or importer thereof demonstrates to the satisfaction of the Secretary of Health and Human Services that such article is— (i) a drug— (I) that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act, or (II) for which an investigational use exemption has been authorized under section 505(i) of the Federal Food, Drug, and Cosmetic Act or under section 351(a) of the Public Health Service Act, or (ii) a combination product (as described in section 503(g) of the Federal Food, Drug, and Cosmetic Act), the constituent parts of which were approved or cleared under section 505, 510(k), or 515 of such Act. (D) Industrial hemp The term industrial hemp means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. (2) THC-measurable cannabis product The term THC-measurable cannabis product means any cannabis product— (A) with respect to which the Secretary has made a determination that the amount of tetrahydrocannabinol in such product can be measured with a high degree of accuracy, or (B) which is not cannabis flower and the concentration of tetrahydrocannabinol in which is significantly higher than the average such concentration in cannabis flower. (3) Cannabis The term cannabis has the meaning given such term under section 102(16) of the Controlled Substances Act ( 21 U.S.C. 802(16) ). (b) Definitions related to cannabis enterprises For purposes of this chapter— (1) Cannabis enterprise The term cannabis enterprise means a producer, importer, or export warehouse proprietor. (2) Producer (A) In general The term producer means any person who plants, cultivates, harvests, grows, manufactures, produces, compounds, converts, processes, prepares, or packages any cannabis product. (B) Personal use exception Subject to regulation prescribed by the Secretary, the term producer shall not include any individual otherwise