United States Code
USC most recently checked for updates: Sep 23, 2023
Every person that, on
Every person that owns or operates a facility that first engages, after
A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.
A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).
The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).
Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.
For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.
The responsible person of a cosmetic product that is marketed on
The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.
A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
A responsible person may submit product listing information as part of a facility registration or separately.
At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),1
The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.
If, after providing opportunity for an informal hearing under paragraph (3), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant.
Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility.
If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products 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.