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What to Know About FDA’s Recent Statements on CBD

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.”

The FDA document does not break much new ground, though it emphasizes again FDA’s concern with the safety of CBD, some of which comes from FDA’s review of the CBD-based epilepsy drug Epidiolex. FDA does not believe it has enough information about certain aspects of CBD, such as what happens if someone takes CBD daily for sustained periods. In addition, FDA specifically identifies as a potential harm the use of CBD with alcohol because of the increased risk of sedation and drowsiness, which can lead to injuries. FDA, in addition to issuing this document, sent 15 warning letters to companies marketing CBD products that FDA views as unapproved drugs primarily because of the drug like claims made for such products.

FDA appears to be on a path toward considering a regulation to allow the marketing of CBD in conventional foods or as a dietary supplement. This approach will likely take a long time—perhaps some 2-4 years—absent legislative changes that do not appear likely in an election year. In the meantime, FDA continues to view putting into interstate commerce a food to which CBD has been added or to market CBD as or in a dietary supplement as a violation of the  Federal Food, Drug, and Cosmetic Act (FD&C Act).

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About this Author

Christopher Lahiff, Attorney, McDermott Law Firm
Partner

Christopher M. Lahiff is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.  He focuses his practice on matters regarding the regulation of pesticides by the U.S. Environmental Protection Agency as well as of food by the Food and Drug Administration and the U.S. Department of Agriculture.

202-756-8219
Marc E. Sorini Alcohol Distribution Attorney McDermott Will law firm
Partner

Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C. office.  He heads the Firm’s Alcohol Regulatory & Distribution Group, where he focuses on regulatory and litigation issues facing the alcohol beverage industry and non-beverage alcohol users.

Marc's alcohol beverage practice covers licensing, labeling, advertising, trade practices, distribution, import-export, formulation and excise taxation.  He has represented alcohol beverage suppliers before federal and state courts, the Alcohol & Tobacco Tax & Trade Bureau (TTB), (formerly the Bureau of Alcohol, Tobacco & Firearms or ATF), the Federal Trade Commission (FTC) and state alcohol beverage control agencies, and he advises clients on compliance with the regulations and policies of TTB, FTC, the Food & Drug Administration and U.S. Customs and Border Protection (CBP).  Chambers USA ranks McDermott’s Alcohol Practice in its first tier and Marc is the only lawyer listed as a “Star Individual” in this field.  

His work also spans a number of traditional areas of legal practice that affect beverage companies, including the following:

  • Corporate, such as drafting and negotiating distribution and co-pack agreements and handling the alcohol regulatory and due diligence aspects of industry transactions
  • Food and beverage, such as counseling on product formulation matters and representing companies in potential product recall situations
  • Government affairs, such as testifying at legislative hearings, preparing legislative and regulatory proposals, and participating in rulemaking proceedings
  • Litigation, such as handling investigations by government alcohol regulatory authorities and representing companies in disputes with distributors
  • Intellectual property, such as reviewing and clearing advertising and labeling under alcohol beverage laws, voluntary industry codes, and false advertising principles
  • Tax, specifically federal and state excise tax matters

Marc has represented alcohol beverage suppliers before federal and state courts, the US Alcohol and Tobacco Tax and Trade Bureau (TTB, formerly the Bureau of Alcohol, Tobacco and Firearms, or ATF) and Federal Trade Commission (FTC) and state alcohol beverage control agencies. He advises clients on compliance with the regulations and policies of the TTB, FTC, Food and Drug Administration (FDA) and Customs and Border Protection (CBP). Marc also advises companies in the chemical, flavor and extract, energy, health care supply, soft drink and other industries on federal and state regulation of non-beverage alcohol. Marc often brings his in-depth knowledge to bear in legal projects involving many other practitioners, working with transactional deal teams from McDermott and other firms, litigation teams in commercial disputes or government investigations, subject matter specialists in food, agriculture, international trade and other areas, and a network of local lawyers and professionals skilled at handling the state and local zoning and licensing issues that arise in this industry.

202-756-8284