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Staking a Claim to Good Health
by Paula Kurtzweil Expediting New Claims A provision in the Food and Drug Administration Modernization Act of 1997 can speed up the process. The new law allows companies to notify FDA of their intent to use a new health claim based on an authoritative statement of one or more federal scientific bodies. It gives FDA 120 days to respond. If the agency does not act to prohibit or modify the claim within that time, the claim can be used.
In a guidance document for industry, FDA earlier this year established interim criteria for determining the adequacy of health claims submitted under the new procedure. Under these criteria, which will remain in place until FDA publishes final regulations, the authoritative statement, which is the basis for the health claim, must:
FDA said it would consult with the scientific body when appropriate to determine whether a statement is an authoritative one.
With the new alternative approach for determining the scientific basis for a health claim, interest in health claims is likely to remain high, and newer claims are likely to hit food labels within the foreseeable future.
"This is a new frontier for industry," says Anna Matz, a spokeswoman for the Grocery Manufacturers of America. "A lot of [consumers] are looking for solid information about the products they buy. Health claims are a perfect way to provide this information."
Paula Kurtzweil is a member of FDA's public affairs staff.
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