Cosmetic regulation

(a)

In general

Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amended— (1)by inserting before section 601 the following:

Adulterated and misbranded cosmetics

;

and

(2)by adding at the end the following:

Regulation of cosmetics

611.

Definitions

In this subchapter: (1)

Domestic establishment

The term domestic establishment means an establishment located in any State that manufactures or packages cosmetics. (2)

Foreign establishment

The term foreign establishment means an establishment that manufactures or packages cosmetics that are exported to the United States. (3)

Manufacturer

The term manufacturer only includes manufacturers that determine the final formulation of a cosmetic. (4)

Ingredient

(A)

In general

The term ingredient means a chemical in a cosmetic, including— (i)chemicals that provide a technical or functional effect; (ii)chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient; (iii)processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetic; (iv)substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect; (v)the components of a fragrance, flavor, or preservative; and (vi)any individual component of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter. (B)

Treatment of contaminants

For purposes of sections 614 through 617, the term ingredient also includes— (i)contaminants present at levels above technically feasible detection limits; and (ii)contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits. (5)

Microbusiness

The term microbusiness means a business— (A)that is engaged in the manufacturing or packaging of cosmetics; and (B)that has annual sales receipts for cosmetic products that do not exceed $2,000,000. (6)

Professional use

The term professional use means the use of any cosmetic— (A)by an employee (within the scope of the employment of such employee) of; or (B)purchased by a consumer in,

a hair salon, nail salon, beauty salon, spa, or other establishment that provides cosmetic treatment services for humans.

(7)

Reasonable certainty of no harm

With respect to an ingredient or cosmetic, the term reasonable certainty of no harm means that no harm will be caused to members of the general population or any vulnerable population by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from— (A)low-dose exposures to the cosmetic or ingredient; or (B)additive effects resulting from repeated exposure to the cosmetic or ingredient over time; or (C)cumulative exposure resulting from all sources, including both the cosmetic or ingredient and environmental sources. (8)

Reproductive or developmental toxicity

With respect to an ingredient or cosmetic, the term reproductive or developmental toxicity means that the ingredient or cosmetic can contribute to biologically adverse effects on the development of humans or animals, including effects on the female or male reproductive system, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions of the body that are dependent on the integrity of the reproductive system as well normal fetal development. (9)

Vulnerable populations

The term vulnerable populations includes pregnant women, infants, children, the elderly, people with compromised immune systems, and highly exposed populations, including workers employed by hair salons, nail salons, beauty salons, spas, other establishments that provide cosmetic treatment services for humans, and cosmetic manufacturing plants.

612.

Registration of establishments and registration fees

(a)

Registration

(1)

In general

Beginning 1 year after the date of the enactment of this subchapter, and annually thereafter, any establishment (except for microbusinesses) engaged in manufacturing or packaging cosmetics for use in the United States shall register with the Secretary and pay to the Secretary the applicable fee, as established under the fee schedule in subsection (e). (2)

Rules for domestic and foreign establishments

To be registered under paragraph (1)— (A)as a domestic establishment, the owner, operator, or agent in charge of the domestic establishment shall submit a registration to the Secretary; or (B)as a foreign establishment, the owner, operator, or agent in charge of the foreign establishment shall— (i)submit a registration to the Secretary; and (ii)include with the registration the name of the United States agent for the foreign establishment. (3)

New establishments

Any establishment that begins to manufacture or package a cosmetic after the date on which the requirements of paragraph (1) apply shall, not later than 60 days after the date on which the establishment began to manufacture or package such cosmetic, register with the Secretary and pay the applicable fee, as required under paragraph (1). (b)

Submission of registration

(1)

In general

In order to register under subsection (a), an establishment (referred to in this section as the registrant) shall submit to the Secretary, with respect to any cosmetics that the establishment manufactures or package, all of the following: (A)Any information necessary to notify the Secretary of the name, address, and legal status of each establishment at which, and all trade names under which, the registrant manufactures or package cosmetics. (B)A description of the establishment’s activities with respect to cosmetics, including a list of all cosmetic products manufactured or packaged by the establishment and the functions of such cosmetics. (C)The gross receipts or sales for the establishment from cosmetics. (D)The name and address of any company that supplies the establishment, if the establishment manufactures cosmetics, with any ingredient and the name of the ingredient supplied to such establishment by such supplier. (2)

Notification of changes

When submitting the annual registration, the registrant shall notify the Secretary of changes to the information described in paragraph (1). (c)

Procedure

Upon receipt of a completed registration submitted under subsection (a), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered establishment. (d)

List of registered establishments

(1)

Maintenance of list

The Secretary shall— (A)compile, maintain, and update as appropriate, a list of establishments that are registered under this section; (B)make such list publically available; and (C)remove from such list the name of any establishment that fails to register in accordance with this section. (2)

Application of FOIA

(A)

Registration documents

Any registration documents submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code. (B)

Other information

Information derived from— (i)the list under paragraph (1); or (ii)registration documents submitted pursuant to this section,

shall not be subject to disclosure under section 552 of title 5, United States Code, except to the extent that such information discloses the identity or location of a specific registrant.

