Bill
HR 7050
Creates a dedicated safety, quality, and transparency framework for homeopathic drug products with tailored standards, labeling, and an advisory committee.
Date introduced: January 14, 2026
Jurisdiction: United States federal statute; House of Representatives
Proposed short title: Homeopathic Drug Product Safety, Quality, and Transparency Act
Primary sponsors: Rep. Pete Sessions; co-sponsors include Rep. Mike Kennedy, Rep. Burgess Owens, Rep. Jonathan Jackson
Purpose and intent
- Establish a distinct regulatory pathway for homeopathic drug products within the Federal Food, Drug, and Cosmetic Act (FD&C Act) to ensure safety, quality, and consumer transparency while preserving access to homeopathic products.
- Reiterate a policy preference that federal action against adulterated or misbranded products should not unduly restrict access to safe homeopathic medicines or information.
Key provisions and changes
1) Definitions (FD&C Act, new terms)
- Defines “homeopathic drug product” as a drug that (a) contains one or more homeopathic ingredients, and (b) contains no other active ingredient.
- Defines “homeopathic ingredient” as:
- An ingredient listed in the Homeopathic Pharmacopoeia of the United States (HPUS) or a state homeopathic formulary; or
- Prepared according to homeopathic safety and quality standards described in HPUS or an accredited voluntary consensus standard, as determined by the Secretary under NTTA 1995 (Public Law 104-113) section 12(d).
2) Safety, quality, and transparency requirements for homeopathic drug products
- Creates a dedicated Section 503E for homeopathic drug products with:
- Limited applicability of FD&C Act provisions: only Sections 501, 502, and 510 (and this new section) apply to homeopathic products; other provisions do not apply unless consistent with this section.
- Adulteration standards: a homeopathic product is adulterated if it does not meet:
- Safety/quality standards and manufacturing practices from HPUS or accredited voluntary consensus standards, or
- If no such standard applies, the new manufacturing practice (GMP) regulations tailored for homeopathic products (to be issued after notice-and-comment) or other applicable standards that do not conflict with this section.
- Interim and alternative GMPs:
- If no HPUS/consensus standard applies, the Secretary may adopt new homeopathic GMPs, following public comment, with a requirement that the Homeopathic Drug Product Advisory Committee recommend.
- Petitions for exemptions/variances: Manufacturers may petition for exemptions or alternatives; the Homeopathic Drug Product Advisory Committee must report within 60 days; the Secretary must decide within 180 days (failure to decide results in deemed approval).
- Final and intermediate product testing:
- Final product testing: Exemption from identity/strength testing of each active ingredient in accordance with 21 CFR 211.165, but continued testing for contaminants and defects.
- Intermediate testing for starting materials: For starting materials that could pose substantial risk in undiluted form, manufacturers must ensure and document that the amount in intermediate preparations does not exceed a safe level, defined by:
- Nationally recognized safety standards (HPUS or accredited consensus standards) or
- If no standard, below analytically detectable limits.
- The Secretary may publish safe levels via Federal Register with rationale and seek public comment.
- Misbranding and labeling:
- A drug must be labeled as homeopathic only if it is a homeopathic drug product; otherwise, misbranding rules apply.
- Labeling requirements for retail and non-retail products, including:
- Dosage units expressed as attenuations (e.g., 3x, 6c) for homeopathic ingredients.
- If retail, required purposes/indications for self-limiting conditions supported by HPUS, recognized homeopathic pharmacopeias of other countries, accredited consensus standards, traditional homeopathic references, peer-reviewed medical journals, clinical data or trials, or credible real-world data.
- Indications must be accompanied by a statement clarifying that these indications have not been evaluated by the FDA and are traditional homeopathic uses.
- Label must disclose the source relied upon for each indication and, if space is limited, may link to a publicly accessible website or QR code.
- Descriptions of sources and ownership (parent/subsidiary information) may be included; if space is insufficient, a QR code linking to such information is permissible.
- Marketing and advertising: Compliance with the labeling provisions for non-false or misleading advertising; other federal/state substantiation requirements do not apply beyond the new labeling framework.
- Private rights of action: No private right of action can be based on lack of clinical trials to substantiate homeopathic indications.
- Registration: Drug establishment registrations and listings must designate a homeopathic establishment and list the product as “homeopathic.”
3) Registration, listing, and premarket considerations
- Distinguishes homeopathic establishments and products in FDA drug establishment registration and drug listing as “homeopathic.”
- Explicitly states there shall be no premarket approval requirement for homeopathic drug products.
4) Homeopathic Drug Product Advisory Committee
- Establishes an advisory committee to assist the Secretary in regulating homeopathic drug products.
- Composition includes:
- A consumer representation from a longstanding homeopathic products consumer group (Chair).
- Domestic homeopathic manufacturers with significant product diversity and varying employee counts.
- Representatives from HPUS and accredited voluntary consensus standards bodies.
- Licensed medical doctors with relevant homeopathic board certifications, naturopathic doctors with appropriate credentials, a licensed pharmacist or chemist experienced in preparing homeopathic products, and a licensed veterinarian with homeopathic credentials.
- The FDA Commissioner (FDA’s involvement is explicit in committee makeup).
- Minimum chamber: 10 voting members. Additional flexible appointments allowed if suitable candidates cannot be found.
- Terms and operation:
- Members serve without compensation.
- Meetings required at least quarterly.
- Committee may investigate reports in the FDA Adverse Event Reporting System to support post-market surveillance.
- The committee’s existence is exempt from standard termination provisions for advisory committees.
5) Enforcement and inspectors
- Requires inspectors to be familiar with HPUS and recognized homeopathic standards.
6) Preemption and state law
- Non-preemption of state law governing the practice of homeopathy and related health care professional relationships; preserves state authority in practice.
7) Conforming amendments
- Related editorial changes to:
- Distribution supply chain provisions (Section 581(13)).
- Serious adverse event reporting for non-prescription drugs (Section 760(a)(2)) to include homeopathic products.
- Exemption from regulation of biological products (Public Health Service Act) to exclude homeopathic drug products.
8) Withdrawal of guidance
- Repeals FDA guidance (December 7, 2022) titled “Homeopathic Drug Products; Guidance for FDA Staff and Industry.”
9) Severability
- If any provision is unconstitutional, the remainder remains in effect.
Potential impact and considerations
Note: The bill is introductory and would require passage by both houses and the President to become law.
Compiled from official sources — confirm details with the bill’s official record.
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