Caffeine seems to have been around forever. I do not remember my first cup of coffee or my first can of cola, but I do remember the over-the-counter (OTC) stimulant drug products containing 200 mg of caffeine that were an absolute necessity for most of my classmates to survive freshman year of college and first year of law school. From all those years ago, how did caffeine become such a popular food and dietary supplement ingredient, and why is it now so controversial?
Ephedra may be to blame. In the late 1990s, ephedra was one of the hottest selling dietary supplements available. Frequently formulated with caffeine, ephedra was marketed primarily for energy and weight loss. Unfortunately, there were also reports of adverse events related to consumption of ephedra, and the media reported it was an unsafe product that needed to be banned.
In June 1997, FDA proposed a regulation to limit the serving size for ephedra-containing products, to 8 mg of ephedrine alkaloids per serving (in a six-hour period) and a total daily intake of 24 mg. At the time, 25 mg of ephedrine alkaloids per serving one or more times per day was standard (based on FDA’s regulation for asthma drugs containing synthetic ephedrine). Looking back, perhaps the industry should have supported the agency’s proposal, and ephedra could have remained on the market, albeit at a low serving size. Instead, industry opposed FDA’s efforts, and some companies continued to come out with products containing higher amounts of ephedra, caffeine and other stimulants.
It took FDA an additional seven years, but in February 2004, the agency issued a final regulation removing all dietary supplements containing ephedrine alkaloids from the market, declaring the products presented a significant or unreasonable risk of illness or injury. I imagine companies began to look for alternatives to ephedra at this time, which is why products such as Red Bull reportedly began U.S. sales in 1997, Rockstar Energy was launched in 2001, and Monster Energy was first sold in 2002. Since their inception, these market leaders and similar products have been successful with millions and even billions of dollars’ worth of sales annually.
But, it’s not just energy drinks; foods with caffeine are attracting attention as well. According to a letter sent to FDA by the Center for Science in the Public Interest (CSPI) on Nov. 16, 2012, caffeinated products include:
• MiO water enhancer packaged in a squirt bottle with 60 mg of caffeine per squirt,
• Crystal Light Energy with 60 mg of added caffeine,
• Jelly Belly’s Extreme Sports Beans with 50 mg of caffeine per ounce,
• Cracker Jack’d adult version of Cracker Jack with approximately 70 mg of caffeine per serving,
• Caffeinated potato chips, granola and nuts from Arma Energy Snx Inc.,
• Bing! Bang! Boom! ice cream with 125 mg of caffeine per 4 ounce serving, and
• Various gummy bears, brownies, cookies and even marshmallow squares.
In addition, a consumer could make Wired Waffles with 200 mg of caffeine per waffle, pour on some Wired All-Natural Caffeinated Maple Syrup (168 mg of caffeine per 2 tbsp), add Steem peanut butter product, which claims 150 mg of caffeine per 2 tbsp, and have a very energetic breakfast. This meal would deliver quite a large amount of caffeine—probably more than anyone should consume in a day.
FDA has taken notice of the increasing amount of caffeine being added to a diverse array of products, and has expressed concerns. In April 2013, when Wrigley announced the launch of a caffeinated gum, FDA stated:
"The only time that FDA explicitly approved the added use of caffeine in a food was for cola, and that was in the 1950s. Today, the environment has changed. Children and adolescents may be exposed to caffeine beyond those foods in which caffeine is naturally found, and beyond anything FDA envisioned when it made the determination regarding caffeine in cola. For that reason, FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on health, particularly vulnerable populations such as children and youth, and if necessary, will take appropriate action."
Within about a week, after a series of discussions with FDA, in which the agency expressed concerns about caffeine appearing in a range of new foods and beverages, Wrigley announced a decision to pause production, sales and marketing of its Alert Energy Caffeine Gum.
Not all companies have responded to FDA as quickly. In a Dec. 17, 2015 announcement, FDA expressed its concern about the marketing of a caffeinated peanut butter, which it noted was a food popular with many children. FDA stated the company, STEEM Peanut Butter Inc., had not submitted to FDA any information about the safety of its use of caffeine in its peanut butter product (reportedly 150 mg per 2 tbsp and 1,200 mg per jar). In its announcement concerning the caffeinated peanut butter, the agency stated:
“The FDA remains concerned about the increasing number of products on the market containing added caffeine and the possibility for harmful effects when multiple caffeinated products are eaten simultaneously, especially in products that are attractive to children. The FDA will continue monitoring the marketing of these novel food products in order to ensure public health and the integrity of the regulatory system designed to protect the food supply."
FDA’s concern should at least be considered by anyone involved in the marketing of caffeine products. And it is not just marketers adding caffeine to a wide array of foods. Some companies have gone beyond what might be considered reasonable. The example of such action is the marketing of pure powdered caffeine, which FDA has taken steps to remove from the marketplace by issuing a number of warning letters.
As noted by FDA, the difference between a safe amount and a toxic dose of caffeine in pure powdered products is small. These products are essentially 100 percent caffeine, and a single teaspoon of pure caffeine is roughly equivalent to the amount in 28 cups of coffee. [link to] Obviously, a safe amount and a potential toxic amount of such a product could depend on a fraction of a teaspoon, which resulted in FDA determining such products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers."
The bottom line is with all of these caffeinated products readily available and the potential for injury, particularly among children, companies need to make careful decisions. This should not become a race to get as much caffeine into as many products as possible. Reports of serious injuries and even deaths have been purportedly attributable to caffeine energy products, and various news outlets have started to question the safety of these products. If this continues, the news media may further turn against such products creating a tidal wave effect, which could cause FDA to take action that might see many caffeine products go the way of ephedra.
Looking for innovative approaches to formulating energy products or the legal considerations in the category? Join us for the Capitalizing on the Future of Energy Drinks, Shots and Supplements workshop on Wednesday, Oct. 6, at 9 a.m., at SupplySide West 2016.
And check out the Healthy INSIDER podcast where Shapiro discusses how the definition of “children" is contested between energy drink product marketers and regulators.
Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.