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Volume XII, Number 343

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New Day, Same Story: FDA Issues Additional Warning Letters for Sale and Marketing of Hemp-Infused Human and Animal Products

This week, the U.S. Food & Drug Administration (FDA) posted warning letters to five hemp companies for, in the words of the FDA, "illegally selling products containing cannabidiol (CBD)." 

The warning letters and additional commentary from the FDA can be accessed for a full review here.  Since the passage and enactment of the 2018 Farm Bill, which removed hemp and tetrahydrocannabinol (THC) found in hemp from the Federal Controlled Substances Act, the FDA has consistently asserted regulatory control over certain aspects of the hemp industry pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act) and its implementing regulations.  Chief among those regulatory concerns has been the FDA's position that it is 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.  You can read more about the background and history of this and the FDA's prior warning letters herehere, or on a number of other news, regulatory, and legal sites across the internet.

The batch of letters posted to the FDA's website this week continues the long line of warnings sent to companies operating in the hemp-derived cannabinoid space.  It is not readily apparent why the FDA chose to single out these companies, in particular, for enforcement.  But the letters released this week, as a group, seem to intentionally target and address the following common activities:

  • Sale and marketing of products intended for human consumption that contain added CBD or THC in a form that consumers may confuse with foods.

  • Sale and marketing of products that pose a risk of unintended consumption of CBD or THC by consumers, including failure to label CBD as an ingredient on product labels (for example, simply listing "full spectrum hemp extract" on the product label).

  • Sale and marketing of products in forms that are appealing to children, like lollipops, gum, and candies.

  • Combination of CBD with caffeine in products, because "CBD may affect caffeine metabolism and may increase and/or prolong caffeine's effects."

  • Sale and marketing of animal products containing added CBD or THC for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.  And,

  • The sale and marketing of animal foods and pet treats that are adulterated by adding CBD and other cannabinoids.

To date, the FDA's prior enforcement actions have largely centered on companies selling or marketing human- or animal-related hemp products in connection with unauthorized claims to cure, mitigate, treat, or prevent various diseases and health-related conditions.  But in an important departure from the FDA's past practice, less than all of the warning letters released this week reference alleged FD&C Act health claim violations by the companies.    So what does that mean?  Are these letters a precursor to an onslaught of new industry warnings to come?  Does this signal that the FDA is gearing up to devote more of its enforcement efforts and energies to regulate the use of CBD, THC, and other cannabinoids in situations where companies are intentional and careful not to make prohibited health-related claims about their hemp products?

While this group of warning letters may mark a shift in the FDA's ongoing regulatory enforcement focus, it does not appear to significantly change the industry's overall legal and regulatory risks in prior years.  Much of what the FDA states in these letters has been incorporated into its prior warnings to the industry.  But it remains important for hemp product manufacturers and sellers to carefully and continuously monitor and consider the FDA's position on CBD, THC, and other cannabinoids utilized in food and supplement products and to incorporate that position into their internal compliance practices as they develop, market, and sell hemp products in interstate commerce. 

© 2022 Ward and Smith, P.A.. All Rights Reserved.National Law Review, Volume XII, Number 327
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About this Author

Jane Francis Nowell Business Attorney Ward and Smith, P.A.
Business Attorney

Jane Francis' practice focuses on business and corporate law, including mergers and acquisitions, contract negotiation and drafting, and general business counseling. She also regularly assists clients with the formation of business entities such as corporations, limited liability companies, and partnerships, and has experience negotiation and drafting various types of commercial contracts and agreements.

Before joining Ward and Smith, Jane was a judicial intern for the Honorable Jeffery K. Carpenter of the North Carolina Court of Appeals. She...

252-215-4045
Tyler Russell, Bankruptcy Attorney, Creditors Rights, Raleigh, North Carolina, Ward and Smith Law Firm
Business and Creditor's Rights Attorney

Tyler's creditors' rights practice encompasses bankruptcy, collections, and lender liability issues.  He concentrates his practice on the representation of creditors in bankruptcy cases and state court litigation, including workouts, reorganizations, Uniform Commercial Code security agreement enforcement, collections cases, and other contested matters.  Tyler has represented national and community lenders, trade creditors, equipment manufacturers, agricultural companies, community associations, contractors, and leasing companies in various reorganization and litigation proceedings. His...

919-277-9122
Hayley R Wells, Alcoholic Beverage and Employment Attorney, Ward and Smith, Asheville, North Carolina, University of Georgia, wage and hour, litigation
Alcoholic Beverage and Employment Attorney

Hayley's practice primarily focuses on labor and employment law and alcoholic beverage law.  She regularly advises individual and corporate clients in matters of covenants not to compete, employment discrimination, discipline and termination, harassment, wrongful discharge, wage and hour matters, personnel policies and procedures, and preparation of employee handbooks and employment agreements.  Hayley also advises brewery and craft alcoholic beverage clients in various aspects of the law, including permitting, negotiation and preparation of distribution agreements,...

828-348-6018
Amy H. Wooten Construction Litigation Attorney Ward and Smith Raleigh, NC
Litigation Attorney

Amy Wooten has a wealth of experience in a wide range of substantive areas. She litigates complex commercial litigation cases; construction disputes; community association matters, and disagreements arising in the HOA context; professional licensing defense; and employment litigation. She represents clients in a broad range of commercial matters, such as breach of contract, breach of fiduciary duty, and unfair and deceptive trade practices claims. 

Amy also has significant experience representing industry professionals and contractors in construction defect disputes in state and...

919.277.9130
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