[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5017 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 5017
To amend the Federal Food, Drug, and Cosmetic Act to treat as
misbranded cosmetics with packaging or labeling using the term
``natural'' unless the product meets certain standards, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 8, 2019
Mr. Sean Patrick Maloney of New York (for himself, Ms. Meng, and Ms.
Schakowsky) 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 to treat as
misbranded cosmetics with packaging or labeling using the term
``natural'' unless the product meets certain standards, 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.
This Act may be cited as the ``Natural Cosmetics Act''.
SEC. 2. COSMETICS WITH CERTAIN TERMS MISBRANDED.
(a) In General.--Section 602 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 362) is amended by adding at the end the
following:
``(g) If its packaging or labeling bears the term `natural'
unless--
``(1) if the term `natural' pertains to the cosmetic
overall, the cosmetic contains--
``(A) at least 70 percent natural substances (other
than water and salt);
``(B) no fragrance ingredient other than a natural
substance or naturally-derived ingredient; and
``(C) other than natural substances and water,
contains only naturally-derived ingredients except to
the extent a naturally-derived ingredient--
``(i) is not available for a specific
function; or
``(ii) is otherwise not feasible;
``(2) if the term `natural' pertains to one or more
ingredients in the cosmetic--
``(A) the ingredient statement identifies natural
ingredients individually with the terms `natural' or
`naturally-derived ingredient';
``(B) the listing of each such ingredient is
followed by a reference mark; and
``(C) the labeling contains the definition of such
terms below the ingredient statement; and
``(3) the cosmetic is not made using any of the following:
``(A) Alkoxylation (including ethoxylation and
propoxylation) using ethylene oxide, propylene oxide,
or other alkylene oxides.
``(B) Deterpenation (other than with steam).
``(C) Halogenation as the main reaction.
``(D) Ionizing radiation.
``(E) Sulphonation as the main reaction.
``(F) Treatment with ethylene oxide.
``(G) Treatment using mercury.''.
(b) Definitions.--Chapter VI of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 361 et seq.) is amended by adding at the end
the following:
``SEC. 604. DEFINITIONS.
``In this chapter:
``(1)(A) The term `natural' means any chemical substance
that is naturally occurring and which is--
``(i) unprocessed;
``(ii) processed only by manual, mechanical,
naturally derived solvent or gravitational means, by
dissolution in water or steam, by flotation, or by
heating solely to remove water; or
``(iii) extracted from air by any means.
``(B) Such term does not include petroleum and petroleum
derived ingredients.
``(2) The term `naturally-derived ingredient' means--
``(A) any substance where the starting material is
of mineral, plant, microbe, or animal origin but has
been chemically processed;
``(B) any substance where the starting material is
of mineral, plant, microbe, or animal origin but has
been chemically processed and combined with other
ingredients, excluding petroleum and fossil fuel-
derived ingredients; or
``(C) an ingredient that is derived from a plant
feedstock and bio-manufactured using processes like
fermentation, saponification, condensation, or
esterification in order to improve performance or make
the ingredient biodegradable or sustainable.''.
(c) Applicability.--Section 602(g) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies beginning on the date
that is 2 years after the date of enactment of this Act.
SEC. 3. RECALL AUTHORITY FOR MISBRANDED COSMETICS PURPORTING TO BE
``NATURAL''.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.), as amended by section 2, is further amended by adding at
the end the following:
``SEC. 605. RECORDKEEPING, NOTIFICATION, NONDISTRIBUTION, AND RECALL OF
MISBRANDED COSMETICS PURPORTING TO BE `NATURAL'.
``(a) Recordkeeping.--A manufacturer or distributer of a cosmetic
purporting to be natural within the meaning of section 602(g) shall--
``(1) maintain records--
``(A) verifying such claim; and
``(B)(i) demonstrating that each ingredient in the
cosmetic has been dated by the supplier of such
ingredient using carbon-14 testing; and
``(ii) including the results of such testing; and
``(2) make such records available to the Secretary for
inspection, request, or audit.
