Homeopathic Drug Product Safety, Quality, and Transparency Act
Sponsored By: Senator Tuberville, Tommy [R-AL]
Introduced
Summary
This bill would create a distinct FDA regulatory category for homeopathic drug products and set tailored safety, labeling, and manufacturing rules that reflect traditional preparation methods and risk profiles.
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- Consumers: Retail homeopathic products would need at least one stated intended use for a self-limiting condition and must carry a notice that uses have not been evaluated by the FDA. Claims about specific conditions must be preceded by "Traditionally used for," and claims must be supported by evidence appropriate to the product's nature and risk.
- Manufacturers and suppliers: Homeopathic products would be governed by a new Sec. 503E and only by select drug provisions (Secs. 501, 502, 510). They would not require an approved application under Sec. 505. The Secretary must issue a final rule on current good manufacturing practices and labeling within 3 years and allow certain final-product testing exemptions while requiring contaminant testing and documented safety checks for risky starting materials.
- FDA oversight and market rules: The bill would create a Homeopathic Drug Product Advisory Committee to advise the Secretary and require consultation on rulemaking. The Committee would terminate 7 years after establishment. The FDA guidance issued in 2022 on homeopathic drug products would have no force or effect.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 0 benefits, 0 costs, 4 mixed.
Homeopathy advisory committee for FDA
If enacted, the Secretary would set up a Homeopathic Drug Product Advisory Committee. The committee would include practitioners (with at least three years of homeopathic practice), large and small manufacturers, educators, and consumer or standards groups. The Secretary must consult the committee on guidance, rulemaking, GMP changes, and enforcement, and include written responses to major recommendations. The committee would end seven years after it is established.
New rules for homeopathic drugs
If enacted, the bill would create a new legal category called "homeopathic drug products." The Secretary would write product-specific cGMP and labeling rules within 3 years. Homeopathic products would not need FDA approval under section 505, but finished products would still face contaminant and defect testing and some lab identity rules would be relaxed. Retail labels would list intended uses for self-limiting conditions and condition claims would begin with "Traditionally used for."
Stricter labeling and safety reporting
If enacted, products that are cosmetics, dietary supplements, or non-homeopathic drugs could not use "homeopathic" terms on their labels unless they meet the new homeopathic drug product definition. The bill would expand serious adverse event reporting to cover homeopathic drug products like nonprescription drugs. Manufacturers and distributors would need to report serious events and keep the same postmarket surveillance duties. These changes aim to reduce misleading labels and improve safety data, while adding reporting duties for sellers.
Legal changes for homeopathic products
If enacted, the bill would say homeopathic drug products are not "biological products" under the Public Health Service Act. It would change supply-chain language to refer to products marketed under the Act rather than guidance. The bill would also state that a named 2022 FDA guidance on homeopathic products has no force or effect. These changes shift legal pathways and references for industry, while removing an existing guidance document.
Sponsors & CoSponsors
Sponsor
Tuberville, Tommy [R-AL]
AL • R
Cosponsors
Sen. Lee, Mike [R-UT]
UT • R
Sponsored 6/4/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov