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TABLE ES-1 Current Status of Foods, Food Additives, Drugs, and Dietary Supplements under the Food and Drug Administration (FDA) Regulations

 

Dietary Supplements

Status

Containing Ingredients in Use prior to DSHEAa

Containing “New” Ingredients Introduced after DSHEA (10/15/94)

Conventional Foodsb

Premarket approval required

No

No; FDA notification 75 days prior to sale required; FDA has 3 options: (1) respond with objection, (2) respond with no objection, (3) not respond

Noe

Postmarket reporting or surveillance by industry required

No

No

No

Burden of proof of safety

FDA must demonstrate significant or unreasonable risk of harm to remove product from market

FDA must demonstrate significant or unreasonable risk of harm to prevent product from being marketed

FDA must demonstrate that food is injurious to health to remove product from market

a DSHEA = Dietary Supplement and Health Education Act of 1994.

b Here “conventional foods” refers to whole agricultural commodities.

c This description applies to “new” drugs. Many over-the-counter drugs are regulated under FDA’s Over-the-Counter Drug Review procedures, which do not provide for postmarketing surveillance.

d GRAS = generally recognized as safe (as defined by the 1958 Food Additives Amendment to Food, Drug, and Cosmetic Act).



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