FDA
has the authority to declare a product misbranded if its
labeling is false or misleading; civil and criminal penalties
apply.
X
X
X
FDA
establishes Good Manufacturing Practices and inspects manufacturing
plants to ensure that provisions are followed.
X
X
X
FDA
has the authority to declare a product adulterated if it
is unsafe (whether the problem involves old or new ingredients
or some other factor such as a contaminant or poor manufacturing
conditions); civil and criminal penalties apply.
X
X
X
Manufacturers'
self-affirmation that a substance is Generally Recognized
as Safe (GRAS) is subject to FDA review.
X
X
FDA
notification is required on the safety of new ingredients;
FDA has the authority to disapprove.
X
FDA
prior approval of safety and efficacy is required.
X
FDA
prior approval of the safety of new food additives is required.
FDA
approval of "nutrient content claims" required
under the Nutrition Labeling and Education Act (NLEA) and
the Dietary Supplement Health and Education Act (DSHEA).
X
X
Claims
Foods
Dietary
Supplements
Drugs
FDA
approval of "health claims" required under NLEA.
X
X
FDA
has the authority to review label statements about structure
and function effects under DSHEA.
X
X
Advertising
Foods
Dietary
Supplements
Drugs
FTC
requires that advertising claims be truthful, not misleading
and substantiated by scientific evidence.
X
X
X
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