Homeopathic Drug Product Safety, Quality, and Transparency Act
Sponsored By: Representative Sessions
Introduced
Summary
Creates a separate federal regulatory pathway for homeopathic drug products that aims to protect access while keeping FDA authority over unsafe or misbranded items. It would define "homeopathic drug product" and set special standards for labeling, manufacturing, registration, and oversight.
Your PRIA Score
Personalized for You
How does this bill affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this bill and every other piece of legislation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
Homeopathic manufacturing and labeling rules
If enacted, the bill would make a homeopathic product “adulterated” if it fails to meet HPUS or an accredited standard. Where no such standard exists, the bill would let FDA apply certain existing GMP rules or issue a new homeopathic GMP after notice, comment, and a favorable advisory-committee recommendation. Finished homeopathic products would be exempt from the specific lab identity/strength test in 21 C.F.R. 211.165(a), but other finished-product checks (for contaminants or defects) would still be required. Labels would have to show homeopathic attenuation (for example, 3x or 6c), list at least one purpose for self-limiting conditions, state that FDA has not evaluated the indication, and disclose the source for that indication or link to it by QR code. Conforming labels that follow these rules would not be treated as false advertising under certain federal rules, and the Secretary could not require premarket approval for homeopathic drugs.
New rules for homeopathic drugs
This bill would add a legal definition for “homeopathic drug product” and for “homeopathic ingredient.” It would say homeopathic drugs only count if they contain no other active ingredient and rely on the Homeopathic Pharmacopoeia or an approved standard. It would limit which Chapter V FD&C Act rules apply to homeopathic products to the new section plus sections 501, 502, and 510. It would also withdraw the FDA’s December 7, 2022 homeopathy guidance for products covered by the new definition.
Advisory panel, petitions, and review
The bill would create a 10-member Homeopathic Drug Product Advisory Committee to advise FDA and help with post-market work. The committee must meet at least quarterly and must report recommendations on petitions within 60 days. The Secretary would have 180 days to decide a petition or it would be deemed approved. The bill would also require the United States to bear the burden of proof in enforcement cases under the homeopathic rules and would direct courts to review those cases de novo.
Sponsors & CoSponsors
Sponsor
Sessions
TX • R
Cosponsors
Rep. Kennedy, Mike [R-UT-3]
UT • R
Sponsored 1/14/2026
Jackson (IL)
IL • D
Sponsored 1/14/2026
Rep. Owens, Burgess [R-UT-4]
UT • R
Sponsored 4/21/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov