The US Food and Drug Administration has given Nevada-based beverage manufacturer Redux Beverages 15 days to rectify the on-package and website marketing of its energy drink Cocaine or face market withdrawal.
Since late 2006, Cocaine has been marketed as a dietary supplement with statements such as "Speed in a Can," "Liquid Cocaine" and "Cocaine — Instant Rush," along with cholesterol-lowering claims. A mock health warning reads: "This beverage should be consumed by responsible adults. Failure to adhere to this warning may result in excess excitement, stamina, fun and possible feeling of euphoria."
According to the FDA, this amounts to Cocaine being sold as a drug, a status the drink can only attain if, unlike dietary supplements, it gains pre-market FDA approval as per the Food, Drug, and Cosmetic Act.
"Your product, Cocaine, is a drug," FDA wrote in a three-page letter to Redux on April 4, after monitoring the product since February. "It's also a new drug and as such cannot be sold without FDA approval. In addition, the FDA said, the product is mislabeled because it doesn't include "adequate directions for its intended uses." "You must immediately correct these violations," FDA said. "If you do not… you may be subject to enforcement action against you without further notice."
Redux managing partner, Hannah Kirby, admitted the company had acted naively but said its marketing was intended to be tongue-in-cheek. "Obviously, we're not a drug. We pretty much have the identical ingredients of every other energy drink out there," said Kirby, while acknowledging Redux was "moving quickly to fully comply with FDA's requests."
Offending material has been removed from the Cocaine website and a statement posted that reads in part: "The purpose of the beverage is to provide essential sugars, amino acids, caffeine and vitamins useful in supplementing and promoting consumer energy levels… Cocaine energy drink is not an illegal substance, and it contains no illegal substances. It is not a substitute, alternative or analog to any illegal substance. It is not designed for or intended to be used to diagnose, cure, treat, mitigate or prevent any diseases."
The FDA action will please dietary supplement industry bodies such as the United Natural Products Association and the Natural Products Association, which have called for Cocaine's censure since last year.