Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements
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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: In this chapter: The term animal test means the internal or external application or exposure of a cosmetic product, cosmetic formulation, or cosmetic ingredient to the skin, eyes, or other body part of a live non-human vertebrate for the purpose of evaluating the safety of a cosmetic product, cosmetic formulation, or cosmetic ingredient. The term contract manufacturer means a manufacturer (including the owner, operator, or agent in charge (or any affiliate thereof)) of a cosmetic ingredient, cosmetic formulation, or cosmetic product that does not sell any such cosmetic ingredient, cosmetic formulation, or cosmetic product unless there is a specific contractual agreement in place with respect to that sale.
The term cosmetic formulation means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition. The term cosmetic ingredient means any single chemical entity or mixture used as a component in the manufacture of a finished cosmetic product or cosmetic formulation. The term cosmetic product means a finished cosmetic comprised of a specified set of cosmetic ingredients, which may come in a range of possible amounts for each cosmetic ingredient and which may include a variety of fragrances and colors, and in some specific cosmetic applications, flavors.
Such term shall include tattoo ink whether or not labeled as a finished cosmetic. The term facility includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer or of any other entity whose name and address appear on the label of a cosmetic product) that manufactures, processes, packs, or holds cosmetic products or cosmetic formulations. Such term does not include— beauty shops and salons that do not otherwise manufacture, process, or package cosmetic products or cosmetic formulations at that location, including beauty stores or counters that offer customized or personalized cosmetic products or cosmetic formulations tailored to individual consumers for sale solely in-person; cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508 of the Internal Revenue Code of 1986), retail distribution facilities, retail franchises, retail warehouses, and pharmacies, that do not otherwise manufacture, process, or package cosmetic products or cosmetic formulations at that location; entities that manufacture or compound cosmetic products solely for use in research, teaching, or pilot plant production and not for sale; hospitals, physicians’ offices, and health care clinics; hotels, airlines, and other entities that provide complimentary cosmetic products to guests; public health agencies and other nonprofit entities that provide cosmetic products or cosmetic formulations directly to the consumer; or trade shows and other venues where cosmetic product samples are provided free of charge.
The term foreign facility means a facility that manufactures, processes, packs, or holds, cosmetic products or cosmetic formulations that are exported to the United States without further processing or packaging inside the United States. A cosmetic product or cosmetic formulation is not considered to have undergone further processing or packaging for purposes of this definition solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the cosmetic product or cosmetic formulation.
The term nonfunctional constituent means any substance that is an incidental component of an ingredient, a breakdown product of an ingredient, or a byproduct of the manufacturing process that has not been intentionally added as a separate substance and serves no technical function in the cosmetic product. With respect to a cosmetic product, the term professional means— a dermatologist or other health care professional that administers or provides cosmetic products to patients; or a cosmetologist, nail technician, barber, or esthetician who administers or provides cosmetics within the scope of their business practices.
With respect to a cosmetic product, the term professional use means a preparation of a cosmetic formulation intended only for use by professionals in settings such as cosmetology, nail care, barbering, esthetics, health care, and other professions as determined by the Secretary through regulation. The term responsible person means the brand owner, operator, or agent in charge who is the domestic or foreign manufacturer, processor, or entity whose name appears on the label of a cosmetic product or a cosmetic formulation distributed in the United States.
