Food Ingredient Testing Requirements Under FDA Regulations

Posted on October 10, 2019

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 Notification can be submitted.
  • Companies seeking voluntary GRAS status for direct food additives can 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 [email protected].

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.