Don't fret, your morning latte is likely safe. But the FDA is taking a close look at caffeine — specifically the proliferation of caffeine in nontraditional products such as energy drinks and gum. The FDA's concern was evident when it asked Wrigley to pull back its new caffeinated gum a few months back.
Caffeine has a limited regulatory status. Only one federal regulation, CFR 182.1180, mentions caffeine and this grants caffeine "Generally Recognized as Safe" (GRAS) status up to .02 tolerance in soft drinks. The FDA has also explicitly banned the use of caffeine in some products. For example, in 2010 the FDA banned the use of caffeine in malt alcohol beverages due to serious public health risks posed by combining a stimulant with a depressant.
The FDA's focus on energy drinks is broader than just the question of caffeine in the product. Many energy drink companies classify their products as dietary supplements (although some are voluntarily changing their status to regular beverages, such as Monster Beverages). Under federal law, this shifts the burden of proof as to the safety of the product.
A product categorized as a food or beverage places the burden on the company to prove it is safe. However, a product classified as a dietary supplement requires the FDA to prove it is unsafe. In addition, a dietary supplement must only list caffeine as an ingredient that is part of the "energy blend" and only must list the aggregate amount of the blend.
Courts are also examining energy drink safety. The first salvo of caffeine litigation and the cases getting the greatest media attention include less than a handful of product liability-based wrongful death lawsuits related to adolescents' consumption of energy drinks. Essentially, family members in those lawsuits claim that the energy drinks contain excessive levels of caffeine for adolescent consumption and, moreover, that the warnings on the energy drinks are insufficient to warn against excessive consumption. The defendants are vigorously defending the claims.
The cases, however, are still in their infancy. Although no legal trends have been established in the cases thus far, a manufacturer faced with such a lawsuit maintains an arsenal of well-established substantive defenses to defeat the claims, including the following:
- Causation Defense: The primary hurdle for a plaintiff in any toxic tort case is to scientifically demonstrate there are sufficient levels of exposure to a substance to show both general and specific causation. Caffeine-based personal injury litigation is no different. Given that caffeine is universally recognized as safe in doses less than 400mg per day and given that the types of injuries involved in the caffeine cases can be caused by numerous non-caffeine-related factors, it will be very difficult for a plaintiff to establish a causal relationship between a defendant's caffeinated product and the injury.
- Misuse Defense: This defense is a complete bar to a product liability claim where a manufacturer cannot be held to have expected that a reasonable consumer would misuse the product in such a way. For example, in the context of caffeine products, a number of media reports indicate that consumers are recklessly abusing caffeine by mixing the products with depressants, such as alcohol. A manufacturer should not be responsible under traditional notions of product liability law for abuse of products that are inherently safe if used properly.
- Pre-emption Defense: In a nutshell, the federal Nutrition Labeling and Education Act specifically governs food labeling, including foods with caffeine. Therefore, if the plaintiff is challenging the content of a food label that is specifically covered by a regulation, the claim may be preempted.
- Primary Jurisdiction Defense: This defense is frequently used where preemption is not currently viable. Generally speaking, primary jurisdiction applies where a claim, such as an "inadequate labeling claim," is currently being addressed by the appropriate regulatory body at issue (i.e., the FDA). If applicable, a case may be dismissed or stayed until the agency makes a final determination.
Given the rapid rise in food-related litigation in recent years, caffeine's growing popularity, ongoing FDA investigations and possible regulations, the bad (and, in many ways, irresponsible) publicity, and a well-funded plaintiffs' bar, caffeine-related food litigation is likely to increase greatly. But understanding the evolving regulatory regime along with available primary defenses against this litigation can help minimize risk and liability exposure for producers of existing caffeinated foods and beverages or those being brought to market.