Structure/Function Label Compliance Mandatory By 2001 29250

Structure/Function Label Compliance Mandatory By 2001

WASHINGTON--"Pipeline products" as well as those already labeled and on the market by January 6, 2000, all must come into labeling compliance with the Food and Drug Administration's (FDA) final structure/function regulation by 2001. FDA published a "partial stay of compliance" in the Federal Register last week in response to petitions filed earlier this year by several industry groups.

Originally, products that were marketed for the first time on or before Jan. 6, 2000, had to be in compliance with the final regulation by Feb. 7, 2000, and products that were already on the market had to be brought into compliance by the end of this year. Under this "stay of compliance," products that were labeled no later than Jan. 6, or had labeling printed by that day, have until next year to be in compliance (small firms by July 7, 2001, and all others by Jan. 7, 2001). Companies that wish to take advantage of the stay must notify FDA under specific requirements, and an individual with the company must certify that those products do meet the requirements for the stay.

The American Herbal Products Association (AHPA) was one group that had petitioned for a broader stay of compliance, including allowing products that were in compliance with the law before the final structure/function regulation changes to be shipped even after the end of the compliance period. "The position taken by the agency provides no meaningful flexibility and implies that manufacturers must be focused on moving fully compliant product labels into the distribution channel sooner rather than later," said Michael McGuffin, AHPA's president.

To learn more about the stay of compliance, visit www.fda.gov/OHRMS/DOCKETS/98fr/092900a.htm or contact the agency at (202) 205-4605.