On March 19, 2013, a group of doctors, researchers, and public health experts sent a joint letter to the Commissioner of the U.S. Food and Drug Administration (“FDA”) urging the FDA to make changes to the regulation of energy drinks. In its letter, the group concluded that there is a “robust correlation between the caffeine levels in energy drinks and adverse health and safety consequences,” especially where children, adolescents and young adults are concerned. Furthermore, the group claims that “there is neither sufficient evidence of safety nor a consensus of scientific opinion to conclude that the high levels of added caffeine in energy drinks are safe under the conditions of their intended use.” As a result of these findings, the group is pushing the FDA to require manufacturers to label energy drinks with the product’s caffeine content and demonstrate that the levels of caffeine in those products are generally recognized as safe (“GRAS”) and comport with existing GRAS standards for beverages.
The FDA has previously dismissed public concerns about the safety of caffeine levels in energy drinks. In an unpublished response to Senator Dick Durbin’s 2012 investigation of dietary supplements, which included energy drinks, the FDA explained that the amount of caffeine in energy drinks is not significantly different from the levels of caffeine in commonly consumed beverages like coffee or carbonated soda. (For more information, please see Natural Insider’s article here.) Furthermore, the FDA noted that most caffeine consumed by Americans comes from what is naturally present in coffee and tea and that a review of the available studies does not indicate any new, previously unknown risks associated with caffeine consumption.
Monster to Market Energy Drinks as Beverage Instead of Dietary Supplement
In a move unrelated to the letter described above, Monster Beverage, the largest seller of energy drinks, recently announced its plan to discontinue marketing its energy drink products as dietary supplements. Instead, Monster will market its products as conventional beverages. In addition to implementing required changes to its product labeling to reflect nutrition facts instead of supplement facts, Monster disclosed that its energy drink products will now specify caffeine content. (For more information about the change in the marketing of Monster energy drinks, please click here.) Monster’s announcement of its plan to shift the marketing of its energy drinks comes just a few months after another energy drink brand, Rockstar, made a similar move.
According to Joseph Cannata, an executive vice president at Rockstar, Rockstar made its decision to market energy drinks as beverages because consumers found food labels easier to read than dietary supplement labels. A spokesperson for Monster, Michael Sitrick, explained that Monster’s decision was influenced by several factors. Specifically, Mr. Sitrick stated that a major reason for the change was to stop the “misguided criticism” that Monster was selling its energy drinks as dietary supplements because dietary supplements are more lightly regulated than beverages. Additionally, Mr. Sitrick explained that “Monster Energy drinks could equally satisfy the regulatory requirements” for either dietary supplements or beverages. (For more information, please read the New York Times article here.)
These announcements from Rockstar and Monster Beverage come after a year of close public scrutiny over energy drinks. In July 2012, the parents of a 14-year-old girl filed a lawsuit against Monster after their daughter died following the consumption of two Monster Energy products. (For more information about this incident, please read CBS’s coverage here.) In November 2012, the FDA received several voluntary adverse health reports listing the dietary supplement 5-hour Energy as contributing to an illness or death. Subsequently, the FDA began a routine investigation to determine whether a possible link exists between the hospitalizations and 5-hour Energy. (For more information about this investigation, please read CBS’s coverage here.) In spite of these recent investigations, the FDA has not officially changed its position regarding the safety of consuming energy drinks.
FDA Regulation of Energy Drinks
The FDA does not have a specific category or specific regulations for energy drinks. Typically, energy drinks have been marketed as either dietary supplements or conventional beverages, depending on the product’s ingredient, intended use, and labeling. For manufacturers, determining the appropriate regulatory framework for a product has important implications on a product’s development, as it can help guide product formulation and establish the limitations on product labeling and marketing, any requirements for pre- or post-market reporting or mandatory adverse event disclosures to the FDA. As we previously explained here, categorizing products as either conventional foods or dietary supplements can be difficult.
The FDA defines conventional foods as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” All ingredients in conventional foods must be pre-approved by the FDA as a food additive or meet the requirements of the GRAS provisions. Dietary supplements, on the other hand, are defined as products “intended for ingestion that contain a dietary ingredient intended to add further nutritional value to (supplement) the diet.” Dietary supplements may be in forms such as tablets, capsules, softgels, gelcaps, liquids, or powder, and may be one, or a combination, of the following substances: vitamins, minerals, herbs or botanicals, amino acids, concentrates, metabolites, constituents, or extracts. Based on these definitions, it may be more difficult to classify certain liquid products where the product is intended to supplement the diet with vitamins or nutrients but resembles a conventional beverage in serving size and taste.
In an attempt to assist manufacturers in properly classifying their products as either liquid dietary supplements or conventional beverages, the FDA issued a draft guidance document in 2009. (The FDA’s Guidance document can be accessed here.) This 2009 draft guidance states that the FDA considers a product’s name, packaging, serving size, recommended conditions of use, and other representations about the product, to be determinants of whether the product is a conventional food or dietary supplement. This guidance has not been finalized; however, the U.S. Government Accountability Office released a report in March 2012 indicating that the FDA is in the process of developing and reviewing a final guidance document that clarifies when a liquid product should be marketed as a dietary supplement or conventional beverage. (The U.S. Government Accountability Office’s report can be accessed here.)
If a product is a conventional food or dietary supplement but improperly marketed as the other type of product, the product could be deemed by the FDA to be misbranded or adulterated in violation of 21 U.S.C. § 331(a) and 21 U.S.C. 342(a)(2)(C). Failure to comply with the appropriate labeling regulations could subject manufacturers to enforcement action. The FDA has issued Warning Letters against manufacturers for mislabeling conventional beverages as dietary supplements. (For more information about the FDA’s past enforcement action regarding the labeling of dietary supplements, please read our previous post here.)
Uncertainty Regarding the Future Regulation of Energy Drinks
Despite the FDA’s current position that the elevated caffeine levels in energy drinks do not pose a significant health risk, the public continues to pressure Congress and the FDA to address its concerns about the safety of consuming energy drinks. Now, with the release of this joint letter to the FDA, doctors, researchers, and public health experts seem to support the push for tighter regulation and increased oversight of these products. At this time, it remains to be seen what steps Congress and the FDA will take to address any gaps in the present regulatory scheme.
Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of compounding pharmacies. For more information, please feel free to contact our offices by email at email@example.com or by phone at (305) 350-5690.