Yes, we believe health products containing hemp may be legal to sell under both federal and state law, provided they meet the statutory definitions of “hemp” or “industrial hemp.” However, hemp products containing cannabis and cannabis-derived compounds also must comply with the Food and Drug Administration’s (FDA) regulations and authority.
With the passage of the federal Agriculture Improvement Act of 2018, hemp is no longer a Schedule I controlled substance under the federal Controlled Substances Act and is legal to sell in the United States — provided that it meets the federal definition of “hemp.” Under the federal law, “hemp” means “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
In addition, Illinois passed the Industrial Hemp Act in 2018, which removed industrial hemp from the general prohibition on manufacturing, delivering or possessing “cannabis” with the intent to deliver under the Illinois Cannabis Control Act. Under the Illinois law, “industrial hemp” means “the plant Cannabis sativa L. and any part of that plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis that has been cultivated under a license issued under this Act or is otherwise lawfully present in this State, and includes any intermediate or finished product made or derived from industrial hemp.”
Whether it is legal to sell health food products containing hemp depends on whether the products contain cannabidiol (CBD) or delta-9-tetrahydrocannabinol (THC) and whether they have received FDA approval. The FDA has announced that foods derived from parts of the hemp plant that do not contain CBD or TCH — including hulled hemp seeds, hemp seed protein, and hemp seed oil — may be lawfully marketed, provided that they meet other requirements and do not make disease treatment claims. However, products containing CBD or THC that are marketed with a claim of a therapeutic benefit, or which are used as food additives or dietary supplements, first must receive FDA approval before being introduced into interstate commerce.
For resources related to our guidance, please see:
- Controlled Substances Act, 21 USC 802(6) (A controlled substance is “a drug or other substance, or immediate precursor, included in schedule I, II, . . .”)
- Controlled Substances Act, 21 USC 812(c)(c)(10) (Schedule I drugs include marihuana.)
- Controlled Substances Act, 21 USC 802(16) (“(A) Subject to subparagraph (B), the term ‘marihuana’ means all parts of the plant Cannabis sativa L. . . . (B) The term “marihuana” does not include
(i) hemp, as defined in section 1639o of Title 7; or
(ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”)
- Agriculture Marketing Act of 1946, 7 USC 1639o(1) (“The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”)
- Illinois Cannabis Control Act, 720 ILCS 550/5 (“It is unlawful for any person knowingly to manufacture, deliver, or possess with intent to deliver, or manufacture, cannabis . . . .”)
- Illinois Cannabis Control Act, 720 ILCS 550/3 (“‘Cannabis’ includes marihuana, hashish and other substances which are identified as including any parts of the plant Cannabis Sativa . . . ‘Cannabis’ does not include industrial hemp as defined and authorized under the Industrial Hemp Act.”)
- Illinois Industrial Hemp Act, 505 ILCS 89/5 (“‘Industrial hemp’ means the plant Cannabis sativa L. and any part of that plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis that has been cultivated under a license issued under this Act or is otherwise lawfully present in this State, and includes any intermediate or finished product made or derived from industrial hemp.”)
- Statement from the FDA Commissioner on signing of the Agriculture Improvement Act (December 20, 2018) (“In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.”)
- Statement from the FDA Commissioner on signing of the Agriculture Improvement Act (December 20, 2018) (“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”)