In the United States, the Food and Drug Administration (FDA) is the regulatory body responsible for promoting public health by ensuring the safety of foods, drugs, biologics, medical devices, radiation-editing electronic products, cosmetics, veterinary products, and tobacco products. Ingredients that are ingested or consumed have the potential to fall into a number of these categories, and it’s important for manufacturers to comply with all necessary regulations for the production and use of these ingredients.
Often, manufacturers must demonstrate the safety of their ingredient, but the regulatory requirements differ among FDA product categories. In order to determine which regulatory pathway to pursue, especially for a novel ingredient, it’s important to first identify which FDA product category the ingredient falls into.
Cosmetics: FDA considers a product a cosmetic if it applied to the human body with the intent to cleanse, increase attractiveness, or alter appearance. Cosmetics can include colognes and perfumes, hair dyes and treatments, makeup, moisturizers, and nail care products. Unless the ingredient is a color additive, which requires a Color Additive Petition (CAP), there is no regulatory requirement for an ingredient to undergo pre-market approval by FDA. More information is available on FDA’s website.
Drugs: While FDA defines the term “drug” in a number of ways, the most relevant definitions here are a substance “other than food” intended to affect structure or function of the body, or which is intended to diagnose, cure, mitigate, treat, or prevent disease. Ingredients that meet the FDA’s definition of “drug” may require an Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) and/or Biologic License Application (BLA). More information is available on FDA’s website.
Dietary Supplements: FDA classifies dietary supplements as a special subcategory of foods, and regulates both dietary ingredients and the dietary supplements that contain them under the Dietary Supplement Health and Education Act of 1994 (DSHEA). As part of the Food, Drug, and Cosmetic Act (FD&C Act), manufacturers and distributors who market dietary supplements that contain new dietary ingredients must first notify FDA about these ingredients through a New Dietary Ingredient Notification (NDIN). More information is available on FDA’s website.
Foods: FDA regulates direct and indirect food additives, and how most conventional foods are processed, packaged, and labeled. Per the Federal Food, Drug, and Cosmetic Act sections 201(s) and 409, pre-market approval must be obtained for food additives unless the substance is GRAS under the conditions of its intended use. Regulations in 21 CFR 170.3 and 21 CFR 170.30 define food additives and the eligibility for a substance to be determined to be GRAS, either through scientific procedures or history of use. A Food Additive Petition (FAP) or Generally Recognized as Safe (GRAS) conclusion are two independent pathways that can be pursued to satisfy regulatory requirements for new or novel food ingredients. Additional information is available on FDA’s website.
Just because an ingredient falls into FDA’s food additive category, doesn’t necessarily mean that pursuing a GRAS conclusion is required or possible. The next blog post in the series is titled: How to Determine if an Ingredient is Eligible for GRAS.
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