The Hill News

When policy makers responsible for writing a bill send a letter telling an enforcement agency that it is out of line, one would hope the agency would sit up and listen. This week, Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) wrote to the Food and Drug Administration (FDA) claiming that the agency's recently released guidelines on dietary supplements undermines the statutory framework for regulating such supplements, as outlined in a bill crafted by the two Senators. If the outcry in the supplement industry and consumer advocates hasn't got the attention of FDA Commissioner Margaret
Hamburg, perhaps the Senators' letter will.

In 2011, Congress passed the Food Safety Modernization Act (FSMA), which among other things, required the FDA to provide clarification on when supplement manufacturers must file New Dietary Ingredient notifications (NDI) and what information they must provide to the agency. The NDI filing system was meant to be a streamlined! way for makers of new supplements to notify the FDA of the proper dosage and uses for the product, as well as why it is reasonably expected to be safe.  As noted in the Senators' letter, the guidance required by the FSMA was meant to clarify the NDI filing process and work in conjunction with legislation already on the books - namely, the Dietary Supplement Health and Education Act of 1994 (DSHEA), which Hatch and Harkin wrote and which created the regulatory framework for the dietary supplements market.

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