The owner, operator, or agent in charge of (or an affiliate thereof) a facility engaged in manufacturing, or processing, of a cosmetic product or a cosmetic formulation distributed in the United States shall register with the Secretary. The Secretary shall— maintain an electronic registration system for purposes of this section; and not later than one year after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 , announce that such system is operational. Not later than the date that is 6 months after the date of the announcement required by paragraph (2)(B), each facility engaged in an activity described in paragraph
(1)shall be registered under such paragraph. In the case of a facility that first engages in an activity described in paragraph
(1)on or after the date that is 18 months after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 , such a facility shall register with the Secretary immediately upon engaging in such activity. The Secretary shall require only a single registration per registration period for a facility required to be registered under paragraph (1), regardless of whether such facility is manufacturing or processing— its own cosmetic products or cosmetic formulations; or cosmetic products or cosmetic formulations on behalf of more than one owner, operator, or agent in charge (or affiliate thereof). Each facility engaged in packing or holding a cosmetic product or cosmetic formulation distributed in the United States shall register with the Food and Drug Administration. Each such facility shall, not later than 6 months after the Secretary announces the establishment of an electronic registration system for purposes of this section, submit a registration utilizing such system. A facility that continues to engage in any activity that would require registration under subsection
(a)or
(b)shall submit to the Secretary an annual registration during the first quarter of the fiscal year for which such renewed registration shall be effective. If the average gross annual sales of cosmetic products in the United States of all of the facilities of the responsible person registered under subsection (a)(1) for the previous 3-fiscal-year period is greater than $1,000,000, a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section 744M. A facility that submitted a registration under this section shall notify the Secretary of any change to the information required under subsection
(a)or
(b)not later than 30 days after the date of such change, unless otherwise specified by the Secretary. Each registration shall be submitted using an electronic format, as specified in a registration form provided by the Secretary. The registration shall contain the following information: Each facility’s name (including any parent company of the facility) and full address, identifying the precise physical location of the facility. The identity of the facility, including the unique facility identifier, if any, previously assigned by the Secretary to the facility under subsection (i). All business trading names used by the facility. The product category (as identified under section 720.4(c) of title 21, Code of Federal Regulations (or any successor regulation)), or other cosmetic categories as determined appropriate by the Secretary (including by guidance) of each cosmetic product or cosmetic formulation manufactured, processed, packed, or held at the facility or on whose label the facility’s name and address appear. The type or types of activities conducted at the facility (such as manufacturing, processing, packing, or holding). The name, title, street address, telephone number, and electronic contact information of the emergency contact for the facility. In the case of a foreign facility, the name, street address, telephone number, emergency contact information for the facility, the name of the United States agent for the facility, and the phone number and electronic contact information of the United States agent. The name, title, street address, telephone number, and electronic contact information of the individual submitting the registration. An assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act. Additional information pertaining to the facility or to the cosmetic products or cosmetic formulations manufactured, processed, packed, or held at the facility, or on whose label the facility’s name and address appear, including all brand names known to consumers, as the Secretary may require by regulation. The Secretary shall provide for an abbreviated registration renewal process for any facility that has not had any changes to the information submitted by the facility for the preceding registration. Subject to paragraph (2), the Secretary may cancel a registration of a facility under this section if— the Secretary has reasonable grounds to believe that the registration was not properly completed or updated in accordance with this section; a required registration fee has not been paid within 30 days; or the registration otherwise contains false, incomplete, or inaccurate information. The Secretary shall, at least 10 days before canceling a registration pursuant to paragraph (1), provide notice to the facility of the intent of the Secretary to cancel such registration that contains the Secretary’s basis for the determination to so cancel the registration. If, not later than 7 days after receipt of a notice of intent to cancel under paragraph (2), the facility corrects the registration in accordance with the basis for the cancellation, and the required registration fee, if any, is paid, the Secretary shall not cancel such registration. At the time of the initial registration of any cosmetic facility under this section, the Secretary shall assign a unique identifier to the facility and provide such identifier to such facility in writing. The Secretary shall compile, maintain, and update a registry of facilities that are registered under this section, and shall remove from such registry the name of any facility whose registration under this section is cancelled. The registry shall be publicly available. Information derived from the registry or registration documents that discloses the residential address of an owner, operator, or agent in charge of (or an affiliate thereof) a facility engaged in manufacturing, processing, packing, or holding a cosmetic product or formulation, or a facility owned by such person, or that discloses specific facilities where specific brands of cosmetic products are manufactured or processed shall not be subject to disclosure under section 552 of title 5, United States Code. For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic ingredient statement, at such time and in such manner as the Secretary may prescribe. The cosmetic ingredient statement shall not become effective until the responsible person pays any applicable fee required under section 744M. In the case of a cosmetic product or cosmetic formulation that is marketed on the date of enactment of the Cosmetic Safety Enhancement Act of 2019 , the responsible person shall— not later than the date that is 6 months after the date of the announcement of an electronic registration system required by section 605, submit to the Secretary a cosmetic ingredient statement in accordance with this section; and beginning one year after the ingredient statement is submitted under subparagraph