(e)

Fee schedule

A schedule of fees shall be developed by the Secretary to provide for oversight and enforcement of this subchapter. The fee structure shall— (1)be prorated based on the establishment’s gross receipts or sales; and (2)only be assessed on companies with annual gross receipts or sales of cosmetics that exceed $10,000,000. (f)

Suspension and cancellation of registration

(1)

Criteria for suspension

Registration under this section is subject to suspension if the Secretary finds— (A)the information submitted by the establishment for registration under subsection (a) is incomplete, inaccurate, or out of date; (B)the establishment fails to notify the Secretary of changes required under subsection (b)(2); (C)the establishment fails to pay registration fees, as required under subsection (a), in a timely manner; or (D)the establishment violates any portion of this chapter. (2)

Suspension of registration

If the Secretary determines that an establishment is subject to suspension under subsection (f) and that it is appropriate to suspend the registration of such establishment, the Secretary shall— (A)suspend the registration of such establishment; and (B)provide a notice of suspension to such establishment. (3)

Cancellation

If the establishment fails to correct the issue that resulted in the suspension under paragraph (2) before the last day of the 30-day period beginning on the date that the establishment receives notice under such paragraph, the Secretary may cancel the registration of such establishment.

613.

Ingredients labels on cosmetics

(a)

In general

Subject to subsections (b) and (c), the Secretary shall require that the label on each package of cosmetics (including cosmetics distributed for retail sale and professional use) bears a declaration of the name of each ingredient in such cosmetic in descending order of predominance. (b)

Adjustments for label size

(1)

Rules for small products

Not later than 6 months after the date of the enactment of this subchapter, the Secretary shall issue regulations that apply to any cosmetic for which the product packaging is not of sufficient size to bear or contain a label that meets the requirements of subsection (a). (2)

Requirements for public disclosure

Such regulations shall establish requirements for listing ingredients on the label of such cosmetics and additional requirements for public disclosure of the ingredients in such cosmetics. (c)

Special rule for contaminants

The Secretary shall require, in the case of a contaminant, that a contaminant be declared on the label of a cosmetic, in the same manner as an ingredient under subsection (a), if the contaminant is present at the lower of the following levels: (1)A level that is greater than one part-per-billion by weight of product formation. (2)A level that is greater than one percent of the restriction on the concentration for such contaminant for such use, as determined by the Secretary under section 616(a)(2). (d)

Labeling of nanomaterials in cosmetics

The Secretary may require that— (1)minerals and other particulate ingredients be labeled as nano-scale on a cosmetic ingredient label or list if not less than 1 percent of the ingredient particles in the cosmetic are 100 nanometers or smaller in not less than 1 dimension; and (2)other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties. (e)

Labeling of ingredients in cosmetics sold through Internet commerce

The Secretary shall require— (1)in the case of a cosmetic sold on the Web site of an Internet vendor, that the manufacturers and distributors of such cosmetic provide to such Internet vendor a list of the ingredients of the cosmetic; and (2)that each Internet vendor display the list of ingredients of a cosmetic sold by such vendor on the Web page that is the primary Web page providing information relating to the sale of such cosmetic on the Web site of the vendor. (f)

Trade secrets

Notwithstanding any other provision of law, an ingredient required to be listed on a label under this section shall not be treated as a trade secret. (g)

Application

Beginning 18 months after the date of the enactment of this subchapter, the requirements of this section shall apply to— (1)all cosmetics that are available for retail sale; and (2)manufacturers, distributors, and Internet vendors of such cosmetics.

614.

