According to the FDA, the alchemy of marketing has transformed Cocaine, the controversial energy drink, into Cocaine, the new, unapproved, misbranded drug. In an April 11 letter, the FDA warns the manufacturer, Redux Beverages, that it is breaking the law by selling the sugary, caffeine-charged drink as a "street drug alternative," by incorrectly identifying it as a "dietary supplement," and by claiming that one of its ingredients can prevent and treat disease.
The last objection is the easiest to deal with. Redux can simply stop talking about the benefits of inositol, which its website used to claim "reduces cholesterol in the blood," "helps prevent hardening of the arteries," "may protect nerve fibers from excess glucose damage," "has a natural calming effect," and "may be used in the treatment of anxiety, depression, and obsessive-compulsive disorder without the side effects of prescription medications." If Redux gives up that marketing angle, it presumably will no longer feel a need to pretend that Cocaine is a dietary supplement (which can legally be advertised as preventing disease if there is substantial evidence to support the claim, although the FDA has a history of trying to squelch such information).
But it's hard to see how Redux can stop selling a "street drug alternative" without giving up on the brand completely. Among other things, the FDA objects to the brand name; the slogans "Speed in a Can," "Liquid Cocaine," and "Instant Rush"; and a tongue-in-cheek warning that use of the product "may result in excess excitement, stamina, ...and possible feeling of euphoria." Redux's founders evidently did not see the FDA's March 2000 guidance document on street drug alternatives, which clearly states:
These products are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations) and have potential for abuse. FDA considers these street drug alternatives to be unapproved new drugs and misbranded drugs under sections 505 and 502 of the [Federal Food, Drug, and Cosmetic] Act.
How does Redux stop intending that its product be used "for recreational purposes to effect psychological states"? That's the whole point of an "energy drink" (and of putting caffeine in soft drinks generally, but the FDA does not deign to notice that). I don't see how Redux can start pretending otherwise, even leaving aside the problematic brand name (a barrier that Coca-Cola, a caffeinated soft drink that actually used to contain cocaine, has managed to overcome). The solution is clear: Redux should ask the FDA to approve Cocaine as a new drug intended for the treatment of sluggishness and depression.
[Thanks to Allen St. Pierre for the tip.]