The FDA says that companies have 30 days to convince them that caffeinated alcoholic beverages are safe and legal, because they don’t seem to remember approving them.

The FDA says that in order for a substance to be intentionally added to food, its particular use has to have been approved by FDA regulation, subject to a prior sanction, or be Generally Recognized As Safe (GRAS). If it isn’t, adding it to food is unlawful.

For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts, says the FDA.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

Various attorneys general from 18 states have written the FDA to express their concerns about caffeinated alcoholic beverages.

From the letter:

Several recent scientific studies published in peer reviewed journals demonstrate the dangers of mixing caffeine and alcohol. As these studies show, stimulants such as caffeine appear to mask the intoxicating effects of alcohol, which may lead to increased risk-taking and other serious alcohol-related problems such as traffic accidents, violence, sexual assault, and suicide.

Do you miss “Bud Extra” and “Sparks?”

CAB Letter to FDA from Attorneys General (PDF) [FDA]
FDA To Look Into Safety of Caffeinated Alcoholic Beverages [FDA]

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