Safety standard and good manufacturing practices

(a)

Safety standard

(1)

In general

Taking into account the expected use of a cosmetic, the Secretary shall establish a safety standard that, with respect to a cosmetic or an ingredient in a cosmetic provides a reasonable certainty of no harm (as such term is defined in section 611(7)) from exposure to the cosmetic or ingredient and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient. (2)

Standards for establishing safety standard

In establishing the safety standard under paragraph (1), the Secretary shall ensure that— (A)the likely level of exposure to all sources of the ingredient or cosmetic (including environmental sources) that will result under the safety standard presents not more than a 1 in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval; or (B)the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating an margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources). (3)

Use of other Federal standards

If any Federal agency has promulgated a standard for an ingredient that satisfies the requirements under paragraph (1), the Secretary may treat such standard as the safety standard under paragraph (1) for purposes of such ingredient. (4)

Application of safety standard

The Secretary may only determine that an ingredient or a cosmetic meets the safety standard under paragraph (1) if there is a reasonable certainty of no harm from exposure to the ingredient or cosmetic. (b)

Good manufacturing practices

(1)

In general

The Secretary shall issue guidance prescribing good manufacturing practices for cosmetics and ingredients, including quality control procedures that the Secretary determines are necessary, and shall update such regulations as necessary. (2)

Consideration of small business

In developing the guidance under paragraph (1), the Secretary shall consider how such practices will impact small businesses.

615.

Cosmetic and ingredient safety information

(a)

Required submission of all safety information

(1)

In general

Manufacturers of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all data and information that the manufacturer can access regarding the safety of the— (A)ingredients listed on the cosmetic label under section 613 for a cosmetic; and (B)cosmetic itself. (2)

Required information

The required data and information under paragraph (1) shall include, for each ingredient in a cosmetic and for the cosmetic, the following: (A)Functions and uses. (B)Data and information on the physical, chemical, and toxicological properties of each such ingredient or cosmetic. (C)Exposure and fate information. (D)Results of all safety tests that the manufacturer can access or has conducted. (E)Any other information used to substantiate the safety of such ingredient and cosmetic. (3)

Deadlines

(A)

Initial submission

A manufacturer shall submit the data and information required under paragraph (1)— (i)in the case of an ingredient or cosmetic which is marketed for sale in interstate commerce on or before the date of the enactment of this subchapter, not later than 1 year after such date; and (ii)in the case of an ingredient or cosmetic which is not marketed for sale on or before such date— (I)not later than the end of the 14-month period beginning on the date of the enactment of this subchapter; or (II)if the ingredient or cosmetic is first marketed for sale in interstate commerce after the end of the period described in subclause (I), not later than 60 days after the date on which such ingredient or cosmetic is first marketed for sale. (B)

Updates

(i)

In general

Subject to clause (ii), a manufacturer shall update the data and information submitted under subparagraph (A) annually. (ii)

Adverse health effects

In the case of information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic, a manufacturer shall update the information not later than 60 days after receiving such information. (4)

Supplier information

(A)

Use of supplier information

In order to meet the requirements of paragraph (1) with respect to an ingredient, a manufacturer may submit safety data and information provided by the supplier of the ingredient. (B)

Supplier provision of information

If a manufacturer requests that a supplier of an ingredient provide to such manufacturer any of the data and information described under paragraph (2), such supplier shall provide such data and information to such manufacturer not later than 90 days after receiving such request. (b)

Database

(1)

Initial publication

Not later than 1 year after the date of the enactment of this subchapter, the Secretary shall publish a comprehensive, publicly accessible database containing all nonconfidential information (as such term is used under section 623) submitted under subsection (a)(1). (2)

Updates

Not later than 90 days after the Secretary receives new or updated information under subsection (a)(3)(B), the Secretary shall update the database under paragraph (1) with such information. (c)

Review and evaluation of information

(1)

In general

Based on the data and information submitted under subsection (a)(1), available from an authoritative source (as such term is defined in paragraph (3), including data described under section 627(b)), and such other information as the Secretary may have available, the Secretary shall review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce. (2)

Consideration of nanomaterials

The Secretary shall— (A)monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetic (including progress in the standardization of testing methods and specific size definitions for nanomaterials); and (B)consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1). (3)

Authoritative source defined

For purposes of this paragraph, the term authoritative source means— (A)the Environmental Protection Agency; (B)the International Agency for Research on Cancer; (C)the National Toxicity Program through the National Institutes of Health; (D)the California Environmental Protection Agency; and (E)any other authoritative international, Federal, and State entity, as determined by the Secretary.

616.

