S 1113 — Personal Care Products Safety Act

Summary

Personal Care Products Safety Act This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities. If the FDA determines that a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic's distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from the facility by suspending the facility's registration. The FDA must review the safety of at least five cosmetic ingredients each year, and it may establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. A cosmetic cannot be sold if it contains an ingredient that is not safe, not safe under the recommended conditions of use, or not safe in the amount present in the cosmetic. Cosmetics companies are required to report to the FDA any serious adverse health event associated with their cosmetics. The FDA must: develop and implement cosmetic manufacturing standards that are consistent with existing national and international standards, be allowed to inspect a company's cosmetic safety records, recall a cosmetic that is likely to cause serious adverse health consequences, and encourage cosmetic safety testing practices that minimize the use of animals.

Bill Text

• Introduced Introduced in Senate Current html May 11, 2017

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds new sections to the Federal Food, Drug, and Cosmetic Act to establish definitions, registration requirements for cosmetic facilities, and fees for cosmetic safety oversight.

• 21 U.S.C. § 361

  SEC. 604. DEFINITIONS. In this chapter: (1) Cosmetic formulation.--The term `cosmetic formulation' means a preparation of cosmetic raw materials with a qualitatively and quantitatively set composition. (2) Cosmetic product.--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. (3) Facility.--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-- (A) beauty shops and salons that do not otherwise manufacture, process, or package cosmetics at that location; (B) cosmetic product retailers, including individual sales representatives, retail distribution facilities, and pharmacies, that do not otherwise manufacture, process, or package cosmetics at that location; (C) hospitals, physicians' offices, and health care clinics; (D) public health agencies and other nonprofit entities that provide cosmetics directly to the consumer; (E) hotels and other entities that provide complimentary cosmetics to guests; (F) trade shows and other venues where cosmetic product samples are provided free of charge; or (G) a factory, warehouse, or establishment of-- (i) domestic manufacturers with less than $500,000 in average gross annual sales of cosmetic products in the United States for the previous 3-year period, or less than $1,000,000 in such sales of cosmetic products produced in a private residence; or (ii) entities that manufacture or compound cosmetic products solely for use in research, teaching, or pilot plant production and not for sale. (4) Foreign facility.--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. (5) Non-functional constituent.--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. (6) Responsible person.--The term `responsible person' means-- (A) 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 (G) of paragraph (3); or (B) a contract manufacturer who provides cosmetic products to the entities described in subparagraphs (A) through (G) of paragraph (3).

  This establishes definitions for key terms related to cosmetic products and facilities, clarifying the regulatory framework.

• 21 U.S.C. § 361

  SEC. 605. REGISTRATION OF COSMETIC FACILITIES. (a) Registration and Fees for Existing Manufacturing or Processing of Cosmetics.-- (1) Registration, in general.--Not later than December 1, 2017, 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. (2) Fees.--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 $2,000,000, a registration shall not be complete under this subsection until the responsible person has paid any registration fee required under section 744L. (b) Registration for Existing Packing or Holding of Cosmetics.--Not later than December 1, 2017, 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. (c) Registration by New Facilities.--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).

  This mandates registration of cosmetic manufacturing and processing facilities with the FDA, introducing fees based on sales volume.

Action History

1. May 11, 2017

   Introduced in Senate

2. May 11, 2017

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S2918-2919)

Sponsors

• Dianne Feinstein · Primary

Subjects