Regulation of cannabidiol

(a) CBD as a dietary supplement Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(3)(B)) is amended, in the matter preceding subclause (i), by inserting, except in the case of cannabidiol derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946) after include. (b) Adulteration Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following new subsection: (j) (1) If it is a dietary supplement that contains cannabidiol, unless— (A) such dietary supplement contains no more than an amount of cannabidiol per recommended daily serving that the Secretary may establish (and revise or repeal as appropriate), subject to paragraph (2), through an interim final rule, notwithstanding any requirement for notice and comment that may otherwise apply under section 553 of title 5, United States Code; (B) such dietary supplement is the subject of a notification submitted to the Secretary in accordance with section 413(a)(2); and (C) the labeling and packaging of such dietary supplement conforms with any requirements that the Secretary establishes regarding labeling or packaging of dietary supplements containing cannabidiol (which may be promulgated (and revised or repealed as appropriate) by the Secretary through an interim final rule, notwithstanding any requirement for notice and comment that may otherwise apply under section 553 of title 5, United States Code). (2) (A) The amount of cannabidiol established in accordance with paragraph (1)(A)— (i) shall be a threshold above which the Secretary may not accept new dietary ingredient notifications; and (ii) shall not be interpreted as a determination that lower amounts of cannabidiol are safe. (B) The Secretary shall establish such a threshold based on such factors as the Secretary determines to be appropriate, which may include a consideration of whether the review of new dietary ingredient notifications for products containing higher levels of cannabidiol may be unduly burdensome.. (c) New dietary ingredient Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(1)) is amended by inserting contains no cannabidiol and before contains only dietary ingredients. (d) New prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 502(b)(6), is further amended by adding at the end the following: (mmm) The introduction or delivery for introduction into interstate commerce of any product labeled as a dietary supplement that fails to meet the definition of a dietary supplement under section 201(ff).. (e) New import exclusion Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended in paragraph (3) of the third sentence by striking section 301(ll) and inserting paragraph (ll) or (iii) of section 301. (f) New seizure authorities Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended— (1) in subsection (a)(1), in the first sentence, by inserting or any article which may not be introduced or delivered for introduction into interstate commerce under section 301(iii), before shall be liable; and (2) in subsection (d)(1), in the first sentence, by inserting, or any product otherwise introduced or delivered for introduction into interstate commerce in violation of section 301(iii) and condemned under this section, after under this section. (g) CBD as a food additive (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall issue draft guidance describing criteria by which the Secretary intends to evaluate the safety of cannabidiol as a food additive in any food additive petition under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). The Secretary shall publish final guidance within 180 days of the close of the public comment period on such draft guidance. (2) Advisory committee Before issuing draft guidance under paragraph (1), the Secretary shall convene and consult an advisory committee, which shall include experts qualified in the subject matter.