No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7050 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 7050
To amend the Federal Food, Drug, and Cosmetic Act with respect to
homeopathic drug products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 14, 2026
Mr. Sessions (for himself, Mr. Kennedy of Utah, and Mr. Jackson of
Illinois) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
homeopathic drug products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Homeopathic Drug
Product Safety, Quality, and Transparency Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Purpose; sense of Congress.
Sec. 3. Definitions.
Sec. 4. Safety, quality, and transparency requirements for homeopathic
drug products.
Sec. 5. Conforming amendments.
Sec. 6. Withdrawal of guidance.
Sec. 7. Severability.
SEC. 2. PURPOSE; SENSE OF CONGRESS.
(a) Purpose.--The purpose of this Act is to address consumer and
practitioner needs for continued access to homeopathic drug products
that meet requirements for safety, quality, and transparency.
(b) Sense of Congress.--It is the sense of Congress that--
(1) homeopathic medicines are important to millions of
American consumers, and continued consumer access to safe
homeopathic products is best ensured by enacting a distinct
statutory pathway for the regulation of homeopathic drug
products; and
(2) while the Federal Government should continue to take
appropriate action against products that are adulterated or
misbranded, Federal agencies should not impose regulatory
barriers that unreasonably limit or prevent consumer and health
care provider access to safe products and accurate information.
SEC. 3. DEFINITIONS.
Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321) is amended--
(1) in paragraph (p), by striking ``except a new animal
drug or an animal feed bearing or containing a new animal
drug'' each place it appears and inserting ``except a new
animal drug, an animal feed bearing or containing a new animal
drug, or a homeopathic drug product'';
(2) in paragraph (v), by inserting before the period at the
end the following: ``, and that a homeopathic drug product is
not a new animal drug''; and
(3) by adding at the end the following:
``(tt) The term `homeopathic drug product' means a drug that--
``(1) contains 1 or more homeopathic ingredients; and
``(2) contains no other active ingredient.
``(uu) The term `homeopathic ingredient' means an ingredient--
``(1) listed in the Homeopathic Pharmacopoeia of the United
States or a State homeopathic formulary; or
``(2) prepared pursuant to homeopathic safety and quality
standards described in--
``(A) the Homeopathic Pharmacopoeia of the United
States or any other officially recognized homeopathic
pharmacopoeia; or
``(B) any accredited voluntary consensus standard
for homeopathic drug products, as determined by the
Secretary in compliance with section 12(d) of the
National Technology Transfer and Advancement Act of
1995.''.
SEC. 4. SAFETY, QUALITY, AND TRANSPARENCY REQUIREMENTS FOR HOMEOPATHIC
DRUG PRODUCTS.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503D
(21 U.S.C. 353d) the following:
``SEC. 503E. HOMEOPATHIC DRUG PRODUCTS.
``(a) Provisions Applicable to Homeopathic Drug Products.--
``(1) Chapter v provisions.--No section of this chapter
shall apply to homeopathic drug products except this section
and sections 501, 502, and 510.
``(2) Requirements for all provisions.--No provision of
law, a regulation, or a guidance document (including sections
501, 502, and 510 and any applicable provisions of this Act
outside of this chapter) shall apply to homeopathic drug
products unless such provision--
``(A) does not conflict with this section; and
``(B) does not impose standards that are in
conflict with standards in the Homeopathic
Pharmacopoeia of the United States or in an accredited
voluntary consensus standard for homeopathic drug
products, as determined by the Secretary in compliance
with section 12(d) of the National Technology Transfer
and Advancement Act of 1995.
``(b) Adulteration; Good Manufacturing Practice Standards.--
``(1) Adulteration.--A homeopathic drug product shall be
deemed to be adulterated if it does not comply with--
``(A) the safety and quality standards and
manufacturing practices described in--
``(i) the Homeopathic Pharmacopoeia of the
United States or any other officially
recognized homeopathic pharmacopoeia; or
``(ii) an accredited voluntary consensus
standard for homeopathic drug products, as
determined by the Secretary in compliance with
section 12(d) of the National Technology
Transfer and Advancement Act of 1995; or
``(B) in the case that no standard or manufacturing
practice described in subparagraph (A) applies to such
homeopathic drug product, the regulations described in
paragraph (2).
``(2) Alternative regulations.--The regulations described
in this paragraph are the following:
``(A) Good manufacturing practice regulations
promulgated under section 501(a)(2) or related guidance
documents, provided that such regulations or related
guidance documents do not conflict with any other
provision of this section.
