FDA Warning Letters Issued To Four Makers of Caffeinated Alcoholic Beverages

Four companies were warned by the U.S. Food and Drug Administration (FDA) about the “unsafe food additive” in the caffeine used in their malt alcoholic beverages. The warning included the threat of seizing their products, a federal law possibility.

The following companies and products are on red alert:
 

The FDA conducted a scientific review of the products, after going through co-consumption of caffeine and alcohol literature published and reviewed by peers, in consultation with experts in the fields of emergency medicine, epidemiology, neuropharmacology, and toxicology. Additionally, they evaluated data from product manufacturers and analyzed the products in they own independent laboratory.

“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

The concerns raised by experts indicate the impairing judgment of intoxication levels due to masking of sensory cues. Peer-reviewed literature implied risky behavior associated with consuming beverages containing alcohol and added caffeine.

FDA intends to work with the products’ manufacturers to meet safety standards.

Caffeine and Alcohol: A Dangerous Mix?

The actual toxic potency of caffeine and alcohol mix is still not fully clear. However, experts conclude that the combination does indeed mask sensory cues indicating intoxication levels. Some researchers call this the "toxic-jock syndrome."

Caffeine gives the body a boost, increasing heart rate and blood pressure. In extreme cases, it can also cause irregular heartbeat and heart palpitations. Sometimes, caffeine triggers agitation, headaches, and abnormal breathing, jitteriness, and stomach ailments. As Lipshultz commented, it is the equivalent of an adrenaline rush.

Conversely, alcohol slows the functioning of the brain. It is a depressant. It affects the ability to talk, think, and walk.

Regulations regarding Caffeine and Alcohol

Caffeine is an unsafe food additive, and therefore if a product containing caffeine is considered adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(2)(C)]. Regulations on the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).

As defined in section 201(s) of the Act [21 U.S.C. § 321(s)], the term "food additive" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use. Under section 409 of the Act [21 U.S.C. § 348], a food additive is unsafe unless a regulation is in effect that prescribes the conditions under which the additive may be safely used, and the additive and its use or intended use are in conformity with that regulation.

FDA regulations approve 0.02 percent caffeine levels under GRAS in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, under this regulation, the use of caffeine in alcoholic beverages or at higher use levels does not fall into the GRAS category.