Table 6     
Safety Criteria for Foods, Additives, and Supplements

Food Food Additives Dietary Supplements Medical Foods Foods for Special Dietary Use
Foods are presumed to be safe unless the FDA determines that a particular food is injurious to health. Presumption is that food additives are unsafe until proven otherwise.

Any ingredients used in a multi-ingredient food product must be pre-approved by the agency unless the ingredient is exempt. Ingredients would be exempt if they are: (a) Generally Recognized as Safe (GRAS) (as demonstrated by scientific evidence or long-time use in food); or (b) the subject of a prior sanction (an informal approval by FDA issued prior to the enactment of the 1958 Food Additives Amendment).

Presumption is that dietary supplements are safe until proven otherwise.

Dietary supplements containing ingredients not in use prior to Oct. 15, 1994 may be marketed 75 days after the manufacturer provides notice and substantiation that the ingredient can “reasonably be expected to be safe.” FDA approval and thorough scientific testing are not required. Notification and substantiation are not required for ingredients that were in use before Oct. 15, 1994. Such products can be banned by FDA only upon a showing of “significant or unreasonable risk.”

It is very difficult for FDA to remove a dietary supplement from the market.

Ingredients are subject to food additive provisions.

There is no additional regulatory framework that:
creates specific quality assurance requirements; ensures that the foods are safe under their conditions of intended use; or ensures that they provide nutrients that they claim to provide within safe ranges or ensures that benefits claimed are supported by adequate scientific evidence.

Ingredients are subject to food additive requirements.

There is no additional regulatory framework to ensure that foods are safe for their intended use.