Lists of ingredients and required responses

(a)

Placement on list

(1)

In general

Based on an initial review and evaluation of an ingredient under subsection (c), the Secretary shall place the ingredient on one of the following lists: (A)The prohibited and restricted list under subsection (b). (B)The safe without limits list under subsection (c). (C)The priority assessment list under subsection (d). (2)

Considerations

In determining the placement of an ingredient on a list under subsection (a), the Secretary shall consider whether the ingredient— (A)reacts with other substances to form harmful contaminants; (B)is found to be present in the body through biomonitoring; (C)is found in drinking water or air; (D)is a known or suspected neurological or immunological toxicant, respiratory asthmagen, carcinogen, teratogen, or endocrine disruptor, or have other toxicological concerns (including reproductive or developmental toxicity); or (E)is known to persist in the environment or bioaccumulate. (3)

Prioritiziation of ingredients that are food

In placing ingredients on the lists under paragraph (1), the Secretary shall prioritize the placement of ingredients that are food (as such term is defined under section 201(f)) on such lists. (b)

Prohibited and restricted list

(1)

In general

Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that are identified by the Secretary— (A)as prohibited for use because the Secretary determines that such ingredients are unsafe for use in cosmetics in any amount because such ingredients fail to meet the safety standard under section 614(a); or (B)as being subject to necessary restrictions in use or concentration to allow the use of the ingredient in a cosmetic to satisfy the safety standard. (2)

Specification of restrictions

In the case of any ingredient listed under paragraph (1)(B), the Secretary shall specify the restrictions on use or concentration that are necessary to satisfy the safety standard for such ingredient. (3)

Updates

The Secretary shall, at a minimum, annually update the list under paragraph (1), including any— (A)determinations under subsection (d)(3); or (B)new information that demonstrates that an ingredient fails to meet the safety standard, or requires restrictions on use to meet such standard. (4)

Manufacturer requirements

Not later than 1 year after the date that an ingredient is placed on a list under subsection (b), any manufacturer using such ingredient in a cosmetic shall reformulate such cosmetic to— (A)eliminate the use of the ingredient, if it is listed under paragraph (1)(A); or (B)modify the use of the ingredient if it is listed under paragraph (1)(B), to meet the restrictions specified under paragraph (2). (c)

Safe without limits list

(1)

In general

Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that the Secretary has determined are safe for use in cosmetics, without limits or restrictions. (2)

Standard for inclusion in list

The Secretary may only include an ingredient on the list under paragraph (1) if the Secretary determines that the ingredient meets the safety standard under section 614(a), regardless of— (A)the type and form of cosmetic the ingredient is used in; and (B)the concentration of the ingredient that is used in a cosmetic. (3)

Updates and redeterminations

The Secretary shall annually update the list under paragraph (1) and may redetermine whether an ingredient distributed in commerce meets the safety standard if, in the judgment of the Secretary, new information raises a credible question as to whether the ingredient continues to meet the safety standard. (d)

Priority assessment list and related safety determinations

(1)

In general

Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall develop and publish a priority assessment list of not less than 300 ingredients— (A)which, because of a lack of authoritative information on the safety of the ingredient, cannot be included on— (i)the list under subsection (b) (relating to prohibited and restricted ingredients); or (ii)the list under subsection (c) (relating to ingredients that are safe without limits); and (B)for which the Secretary has determined it is a priority to conduct a safety determination under paragraph (3). (2)

Annual addition of ingredients

After the list is developed under paragraph (1), the Secretary shall annually add at least 100 additional ingredients to such list until all ingredients that are used in the formulation or manufacture of cosmetics have been added— (A)to such list; (B)to the list under subsection (b); or (C)to the list under subsection (c). (3)

Determination of whether ingredient meets safety standard

(A)

Review of priority ingredients

During the 2-year period following the date on which an ingredient is placed on the list under paragraph (1), the Secretary shall— (i)collect data and information on such ingredient; and (ii)review and evaluate the safety of such ingredient. (B)

Determination of list placement

Not later than the end of the period under subparagraph (A), the Secretary shall issue a determination, based on the review and evaluation under such clause, that— (i)the ingredient meets the requirements for inclusion on a list under subsection (b) (relating to prohibited and restricted ingredients) or subsection (c) (relating to ingredients that are safe without limits); or (ii)insufficient information exists to place the ingredient on either such list. (C)

Guidance in the case of insufficient information

If the Secretary determines under subparagraph (B) that, with respect to an ingredient, insufficient information exists to place such ingredient on either of the lists under subsection (b) or subsection (c), the Secretary shall provide guidance to manufacturers on the data and information (including minimum data requirements and safety testing protocols) that the Secretary requires to evaluate whether the ingredient meets the safety standard under section 614(a) for purposes of placing such ingredient on such a list. (D)

