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HR7050119th CongressWALLET

Homeopathic Drug Product Safety, Quality, and Transparency Act

Sponsored By: Representative Sessions, Pete [R-TX-17]

Introduced

Summary

This bill would create a distinct regulatory pathway for homeopathic drug products and set rules on safety, quality, labeling, and oversight while preserving state authority over the practice of homeopathy.

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  • Consumers and families would see clearer product information. Labels must state homeopathic status, include a mandatory adjacent disclaimer that the product's indications have not been evaluated by FDA, and show the source for each indication or link via QR code.
  • Manufacturers would face a tailored quality regime. The bill allows recognized homeopathic standards to govern adulteration and quality or a new homeopathy-specific good manufacturing practice. It bars premarket approval and creates a petition process with a 60-day advisory review and a 180-day decision clock that can lead to deemed approval.
  • Regulators and practitioners would get a dedicated advisory body and trained inspectors. A 10-member Homeopathic Drug Product Advisory Committee would advise on standards, meet quarterly, and review adverse event reports while inspectors must be knowledgeable about homeopathic standards.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

New rules for homeopathic products

If enacted, this bill would create a new, separate regulatory path for homeopathic drug products under the FDA law. It would bar FDA from requiring premarket approval for these products and would exempt finished homeopathic products from the usual identity-and-strength lab test while still requiring testing for contaminants. Manufacturers would have to follow HPUS or other recognized homeopathic standards or new homeopathic-specific good manufacturing practices the Secretary would develop after public comment. Makers could petition for exemptions or alternative standards; an advisory committee would report in 60 days and the Secretary would have 180 days to decide or the petition would be deemed approved. The Secretary would also be able to set and publish "safe levels" for risky starting materials in the Federal Register.

Sponsors & CoSponsors

Sponsor

Sessions, Pete [R-TX-17]

TX • R

Cosponsors

  • Rep. Kennedy, Mike [R-UT-3]

    UT • R

    Sponsored 1/14/2026

  • Rep. Jackson, Jonathan L. [D-IL-1]

    IL • D

    Sponsored 1/14/2026

  • Rep. Owens, Burgess [R-UT-4]

    UT • R

    Sponsored 4/21/2026

  • Rep. Mills, Cory [R-FL-7]

    FL • R

    Sponsored 5/20/2026

  • Rep. Gosar, Paul A. [R-AZ-9]

    AZ • R

    Sponsored 7/20/2026

  • Rep. Cloud, Michael [R-TX-27]

    TX • R

    Sponsored 7/20/2026

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
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