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1 1 (April 18, 2016)

handle is hein.crs/crsnalcaaaan0001 and id is 1 raw text is: I Congressional Research Service ~Info rming te Veslat've debate since 1914 April 18, 2016 Potential Use of Industrial Hemp in Cannabidiol Products Industrial hemp refers to an agricultural commodity that is cultivated for use in the production of a wide range of products, including foods and beverages, cosmetics and personal care products, and nutritional supplements, as well as fabrics and textiles, and a range of other manufactured goods. Botanically, hemp is a variety of Cannabis sativa and is of the same plant species as marijuana and therefore subject to federal drug laws. As part of the Agricultural Act of 2014 (farm bill, P.L. 113-79; 7 U.S.C. §5940) Congress made changes to U.S. agricultural policies regarding industrial hemp, allowing for hemp production under certain circumstances. Under the law, certain research institutions and state departments of agriculture may grow hemp, as part of an agricultural pilot program, if allowed under state laws where the institution or state department of agriculture is located. The farm bill also established a statutory definition of industrial hemp as the plant Cannabis sativa L. and any part of such plant with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3% on a dry weight basis. Bills in the House and Senate could further facilitate the use of industrial hemp to produce cannabidiol (CBD), which is considered to offer a wide scope of possible medical applications With industrial hemp cultivation increasing under the farm bill, some are examining additional potential uses for hemp. One such potential application includes the use of hemp to produce cannabidiol (CBD). CBD refers to one of the primary non-psychoactive compounds in Cannabis sativa. In general, cannabis with high levels of CBD is generally low in psychoactive compounds, such as THC, marijuana's primary psychoactive chemical. Products containing CBD are increasingly being considered as offering a potentially wide scope of medicinal applications, which has garnered the attention of some in Congress. For example, in June 2015, the Senate Caucus on International Narcotics Control, led by Senators Chuck Grassley and Dianne Feinstein, held a hearing on the barriers to research and the potential medical benefits of CBD. The caucus leaders claimed that many leading medical organizations have called for further research into the potential medical use of CBD. Products containing CBD are currently being produced and marketed using primarily marijuana-grade cannabis plants and their byproducts, generally as prescription drugs. Some companies, however, are producing and marketing products containing CBD as an herbal (dietary) supplement. Some companies are using industrial hemp as a source of CBD. Many hemp stakeholders support the use of industrial hemp to produce CBD and related products. In the 114th Congress, bills in both the House and Senate would amend the Controlled Substances Act (CSA, 21 U.S.C. §§801 et seq.) to exclude cannabidiol and cannabidiol-rich plants from the definition of marihuana, and for other purposes. Both bills would also amend the CSA to define a cannabidiol-rich plant to mean the plant Cannabis sativa L. and any part of such plant' with a THC concentration of not more than 0.3% on a dry weight basis-a definition similar to the 2014 farm bill. The two bills are related but not identical. The House bill (Charlotte's Web Medical Access Act of 2015, H.R. 1635) would further exclude CBD and CBD-rich plants from being subject to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). This provision is not part of the Senate bill (Therapeutic Hemp Medical Access Act of 2015, S. 1333). The Charlotte's Web reference in the House bill refers to a high-CBD (low THC) cannabis extract that has been sold as a dietary supplement and marketed as helping to address various ailments, including neuropathic pain, epilepsy, post- traumatic stress disorder, nausea from chemotherapy, and other disorders. FDA Actions Regarding Products Containing CBD Recently, the Food and Drug Administration (FDA) has taken a series of actions regarding the production and marketing of certain CBD products. First, in February 2015, FDA issued warning letters to several companies selling products claiming to contain CBD that lab tests showed to contain little or no CBD. These companies allegedly also made unsubstantiated product claims (e.g., for use in treating cancer). (See partial listing of products in the text box on the next page). FDA claimed these products were unapproved drugs and not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease, and often they do not even contain the ingredients found on the label. These products were reportedly pulled from the market. Reportedly, other companies producing products containing CBD with a much higher percentage weight per weight concentration did not receive FDA warning letters. This action involved concerns about product fraud and product claims, and was not related to the use of a cannabis-derived substance (i.e., FDA did not issue these warning because of concerns about a cannabis-containing substance that could be in violation of the Controlled Substances Act). Press reports indicate that agency personnel claim FDA has not approved any drug product containing CBD, for any indication (i.e., no products containing CBD have been determined by FDA to be safe or effective for their intended indications). These same press reports indicate that FDA is concerned at the proliferation of therapeutic claims made about an increasing number of products containing CBD, which are for sale in all 50 states. Hemp industry activists have also expressed concerns about the potential misrepresentation of using industrial hemp to produce CBD and related products. www.crs.gov i 7-570 0

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