Rare FDA Warning Letter Calls Hemp-Laced Beverage a Drug
Latest News | Posted: 17 December 2013
By Alexander Gaffney, RF News Editor
Related Links
FDA Warning Letter to Green Planet
fda.gov
Most of the Warning Letters issued by the US Food and Drug Administration (FDA) are for fairly predictable indiscretions on the part of manufacturers—misbranded labeling, deficient manufacturing operations, a lack of documentation or poor controls.
But this week saw a violation not often seen in its letters: By marketing a food product as an alternative to an illegal "street drug," a company's product is therefore a drug under the Federal Food, Drug and Cosmetic Act (FD&C Act) and, having not obtained approval, is misbranded.
An Unusual Violation of the FD&C Act
It's an unusual violation, one mentioned in just 14 Warning Letters since 2002 (the first instance in FDA's database), and just four times since 2004. Eight of those letters, in fact, were issued on the same day in 2003 when FDA apparently tried to send all manufacturers of "street drug" products a notice that their activities were unwelcome.
In the agency's latest letter to Green Planet Inc, a California-based dietary supplement manufacturer, FDA alleges that the company markets a drug known as "Hemp Garden Tea," a beverage that looks similar to iced tea drinks commonly found in convenience stores, such as "AriZona Iced Tea."
FDA writes in its Warning Letter that the container for the product is adorned with marijuana leaves and the phrase, "Chill your head with the good stuff."
"The claims […] demonstrate that the product is to be used as a street drug alternative," FDA charged, "Therefore, 'Hemp Garden Tea' is a drug, as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because it is an article (other than food) intended to affect the structure or any function of the body of man or other animals."
And, as that drug has not been approved for use in the US, it is misbranded and improperly marketed under the FD&C Act, FDA concluded.
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