Food Ingredients Must be FDA Approved

Do you have a great idea for a food product? Or maybe you want to import your favorite food from overseas and introduce it to American consumers? If either of these scenarios describe you, congratulations! But before you move forward with your new business venture, you first need to be aware of a few things that govern food in the United States, especially when it comes to ingredients.

All businesses engaged in the manufacturing of foods must ensure that ingredients and substances added to their products are lawful under the laws and regulations administered by the U.S. Food and Drug Administration (“FDA”). Under the Food, Drug and Cosmetic Act (“FDCA”), foods are defined as:

• Articles used for food or drink, such as a apples or soda.
• Chewing gum.
• Articles used for components of those articles, such as food additives.
  (21 U.S.C. § 321(f))

Substances added to food must be either:

• FDA-approved food additives, which are substances having an intended use that results in their becoming a component of food or otherwise affecting the characteristics of food (21 C.F.R. Parts 172 and 173).
• Generally recognized as safe (GRAS) substances, which are substances generally recognized by qualified experts as having been adequately shown to be safe under the conditions of the substance's intended use. Many, but not all, GRAS substances are listed in FDA regulations (21 C.F.R. Parts 182 and 184). Manufacturers can deem a substance to be GRAS for use in food without FDA approval or notification, provided certain requirements are met.
• Prior-sanctioned substances, which are those substances the FDA or the USDA explicitly approved before 1958 for use in food in certain amounts and under certain conditions. Some prior-sanctioned substances are listed in FDA regulations (21 C.F.R. Part 181).
• FDA-approved color additives, which include synthetic and naturally-derived colors (21 C.F.R. Parts 73 and 74).
  (21 U.S.C. §§ 321(s), (t) and 348)

The FDA has a repository of substances that can be added to food (see FDA: Substances Added to Food (Formerly EAFUS)). However, this repository does not contain all substances that can be lawfully added (for example, only some GRAS substances are listed).

Frequently businesses with new or novel products do not check to see if all their ingredients have been approved for use in food. Many businesses also don’t realize that FDA monitors the market to ensure that their regulations are being complied with and will send businesses running afoul of these regulations warning letters. Start 2024 out right by doing your diligence to ensure your products are ready for the market.