Homeopathic Drug Product Safety, Quality, and Transparency Act
Sponsored By: Senator Tuberville, Tommy [R-AL]
Introduced
Summary
Creates a dedicated federal regulatory category for homeopathic drug products. The bill would set tailored manufacturing, labeling, and safety rules for homeopathic products rather than forcing them through standard drug premarket approval pathways.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
4 provisions identified: 1 benefits, 0 costs, 3 mixed.
Testing and safety rules for homeopathics
If enacted, the bill would exempt finished homeopathic products from the federal lab test that separately verifies identity and strength of each active ingredient. Makers would still have to meet other final specifications, including tests for contaminants and defects. The bill would also require manufacturers using risky starting materials to document that any intermediate preparation stays at a 'safe level' set by recognized standards or below analytically detectable amounts.
Labels and claims rules for homeopathics
If enacted, retail homeopathic products would need to list intended uses for self-limiting conditions and carry the statement that those uses "have not been evaluated by the Food and Drug Administration" and are for traditional homeopathic uses. Any condition-specific claim would have to start with "Traditionally used for," and claims must be supported by competent and reliable evidence appropriate to the product. The bill would treat other products that label themselves 'homeopathic' as misbranded unless they follow the Act. Products that follow these labeling and claim rules would get limited protection from FTC false-advertising treatment under the bill.
New rules for homeopathic products
If enacted, the bill would create a distinct statutory pathway for homeopathic drug products and define what counts as a homeopathic ingredient. It would say homeopathic drugs are not subject to the usual FDA premarket approval and would remove current FDA guidance. The bill would also exclude homeopathic drugs from the biologics definition and require the Secretary to issue homeopathic-specific manufacturing and labeling rules within three years. The Secretary would set up a balanced Homeopathic Drug Product Advisory Committee and must respond in writing to major committee recommendations; the committee would end seven years after creation.
More safety reports for homeopathics
If enacted, the bill would add homeopathic drug products to the serious adverse event reporting rules. Manufacturers would need to report serious health events for homeopathic products the same way they do for other drugs. This would strengthen postmarket safety monitoring for consumers.
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