Comment period

Upon issuing the determination under subparagraph (B), and, if applicable, the guidance under subparagraph (C), the Secretary shall provide a period of not less than 60 days for public comment on the determination before applying such determination to an ingredient, except that a shorter period for comment may be provided if the Secretary— (i)finds that it would be in the public interest to have a shorter period; and (ii)publically declares the reasons for such finding. (4)

Manufacturer response to inadequate information

Not later than 18 months after the date that the Secretary issues guidance under paragraph (3)(C) with respect to an ingredient subject to a determination under paragraph (3)(B), a manufacturer using such ingredient in a cosmetic shall— (A)reformulate such cosmetic to eliminate the use of the ingredient; or (B)provide the Secretary with the data and information specified in such guidance. (5)

Evaluation of additional data and information

With respect to an ingredient, not later than 6 months after a manufacturer provides the Secretary with the data and information under paragraph (4)(B) the Secretary shall review such data and information and shall make a redetermination under paragraph (3)(B) for such ingredient, subject to the comment period under paragraph (3)(D). (6)

Limitation

If the Secretary has not placed an ingredient on either of the lists under subsection (b) and subsection (c) by the end of the 5-year period beginning on the date that such ingredient is first placed on the list under subsection (d), beginning on the first day after such period such ingredient may not be— (A)used in a cosmetic; and (B)manufactured, imported, distributed, or marketed for use in cosmetics.

617.

Treatment of cosmetics based on ingredient lists

(a)

In general

Subject to subsections (b)(4) and (d)(4) of section 616, a manufacturer may only manufacture a cosmetic for distribution in interstate commerce if such cosmetic meets the safety standard under section 614(a). (b)

Presumption related to the safety of cosmetics

(1)

In general

Subject to paragraph (2), for purposes of subsection (a), the Secretary shall presume that the following cosmetics meet the safety standard under section 614(a): (A)A cosmetic that is made solely of ingredients on the list under section 616(c)(1) (relating to ingredients that are safe without limits). (B)A cosmetic that is made solely of ingredients on the list under section 616(b)(1)(B) (relating to ingredients subject to restrictions) and the use of each of such ingredients in such cosmetic is in compliance with the restrictions on the use of such ingredients specified under section 616(b)(2). (C)A cosmetic that is made solely of ingredients described under subparagraph (A) and subparagraph (B). (2)

Exceptions

The Secretary may require that a manufacturer demonstrate that a cosmetic meets the safety standard under section 614(a) (including by requiring that the manufacturer conduct safety testing of a cosmetic described under paragraph (1)) if the cosmetic— (A)contains penetration enhancers, sensitizers, estrogenic chemicals, or other similar ingredients; (B)contains ingredients that react with each other or with other substances to form harmful byproducts; or (C)the Secretary has any additional reason to believe that such cosmetic does not meet the safety standard under section 614(a). (3)

Guidance

If, under paragraph (2), the Secretary requires that a manufacturer demonstrate that a cosmetic meets the safety standard under section 614(a), the Secretary shall provide the manufacturer with guidance on the data and information that the Secretary requires to evaluate whether the cosmetic meets the safety standard under such section. (c)

Notification of failure of Secretary To act

If the Secretary fails to act by an applicable deadline under section 616 or this section, a manufacturer of an ingredient or a cosmetic affected by such failure of the Secretary to act shall issue to the Secretary, the public, and each known customer of the ingredient or cosmetic, a written notice that a determination by the Secretary of the safety of the ingredient for use in cosmetics is pending.

618.

Treatment of contaminants

(a)

Publication of list

Not later than 1 year after the date of the enactment of this subchapter, and annually thereafter, the Secretary shall publish a list of— (1)ingredients used in cosmetics that may contain contaminants; (2)combinations of ingredients that may create contaminants when such ingredients interact; (3)contaminants that may leech from product packaging into a cosmetic; and (4)any other contaminant of cosmetics identified by the Secretary. (b)

Requirements for testing

(1)

In general

Not later than 1 year after the date of enactment of this subchapter, the Secretary shall establish, by rule, requirements for testing ingredients and cosmetics for contaminants listed under subsection (a). (2)

Contents

The requirements under paragraph (1) shall include— (A)testing methods and applicable protocols; and (B)maximum allowable detection limits for each contaminant in an ingredient. (3)

Update

The Secretary shall annually update the requirements under paragraph (1). (c)

