Proposed legislation that would amend the drug preclusion provision in the Dietary Supplement Health Education Act of 1994 (DSHEA) has caused quite a buzz in dietary supplement industry groups. DSHEA is in need of at least a revamp since technological advances have rendered the thoughtful language from the early 1990’s somewhat unworkable. Industry and regulators have very different views about the meaning of that language and now, more than thirty years since enaction of the law, innovation in the dietary supplement industry has been throttled. In response, Congresswoman Diana Harshbarger introduced The Dietary Supplement Innovation Act on September 10, 2026.
DSHEA amended the Food Drug and Cosmetic Act (FDCA) and provided the dietary supplement regulatory pathway that led to the $60-plus billion dollar U.S. industry that we know today. DSHEA defined dietary supplements in part by stating that supplements could not include drugs. The language in Section 201(ff)(3)(B) of the FDCA is worth a review. 201(ff) tells us what dietary ingredients and supplements are, and then, 201(ff)(3)(B) states:
and
(B) not include—
(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 8, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act (Emphasis added).
The proposed Dietary Supplement Innovation Act specifies that “substantial clinical investigations” means “Phase 2 or Phase 3 clinical investigations.” This language would prevent pharmaceutical companies from blocking commercialization of, let’s say botanical constituent, as a dietary supplement by initiating early phase studies.
Congresswoman Harshbarger’s legislation would also add a provision to allow some substances that have been studied in Phase 2 or Phase 3 clinical investigations to become dietary ingredients if, “each Phase 2 or Phase 3 clinical investigation referred to in the matter preceding subparagraph has been on inactive status, withdrawn, or both for a continuous period of at least seven years, or the sponsor has publicly announced discontinuation of drug development activities.” In other words, if the ingredient is not actively being studied as a drug, the opportunity to develop it as a dietary supplement is renewed.
Further interesting language in the proposed legislation addresses controversies regarding N-acetyl cysteine, which was used as an intravenous drug at doses different from those sold for oral ingestion as a dietary supplement. Specifically, the bill includes “Standards of Evaluation” for determining whether a drug was added to food or dietary supplements that include consideration of any difference between the substance used as a drug and the substance when added to a food or supplement. The listed standards to consider are:
(1) route of administration;
(2) recommended dosage and serving amount;
(3) concentration or composition; or
(4) the degree of safety of the substance when added to— (A) a food; or (B) a dietary supplement
Further, any FDA warning letter or response to a new dietary ingredient notification that an ingredient is considered a drug and precluded from being used in dietary supplements would be immediately reviewable by the courts. Further, the United States (and not industry) would have the burden of proof to show that introduction of the ingredient (in a dietary supplement) would violate the FD&C Act.
The legislation that became the Dietary Supplement Health Education Act resulted from a public letter-writing campaign. Congresswoman Harshbarger’s Dietary Supplement Innovation Act would likely benefit from a few thousand letters as well.
