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
The Tan Sheet, May 17,
- 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
by Herb Research Foundation, Boulder, CO, USA.