``(B) In the case that no regulation described in
subparagraph (A) applies to the homeopathic drug
product, a new good manufacturing practice regulation,
which shall be promulgated by the Secretary after
notice and opportunity for public comment pursuant to
chapter 5 of title 5, United States Code--
``(i) that does not conflict with any other
provision of this section;
``(ii) that is specific to and appropriate
for homeopathic drug products; and
``(iii) with respect to which the Secretary
has requested and received a favorable
recommendation from the Homeopathic Drug
Product Advisory Committee.
``(3) Petition for exemption, variance, or alternative
standard or practice.--
``(A) Petition.--A manufacturer of a homeopathic
drug product subject to a good manufacturing practice
regulation may submit to the Secretary a petition for
an exemption, variance, or alternative standard or
practice with respect to such product. The Secretary
shall refer such petition to the Homeopathic Drug
Product Advisory Committee, which shall report its
recommendation to the Secretary not later than 60 days
after receiving such petition.
``(B) Deadline for approval.--The Secretary shall
make a decision on a petition submitted under
subparagraph (A) not later than 180 days after the
submission of the petition. If the Secretary fails to
make a decision on such a petition within such 180-day
period, the petition shall be deemed approved and the
proposed exemption, variance, or alternative standard
or practice established.
``(C) Standard for approval.--The Secretary may
approve a petition submitted under subparagraph (A) and
establish the proposed exemption, variance, or
alternative standard or practice with respect to the
homeopathic drug product only if such exemption,
variance, or alternative standard or practice does not
affect the safety of the homeopathic drug product.
``(D) Judicial review.--For the purposes of chapter
7 of title 5, United States Code, a decision of the
Secretary on a petition submitted under subparagraph
(A) shall be considered final agency action.
``(4) Final and intermediate product testing.--
``(A) Final product testing.--A finished
homeopathic drug product shall be exempt from the
requirement for a laboratory determination of identity
and strength of each active ingredient described in
section 211.165(a) of title 21, Code of Federal
Regulations (or any successor regulation), but shall
continue to be required to meet other final
specifications, such as testing for contaminants and
defects of the finished product, consistent with this
section.
``(B) Intermediate testing for certain starting
materials.--
``(i) In general.--The manufacturer of a
homeopathic drug product made from a starting
material containing a substance which may
present a substantial risk of illness or injury
in its undiluted form shall ensure and document
that the amount of such substance in an
intermediate level preparation used to make all
further attenuations does not exceed a safe
level, as determined by the Secretary under
this subparagraph.
``(ii) Safe level defined.--In this
subparagraph, the term `safe level' means--
``(I) a level set by nationally
recognized standards for safety,
including the Homeopathic Pharmacopoeia
of the United States or an accredited
voluntary consensus standard for
homeopathic drug products, as
determined by the Secretary in
compliance with section 12(d) of the
National Technology Transfer and
Advancement Act of 1995; or
``(II) in the absence of a standard
described in subclause (I), a level
below an analytically detectable
presence.
``(iii) Publication of safe levels.--The
Secretary may issue an order, notice of which
shall be published in the Federal Register,
establishing a safe level, based on appropriate
scientific and technical data, for a substance
under clause (i). Such notice shall include--
``(I) a statement of the basis for
the Secretary's finding that there is a
reasonable probability that the
substance may present a substantial
risk of illness or injury in its
undiluted form;
``(II) a statement of the basis for
the establishment of the safe level,
including any available methods to
establish such level; and
``(III) a request for public
comments.
``(c) Misbranding.--
``(1) In general.--A drug shall be deemed to be misbranded
if--
``(A) it is not a homeopathic drug product, and its
labeling bears the term `homeopathic', `homeopathy',
`homeopath', or such similar term as determined by the
Secretary; or
``(B) it is a homeopathic drug product, and its
labeling does not comply with the requirements
described in paragraph (2).
``(2) Labeling requirements.--With respect to the labeling
of a homeopathic drug product, the requirements described in
this paragraph are the requirements for the labeling of a drug
under this Act, subject to the following:
``(A) The labeling need not adhere to any
requirement that does not apply to homeopathic drug
products under subsection (a).
``(B) The dosage units of the homeopathic
ingredients shall be expressed as attenuations
particular to homeopathic ingredients (such as `3x' or
`6c').
``(C) If the homeopathic drug product is not
intended for retail sale, the label of such product
need not contain a purpose or indication for use.
