New Bill Proposes Changing DSHEA’s 1994 Grandfathered-Ingredient Cutoff Date to 2007

November 16, 2011

As reasoning, the bill states that dietary supplements have had “an exemplary public health safety record” over the years.

A new legislative bill filed by Representative Dan Burton (R-IN) proposes changing the cutoff date separating new dietary ingredients (NDIs) and old dietary ingredients (ODIs) under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Under DSHEA, any ingredients marketed as dietary ingredients in the United States before October 15, 1994, (the date of DSHEA’s enactment) can be grandfathered in as old dietary ingredients and do not require the FDA premarket notification required for new dietary ingredients (any dietary ingredients introduced to the U.S. market only after October 15, 1994).

However, the new “Dietary Supplement Protection Act of 2011” (H.R. 3880) proposes changing the grandfathered date covering old dietary ingredients from October 15, 1994, to January 1, 2007.

As reasoning, the bill states that dietary supplements have had “an exemplary public health safety record” over the years, with many ingredients on the market after 1994 having been safely consumed by Americans-implying that these ingredients should not require NDI premarket approval.

The bill states: “Since the enactment of DSHEA, there has [sic] been 17 years of additional historical use-safety experience conducted by millions of Americans.”

The cutoff date the bill proposes, January 1, 2007, reflects the date when good manufacturing practices (GMPs) for dietary supplements were established. The bill uses the GMPs as an example of the postmarket measures in place to further ensure safety.

“Since January 2007, FDA regulations governing dietary supplement manufacturer good manufacturing practices, dietary supplement adverse event reporting, and private sector voluntary testing and auditing for supplement quality and purity have improved postmarketing consumer safety,” it states.

It is not yet clear how industry will respond to this newly proposed legislation. However, it’s notable that this bill comes at a time when many industry members are preparing their final comments on FDA’s recent new dietary ingredient draft guidance, whose deadline for comment submission is December 2, 2011.

Nutritional Outlook thanks UNPA for the tip.

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