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Homeopathic Drug Product Safety, Quality, and Transparency Act

USA119th CongressS-4692| Senate 
| Updated: 6/4/2026
Tommy Tuberville

Tommy Tuberville

Republican Senator

Alabama

Cosponsors (1)
Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Homeopathic Drug Product Safety, Quality, and Transparency Act" establishes a comprehensive statutory framework for regulating homeopathic drug products under the Federal Food, Drug, and Cosmetic Act. It defines a homeopathic drug product as one containing only homeopathic ingredients, which are listed in recognized pharmacopoeias or prepared using specific homeopathic methods. Crucially, the bill exempts these products from the premarket approval requirements of section 505 of the FFDCA, treating them as a distinct category with appropriate regulatory oversight. The legislation mandates the Secretary of Health and Human Services to issue a final rule within three years, establishing current good manufacturing practices (CGMPs) and labeling requirements tailored to homeopathic products. These rules must be appropriate, consistent with established standards, and avoid requiring analytical methodologies that are not currently available. While exempting finished products from certain active ingredient identity and strength testing, the bill requires testing for contaminants and defects, and for intermediate preparations of high-risk starting materials to ensure they do not exceed a safe level. For labeling, retail homeopathic products must state intended uses for self-limiting conditions and include a disclaimer that the uses have not been evaluated by the FDA. Claims must be supported by competent evidence, including traditional homeopathic principles and real-world evidence, and be preceded by "Traditionally used for." The bill also establishes a Homeopathic Drug Product Advisory Committee to provide recommendations on safety, quality, and labeling standards, and to advise on regulatory approaches, with the Secretary required to consult the committee on significant regulatory actions.
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Timeline
Jan 14, 2026

Latest Companion Bill Action

HR 119-7050
Introduced in House
Jun 4, 2026
Introduced in Senate
Jun 4, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 14, 2026

    Latest Companion Bill Action

    HR 119-7050
    Introduced in House


  • June 4, 2026
    Introduced in Senate


  • June 4, 2026
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Homeopathic Drug Product Safety, Quality, and Transparency Act

USA119th CongressS-4692| Senate 
| Updated: 6/4/2026
The "Homeopathic Drug Product Safety, Quality, and Transparency Act" establishes a comprehensive statutory framework for regulating homeopathic drug products under the Federal Food, Drug, and Cosmetic Act. It defines a homeopathic drug product as one containing only homeopathic ingredients, which are listed in recognized pharmacopoeias or prepared using specific homeopathic methods. Crucially, the bill exempts these products from the premarket approval requirements of section 505 of the FFDCA, treating them as a distinct category with appropriate regulatory oversight. The legislation mandates the Secretary of Health and Human Services to issue a final rule within three years, establishing current good manufacturing practices (CGMPs) and labeling requirements tailored to homeopathic products. These rules must be appropriate, consistent with established standards, and avoid requiring analytical methodologies that are not currently available. While exempting finished products from certain active ingredient identity and strength testing, the bill requires testing for contaminants and defects, and for intermediate preparations of high-risk starting materials to ensure they do not exceed a safe level. For labeling, retail homeopathic products must state intended uses for self-limiting conditions and include a disclaimer that the uses have not been evaluated by the FDA. Claims must be supported by competent evidence, including traditional homeopathic principles and real-world evidence, and be preceded by "Traditionally used for." The bill also establishes a Homeopathic Drug Product Advisory Committee to provide recommendations on safety, quality, and labeling standards, and to advise on regulatory approaches, with the Secretary required to consult the committee on significant regulatory actions.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 14, 2026

Latest Companion Bill Action

HR 119-7050
Introduced in House
Jun 4, 2026
Introduced in Senate
Jun 4, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 14, 2026

    Latest Companion Bill Action

    HR 119-7050
    Introduced in House


  • June 4, 2026
    Introduced in Senate


  • June 4, 2026
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Tommy Tuberville

Tommy Tuberville

Republican Senator

Alabama

Cosponsors (1)
Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted