Nutraceutical Research and Education Act

Summary

Nutraceutical Research and Education Act - Amends the Federal Food, Drug, and Cosmetic Act to define "nutraceutical" as a dietary supplement, food, or medical food, as defined in specified provisions of the Orphan Drug Act, that: (1) has a benefit which prevents or reduces the risk of a disease or health condition, including the management of a disease or health condition or the improvement of health; and (2) is safe for human consumption in the quantity and with the frequency required to realize such properties. (Sec. 4) Allows any person to petition the Secretary of Health and Human Services to issue a regulation regarding a nutraceutical claim. Requires that the petition contain specified information, including a report of at least one clinical trial and evidence that the nutraceutical is safe. (Sec. 5) Prohibits the Secretary, if the Secretary issues a regulation in response to a petition, from issuing another regulation for an essentially identical nutraceutical claim for ten years, unless: (1) the new petition involves a use that provides greater effectiveness, greater safety, or otherwise a major contribution to patient care; or (2) the first petition is subsequently revoked. Deems a food adulterated if it is a nutraceutical and it: (1) has not had a petition approved; or (2) has been prepared, packed, or held under conditions that do not meet good manufacturing practice regulations. Authorizes the Secretary to issue such regulations. (Sec. 7) Establishes in the Food and Drug Administration (FDA) the Advisory Council on Nutraceuticals to evaluate whether a petition is worthy of review by the FDA and whether the petition conflicts with any other petition. Exempts the Council from the Federal Advisory Committee Act. (Sec. 8) Directs the Secretary to maintain and periodically publish an index, with specified contents, listing: (1) each nutraceutical having an approved petition; and (2) each pending petition. (Sec. 10 (sic)) Makes it not unlawful under the antitrust laws for two or more small businesses to agree to combine their resources to meet FDCA requirements for claims of nutraceutical health benefits. Defines: (1) "antitrust laws" as it is defined in specified provisions of the Clayton Act plus specified provisions of the Federal Trade Commission Act as those provisions apply to unfair methods of competition; and (2) "small businesses" as entities that have fewer than 500 employees, including employees of affiliates.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 1 October 1999

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• Introduced in House (PDF)

  Introduced in House · EN · 1 October 1999

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• Introduced in House

  summary · EN · 1 October 1999

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