FDA Food Additive Petition Process: How Foreign Manufacturers Get New Ingredients Approved for the US Market

The United States regulates food ingredients differently from most other countries. Under the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive and requires premarket authorization by the FDA — unless the substance is Generally Recognized as Safe (GRAS) or is otherwise excluded from the definition. For foreign food manufacturers who use ingredients that are commonly approved in Europe, Asia, or other markets but have not been authorized in the United States, the path to market entry requires either a Food Additive Petition (FAP) under 21 CFR 171 or a GRAS determination — and both processes require substantial scientific data and regulatory expertise.

The food additive petition process under 21 CFR 171

A Food Additive Petition is a formal request to the FDA to issue a regulation authorizing the use of a new food additive. The petition must include the identity and composition of the additive, its intended conditions of use (what foods it will be used in, at what levels, and for what technical purpose), the cumulative effect of the additive in the diet, safety data sufficient to demonstrate that the proposed use is safe, analytical methods for detecting and measuring the additive in food, and proposed labeling. The safety data typically includes toxicological studies — depending on the expected dietary exposure, these may range from short-term toxicity studies to chronic feeding studies and carcinogenicity assessments. The FDA review period for a Food Additive Petition is typically 12 to 24 months, though complex petitions can take longer.

GRAS determination as an alternative

A substance that is Generally Recognized as Safe for its intended use is exempt from the food additive definition and does not require a Food Additive Petition. GRAS status can be based on either a history of safe use in food before 1958 or on scientific evidence evaluated by qualified experts. The scientific standard for GRAS is the same as for a food additive — 'reasonable certainty of no harm' — but the difference is that the evidence must be publicly available and generally recognized by qualified experts, rather than being proprietary data submitted to the FDA. Since 1997, the FDA has operated a voluntary GRAS Notification program (21 CFR Part 170, Subpart E) under which manufacturers can notify the FDA of their GRAS determination and receive a response letter indicating whether the FDA has any questions.

A GRAS Notification is substantially faster and less expensive than a Food Additive Petition. The FDA typically responds to GRAS Notifications within 180 days, and the data requirements — while still rigorous — may be less extensive than those for a food additive petition if the substance has a well-documented history of safe use. However, GRAS status carries its own risks: the determination is made by the manufacturer, and if the FDA later disagrees that the substance is GRAS, the manufacturer bears the consequences of having marketed an unapproved food additive.

Common situations where foreign manufacturers face ingredient authorization issues

Foreign food manufacturers frequently discover that ingredients routinely used in their home market are not authorized in the United States. Steviol glycosides with specific purity profiles, novel enzyme preparations, certain plant extracts used as natural preservatives, new sources of dietary fiber, and innovative protein ingredients are all examples of substances that may be approved in the EU under Novel Food regulations or in Japan under MHLW approvals but lack FDA authorization. In some cases, the ingredient may already be GRAS in the US but for a different use or at different levels than the foreign manufacturer intends — and the existing GRAS determination may not cover the new use. Reformulating the product for the US market or pursuing a new GRAS determination is often the most practical path forward.

Prior sanctioned substances and color additives

Certain food ingredients fall outside the food additive and GRAS frameworks entirely. Prior sanctioned substances — ingredients that were approved by the FDA or the USDA before the 1958 Food Additives Amendment — retain their approved status under the original sanction. Color additives are regulated under a separate framework (21 CFR Parts 70 through 82) and require their own petition process for authorization. Foreign manufacturers who use colorants must verify that each colorant is listed in the US color additive regulations and, for certain colorants, that the specific batch has been certified by the FDA. EU-authorized colorants are not automatically authorized in the US, and the lists differ significantly.

How FDABridge helps with ingredient compliance

FDABridge helps foreign food manufacturers identify potential ingredient authorization issues before they become compliance problems. Our food registration and label review services include evaluation of ingredient lists against current US food additive and GRAS regulations, helping you understand which ingredients require additional authorization before your products can enter the US market. Visit fdabridge.com/food to learn about our food services or fdabridge.com/contact to discuss your ingredient compliance questions.