The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has been tracking allegations of adverse health effects tied to various brands of popular energy drinks or energy supplements since January of 2004. While the allegations of injuries and deaths keep rolling in and the lawsuits are piling up, FDA has yet to take any position. With so many varying opinions, allegations and suggested actions, how does an energy drink manufacturer manage risk and protect itself from potential future liability?
Energy drink and supplement manufacturers currently find themselves in the “Twilight Zone”—a period after initial allegations have been made but before definitive conclusions of health hazards are known. The “Twilight Zone” is the investigative period which may lead to nothing but which may be the period before potential mass litigation. Manufacturers of food products have found themselves in this “Twilight Zone” all too frequently in the past.
Each time an article is published, a lawsuit filed or an allegation made that a food product potentially causes harm, it is unreasonable to expect a manufacturer to run out and change ingredients or labels. Instead, most choose to wait for further investigation and conclusions, usually by industry or governmental agencies such as FDA. Yet, if those claims of harm ultimately turn out to have some basis, future plaintiffs will argue that the manufacturers and distributors were on notice and should have acted on the early allegations and warnings rather than waiting for more definitive results or ultimate FDA or legislative action. At what point in the “Twilight Zone” does a food manufacturer, such as those in the energy drink industry, take action to manage potential liability?
Current Medical Concerns
The current alleged risks relating to consumption of energy drinks or supplements include the following:
• Increase heart palpations, increase heart rate and blood pressure. Those with medical conditions may have more significant reactions. Those with hypertrophic cardiomyopathy may experience irregular heart rhythms, high blood pressure and sudden death from cardiac arrest.
• Among children and teenagers, increased substance abuse and mental health issues. Children may be less able to handle increased caffeine levels, resulting in risky behaviors such as increased alcohol use, cigarette use and drug use.
• Between January 1, 2004 and March 10, 2014, FDA has been informed of the following events possibly related to energy products: 34 possible deaths and 241 nonfatal events, including 15 that resulted in disabilities.
• FDA has issued warning letters and gotten caffeine drinks that also contain alcohol off the market.
• Between 2007 and 2011, emergency room visits relating to energy drink consumption increased from 10,000 to 20,000 per year.
Current State of the Law
As a threshold issue, FDA has been thus far unable to define whether energy drinks and supplements are conventional food or dietary supplements. The distinction is critical. Some energy drinks label themselves as conventional foods/energy drinks (such as Red Bull) and some as dietary supplements (such as 5 Hour Energy, Monster and Rockstar). The importance of the distinction is that the standards for regulating each require different processes. For conventional foods, a food additive can’t be included unless it is Generally Recognized As Safe (“GRAS”) or unless FDA has specifically approved the additive. While caffeine is an approved food additive for conventional foods, the extreme levels of caffeine in these products may form the basis for challenge the additive should FDA choose to do so. On the other hand, a dietary supplement can include any ingredient, unless FDA conducts vigorous scientific testing to establish the supplement as unsafe. Thus, extreme levels of caffeine are allowed in dietary supplements unless affirmatively proven as unsafe.
In August 2013, FDA asked the Institute of Medicine (IOM) to undertake a workshop to assess the health risks of the consumption of caffeine above moderate levels and whether the consumption among children and teenagers should be better monitored. IOM has yet to issue a report and FDA has yet to take any significant action. Consumer groups have asked that FDA begin requiring warning labels and have also recommended that levels of caffeine in energy drinks not be permitted to exceed the levels in soda. FDA recently stated that it has no current plans to require warning labels and apparently has no intention to take any further action until receiving the IOM findings.
A reasonable person might assume that because energy drink and supplement manufacturers are generally compliant with all current state and federal laws, FDA regulations and industry standards, they should have no concern of civil liability. But in most states, compliance with the law and current industry standards provides only “some” evidence that the food manufacturer was not negligent. Unfortunately, that isn’t the whole story. It is during this “Twilight Zone” that the management of legal risk is sometimes most difficult.
Currently, there are some medical studies alleging health risks associated with the products. There are at least a few dozen personal injury or wrongful death lawsuits that have been filed. There is a suit seeking to enjoin various advertising, labeling and sales to minors. A search on Google will turn up dozens of plaintiff’s attorneys currently advertising on the Internet for cases against energy drink manufacturers and distributors. And there is a lot of evidence that the products are safe.
So what are the options available to manufacturers and distributors of energy drinks and supplements during this phase? One choice is to simply comply with the current laws, regulations and industry standards, while awaiting the conclusion of the ongoing investigations. Additional potential options include:
• Provide additional warning labels of some sort on the energy drink or supplement;
• Change advertising practices; and/or
• Reduce the caffeine levels in their products.
The problem with this option is that while it may do the most to potentially reduce the risk of injuries and thus potential lawsuits, no studies or reports have yet defined what a “safe” level of caffeine is for energy drinks unless reduced to the levels of sodas—and then it’s not an energy drink or supplement anymore.
When food manufacturers find themselves in the “Twilight Zone,” where they are still in compliance with the law yet there are allegations and even a few lawsuits alleging their products cause significant harm, how do they manage their risk? Every option has multiple potential repercussions, both positive and negative. But in this zone, the issue can’t be ignored, and risk analysis and management must be carefully analyzed from both a business and legal perspective.
Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is comprised of a team of attorneys from every legal practice area and who each have a focused background in the food industry.