(A)and each year thereafter, submit to the Secretary a renewal of such statement, consistent with the requirements in subsection (e), during the first quarter of the fiscal year for which such renewed statement is applicable. Except as provided under subparagraph (B), in the case of a cosmetic product or cosmetic formulation that is first marketed after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 or a cosmetic product or cosmetic formulation that is reformulated after such date of enactment, the responsible person shall— submit to the Secretary a cosmetic ingredient statement prior to first marketing the new cosmetic product, new cosmetic formulation, or the reformulated cosmetic product or reformulated cosmetic formulation; and beginning one year after the ingredient statement is submitted under clause (i), submit to the Secretary annually thereafter a renewal of such statement during the first quarter of the fiscal year for which the cosmetic ingredient statement is applicable, consistent with the requirements in subsection (e). In the case of a responsible person that is a small business, the Secretary shall allow such responsible person to have an additional time period, of a duration to be determined by the Secretary, in which to submit the first cosmetic ingredient statement under subparagraph (A). Such responsible person shall, consistent with the requirements in subsection (e), submit a cosmetic ingredient statement annually thereafter during the first quarter of the applicable fiscal year. In applying subparagraph (A), a cosmetic product or cosmetic formulation shall not be considered to be first marketed or reformulated after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 if the only change in such product or formulation is— a change in the amount of an existing ingredient that is previously reported under subsection (c)(2)(E); or the addition or subtraction of a fragrance, flavor, or color, or such other interchangeable ingredients specified by the Secretary in regulations or guidance, previously reported as a potential ingredient under subsection (c)(2). The Secretary shall provide for an abbreviated process for the renewal of any cosmetic ingredient statement under this subsection with respect to which there has been no change since the responsible person submitted the previous statement. For each cosmetic ingredient statement submitted with respect to a cosmetic product or cosmetic formulation under this section, such statement shall be submitted using an electronic format, in a form specified by the Secretary. Each such cosmetic ingredient statement shall include the following information: The unique identifier, assigned under section 605(h), as applicable, of— the facility or facilities where the cosmetic product or cosmetic formulation is manufactured, processed, packed, or held or, if the same cosmetic product or cosmetic formulation is manufactured, processed, packed, or held in more than one facility, the unique facility identifier of each facility where it is manufactured, processed, packed, or held; and the facility whose name and address appear on the label, unless the statement is filed by a contract manufacturer, described in section 604(6)(B). The brand name and the full name for the cosmetic product or cosmetic formulation as it appears on the label. The listing number, if any, previously assigned by the Secretary under subsection
(f)to the cosmetic product or cosmetic formulation. The applicable cosmetic category for the cosmetic product or cosmetic formulation. A list of ingredients in the cosmetic product or cosmetic formulation that— with respect to each such ingredient, the name adopted in regulations promulgated by the Secretary, if any, or by the common or usual name of the ingredient; is consistent with the regulations promulgated by the Food and Drug Administration related to cosmetic labeling requirements; and contains a list of fragrances, flavors, and colors that may be included in the product, interchangeably, which shall include— in the case of fragrances, each fragrance allergen contained in the cosmetic product as described in section 615, and for fragrances that are purchased from a fragrance supplier, the fragrances shall be identified by the name or code provided by the supplier, and include the name and contact information for the fragrance supplier ; and in the case of flavors that are purchased from a flavor supplier, the flavors shall be identified by the name or code provided by the supplier, and include the name and contact information for the flavor supplier; other appropriate interchangeable ingredients as the Secretary may specify in regulations or guidance that may be included in the product; and in the case of an ingredient (other than a fragrance, flavor, or color) that has been designated for review under section 608, includes potential ranges and amounts of such ingredient. The title and full contact information of each individual submitting the statement. If applicable, information on labeling required under section 614. Such additional information pertaining to the cosmetic product as the Secretary may require by regulation. Fragrance ingredients included in a cosmetic ingredient statement under paragraph (2)(E), other than fragrance allergens, shall be treated as confidential commercial or trade secret information. If a facility manufactures or processes cosmetic products or cosmetic formulations on behalf of an owner, operator, or agent in charge whose name appears on the label of such products or formulations, the Secretary shall require only a single cosmetic ingredient statement for such cosmetic product. Such single cosmetic ingredient statement shall be submitted to the Secretary by the responsible person. Notwithstanding any other provision of this subsection, in the case of a responsible person that has had an average of less than $1,000,000 in annual domestic cosmetic sales over the previous 3 years, the Secretary may allow such responsible person— to submit a simplified cosmetic ingredient statement under this section; and an additional time period, of a duration to be determined by the Secretary, in which to submit such simplified cosmetic ingredient statement. A responsible person described in subparagraph
