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 cosmetic formulation means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition. The term cosmetic product means a cosmetic comprised of a specified set of ingredients, which may come in a range of possible amounts for each ingredient and which may include a variety of fragrances, flavors, and colors.
The term facility includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds cosmetic products or cosmetic formulations, or any other entity whose name and address appear on the label of a cosmetic product. Such term does not include— beauty shops and salons that do not otherwise manufacture, process, or package cosmetics at that location; cosmetic product retailers, including individual sales representatives, retail distribution facilities, and pharmacies, that do not otherwise manufacture, process, or package cosmetics at that location; hospitals, physicians’ offices, and health care clinics; public health agencies and other nonprofit entities that provide cosmetics directly to the consumer; hotels and other entities that provide complimentary cosmetics to guests; trade shows and other venues where cosmetic product samples are provided free of charge; domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products; or entities that manufacture or compound cosmetic products solely for use in research, teaching, or pilot plant production and not for sale.
The term foreign facility means a facility that manufactures, processes, packs, or holds, a cosmetic formulation or cosmetic product that is exported to the United States without further processing or packaging inside the United States. A cosmetic 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.
The term non-functional 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. The term responsible person means— the brand owner who is the domestic or foreign manufacturer, packer, or entity whose name appears on a cosmetic product label of a cosmetic product distributed in the United States, except for entities described in subparagraphs
(A)through
(H)of paragraph (3); or a contract manufacturer who provides cosmetic products to the entities described in subparagraphs
(A)through
(H)of paragraph (3). . Not later than December 1, 2015, and at a similar time in each subsequent year, as determined by the Food and Drug Administration, each responsible person engaged in manufacturing or processing a cosmetic product or a cosmetic formulation distributed in the United States shall register all of the responsible person’s facilities with the Food and Drug Administration. If the average gross annual sales in the United States of cosmetic products of all of the responsible person’s facilities registered under paragraph
(1)for the previous 3-year period is greater than $500,000, a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section 744L. Not later than December 1, 2015, and at a similar time once every 3 years thereafter, as determined by the Food and Drug Administration, each person who owns or operates a cosmetic facility or facilities engaged in packing or holding a cosmetic product distributed in the United States shall register each such facility with the Food and Drug Administration. Any facility first engaging after the date of enactment of the Personal Care Products Safety Act in an activity that would require it to register under subsection
(a)or
(b)shall register with the Food and Drug Administration within 60 days of first engaging in such activity, and thereafter in accordance with subsection
(a)or (b). A registrant who has submitted a registration under this section shall notify the Food and Drug Administration of any change to the information required under subsection
(a)or
(b)not later than 60 days after the date of such change, unless otherwise specified by the Food and Drug Administration. Each registration shall be submitted using an electronic format, as specified in a registration form provided by the Food and Drug Administration. The registration shall contain the following information: Each facility’s name 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 Food and Drug Administration to the facility under subsection (g). All business trading names used by the facility. The product category or categories 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 of activity 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, if available, the 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 Food and Drug Administration 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 Food and Drug Administration may require by regulation. The Food and Drug Administration shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information with respect to the facility or facilities involved since the registrant submitted the preceding registration. Not earlier than 10 days after providing notice of the intent to cancel a registration and the basis for such cancellation, the Food and Drug Administration may cancel a registration under this section if the Food and Drug Administration has reasonable grounds to believe that the registration was not properly completed or updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information. If, not later than 7 days after receipt of a notice of intent to cancel, the sponsor corrects the registration in accordance with the basis for the cancellation, and the required registration fee, if any, is paid, the Food and Drug Administration shall not cancel such registration. At the time of the initial registration of any cosmetic facility under this section, the Food and Drug Administration shall assign a unique identifier to the facility. The Food and Drug Administration 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 a registrant or that discloses specific facilities where specific 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 Food and Drug Administration a cosmetic ingredient statement, at such time and in such manner as the Food and Drug Administration may prescribe. The cosmetic ingredient statement shall not become effective until the responsible person pays any applicable fee required under section 744L. In the case of a cosmetic product that is marketed on the date of enactment of the Personal Care Products Safety Act , the responsible person shall submit a cosmetic ingredient statement not later than December 1, 2015. The responsible person shall submit to the Food and Drug Administration a renewal of such statement on a yearly basis. Except as provided under subparagraph (B), in the case of a cosmetic product that is first marketed after the date of enactment of the Personal Care Products Safety Act or a cosmetic product that is reformulated after such date of enactment, the responsible person shall submit a cosmetic ingredient statement to the Food and Drug Administration within 60 days of first marketing the new cosmetic product or the reformulated cosmetic product, and annually thereafter. The Food and Drug Administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act to have a period longer than 60 days to submit an initial new cosmetic ingredient statement under subparagraph (A). Such responsible person shall submit a cosmetic ingredient statement annually thereafter. A cosmetic product shall not be considered first marketed or reformulated after the date of enactment under subparagraph
(A)if the only change in such product is in— the amount of an existing ingredient if it is within the range 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 Food and Drug Administration in regulations or guidance, previously reported as a potential ingredient under subsection (c)(2)(E), if, in the case of such an addition, the amount is within the range previously reported. For each cosmetic product, the cosmetic ingredient statement shall be submitted using an electronic format, as specified in a cosmetic and ingredient form provided by the Food and Drug Administration. The cosmetic ingredient statement shall include the following information: The unique identifier, assigned under section 605(g), as applicable, of— the facility or facilities where the cosmetic product is manufactured, processed, packed, or held or, if the same cosmetic product 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 as it appears on the label. The cosmetic product listing number, if any, previously assigned by the Food and Drug Administration under subsection
