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Public meeting on health claims under FDA Modernization Act (FDAMA)

On May 11, the FDA sponsored a public meeting in Washington DC to discuss implementation of the FDAMA. This act allows the dietary supplement industry to make health claims for products without seeking FDA preapproval, if the claims are based on "authoritative" statements from approved government scientific bodies. To date, companies attempting to use this process have faced resistance from FDA. Participants at the meeting made several important points:

  • FDA should clarify rules under the FDAMA, by assisting the scientific community in creating a "white paper" to provide samples of acceptable authoritative statements.
  • Each FDA-approved scientific body should set up an internal review process for approval of "authoritative" statements. This strategy was viewed as less limiting than designating a single internal publication as a source for authoritative statements.
  • The FDA should reconsider its current stance which forbids subdivisions of federal agencies to issue authoritative statements.
  • "Qualified" health statements should be allowed when scientific support is not conclusive, as long as they are accompanied by a disclaimer.
The Tan Sheet, May 17, 1999.

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