Will coffee stout be illegal?

image by zappowbang

Today, the FDA has issued a notice to 30 manufacturers stating that it intends to look into the “safety and legality” of their caffeinated alcoholic beverage products. Alcohol manufacturers receiving the notice have 30 days to prove to the FDA that their products are safe and legal.

Caffeine as an additive has only been approved by the FDA in soft drinks in concentrations of no more than 200 parts per million. The manufacturers now must prove that their use of caffeine is safe, or else their products will be pulled from the market.

Under the Food, Drug, and Cosmetic Act, a substance added to food is not considered safe, or legal, unless: 1) the FDA has approved its use, 2) the substance is subject to a prior sanction, or 3) the substance is generally recognized as safe. “For a substance to be [generally recognized as safe], 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.”

What is the impetus of this investigation, or, rather, demand? According to the FDA, it is the “increasing popularity” among college students of caffeinated alcoholic beverages, and “reports of potential health and safety issues.” The reports, apparently, came from a letter from 18 Attorney Generals and a city attorney that alleged caffeine masks the effects of alcohol and leads to violent behavior.

Keep in mind that any formula for an alcoholic beverage that is not a traditional process, or including traditional ingredients, must be approved by the TTB prior to is production and sale. So, each of these manufacturers’ beverages have already been approved by one federal agency.

Will manufacturers now have to prove that combining any caffeinated substance with alcohol is safe? There is no clear guidance from the FDA, merely a demand that the manufacturers prove the product is safe and legal.

What does this mean for mixed drinks (Irish Coffees, Red Bull and Vodka)? If the FDA decides that it is not safe to combine caffeine and alcohol, will bar tenders no longer be able to make these mix drinks?

What about coffee stouts? Caffeine is not being added by itself, but there are still trace amounts in the beer. Most likely, coffee stouts will not be affected; the beverages in question actually add caffeine to the product (caffeinated beer, for example).

Depending on what the FDA determines on this issue, the potential for very complicated regulation is high.