``(b) Notification of Misbranded Cosmetics.--
``(1) In general.--A responsible party that has reason to
believe that a cosmetic, when introduced into or while in
interstate commerce, or while held for sale (regardless of
whether such sale is the first sale of such cosmetic) after
shipment in interstate commerce, is misbranded under section
602(g) shall notify the Secretary of the identity and location
of the cosmetic.
``(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Secretary may require by regulation or guidance.
``(3) Responsible party defined.--For purposes of this
subsection, the term `responsible party' means a brand owner,
manufacturer, packager, retailer, or distributor of the
cosmetic.
``(c) Voluntary Recall.--The Secretary may request that any person
who distributes a cosmetic that the Secretary has reason to believe is
misbranded under section 602(g) voluntarily--
``(1) recall such cosmetic; and
``(2) provide for notice, including to individuals as
appropriate, to persons who may be affected by the recall.
``(d) Order To Cease Distribution.--
``(1) In general.--If the Secretary has reason to believe
that the cosmetic is misbranded under section 602(g), the
Secretary shall have the authority to issue an order requiring
any person who distributes such cosmetic to immediately cease
distribution of such cosmetic.
``(2) Cease distribution and notice.--Any person who is
subject to an order under paragraph (1) shall immediately cease
distribution of such cosmetic and provide notification as
required by such order.
``(3) Appeal.--
``(A) 48 hours.--A person subject to an order under
paragraph (1) may appeal such order to the Secretary
within 48 hours of the issuance of such order.
``(B) Contents of appeal.--Such appeal may include
a request for an informal hearing and a description of
any efforts to recall such cosmetic undertaken
voluntarily by the person, including after a request
under subsection (b).
``(C) Informal hearing.--An informal hearing shall
be held as soon as practicable, but not later than 5
calendar days (or less as determined by the Secretary)
after such an appeal is filed, unless the parties
jointly agree to an extension.
``(D) Impact on recall.--If an appeal is filed
under subparagraph (A), the Secretary may not amend the
order to require a recall under subsection (d) until
after the conclusion of the hearing under subparagraph
(C).
``(4) Vacation of order.--If the Secretary determines that
inadequate grounds exist to support the actions required by the
order under paragraph (1), the Secretary shall vacate the
order.
``(e) Notice to Consumers and Health Officials.--The Secretary
shall, as the Secretary determines to be necessary, provide public
notice of an order to cease distribution or recalling a misbranded
cosmetic under this section to all consumers in a prominent manner on
the website of the Food and Drug Administration and to appropriate
State and local health officials.
``(f) Supply Chain Information.--
``(1) In general.--In the case of a cosmetic that the
Secretary has reason to believe is misbranded under section
602(g), the Secretary shall request that the brand owner named
on the label of such cosmetic (as required under section
602(b)(1)) submit all of the following information:
``(A) The name and place of business of the
manufacturer, packager, supplier, or distributor from
which such entity received the cosmetic or ingredients
for manufacturing such cosmetic.
``(B) The name and place of business of any entity
(including any retailer) that was provided with such
cosmetic by the entity named on the label.
``(2) Collection of additional supply chain information.--
In the case of a cosmetic that the Secretary has reason to
believe is misbranded under section 602(g), to the extent
necessary to protect the safety of the public, the Secretary
may request that any entity (including a supplier of an
ingredient, manufacturer, packer, distributor, or retailer) in
the supply chain of such cosmetic submit to the Secretary
information that is similar to the information described under
subparagraphs (A) and (B) of paragraph (1).
``(3) Maintenance of records.--Any entity in the supply
chain of a cosmetic (including the brand owner named on the
label of a cosmetic) shall--
``(A) maintain records sufficient to provide the
information described in subparagraphs (A) and (B) of
paragraph (1); and
``(B) provide such information to the Secretary
upon the request of the Secretary.
``(g) Savings Clause.--Nothing contained in this section shall be
construed as limiting the authority of the Secretary to issue an order
to cease distribution of, or to recall, a cosmetic under any other
provision of this Act.''.
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