ENFORCEMENT AND CONFORMING AMENDMENTS.

SEC. 3503. ENFORCEMENT AND CONFORMING AMENDMENTS.(a) In General.—(1) Prohibited acts.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 3210, is further amended—(A) by adding at the end the following:“(hhh) The failure to register or submit listing information in accordance with section 607. “(iii) The refusal or failure to follow an order under section 611.” ; and (B) in paragraph (d), by striking “or 564” and inserting “, 564, or 607”. (2) Adulterated products.—Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the following:“(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 606. “(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in section 608(c).” . (3) Misbranded cosmetics.—Section 602(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362(b)) is amended—(A) by striking “and (2)” and inserting “(2)”; and (B) by inserting after “numerical count” the following: “; and (3) the information required under section 609”. (4) Adverse event reporting.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—(A) in section 301(e) (21 U.S.C. 331(e))—(i) by striking “564, 703” and inserting “564, 605, 703”; and (ii) by striking “564, 760” and inserting “564, 605, 611, 760”; (B) in section 301(ii) (21 U.S.C. 331(ii))—(i) by striking “760 or 761) or” and inserting “604, 760, or 761) or”; and (ii) by inserting “or required under section 605(a)” after “report (as defined under section 760 or 761”; (C) in section 801(a) (21 U.S.C. 381(a))—(i) by striking “under section 760 or 761” and inserting “under section 605, 760, or 761”; (ii) by striking “defined in such section 760 or 761” and inserting “defined in section 604, 760, or 761”; (iii) by striking “of such section 760 or 761” and inserting “of such section 605, 760, or 761”; and (iv) by striking “described in such section 760 or 761” and inserting “described in such section 605, 760, or 761”; and (D) in section 801(b) (21 U.S.C. 381(b))—136 STAT. 5859(i) by striking “requirements of sections 760 or 761,” and inserting “requirements of section 605, 760, or 761”; (ii) by striking “as defined in section 760 or 761” and inserting “as defined in section 604, 760, or 761”; and (iii) by striking “with section 760 or 761” and inserting “with section 605, 760, or 761”. (b) Effective Dates.—(1) In general.—The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act. (2) Labeling requirement.—Section 609(a) of the Federal Food, Drug, and Cosmetic Act, as added by section 802, shall take effect on the date that is 2 years after the date of enactment of this Act. (c) Confidentiality.—(1) In general.—The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential commercial information that is obtained by the Secretary of Health and Human Services pursuant to this subtitle, including the amendments made by this subtitle. (2) Clarification.—Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.