``(D) If the homeopathic drug product is intended
for retail sale, the label of such product shall
contain--
``(i) 1 or more purposes or indications for
use for self-limiting conditions that are
supported by--
``(I) the Homeopathic Pharmacopoeia
of the United States, an official
pharmacopeia of another country where
the practice of homeopathy is licensed
or certified, or an accredited
voluntary consensus standard for
homeopathic drug products, as
determined by the Secretary in
compliance with section 12(d) of the
National Technology Transfer and
Advancement Act of 1995;
``(II) a traditional homeopathic
reference, including a homeopathic
Materia Medica in general use by
licensed medical practitioners who
practice homeopathy or certified
homeopaths in the United States or
another country;
``(III) a peer-reviewed medical
journal, including any homeopathic
medical journal;
``(IV) citation to scientific
evidence, including clinical data or
trials;
``(V) beneficial clinical usage
documented by clinical reports from
national or international
organizations, professionally
recognized publications of clinical
indications and contraindications,
national or international instructional
courses providing training in the use
of homeopathic drug products, or
professional peer review presentations
of physicians' usage results with
homeopathic drug products at local,
county, State, national, or
international meetings; or
``(VI) quality real-world data that
provides sufficient evidence to support
such purposes or indications for use;
and
``(ii) adjacent to such purposes or
indications for use, the following statement:
`These indications have not been evaluated by
the Food and Drug Administration. This product
is intended for traditional homeopathic uses.'.
``(E) The labeling shall not be considered false or
misleading for the purposes of section 502(a)(1) due to
the inclusion of a purpose or indication for use that
is supported by any source described in subclauses (I)
through (VI) of subparagraph (D)(i).
``(F)(i) Subject to clause (ii), the label shall
describe--
``(I) the source relied upon for each
purpose or indication for use under
subparagraph (D)(i); and
``(II) if applicable, the name and place of
business of any parent, subsidiary, or
affiliate company of the manufacturer of the
homeopathic drug product, if under common
ownership or control.
``(ii) If the label has insufficient space for the
information required by clause (i), in lieu of such
information the label may contain a quick response code
(commonly known as a `QR code') or similar mechanism
that links to a publicly accessible website containing
such information.
``(3) Application of other misbranding-related
provisions.--
``(A) FTC act.--Labeling or marketing claims
associated with a homeopathic drug product that are in
compliance with this subsection may not be considered a
false advertisement or an unfair or deceptive act or
practice in or affecting commerce for purposes of
section 5 or 12 of the Federal Trade Commission Act.
``(B) Other provisions of federal or state law.--If
a homeopathic drug product's label, labeling,
advertising, and marketing materials are in compliance
with this subsection, no other substantiation
requirement in Federal or State law shall apply to such
product.
``(C) Private rights of action.--No private right
of action for false or deceptive advertising may be
predicated on the lack of clinical trials to
substantiate indications for a homeopathic drug
product.
``(d) Registration and Listing.--For purposes of drug establishment
registration and drug listing under section 510, the Secretary shall--
``(1) designate a homeopathic drug product establishment as
a `homeopathic' establishment; and
``(2) list a homeopathic drug product as `homeopathic',
with no other designation.
``(e) No Premarket Approval.--The Secretary may not require
premarket approval of a homeopathic drug product.
``(f) Homeopathic Drug Product Advisory Committee.--
``(1) Establishment.--The Secretary shall establish a
Homeopathic Drug Product Advisory Committee (in this subsection
referred to as the `Committee') to advise the Secretary on the
regulation of homeopathic drug products.
``(2) Membership.--
``(A) In general.--Subject to subparagraph (B), the
Committee shall be composed of 10 members, to be
appointed by the Secretary, as follows:
``(i) 1 representative from an organization
of homeopathic product consumers that has been
operating for a minimum of 3 continuous years
with a minimum of 10,000 members, who shall
serve as the Chair of the Committee.
``(ii) 1 representative from a domestic
homeopathic drug manufacturer that produces at
least 50 distinct homeopathic drug products and
has no fewer than 50 employees.
``(iii) 1 representative from a domestic
homeopathic drug manufacturer that produces at
least 50 distinct homeopathic drug products and
has no more than 50 employees.
``(iv) 1 representative from the
Homeopathic Pharmacopoeia Convention of the
United States.
``(v) 1 representative from an accredited
voluntary consensus standards body for
homeopathic drug products that has been
operating for a minimum of 3 continuous years.
