• Jason

CBD Regulation Draws Near

A new memo out from the federal agency responsible for patents and trademarks says that it is executing revised guidelines for registering hemp products since the passage of the 2018 Farm Bill, which legalized hemp federally. In an examination guide released last week the U.S. Patent and Trademark Office (USPTO) asserted that it wouldn’t register goods and services, including federally illegal controlled substances. However, it noted that while cannabis remains prohibited, the agriculture legislation signed last year had removed hemp and hemp-derived products from the Controlled Substances Act (CSA). Applications for trademarks for products that fall in the category of hemp, which can not contain more than 0.3 percent THC on a dry weight basis, would therefore be accepted, USPTO said—with some outliers.


First, the applications must have been submitted on or after December 20, 2018, when President Trump signed the Farm Bill into law. Trademark applications for hemp goods and services that were delivered before the signing will be refused “due to the unlawful use or lack of bona fide intent to use in lawful commerce under the CSA.” “Such applications did not have a valid basis to support registration at the time of filing because the goods violated federal law,” USPTO wrote. “However, because of the enactment of the 2018 Farm Bill, the goods are now potentially lawful if they are derived from ‘hemp’ (i.e., contain less than 0.3 percent THC). Therefore, the examining attorney will provide such applicants the option of amending the filing date and filing basis of the application to overcome the CSA as a ground of refusal.”


However, simply because hemp and its derivatives are legal, that does not mean the agency will approve all trademark applications for concurrent products; it will instead defer to the Food and Drug Administration (FDA) for applications concerning hemp that’s added to the food supply, for example. “Applicants should be aware that even if the identified goods are legal under the CSA, not all goods for CBD or hemp-derived products are lawful following the 2018 Farm Bill,” the new memo says. “Such goods may also raise lawful-use issues under the Federal Food Drug and Cosmetic Act (FDCA).”


The FDA has said that it is illegal to market hemp-derived CBD in the food supply, due to its approval as an FDA-backed drug in the form of Epidolex. There are no precedents for CBD being in the food supply. Applicants looking for a trademark for such products will more than likely be denied. However, if the FDA establishes and follows an alternative regulatory pathway for hemp-derived CBD, that could change. Until then, USPTO will stick to FDA guidance. “The U.S. Patent & Trademark Office’s relatively quick recognition of the revised legal status of hemp and hemp-derived CBD is both commendable and encouraging,” Larry Sandell, a registered patent attorney with Mei & Mark LLP, told Marijuana Moment. “Although a clear pathway for some businesses in the CBD space to protect their branding has been confirmed, many CBD businesses are still unable to federally register their trademarks.”


Sandell suggested taking a preliminary step as the FDA decides how to regulate CBD. Last year, he also provided an overview of intellectual property considerations for cannabis businesses in a sponsored article for Marijuana Moment. “Ultimately, the best course of action for most CBD businesses seeking to secure their brands may be to join the rapidly increasing number of cannabis entrepreneurs that have filed ‘Intent to Use’ (ITU) Trademark Applications at the USPTO,” he said. “These ITUs applications serve to stake ground until the USPTO considers each cannabis-related trademark to have been legally used in commerce under (future) federal law.” A different federal agency made a similar point about its FDA deference in post-Farm Bill updated guidance this past month. The Alcohol and Tobacco Tax and Trade Bureau pointed to FDA policy as the reason it wouldn’t approve formulas for alcoholic beverages with CBD in them regardless of where it came from.

6 views

Food and Drug Administration (FDA) Disclosure

These statements have not been evaluated by the FDA and are not intended to diagnose, treat or cure any disease. Always check with your physician before starting a new dietary supplement program.

Leaving Our Website Disclaimer: If we have a research link to a website where we sell products or have product information you are now leaving the agronomed.com website. Links to any informational websites are provided solely as a service to our users.

The link provides additional information that may be useful or interesting and has no affiliation to the promotion, sale and distribution of Agronomed products. The link does not constitute an endorsement of these organizations by Agronomed and none should be inferred. Please view our full Terms of Use Agreement for more information and the terms and conditions governing your use of this site.

Cannabidiol (CBD) is a naturally occurring constituent of the industrial hemp plant.

Agronomed does not sell or distribute any products that are in violation of the United States Controlled Substance Act (US.CSA). The company does grow, sell and distribute hemp based products.

© 2018 Copyright Agronomed Pharmaceuticals LLC. All rights reserved.