Supplier requirements

Not later than 1 year after the promulgation of the rule under subsection (b)(1), a supplier of an ingredient that is used in a cosmetic shall, with respect to such ingredient— (1)comply with the requirements under subsection (b)(1) for any ingredient listed under subsection (a); (2)conduct similar testing on any ingredient that— (A)the supplier expects may be used in a cosmetic; (B)the supplier suspects may contain a contaminant; and (C)is not listed under subsection (a); and (3)upon the sale of an ingredient to the manufacturer, provide to the manufacturer specifications for the ingredient that— (A)include the levels of contaminants present in such ingredient; and (B)are based on the results of the tests under paragraph (1) and paragraph (2). (d)

Manufacturer requirements

Not later than 1 year after the promulgation of the rule under subsection (b)(1), a manufacturer of a cosmetic shall, with respect to each ingredient that the manufacturer uses in a cosmetic— (1)obtain, from each supplier of the ingredient, specifications for the ingredient that include— (A)the level of each contaminant present in the ingredient; and (B)the detection limits of the analytical test used to detect the contaminant; or (2)comply with the requirements under paragraphs (1) and (2) of subsection (c) for the ingredient, in the same manner as if the manufacturer were a supplier.

619.

Cosmetic and ingredient statements

(a)

In general

Beginning 1 year after the date of the enactment of this subchapter, each establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States shall submit electronically to the Secretary, for each cosmetic manufactured in the establishment that is intended to be marketed in the United States, a statement containing— (1)the registration number of the manufacturing establishment where the cosmetic is manufactured or, if the same cosmetic is manufactured in more than 1 establishment, the registration number of each establishment where it is manufactured; (2)the registration number of the establishment responsible for distributing the cosmetic; (3)the brand name and the product name for the cosmetic; (4)the applicable use for the cosmetic; (5)the ingredient list as it appears on the cosmetic label or insert, including the particle size range of any nanoscale cosmetic ingredients; (6)any warnings and directions for use from the cosmetic label or insert; and (7)the title and full contact information for the individual responsible for submitting and maintaining such statement. (b)

New cosmetics

Any establishment that begins to manufacture a cosmetic after the date of the enactment of this subchapter shall comply with the requirements of subsection (a) beginning on the later of the following: (1)The end of the 18-month period beginning on the date of the enactment of this subchapter. (2)The 6-month period after the date on which the establishment begins to manufacture such cosmetic. (c)

Notification of changes

The establishment shall notify the Secretary annually of any change to the information required under subsection (a). (d)

Procedure

Upon receipt of a completed statement described under subsection (a), the Secretary shall notify the establishment of the receipt of such statement and assign a cosmetic statement number. (e)

List

The Secretary shall compile, maintain, and update as appropriate, a list of cosmetics for which statements are submitted under this section. (f)

Access to safety information

The cosmetic and ingredient statements collected under this section shall be added to the publicly accessible database created by the Secretary under section 615(b).

620.

Notification, nondistribution, and recall of adulterated or misbranded cosmetics

(a)

Notification of adulterated or 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 adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health effects or death to humans 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 manufacturer, packager, retailer, or distributor of the cosmetic. (b)

Voluntary recall

The Secretary may request that any person who distributes a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily— (1)recall such cosmetic; and (2)provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. (c)

Order To cease distribution

(1)

In general

If the Secretary has reason to believe that— (A)the use of, or exposure to, a cosmetic may cause serious adverse health effects or death to humans; (B)the cosmetic is misbranded; or (C)the cosmetic is manufactured, packaged, or distributed by an unregistered facility;

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)

24 hours

A person subject to an order under paragraph (1) may appeal such order to the Secretary within 24 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

Except as provided in subsection (e), 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. (d)

Order To recall

(1)

Amendment

Except as provided under subsection (e) and subject to subsection (c)(3)(D), if the Secretary determines that a recall of a cosmetic subject to an order under subsection (c) is appropriate, the Secretary shall amend the order to require a recall. (2)

Contents

An amended order under paragraph (1) shall— (A)specify a timetable in which the recall will occur; (B)require periodic reports to the Secretary describing the progress of the recall; and (C)provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.