``(vi) 1 licensed medical doctor (M.D.) or
doctor of osteopathy (D.O.) who holds a
Diplomate, American Board of Homeopathic
Medicine (DABHM) or Diplomate,
Homeotherapeutics (DHt) and who maintains a
homeopathic practice that has been in operation
for a minimum of 3 continuous years.
``(vii) 1 licensed naturopathic doctor
(N.D.) who holds a Diplomate, American Board of
Homeopathic Medicine (DABHM) or Diplomate,
Homeopathic Academy of Naturopathic Physicians
(DHANP) and who maintains a homeopathic
practice that has been in operation for a
minimum of 3 continuous years.
``(viii) 1 licensed pharmacist or chemist
actively engaged in the preparation of
homeopathic drug products for a minimum of 3
continuous years.
``(ix) 1 licensed veterinarian certified by
the Academy of Veterinary Homeopathy or
accredited by a recognized homeopathy
institution who maintains a practice that has
been in operation for a minimum of 3 continuous
years.
``(x) The Commissioner of Food and Drugs.
``(B) Alternative members.--If the Secretary is
unable to find a suitable individual to serve in the
position of a representative described in clauses (i)
through (ix), the other members of the Committee may
appoint to such position, by majority vote, such other
expert in the field of homeopathic drug products as the
Committee determines appropriate.
``(C) Balance of membership.--In making
appointments under subparagraph (A), the Secretary
shall ensure that the membership of the Committee
reflects a proper balance of perspectives from the
homeopathic practitioner, manufacturer, and consumer
communities.
``(D) No compensation.--The members of the
Committee shall serve without compensation.
``(3) Frequency of sessions.--The Secretary shall call the
Committee into session at such times and in such places as the
Secretary determines appropriate, but in no case less
frequently than once every 3 months.
``(4) Investigations.--The Committee may investigate any
report of a homeopathic drug product to the FDA Adverse Event
Reporting System to assist in post-market surveillance.
``(5) Termination.--Section 1013 of chapter 5, United
States Code (relating to termination of advisory committees),
shall not apply to the Committee.
``(g) Inspectors.--All Federal inspectors whose duties or
authorities extend to homeopathic drug products shall be familiar with
the requirements of this section, including the safety and quality
manufacturing standards in the Homeopathic Pharmacopoeia of the United
States or an accredited voluntary consensus standard for homeopathic
drug products.
``(h) Non-Preemption of State Law on Practice of Homeopathy.--
Nothing in this section shall be construed to preempt, limit, or
interfere with State jurisdiction concerning the practice of homeopathy
and related activities within the scope of the health care
professional-patient relationship.
``(i) Burden of Proof.--The United States shall bear the burden of
proof to establish a violation of this section. Any Federal court with
jurisdiction shall decide any matter under this section on a de novo
basis.''.
SEC. 5. CONFORMING AMENDMENTS.
(a) Pharmaceutical Distribution Supply Chain.--Section 581(13) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee(13)) is
amended by striking ``homeopathic drugs marketed in accordance with
applicable guidance under this Act'' and inserting ``homeopathic drug
products marketed in accordance with this Act''.
(b) Serious Adverse Event Reporting for Nonprescription Drugs.--
Section 760(a)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379aa(a)(2)) is amended to read as follows:
``(2) Nonprescription drug.--The term nonprescription
drug--
``(A) means a drug that is--
``(i) not subject to section 503(b); and
``(ii) not subject to approval in an
application submitted under section 505; and
``(B) includes a homeopathic drug product.''.
(c) Exemption From Regulation of Biological Products.--Section
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is
amended by adding at the end the following: ``Such term does not
include a homeopathic drug product (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act).''.
SEC. 6. WITHDRAWAL OF GUIDANCE.
The guidance of the Food and Drug Administration titled
``Homeopathic Drug Products; Guidance for Food and Drug Administration
Staff and Industry; Availability'' (87 Fed. Reg. 75054; published on
December 7, 2022) shall have no force or effect with respect to
homeopathic drug products (as defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321), as amended by section
3(3)).
SEC. 7. SEVERABILITY.
If any provision of this Act (including the amendments made by this
Act) is declared unconstitutional, or the applicability of this Act
(including the amendments made by this Act) to any person or
circumstance is held invalid, the constitutionality of the remainder of
this Act (including the amendments made by this Act) and the
applicability thereof to other persons and circumstances shall not be
affected.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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