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December 12, 2023
The U.S. Food and Drug Administration has continued a focus on delta-8 THC enforcement with a warning letter to a Greensboro, North Carolina-based company that was allegedly adding the substance to foods.
The warning letter was issued to a firm known as GCHNC LLC that was doing business under several different names. The letter was dated Sept. 28, 2023, but was only posted to the public portal this month.
The letter alleges the firm was manufacturing a variety of food products that contained both delta-8 THC as well as CBD (cannabidiol).
The company allegedly was manufacturing cookies, gummies, candies and a honey product that contained delta-8 THC and/or CBD.
In 2022, FDA issued a consumer update about its concerns with delta-8 THC. The agency listed five primary issues:
Delta-8 THC products have not been evaluated by FDA for safe use.
Adverse events have been reported in connection with these products.
Delta-8 THC has psychoactive and intoxicating effects.
Harmful chemicals may have been used to create the delta-8 THC concentrations claimed in the marketplace.
Delta-8 THC products should be kept away from children and pets.
Attorney Rend Al-Mondhiry, a partner in the firm Amin Talati Wasserman, said this last concern seemed to have loomed large in the issuance of this particular warning letter.
“FDA, and I think rightly so, has focused on delta-8 THC products that resemble common foods, especially those that appeal to children,” she told Natural Products Insider during a phone interview.
“The concern is accidental consumption by children or even accidental over-consumption by adults,” Al-Mondhiry added. “We’ll probably continue to see FDA focus on this group of products that pose the greatest risk.”
In the warning letter, FDA noted there has been no GRAS (generally recognized as safe) determination for delta-8 THC, making any food containing it to be adulterated by definition. In addition, the letter noted that since CBD has been studied as a drug, adding it to a food (in this case one of the honey products the company was allegedly selling) renders it adulterated, too.
FDA said an administrative error prevented the timely posting of the warning letter.
The company did not immediately respond to a request for comment.
Senior Editor, Informa
His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.
The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.
Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.
In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.
When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.
Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.
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