Cosmetics manufacturing bill (H.R. 575) hides adverse events

Rep. Pete Sessions (R-Tx.) has introduced legislation that appears to allow cosmetics manufacturers to keep product complaints reported to the federal government secret. The legislation (H.R. 575), appears to allow the executive branch wide latitude to determine through regulation what agencies must require manufacturers to disclose publicly.

“(g) List.—The Secretary shall compile and maintain an up-to-date and publicly available electronic list of cosmetics and ingredients for which statements are submitted under this section. A statement submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code. The Secretary may make publicly available information derived from such statements that discloses the names of ingredients used in cosmetics and the number of cosmetics in which a specific ingredient is used, but may not make publicly available any information that relates to any ingredient that is exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations), or that discloses at what establishment a cosmetic is manufactured. At the written request of the director of a State agency responsible for regulating the safety of cosmetics stating good cause therefor, the Secretary may disclose to such official confidential business and trade secret information contained in a statement and such official and other State employees who have access to such information shall then be subject to the provisions of section 301(j) of this Act, section 552(b) of title 5, United States Code, and section 1905 of title 18, United States Code, with respect to such information.

“(h) Exemptions.—Submission of a statement under subsection (a) shall not be required—

“(1) for a cosmetic for which as of the date of enactment of this section a cosmetic ingredient statement has been submitted to the Secretary under part 710 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017);

“(2) for a cosmetic ingredient exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations); or

“(3) by an entity to the extent such entity is exempted by section 605(e) from registration under section 605.”.

SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.
(a) In General.—Chapter VI (21 U.S.C. 361 et seq.), as amended by sections 3, 4, and 5, is further amended by adding at the end the following:

“SEC. 607. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.

“(a) In General.—The Secretary shall by regulation require that a domestic or foreign manufacturer, packer, or distributor whose name appears on the label pursuant to section 602(b)(1) of a cosmetic marketed in the United States submit to the Secretary under subsection (b) a report containing—

“(1) information received concerning any serious and unexpected adverse event in the United States allegedly associated with the use of the cosmetic for which it is reasonably likely that the adverse event was caused by the cosmetic when used as recommended or suggested in the labeling; and

“(2) a copy of the label for the cosmetic.

“(b) Submission Of Reports.—A report on an adverse event under subsection (a) shall be submitted to the Secretary not later than 15 business days after information concerning the adverse event is received at the place of business labeled on the cosmetic pursuant to section 602(b)(1).

“(c) Required Contents.—A report under subsection (a) shall include all of the following information:

“(1) An identifiable patient.

“(2) An identifiable reporter.

“(3) A suspect cosmetic or component thereof.

“(4) A serious adverse event.

“(d) Additional Contents; Supplemental Reporting.—The person submitting a report under subsection (a) may—

“(1) include pertinent information in addition to the information listed in subsection (c); and

“(2) after submitting the initial report, supplement the report with additional information.

“(e) Special Rules.—

“(1) PROTECTED INFORMATION.—A serious and unexpected adverse event report (including all information submitted in the initial report or added later) submitted under subsection (a)—

“(A) shall be considered to be a safety report under section 756 that is subject to the provisions of that section; and

“(B) shall be considered to be a record about an individual under section 552a of title 5, United States Code, and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5, and shall not be publicly disclosed unless all personally identifiable information is redacted.