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# Suggestions on Dietary Supplement Innovation
- URL: https://www.fdaweb.com/suggestions-on-dietary-supplement-innovation/
- Published: 2019-07-17T12:00:00.000Z
- Updated: 2026-09-15T01:38:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144555

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should reaffirm and reinforce the statutory distinction between drugs and dietary supplements as established in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Responding to an FDA request for comments on responsible innovation in dietary supplements, PhRMA [says](https://www.regulations.gov/document?D=FDA-2019-N-1388-0067&ref=fdaweb.com) that failing to preserve the statutory distinction would be inconsistent with the law’s structure and design, would expose the public to potentially unsafe and/or ineffective products, and would create disincentives for drug development and innovation, such that the therapeutic benefit of certain substances may never be realized.

PhRMA called on FDA to: **(1)** take action against dietary supplement companies marketing products with synthetic substances that do not qualify as “dietary ingredients” under DSHEA; and **(2)** take action against dietary supplement companies marketing products with an article that is excluded from the definition of dietary supplement by the exclusionary clause.

The Pew Charitable Trusts comment [letter](https://www.regulations.gov/document?D=FDA-2019-N-1388-0050&ref=fdaweb.com) says that “innovation in the dietary supplement marketplace must not compromise safety, yet dietary supplements can pose a range of safety concerns.” The letter urges FDA to take several specific steps to incentivize wide use of the new dietary ingredient notification process, which it says could improve safety and spur introduction of new dietary ingredients.

In its [comment](https://www.regulations.gov/document?D=FDA-2019-N-1388-0062&ref=fdaweb.com), the Consumer Healthcare Products Association says FDA’s policy position on the DSHEA phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” is the greatest hurdle with respect to product innovation in the FDA 2016 draft guidance and one of the most inconsistent positions FDA has taken against the intent of DSHEA. “The U.S. Congress inserted a separate definition for non-food ingredients in order to anticipate expansion and innovation in dietary supplement development,” it says.

Comments from the Biotechnology Innovation Organization [echo](https://www.regulations.gov/document?D=FDA-2019-N-1388-0054&ref=fdaweb.com) the requests made by PhRMA.