Fox Rothschild: The Regulation Of Hemp, Hemp Derivatives And CBD In Animal Product

Fox Rothschild: The Regulation Of Hemp, Hemp Derivatives And CBD In Animal Product
The Regulation Of Hemp, Hemp Derivatives And CBD In Animal Products

Published via JD Supra..

If you are trying to navigate the space where hemp products intersects with animal products, it can be unclear as to which authority to turn to for guidance. In the United States, FDA, FTC, DEA and USDA share governance over the cannabis and hemp animal product industry, including regulations on labeling, distribution, growing, and sales. Understanding these intersecting laws and agency policies can help companies navigate this evolving marketplace.

The Food and Drug Administration (FDA)

Whether derived from marijuana or hemp, FDA considers CBD products to be drugs if intended for use (including advertisements) in the diagnosis, cure, mitigation, treatment or prevention of disease and/or intended to affect the structure or any function of the body. FDA considers products containing CBD marketed as animal food to be adulterated animal foods and are therefore prohibited pursuant to Section 301(II) of the FD&C Act, 21 U.S.C. 331(II), since the FDA found no evidence that the substance was marketed in food before the drug was approved (has not been approved for use in animals), or before the substantial clinical investigations involving the drug has been instituted. FDA would not consider CBD to be a “food additive” since it has not been generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.

FDA uses warning letters and enforcement actions to control how and what products are put into the marketplace. Failure to comply could result in product seizures, injunctions or civil and criminal penalties. In a 2019 FDA presentation, the agency highlighted its policy interests in regulating cannabis products. Among top priorities, the FDA is focused on both protecting the public from harmful or fraudulent products and encouraging scientific research in order to protect “the integrity of the conventional food supply.”

As an example, FDA has issued warning letters to several companies that produce cannabis pet products. These letters inform the companies of their violations, which typically are related to unfounded advertisements that the cannabis product can cure or treat a disease, which the FDA does not permit. Failure to make the appropriate changes after receipt of a warning letter could result in additional legal action.

The Federal Trade Commission (FTC)

The FTC regulates product advertisements to ensure that consumers are not being misled with false claims on product labels. Its regulating authority also permits it to freeze assets, seek temporary restraining orders, or institute civil litigation against companies or brands that engage in deceptive marketing practices. The FTC has sent warning letters to companies producing CBD infused products that state it is illegal to “advertise that a product can prevent, treat, or cure” a disease without the proper “competent and reliable scientific evidence.”

The Drug Enforcement Administration (DEA)

The DEA is responsible for overseeing the manufacturing, distribution, and advertising of controlled substances. Although the 2018 Farm Bill (see below) removed hemp from the definition of marijuana, marijuana remains a Schedule I controlled substance and the DEA continues to regulate it as such. The DEA has the authority to inspect products, issue warning letters, or enforce compliance with controlled substance regulations by issuing criminal or civil penalties.

Currently, the DEA does not give Schedule I clearance to health care practitioners, a category which includes veterinarians. As a result, veterinarians have no authority under the DEA to prescribe or recommend cannabis products. Doing so could subject them to DEA prosecution.

The United States Department of Agriculture (USDA)

Finally, the catalyst for the hemp product explosion – The 2018 Farm Bill. The Farm Bill is a package of legislation that is passed every 5 years. It shapes the programs, priorities and budgets for the USDA and its related entities. The 2018 Farm Bill removed hemp from the definition of marijuana and established the ability for states to work with the USDA to coordinate their own hemp production framework.

Current Status

Even though there have been many recent updates to hemp production and product regulation, there has not been much movement when it comes to changes on the cannabis pet products side. The FDA has not approved hemp or any hemp derivatives for use in any animal food, including animal treats. Furthermore, veterinarians who administer, prescribe or recommend CBD products with the intent to prevent, mitigate, treat or cure a condition in animals are utilizing the products as drugs. The FDA considers this to be unapproved animal drug use, subjecting the prescribing veterinarian to disciplinary action.

There are additional concerns that stem from the cannabis pet products industry. Check back for two additional blog posts that explore labeling concerns, potential side effects, current research efforts, and the regulation of cannabis pet products on an individual veterinarian basis.

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Canada
Matt Maurer – Minden Gross
Jeff Hergot – Wildboer Dellelce LLP

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Tim Morales – The Cannabis Industry Association Costa Rica

Nicaragua
Elvin Rodríguez Fabilena

USA

General
Julie Godard
Carl L Rowley -Thompson Coburn LLP

Arizona
Jerry Chesler – Chesler Consulting

California
Ian Stewart – Wilson Elser Moskowitz Edelman & Dicker LLP
Otis Felder – Wilson Elser Moskowitz Edelman & Dicker LLP
Lance Rogers – Greenspoon Marder – San Diego
Jessica McElfresh -McElfresh Law – San Diego
Tracy Gallegos – Partner – Fox Rothschild

Colorado
Adam Detsky – Knight Nicastro
Dave Rodman – Dave Rodman Law Group
Peter Fendel – CMR Real Estate Network
Nate Reed – CMR Real Estate Network

Florida
Matthew Ginder – Greenspoon Marder
David C. Kotler – Cohen Kotler

Illinois
William Bogot – Fox Rothschild

Massachusetts
Valerio Romano, Attorney – VGR Law Firm, PC

Nevada
Neal Gidvani – Snr Assoc: Greenspoon Marder
Phillip Silvestri – Snr Assoc: Greenspoon Marder

Tracy Gallegos – Associate Fox Rothschild

New Jersey

Matthew G. Miller – MG Miller Intellectual Property Law LLC
Daniel T. McKillop – Scarinci Hollenbeck, LLC

New York
Gregory J. Ryan, Esq. Tesser, Ryan & Rochman, LLP
Tim Nolen Tesser, Ryan & Rochman, LLP
Cadwalader, Wickersham & Taft LLP

Oregon
Paul Loney & Kristie Cromwell – Loney Law Group
William Stewart – Half Baked Labs

Pennsylvania
Andrew B. Sacks – Managing Partner Sacks Weston Diamond
William Roark – Principal Hamburg, Rubin, Mullin, Maxwell & Lupin
Joshua Horn – Partner Fox Rothschild

Washington DC
Teddy Eynon – Partner Fox Rothschild