The FDA Claims Cocaine Soda A Drug
Earlier this month, the FDA came down on Redux Beverages, the company behind Cocaine Soda, claiming they were marketing it as a drug.
Let me begin by saying that the whole premise and ad campaign for Cocaine Soda is tasteless and appeals to people's baser instincts. It's worthy of being mocked and spoofed. But bad taste is not illegal. Offensive, yes. Illegal, no. Certainly every reasonable person would like to see Cocaine Soda disappear from the market – but by market forces, not by extra FDA censorship. It's a very dangerous precedent.
Let's take a look at the FDA complaint in the letter they sent to Redux Beverages:
"The following statements that are noted on your product container or on your website demonstrate that your product is intended as an alternative to an illicit street drug:
- "The Legal Alternative"
- The product name is "Cocaine," and the letters in the product name appear to be spelled out in a white granular substance that resembles cocaine powder.
- "Speed in a Can"
- "Liquid Cocaine"
- "Cocaine - Instant Rush"
- "The question you have to ask yourself is: "Can I handle the rush?"
- This beverage should be consumed by responsible adults. Failure to adhere to this warning may result in excess excitement, stamina, . . . and possible feeling of euphoria."
Please! As I said, the name Cocaine Soda and its campaign may be tasteless, but their marketing statements cited by the FDA are so tongue in cheek that no cognizant human being would believe they amounted to a claim that the drink was supposed to be a pharmaceutical alternative to the illicit street drug cocaine – particularly when you look at the ingredients. They are virtually identical to every other energy drink – caffeine, sugar, inositol, taurine, etc. Attacking Redux's marketing campaign represents a huuuuge stretch of the intent of the DSHEA Act, which covers labeling and efficacy claims for foods and supplements. This issue has nothing to do with protecting the public from false health claims. The FDA is turning the intent of DSHEA upside down and is using it to enforce its own view of morality – far outside the purview of the law, and reason for everyone to be concerned. What's next, the FDA banning Sly and the Family Stone's, “I Want to Take You Higher” because the song's explicit purpose is to simulate the effects of a controlled substance – to take you higher? You think this is an exaggeration? Not so much. According to the proposed new guidelines, energy work and massage therapy can be considered "medical" treatments and regulated accordingly. We're on very dangerous ground here.
The FDA went on to say about the company's website:
“The following statements on your website about an ingredient of "Cocaine" demonstrate that your product is intended to treat or prevent certain diseases:
"Inositol -... reduces cholesterol in the blood; it helps prevent hardening of the arteries, and may protect nerve fibers from excess glucose damage. Inositol 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."
So what is inositol? It's part of the vitamin-B complex and is required for proper formation of cell membranes.
Was the statement on the Redux website illegal? Not necessarily. Technically, it falls in DSHEA gray area. Redux did not claim that their soda reduced cholesterol or helped with anxiety, only that one of the ingredients could. Was that illegal? Again, not necessarily. There is substantial credible scientific evidence that it can indeed help with these things.
- Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder.
- Inositol treatment of obsessive-compulsive disorder.
- Double-blind, controlled trial of inositol treatment of depression.
- Follow-up and relapse analysis of an inositol study of depression.
- Clinical applications for exogenous use.
- Accumulation of cholesterol in inositol deficiency.
Despite the support of this study, it appears the people at Redux probably confused inositol with inositol hexaniacinate, which is actually a form of niacin and which has a long history of use in controlling blood lipids.
The use of the standard disclaimer on the company's website that the FDA had not approved their statements should have been enough to clear the intent of DSHEA in terms of the supposed medical claims. In the end, though, this wasn't about medical claims. It was about the FDA using an expansion of DSHEA to implement a social agenda because some influential people were offended by the Redux ad campaign. Whatever your opinion of the morality of the issue, the DSHEA laws were clearly not designed to regulate it. By itself, the FDA's action means nothing, but for everyone in the health and nutrition industry and for everyone who uses nutritional supplements, it's a shot across the bow. It's a statement as to how serious the FDA is about their new guidance document and how far they intend to stretch the boundaries of DSHEA. Be afraid. Be very afraid.
There is nothing about Cocaine Soda that is noble. They are not standing up for any great principles. There is nothing about them that is worth defending. But that's exactly why the FDA went after them. They are the perfect patsy on which to test the expansion of their power as augured in their guidance document.
And before we get too indignant about Cocaine Soda, let's remember where Coca Cola got its name – from the coca leaf extract (cocaine) that was used in the original formula. The caffeine in Coke was deliberately put into the formula as a replacement/alternativeto an illicit street drug. There's no ambiguity here. Just think of their advertising slogan: “It's the real thing!” Let' be absolutely clear here. If the FDA's real issue with Cocaine Soda was their choice of name and its positioning as an alternative to an illicit drug, they'd have gone after Coke years ago. Speaking of which, where are the country's moralists when it comes to Coca Cola's name and branding? Probably sipping on their Cokes when they made the decision to go after Cocaine Soda for its publicity value.
Update: the State of Connecticut just seized 300 cases of Cocaine Soda from distribution warehouses throughout the state. Why? The State claims the water used in the sodas is not certified. This is patent nonsense. The real reason was made clear a week earlier when the State Attorney General and the Mayor of Hartford denounced the drink's name. Like the FDA, this is the government turning health and nutrition law upside down in an extralegal attempt to enforce a personal agenda. But in Connecticut's case, I think the agenda is political. They saw how much publicity New York City got for banning trans fatty acids, and they didn't want to get scooped again. All nonsense, except for the fact that it establishes precedent. Everyone in the alternative health community should be concerned.