Summary: H.R.4004 — 108th Congress (2003-2004)All Information (Except Text)

There is one summary for H.R.4004. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (03/18/2004)

Health Information Independence Act - Prevents the Federal Government from restricting the distribution of a dietary supplement or other nutritional food because the manufacturer makes health claims unapproved by the Food and Drug Administration (FDA) if: (1) the product has a label clearly stating that its health claims are not FDA-approved; (2) the FDA lacks evidence establishing probable cause that the claims contain misleading information posing a threat to the safety and well-being of those who use the product. Requires an independent review of a determination by the FDA that there is such probable cause.

Amends the Federal Food, Drug, and Cosmetic Act to extend certain food nutrition labeling requirements to dietary supplements. Requires nutrition labels to include the relationship of a nutrient to the prevention, treatment, or cure of a disease.

Directs the Secretary of Health and Human Services to solicit independent scientific reviewers from the university community to review, evaluate, and make recommendations regarding particular health claims, based on the scientific evidence available. Excludes health claims only if they are unsupported by credible scientific evidence and no disclaimer could eliminate potentially misleading connotations. Makes recommendations of such reviewers binding on the Secretary and reviewable only by the U.S. Court of Appeals for the District of Columbia Circuit. Requires costs of this program to be offset against the operating budget of the Department of Health and Human Services.