Academic journal article American Journal of Law & Medicine

The New Dietary Ingredient Safety Provision of DSHEA: A Return to Congressional Intent

Academic journal article American Journal of Law & Medicine

The New Dietary Ingredient Safety Provision of DSHEA: A Return to Congressional Intent

Article excerpt


In the ten years since the passage of the Dietary Supplement Health and Education Act of 1994 ("DSHEA"),1 dietary supplements have become a widely available and important element of individualized preventative healthcare. Congress created DSHEA in response to great consumer demand,2 thereby embracing the dietary supplement category and opening the door for the growth of the dietary supplement industry. DSHEA introduced an expansive definition of dietary supplements and laid out available claims and strict safety standards for such products.

While the statute has remained unchanged since its passage in 1994,4 the Food and Drug Administration ("FDA") appears to be in the process of re-interpreting sections of DSHEA in ways that could fundamentally limit the availability of dietary supplements. Specifically, FDA has been utilizing DSHEA's "new dietary ingredient" ("NDI") safety provision5 to narrow the scope of ingredients that can be considered, even before addressing their safety, for use in dietary supplements.6 The challenges PDA's actions pose to the availability of dietary supplements are potentially as significant as any statutory challenge and therefore should be the subject of careful scrutiny and public discussion.

In response to these developments, this article aims to review Congress' intent in drafting the NDI section of DSHEA and to urge that this portion of the statute is utilized to ensure the safety of new dietary ingredients, as Congress intended. As written, the statute does not require a dietary ingredient that is the subject of a safety submission under the NDI section to meet the definition of a dietary supplement.7 FDA has adopted this interpretation.8

The NDI section is one of DSHEA's multiple safety provisions, which together ensure that dietary supplements are "reasonably expected to be safe" for their intended uses.9 DSHEA safety elements include:

(1) emergency powers to remove unsafe products from the market;10

(2) an adulteration standard that makes a dietary supplement adulterated if it "presents a significant or unreasonable risk of illness or injury" under indicated conditions of use;"

(3) race to market provisions that effectively bar ingredients that were first utilized in drugs from being marketed as dietary supplements;12

(4) stringent Good Manufacturing Practices ("GMPs") intended to ensure high standards of manufacturing;13 and

(5) the NDI section.14

Congress intended the NDI section of DSHEA to ensure that there was an opportunity for FDA to review the safety of new dietary supplement ingredients that had not previously been on the market while keeping the level of premarket scrutiny below that required for a drug or a food additive.15 The definitional section of the statute, 21 U.S.C. § 321(ff)(1), serves a different purpose. It was drafted broadly so as to encompass the entire range of dietary ingredients that had been available as dietary supplements prior to DSHEA.16 Importantly, Congress did not intend the 21 U.S.C. § 321(ff)(1) definition as an element of the statute directed at safety.17

Attempts to use the 21 U.S.C. § 321(ff)(1) definition of "dietary supplement" as a bar to further consideration of dietary ingredients that are the subject of safety reviews under the NDI section are misguided. Indeed, merging the 21 U.S.C. § 321(ff)(1) definition of dietary supplement into the NDI section reflects a selective reading of the dietary supplement definition. The definitional section of the statute not only lists a range of possible dietary ingredients, but also specifies dietary supplement form and labeling requirements and states that a dietary supplement cannot contain ingredients that were the subject of new drug approvals or that are articles authorized as investigational new drugs, antibiotics, or biologies.18 Moreover, Congress intended the 21 U.S.C. § 321(ff)(1) dietary supplement definition to be expansive, effectively opening the dietary supplement category to a very broad range of potential ingredients. …

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