Cocaine clampdown highlights regulator power

The US Food and Drug Administration (FDA) has bared its teeth against an energy drink claiming to give users a feeling of euphoria, and going under the name Cocaine. The beverage, which contains the caffeine equivalent of 3.5 cups of coffee as well as dextrose, guarana, the amino acid taurine and a vitamin cocktail, was marketing itself as 'the legal alternative,' a direct reference to the illegal status of its namesake narcotic — cocaine. Other claims included 'Speed in a Can,' 'Liquid Cocaine' and 'Cocaine — Instant Rush.'

In an April letter, the FDA ordered Redux Beverages — the Las Vegas-based start-up that manufactures Cocaine — to alter its marketing or have its product removed from retail shelves. Redux quickly removed all offending slogans from its website, posted a conciliatory statement that reiterated its status as an energy drink and added, "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."

Redux announced in May that it would temporarily cease distribution of Cocaine in the US until legality of using the name could be established. Despite the company's campaign to write letters in support of the product's status as "an energy drink like all of the other energy drinks," it plans on relaunching the product in spring under a new name.

Cocaine has already been banned in Australia for exceeding permitted caffeine levels there, and the US convenience store chain, 7-11, refused to stock it despite potentially lucrative sales as a prime outlet for Cocaine's core 16-25 market. The state of Connecticut has also banned it.

The FDA's action has heartened those who defend the ability of the Dietary Supplements Health and Education Act (DSHEA) to create and ward over a safe and responsible dietary-supplements industry. Cocaine is sold as a dietary supplement, a status the FDA questioned in its letter to Redux. "Your product, Cocaine, is a drug. It's also a new drug and as such cannot be sold without FDA approval," the FDA decreed.

DSHEA critics argue the 1994 legislation doesn't contain enough measures to scrutinise products before they enter the market and does not grant the FDA enough power to adequately police the sector even though products whose safety was brought into question, such as ephedra, have been removed from shelves by the FDA. Others, such as bitter orange, are being monitored by the FDA as well as Health Canada, which has issued two warnings against the citrus extract.

Daniel Fabricant, PhD, the vice president of scientific and regulatory affairs at the Washington, DC-based Natural Products Association, said the DSHEA gave enough power to regulators. "This action against Cocaine sends a clear message to industry critics who claim that the industry is unregulated. It demonstrates the industry is, in fact, regulated; that the FDA has all the authority necessary to take action when and where appropriate. That makes for a level playing field. A reputable company should not have to compete for business or be associated with companies that don't operate within the law."

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