Tens of billions of energy drinks have been sold and safely consumed worldwide for approximately 25 years, including more than 8 billion cans of Monster Energy® that have been sold and safely consumed in the United States and around the world since 2002.
Monster is confident in the safety of its products and their ingredients. We believe that consumers are justified in having confidence in the safety of our products, based on our long track record and the scientific evidence supporting the safety of our ingredients.
Energy drinks are fully regulated by the U.S. Food and Drug Administration (FDA). Monster appreciates the FDA’s science-based review of this product category. The company has been communicating with the agency to share data and information, including third-party scientific literature that documents the safety of its products and their appropriate labeling.
Monster welcomes FDA’s conclusions to date, which the agency has expressed in publicly available letters dated August 10, 2012, and November 21, 2012. In those letters, FDA explained that there is a long history of safe use of caffeine-containing products in the United States and that the average amount of caffeine consumed by the U.S. population has not increased despite the entry of energy drinks into the marketplace.
FDA stated in August, “In response to the emergence of energy drinks as a new class of caffeinated products, FDA completed an updated assessment of the amount of caffeine that people in the United States ingest from all sources. The results show that, even when the consumption of energy drinks is considered, most of the caffeine consumed comes from what is naturally present in coffee and tea.” The study commissioned by FDA also showed that caffeine consumption remains at only approximately 300 milligrams per person per day. That amount is within safe levels, for FDA stated that, “For healthy adults, caffeine intake up to 400 mg per day (mg/d) is not associated with general toxicity, cardiovascular effects, effects on bone status and calcium balance (with consumption of adequate calcium), changes in adult behavior, incidence of cancer, or effects on male fertility.” The agency concluded that, although FDA’s “project to identify safety studies on caffeine is still underway, the available studies do not indicate any new, previously unknown risks associated with caffeine consumption.”
Monster energy products generally contain approximately 10 mg of caffeine per ounce from all sources. The leading brands of coffeehouse-brewed coffee, for example Starbucks, contain on average in excess of 20 mg of caffeine per ounce. In other words, a 16-ounce can of Monster Energy contains roughly half the caffeine of a 16-ounce cup of coffeehouse-brewed coffee. Our products are therefore just as safe for consumers as a cup of coffee purchased at your favorite coffee house.
In any case, Monster Energy products have been labeled for years with the statement, “Not recommended for children, pregnant women or people sensitive to caffeine."
Regarding other ingredients in energy drinks, FDA stated, “FDA has yet to identify any safety studies that call into question the safety of combinations of various ingredients added to ‘energy drinks’ under intended conditions of use.” In particular, with respect to the common energy drink ingredients, taurine and guarana, the agency stated that “FDA searched the literature but did not find any information that calls into question the safety of these ingredients as currently used in beverages.”
An area of recent media focus has been on the fact that Monster Energy products are labeled as dietary supplements rather than as foods. Monster Energy products meet the definition of “dietary supplement” in the Federal Food, Drug, and Cosmetic Act because they are products intended to supplement the diet with dietary ingredients such as caffeine, taurine, B vitamins, and the amino acid L-Carnitine. FDA has not objected to such products being marketed as dietary supplements, which it fully regulates, and has stated that energy drinks could be marketed either as dietary supplements or as foods as long as they meet all of the legal requirements for the category. A recent memorandum prepared for the American Beverage Association may also provide further education regarding the regulation of energy drinks as foods and dietary supplements (see the ABA memorandum attached.)
Monster Energy products could be legally labeled and sold as foods if we chose to do so because our ingredients at current levels are either FDA approved food additives or are GRAS, which stands for Generally Recognized as Safe, and are therefore permissible food ingredients. Apart from minor changes in form, the labels of Monster Energy as a food would be almost precisely the same and contain the same details as currently appear on our cans. As a result, whether Monster Energy drinks are classified as a dietary supplement or as a food is a distinction without a difference.
Finally, the media has focused recently on so-called adverse event reports (AERs) that are filed with the FDA. These reports were received by the FDA over an eight year period between 2004 and 2012, so there are no new or sudden issues. The FDA has long been aware of these reports.
In a statement that accompanied FDA’s Nov. 16, 2012, release of AERs pertaining to energy drinks, the agency stated that: “The existence of an adverse event report does not necessarily mean that the product identified in the report actually caused the adverse event. FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event.”
More specifically, the FDA has made it clear that it has not established any cause or link between Monster Energy products and any of the handful of events reported in the adverse event reports database. Notably, FDA had already received virtually all of the adverse event reports that are currently being discussed when it stated its conclusions, cited above, that the evidence reveals no new, previously unknown risks associated with caffeine consumption. Monster Beverage Corporation monitors consumer communications it receives, and is not aware of any fatality anywhere that has been caused by its products.
In summary, neither the science nor the facts support the allegations that have been made regarding the safety of Monster Energy products. Monster reiterates that its products are and always have been safe.