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.
Major Omissions Relative to Earlier Letters
FDA's letter to Green Planet excludes warnings issued in other letters, such as one issued in 2012 to Evol Nutrition.
"Street drug alternatives, i.e., products that claim to mimic the effects of recreational drugs, are not intended to supplement the diet and, as a result, cannot lawfully be marketed as dietary supplements," explained FDA in that letter.
But FDA's letter also leaves out much of the explanations that have adorned other letters, such as a 2008 letter to Jennifer Gulla, who maintained a website for a product known as "Blow."
"The name of your product, 'Blow,' is well known street drug terminology for illicit cocaine, and as such suggests that the product is intended to affect the structure or function of the body," FDA charged in its letter. "In conjunction with the information below, the name 'Blow' may suggest to the ordinary observer that the product may have effects on the body similar to cocaine."
FDA presumably had similar qualms with Green Planet's use of marijuana leaves on its product, but it is curious that it did not take the same effort to explain its problems with the product using the same standard as set forth in the 2008 letter.
In addition, FDA's letter to Green doesn't call Hemp Garden Tea a dietary supplement. Photos of the product posted online appear to show it labeled as an ordinary food product, albeit one containing "hemp oil extract" as an ingredient.
Other materials used to market the product, such as the company's Facebook page, clearly associate the product with the term "marijuana," however.
Whatever the veracity of FDA's claims, the letter undoubtedly constitutes an unusual use of its enforcement powers.
The company has 15 days from its receipt of the letter to respond to FDA.
FDA Warning Letter to Green Planet