(f)to the cosmetic product. The applicable cosmetic category for the cosmetic product. A list of ingredients in the cosmetic product, including a range of possible amounts of each ingredient, and with each ingredient identified by the name adopted in regulations promulgated by the Food and Drug Administration, if any, or by the common or usual name of the ingredient. The cosmetic ingredient statement shall contain— a list of fragrances, flavors, and colors that may be included in the product, interchangeably, with ranges of possible amounts, which shall include— in the case of 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; 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; and in the case of a notification provided by the Food and Drug Administration to the responsible person for the cosmetic manufacturer, the Food and Drug Administration may request, from the fragrance or flavor supplier, the complete list of ingredients in specific fragrances or flavors and the supplier shall have 30 days to provide such list to the Food and Drug Administration; and other appropriate interchangeable ingredients as the Food and Drug Administration may specify in regulations or guidance that may be included in the product, with ranges of possible amounts. The title and full contact information of each individual submitting the statement. If applicable, information on the labeling required under section 614. Such additional information pertaining to the cosmetic product as the Food and Drug Administration may require. Notwithstanding any other provision of this subsection, the Food and Drug Administration may permit a simplified cosmetic ingredient statement under this section for a responsible person that— is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act; and has had an average of less than $500,000 in annual domestic cosmetic sales over the previous 3 years. A responsible person described in subparagraph
(A)shall include in each cosmetic ingredient statement under this section, at a minimum, a list of ingredients in the cosmetic product and the applicable cosmetic category for the cosmetic product. Not earlier than 10 days after providing notice under paragraph (2), the Food and Drug Administration may nullify a cosmetic ingredient statement filed under this section if the Food and Drug Administration has reasonable grounds to believe that the cosmetic ingredient statement was not completed or updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information. A nullification under paragraph
(1)shall be preceded by notice to the responsible person of the intent to cancel the cosmetic ingredient statement and the basis for such cancellation. If the cosmetic ingredient statement is appropriately updated or corrected not later than 7 days after notice is provided under paragraph (1), the Food and Drug Administration shall not nullify such cosmetic ingredient statement. In filing each cosmetic ingredient statement cosmetic product, the responsible person shall include an attestation that the safety of the product, including the individual ingredients of such product and the product as a whole, has been substantiated in accordance with section 609. In the case of a cosmetic ingredient statement that includes a range of possible amounts (as described in subsection (c)(2)(E)), the responsible person shall include an attestation that the safety of the full range in the finished product has been substantiated, in accordance with section 609. The Food and Drug Administration shall provide for an abbreviated renewal process for any such filing with respect to which there has been no change since the responsible person submitted the previous filing. Except as provided in subparagraph (B), the responsible person shall notify the Food and Drug Administration within 60 days of any change to the information required to be in a cosmetic ingredient statement, including discontinuation of the manufacture of a cosmetic product, except that notification under this paragraph is not required for a change in— the amount of an existing ingredient if it is within the range 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 Food and Drug Administration in regulations or guidance, previously reported as a potential ingredient under subsection (c)(2)(E), if, in the case of an addition of such an ingredient, the amount is within the range previously reported. The Food and Drug Administration shall allow a responsible person that is a business that meets the applicable industry-based small business size standard established by the Administrator of the Small Business Administration under section 3 of the Small Business Act to have a period longer than 60 days, but not longer than the next annual registration deadline under section 605(a)(1), to submit any change to the information required to be in a cosmetic ingredient statement as described in subparagraph (A). At the time of the initial submission of any cosmetic ingredient statement under this section, the Food and Drug Administration shall assign a unique cosmetic product listing number to the cosmetic ingredient statement. Based on such cosmetic ingredient statements, the Food and Drug Administration shall compile and maintain a list of cosmetic products distributed in the United States, including the ingredients of each such product, and shall make available such list to any State, upon request. 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. If the Food and Drug Administration determines that a cosmetic formulation or cosmetic product manufactured, processed, packed, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans, and there is reason to believe that other formulations or products manufactured, processed, packed, or held by the facility may be similarly affected because of a failure affecting multiple products in that facility, the Food and Drug Administration may suspend the registration of a facility. If the Food and Drug Administration determines that a cosmetic product manufactured in a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans, the Food and Drug Administration may suspend the cosmetic ingredient statement of that product. Before suspending a facility registration or a cosmetic ingredient statement under this section, the Food and Drug Administration shall provide— notice to the facility registrant of the cosmetic product or formulation or other responsible person, as appropriate, of the intent to suspend the facility registration or the cosmetic ingredient statement, which shall specify the basis of the determination by the Food and Drug Administration that the facility or the cosmetic ingredient should be suspended and recommendations for specific actions to avoid suspension; and an opportunity, within 2 business days of the notice provided under paragraph (1), for the responsible person to address the reasons for possible suspension of the facility registration or cosmetic ingredient statement. Upon a determination by the Food and Drug Administration that adequate grounds do not exist to continue the suspension actions, the Food and Drug Administration 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 cosmetics from such facility. If the cosmetic ingredient statement for a cosmetic product is suspended under this section, no person shall import or export such cosmetic product or otherwise distribute in the United States such cosmetic product that is the subject of such statement. 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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