substitute for sound scientific judgement. This guidance presents recommendations – not hard and fast rules. If an investigator believes that he/she can provide the Agency with useful toxicological information by modifying a recommended study protocol, and is able to support the modification with sound scientific arguments, then the investigator should propose the modified protocol to the appropriate program division within [the Office of Food Additive Safety]. As always, petitioners and notifiers should consult with the FDA prior to and during the design of study protocols for toxicity studies and/or before commencement of studies.7

Thus, non-animal testing approaches can be used to obtain premarket approval of or GRAS status for food ingredients. The PETA Science Consortium International e.V. has developed a user-friendly workflow to help petitioners who are interested in pursuing non-animal food ingredient safety assessment, available here.

 

If you have any questions or require additional information, please contact the PETA Science Consortium International at [email protected]i.eu.

References

  1. FDA. Determining the regulatory status of a food ingredient. https://www.fda.gov/food/food-ingredients-packaging/determining-regulatory-status-food-ingredient. Updated 20 September 2018.
  2. FDA. Code of Federal Regulations (CFR) citations for color additives, food ingredients and packaging. https://www.fda.gov/food/ingredients-additives-gras-packaging-guidance-documents-regulatory-information/code-federal-regulations-cfr-citations-color-additives-food-ingredients-and-packaging. Updated 18 October 2017.
  3. FDA. Draft guidance for industry: Providing regulatory submissions to the Office of Food Additive Safety. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-providing-regulatory-submissions-office-food-additive-safety. Updated 6 June 2018.
  4. FDA. Code of Federal Regulations (CFR) citations for color additives, food ingredients and packaging.
  5. FDA. Guidance for industry: Summary table of recommended toxicological testing for additives used in food. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-summary-table-recommended-toxicological-testing-additives-used-food. Updated 20 September 2018.
  6. FDA. Guidance for industry and other stakeholders: Toxicological principles for the safety assessment of food ingredients (Redbook 2000). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-other-stakeholders-toxicological-principles-safety-assessment-food-ingredients-0. Updated 20 September 2018.
  7. Ibid.