(3)

Nondelegation

An amended order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee. (4)

Determination

If the Secretary determines that inadequate grounds exist to support the amendment made to the order under paragraph (1), the Secretary shall remove such amendment from such order. (e)

Emergency recall order

(1)

In general

If the Secretary has credible evidence or information that a cosmetic subject to an order under subsection (c) presents an imminent threat of serious adverse health effects or death to humans, the Secretary may issue an order requiring any person who distributes such cosmetic— (A)to immediately recall such cosmetic; and (B)to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. (2)

Recall and notice

Any person who is subject to an emergency recall order under this subsection shall immediately recall such cosmetic and provide notification as required by such order. (3)

Appeal

(A)

24 hours

Any person subject to such an order may appeal such order to the Secretary within 24 hours of the issuance of such order. (B)

Contents of appeal

Informal hearing

An informal hearing shall be held as soon as practicable after the appeal is filed under subparagraph (A), but not later than 5 calendar days after such an appeal is filed, or fewer days (as determined by the Secretary), unless the parties jointly agree to an extension. (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. (5)

Nondelegation

An order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee. (f)

Notice to consumers and health officials

The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the cosmetic was, or may have been, distributed and to appropriate State and local health officials. (g)

Supply chain information

(1)

In general

In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, the Secretary shall request that the entity 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, packer, 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 adulterated, misbranded, or otherwise in violation of this Act, 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 supply chain of a cosmetic (including the entity 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. (h)

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.

621.

Petitions

(a)

In general

The Secretary shall complete and publish a review, and, if appropriate, immediately revise related, relevant information, including ingredient lists, ingredient restrictions or prohibitions, or ingredient or cosmetic safety determinations, not later than 6 months after the date on which the Secretary receives from any individual or entity a reasonable petition— (1)to prohibit or restrict an ingredient for use in cosmetics and list such ingredient on the list under section 616(b); (2)to remove an ingredient from the list of ingredients that are safe without limits under section 616(c); (3)to add an ingredient to the priority assessment list under section 616(d); or (4)to add an ingredient to the list of contaminants under section 618. (b)

Reasonable petition

Not later than 1 year after the date of the enactment of this Act, the Secretary shall issue rules specifying the criteria which the Secretary will use to determine if a petition submitted under this section is a reasonable petition.

622.

Mandatory reporting of adverse health effects

(a)

Submission of report on adverse health effects

The Secretary shall require that the manufacturer, packager, or distributor of a cosmetic whose name appears on the label of a cosmetic marketed in the United States submit to the Secretary a report containing information received concerning any adverse health effect associated with the use of the cosmetic. (b)

Timing of report

A report under subsection (a) shall be submitted to the Secretary not later than 15 business days after information concerning the adverse health effect is received at the place of business of the manufacturer, packager, or distributor. (c)

Content of report

A report under subsection (a) shall include the following information, to the extent to which the manufacturer, packager, or distributor submitting the report has been able to verify the information: (1)The identity of the individual experiencing the adverse health effect. (2)An identifiable report of such effect. (3)The name of the cosmetic suspected of causing such effect. (4)A description of the adverse health effect. (d)

Public availability and privacy

(1)

Public availability

Subject to paragraph (2), the adverse health effect reports collected by the Secretary under this section shall be submitted electronically and shall be made accessible to the public. (2)

Privacy

(A)

Personally identifiable information

Notwithstanding any other provision of law, personally identifiable information in adverse health effect reports provided to the Secretary under this section, shall not— (i)be made publicly available pursuant to any State or other law requiring disclosure of information or records; or (ii)otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary. (B)

Treatment of information under Privacy Act and FOIA

An adverse health effect report submitted to the Secretary under this section, shall be considered to be a record about an individual under section 552a of title 5, United States Code (commonly referred to as the ‘‘Privacy Act of 1974’’) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the ‘‘Freedom of Information Act’’), and shall not be publicly disclosed unless all personally identifiable information is redacted.

623.

Nonconfidential information

(a)

Information available to public

Subject to subsection (c) and section 622(d)(2), all nonconfidential information submitted pursuant to this subchapter shall be made available to the public, including the following types of information: (1)The name, identity, and structure of a chemical substance, contaminant, or impurity that is an ingredient. (2)All information concerning function, exposure, health hazards, and environmental hazards for a cosmetic., and (3)The functions of ingredients in cosmetics. (4)Fragrance, flavor, and colorants in a cosmetic (b)

Confidential information

The concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public under subsection (a). (c)

Petition for information To remain confidential

(1)

In general

The Secretary shall create a process for an entity to petition for nonconfidential information described in subsection (a) to remain confidential if the entity shows that there would be a serious negative impact to the entity’s commercial interests if such information were disclosed to the public. (2)

Limitation

The Secretary may not approve a petition under paragraph (1) to the extent that such petition would prevent the public disclosure of— (A)the name, identity, and structure of any chemical substance, contaminant, or impurity that is an ingredient; (B)all health and safety data related to that substance, contaminant, or impurity; or (C)any data used to substantiate the safety of that substance, contaminant, or impurity.

624.

