To amend the Federal Food, Drug, and Cosmetic Act to establish provisions regarding the composition and labeling of dietary supplements.
Health Freedom Act of 1992 - Amends the Federal Food, Drug, and Cosmetic Act to define "dietary supplement" as an article that: (1) includes, and is intended to supplement the diet with, a vitamin, mineral, herb, or another similar nutritional substance; or (2) is intended for ingestion in tablet, capsule, or liquid form, or another similar form.
Provides that a dietary supplement shall not be considered to be a drug solely because: (1) of the potency of a substance in such supplement; and (2) the labeling or advertising for the supplement contains a claim, or provides information, concerning the potency of a substance in the supplement, or contains a health claim of the type permitted under this Act.
Specifies that: (1) a substance in a dietary supplement is not a food additive if the substance is identified in the labeling of the dietary supplement as a substance provided by the product to supplement the diet; and (2) an article that is a dietary supplement may be described as a dietary supplement in labeling or advertising.
Permits labeling or advertising for such a supplement to include a claim or other information that characterizes the relationship of the supplement, or the presence or absence of one or more of the substances provided by the supplement, to a disease or health-related condition, if: (1) such claim or other information is truthful and not misleading; and (2) there is scientific evidence, whether published or unpublished, that provides a reasonable basis for such claim or other information.
Prohibits the Secretary of Health and Human Services from establishing any requirement that such a claim or other information that meets the requirements of this Act be approved by or conform to a regulation issued by the Secretary before the claim or information may be used.
Provides that, if the Secretary asserts that labeling or advertising for a dietary supplement includes a claim or other information that fails to comply with the Act, the manufacturer (or other specified parties) may bring an action to secure a declaratory judgment regarding the validity of the assertion and obtain any other means of judicial relief authorized by law.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health and the Environment.
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