Natural Products Insider

JAN-FEB 2018

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26 INSIDER January/February 2018 Cannabidiol (CBD) is one of the naturally occurring cannabinoids found in cannabis plants, which produce both marijuana and hemp, according to the World Health Organization (WHO). Hemp typically has a much lower concentration of tetrahydrocannabinol (THC), the psychoactive chemical found in marijuana that produces a "high" when consumed. If pure CBD does not produce a high or cause dependence in users, why is there a question about its legality? When it comes to the legal status of CBD, several areas of law must be examined. The fi rst consideration regarding the legal status of CBD is the Agricultural Act of 2014 (U.S. Farm Bill), which includes Section 7606, "Legitimacy of Industrial Hemp Research." It allows universities and state departments to grow or cultivate industrial hemp if the hemp is grown or cultivated for purposes of research and the growing or cultivating of industrial hemp is allowed under the laws of the state. The Farm Bill defi nes "industrial hemp" as "the plant Cannabis Sativa L. and any part of such plant, whether growing or not," with a THC concentration of "not more than 0.3 percent on a dry weight basis." Based on this guidance, it appears if a product is manufactured using CBD made from industrial hemp grown and cultivated according to the requirements of Section 7606 of the Farm Bill, it would be legal. However, DEA must also be considered. On Dec. 14, 2016, DEA established a new drug code within Schedule I for "Marijuana Extract." The rule stated in part that CBD and other cannabinoids were included in the new drug code and as a result were Schedule I substances under the Controlled Substances Act (CSA). Marijuana is a Schedule I substance, which is in direct confl ict with the defi nition of industrial hemp in Section 7606 of the Farm Bill. To address the confl ict, on March 14, 2017, DEA issued a "Clarifi cation of the New Drug Code (7350) for Marijuana Extract." DEA stated, "The new drug code (7350) established in the fi nal rule does not include materials or products that are excluded from the defi nition of marijuana set forth in the Controlled Substances Act (CSA). The new drug code includes only those extracts that fall within the CSA defi nition of marijuana." Therefore, DEA conceded CBD that comes from industrial hemp is legal so long as the industrial hemp is grown and cultivated legally pursuant to the requirements of the 2014 Farm Bill. If industrial hemp, legal pursuant to the 2014 Farm Bill, is not a scheduled substance according to DEA, then are compliant products containing CBD legal? Unfortunately, other regulatory agencies are in the mix. Next up is FDA. Within FDA's jurisdiction is the Dietary Supplement Health and Education Act of 1994 (DSHEA), which defi nes a dietary supplement as a product (other than tobacco) intended to supplement the diet that contains one or more "dietary ingredients." Botanicals are considered dietary ingredients. Because CBD is a botanical, products containing CBD that are intended to supplement the diet and are not the sole item of a meal or the diet fall within the defi nition of a dietary supplement. As a result, companies that market and sell CBD products must comply with the regulations for dietary supplements. These regulations include, but are not limited to, following cGMPs (current good manufacturing practices); labeling the products in accordance with 21 CFR 101.36; and not marketing the product to diagnose, treat, cure or prevent any disease state. Several companies that sell products containing CBD have received warning letters from FDA for making disease claims, such as the product having a positive effect on conditions such as cancer, anxiety, dementia and infl ammation. FDA has also issued warning letters because certain products containing CBD had THC levels that exceeded the 0.3 percent allowed under the 2014 Farm Bill, and therefore, under the CSA. Also under FDA's purview, according to 21 U.S.C. ยง 321(ff)(3)(B)(ii), by defi nition, a dietary supplement cannot include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, if that article had not been marketed as a dietary supplement or as a food before the clinical investigations were instituted. FDA has raised this issue in warning letters sent to companies marketing and selling CBD products. The Hemp Industry Association (HIA) disagreed with FDA's position, stating that CBD was marketed as a food and dietary supplement long before it was authorized for drug trials. HIA claimed it submitted evidence of this fact to FDA on a question and answer webpage, but FDA did not comment on this information or acknowledge receipt of the materials. Even if CBD overcomes the hurdles of the Farm Bill, DEA concerns and FDA regulations, other regulatory bodies need to be considered. FTC reviews how products are marketed, including advertising and promotional materials. Further, each state may have its own laws, rules and regulations. All the regulatory bodies that may have authority over CBD are too numerous to cover here. One thing for certain is that the marketing of CBD is exploding. Jonathan (Jay) Manfre is an associate attorney at Collins Gann McCloskey & Barry PLLC (supplementcounsel.com). Ala n Feldstein, Esq., serves as attorney to many of the top names in sports nutrition in his capacity as Of Counsel to Collins Gann McCloskey & Barry PLLC. Legal: CBD The Legality of CBD Oil in the United States: A 'High'ly Complex Issue by Jonathan Manfre and Alan Feldstein

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