Food

What is a food? 

According to FDA a food is defined as (1) articles used for food or drink for man or other animals; (2) chewing gum; and (3) articles used for components of any such article. Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live animals, bakery goods, snack foods, candy, and canned foods.

Whether or not something is considered a food by FDA regulations is based on the intended use of the food. 

What is intended use of a food?

Intended use may be established through the following:

  • Statements on the product labeling, in advertising, on the Internet, or in other promotional materials.  Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a conventional food.  Such claims establish the product as a drug because the intended use is to treat, cure, mitigate, or diagnose disease.  
  • Consumer perception, which may be established through the products reputation. 
  • Ingredients that may cause the product to be considered a drug because the ingredient is well known to the public and industry to have therapeutic use.
How do I get my food approved by FDA?

FDA does not approve food products. FDA issues regulations and requires that industry follow those regulations. All foods must contain generally recognized as safe (GRAS) ingredients, have compliant labeling, make only those claims permitted on its labeling, be manufactured in a facility that follows current Good Manufacturing Practices (cGMPs), be manufactured in a facility that is registered with FDA under the Bioterrorism Act. 

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