Animal testing alternatives

(a)

In general

To minimize the use of animal testing of ingredients and cosmetics, the Secretary shall— (1)require, where practicable, alternative testing methods that— (A)do not involve the use of an animal to test the chemical substance; (B)provide information that is equivalent or superior in scientific quality to the animal testing method; and (C)use fewer animals than conventional animal-based tests when nonanimal methods are impracticable, including the use of tests that combine multiple endpoints; and (2)encourage, where practicable— (A)estimation of toxicological properties of a chemical through the use of testing information for 1 or more structurally similar chemicals where such estimates provide information of sufficient scientific quality; (B)the formation of industry consortia to conduct testing to avoid duplication of tests; and (C)funding for research and validation of alternative test methods, in accordance with this subsection. (b)

List of alternative testing methods

Not later than 1 year after the date of the enactment of this subchapter, and triennially thereafter, the Secretary shall publish a list of the alternative testing methods described in subsection (a).

625.

Product Testing and Review Audit

The Secretary shall conduct annual audits of random samples of cosmetics to assess or test for acute negative reactions, pathogen hazards, contaminants, leaching of packaging additives, mislabeling, or other relevant issues of concern (as determined by the Secretary).

626.

Resources for small businesses

The Secretary shall provide technical support to assist small businesses in carrying out the requirements of this subchapter.

627.

Interagency cooperation

(a)

Interagency Council on Cosmetic Safety

There is established an Interagency Council on Cosmetic Safety for the purpose of sharing data and promoting collaboration on cosmetic safety between the Food and Drug Administration, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and the Environmental Protection Agency. (b)

Use of data from Federal sources

For purposes of this subchapter, the Secretary, as appropriate, shall request and utilize ingredient and cosmetic toxicity, use, and exposure data from other Federal agencies.

628.

Savings clause

Nothing in this subchapter shall affect the right of a State, political subdivision of a State, or tribe to adopt or enforce any regulation, requirement, liability, or standard of performance that is more stringent than a regulation, requirement, liability, or standard of performance established by this subchapter, including requiring the provision of a warning of risk, illness, or injury.

629.

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this subchapter for each of the fiscal years 2012 through 2016.

(b)

Adulterated and misbranded cosmetics

(1)

Adulterated cosmetics

Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended in paragraph (a)— (A)by striking , except that this provision shall not apply to coal-tar hair dye and all that follows through or eyebrow dyes; and (B)by adding at the end the following:

(f)If it is manufactured in a manner that fails to comply with section 617(a). (g)If it is imported, distributed, or marketed and— (1)it contains an ingredient on the list under section 616(b)(1)(A), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic; or (2)it contains an ingredient on the list under section 616(b)(1)(B), such ingredient is being used in a manner that violates the limit on use or concentration of such ingredient under section 616(b)(2), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic. (h)If it is manufactured by a manufacturer that, with respect to such cosmetic, is required to demonstrate, under section 617(b)(2), that the cosmetic meets the safety standard and the manufacturer has not yet submitted the required data under section 617(b)(3).

(2)

Misbranded cosmetics

Section 602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amended— (A)in paragraph (a), by inserting or fails to meet the requirements of section 613 before the period; and (B)by adding at the end the following:

(g)If it— (1)was manufactured, packaged, or distributed by an entity that failed to register and pay the applicable fee as required under section 612; (2)is manufactured, packaged, distributed, or sold in retail by a manufacturer, packager, distributor, or retailer, respectively, who fails to notify the Secretary as required under section 620(a)(1); (3)is distributed in violation of an order under section 620(c); (4)is not recalled as required by an order under subsection (d) or (e) of section 620; (5)is manufactured in a manner that fails to comply with good manufacturing practices prescribed by the Secretary under section 614(b); or (6)is manufactured by a manufacturer who fails— (A)to submit the statement required under section 619; or (B)notify the Secretary of changes to information contained in such report, as required by such section.

(3)

Additional prohibitions

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(aaa)The failure of a manufacturer of a cosmetic or an ingredient for use in a cosmetic to submit and update data and information as required under section 615(a). (bbb)The manufacture, importation, distribution, or marketing of an ingredient for use in a cosmetic that is on the list under section 616(b)(1)(A). (ccc)The failure of a supplier of an ingredient for use in a cosmetic— (1)to provide data and information as required by section 615(a)(4)(B); or (2)comply with the testing requirements under section 618(c). (ddd)The failure of a manufacturer to comply with the requirements of section 618(d). (eee)The failure of a manufacturer, packager, or distributor of a cosmetic to comply with the requirement of reporting adverse health effects under section 622.