(A)shall include in each cosmetic ingredient statement submitted under this section, at a minimum— a list of ingredients in the cosmetic product or cosmetic formulation, including any fragrance allergens as described in section 615; the applicable cosmetic category for the cosmetic product or cosmetic formulation; and in the case of a cosmetic product or cosmetic formulation that includes a fragrance or flavor purchased from a fragrance or flavor supplier, the contact information for the fragrance or flavor supplier, including the supplier’s name, street address, telephone number, and electronic contact information. Not earlier than 30 days after providing notice under paragraph
(2)and subject to paragraph (3), the Secretary may nullify a cosmetic ingredient statement submitted under this section if the Secretary has reasonable grounds to believe that, except for minor or immaterial errors, the cosmetic ingredient statement was not completed or updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information. If the Secretary nullifies a cosmetic ingredient statement under paragraph (1), the Secretary shall provide to the responsible person submitting such cosmetic ingredient statement under this section notice of any such nullification, including the basis for such nullification. In the case of a cosmetic ingredient statement with respect to which the Secretary has provided notice under paragraph (2), the Secretary shall not nullify such cosmetic ingredient statement if the cosmetic ingredient statement is appropriately updated or corrected not later than 10 days after the date on which such notice is provided. No person shall import, export, or otherwise distribute any cosmetic product or cosmetic formulation that is the subject of a cosmetic ingredient statement that is nullified under this subsection. In submitting a cosmetic ingredient statement for each cosmetic product or cosmetic formulation under this section, a responsible person shall include an attestation that the safety of the product or formulation, including the individual ingredients of such product or formulation, has been substantiated in accordance with section 609. Not later than 90 days after any change to the information required to be in a cosmetic ingredient statement under this section, the responsible person shall notify the Secretary of such change, including the discontinuation of the manufacture of a cosmetic product. Such notification is not required for a change described in subsection (b)(2)(C). At the time of the initial submission of any cosmetic ingredient statement under this section, the Secretary shall— assign a unique cosmetic product listing number to the cosmetic ingredient statement; and provide such number to the responsible person who submitted such statement in writing. Using cosmetic ingredient statements submitted under this section, the Secretary shall— compile and maintain a list of cosmetic products or cosmetic formulations distributed in the United States, including the ingredients of each such product or formulation; and upon request of any State, shall make such list available to such State. Information disclosed to a State that is exempt from disclosure under section 552(b)(4) of title 5, United States Code, shall be treated as a trade secret and confidential information by the State. Such State and its employees in possession of such information shall be subject to the same laws governing information disclosure as employees of the Food and Drug Administration. A responsible person shall be exempt from the requirements of this section if such person has had an average of less than $500,000 in annual domestic cosmetic product sales over the previous three years. Such exemption shall not apply to cosmetic products that are intended to be injected under the skin or into the eye, including tattoo ink, or ingredients selected by the Food and Drug Administration for review under section 608 if such ingredient is included in a cosmetic product or cosmetic formulation distributed by such person described. If the Secretary determines that a cosmetic product or cosmetic formulation manufactured, processed, packed, or held by a facility registered under section 605 has a reasonable probability of causing serious adverse health consequences or death to humans, the Secretary may suspend the registration of such facility. If the Secretary determines that a cosmetic product or cosmetic formulation manufactured in a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans, the Secretary may suspend the cosmetic ingredient statement of that product or formulation. Before suspending the registration of a facility or a cosmetic ingredient statement under this section, the Secretary shall provide— notice to the facility or responsible person, as appropriate, of the intent to suspend such registration or the cosmetic ingredient statement , which shall specify the basis of the determination by the Secretary for that suspension; and an opportunity, within 2 business days of the notice provided under paragraph (1), for the facility or responsible person that is the subject of such notice, as appropriate, to address the reasons for possible suspension of the registration of the facility or cosmetic ingredient statement. Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions under subsection
(a)or (b), the Secretary shall promptly vacate the suspension and reinstate the registration of the facility or the cosmetic ingredient statement. If the registration of a facility is suspended under this section, no person shall import or export cosmetics or otherwise distribute cosmetic products or cosmetic formulations from such facility. The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner. .
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Sec. 101
Registration of cosmetics facilities and cosmetic ingredient statements
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