April 11, 2013
WASHINGTONU.S. Rep. Edward J. Markey (D-Mass.) and Senators Richard J. Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have released a report based on their ongoing concerns over the way energy drinks are regulated and marketed, contending the safety of these products is a major concern for children.
The report is based on theirinvestigation of 14 commonly sold "energy drink" products and details marketing, labeling, safety and regulatory findings, as well as recommendations to improve transparency and protect consumers, especially children.
The primary target of the lawmakers' ire is caffeine content, targeting children and the way these products can be marketed as beverages or supplementsrules on labeling and caffeine limits are different between the two categories.
The report opens with notes on how FDA has released a number of adverse event reports (AERs) associated with energy drink products and is currently investigating this segment of products. It also noted the Department of Health and Human Services has reported emergency room visits related to energy drink consumption have doubled to 20,000 between 2007 and 2011.
In their report, the legislators note, "...nearly identical energy drinks can be marketed and represented to consumers differently, leading to consumer confusion and a lack of transparency." They said marketing identical products in different regulatory categories can result in full disclosure of caffeine content in one product and little to no disclosure of caffeine in the similar product. The report further lists some known caffeine amounts for popular energy drinks, including CocaCola's NOS (260 mg per can, among the highest) and Monster's Worx Energy Shot (200 mg per 2 ounces).
What was not in the report were caffeine amounts for popular beverages like coffee and tea. According to the Mayo Clinic, generic brewed coffee can range from 95 to 200 mg, while Starbucks brewed can be as high as 330 mg per 16-ounce servingat Starbucks, 16 ounces is a Grande, while a Tall is 12 ounces, a Venti is 24 ounces and a Trenta is 31 ounces. Mayo also lists amounts for tea (most are lower than 100 mg per 8 ounces), soft drinks (nothing on the list is more than 55 mg per 12 ounces) and energy drinks (most popular names are under 100 mg per 8 ounces, except for 5-Hour Energy, which packs 207 mg in two ounces.)
The ingredients issue is not with caffeine alone, but additional, often undisclosed, sources of caffeine, as well as other stimulants such as guarana and green tea. The report takes a shot at taurine, a popular energy drink ingredient, saying it is not approved as a food additive, but instead is self-determined as safeself-GRAS, generally recognized as safeby manufacturers for inclusion in such products.
Among the bigger claims in the report is the argument energy drink marketers target children. Countering statements from 14 such companies that denied marketing to children, the lawmakers assured the evidence is clear the products are paraded to young Americans, via sports-based marketing. "The use of unconventional marketing practices combined with product design and placement on store shelves assists in creating product images that appeal to children and teens," the report states. They further lament some energy drink products are meant to mimic alcoholic drinks.
The marketing is rife with irresponsible claims, according to the report, which singles out claims to "energize and hydrate," provide "50 percent more focus," improve "up to the nanosecond performance," and provide "increased concentration and reaction speed."
Recommendations in the report include a call for clearly labeling the products for total caffeine content (from all sources) and for the entire container, not just whatever is deemed as a serving. In addition, the legislators would like to see all products containing more than 200 mg of added caffeine, the limit for self-GRAS by FDA, bear a warning statement such as: "This product is not intended for individuals under 18 years of age, pregnant or nursing women or for those sensitive to caffeine. Consult with your doctor before use if you are taking medication and/or have a medical condition."
The report's recommendation to cease marketing of energy drinks to children and teens under 18 could be an even trickier suggestion, as it calls for curtailing the use of social media and sponsorship of sports and other events.
Further, the proposal to mandate reporting of serious AERs to FDA when they relate to energy drinks marketed as beverages appears to address earlier criticisms of the lawmakers' complaintsthe argument was energy drinks were marketed as dietary supplements for easier regulation, but supplements are regulated by a serious AER law that beverages are not.
How this report will influence regulators and legislators is unclear, but it sends a clear message these lawmakers are not giving up on making changes to this category. "Well follow up with the FDA and FTC to make sure they are taking appropriate action, because even one more emergency room visit linked to energy drinks is unacceptable," Blumenthal said.
Rend Al-Mondhiry, regulatory counsel for the dietary supplement-focused trade group Council for Responsible Nutrition (CRN), said the recently released recommended guidelines for caffeine-containing dietary supplements are very similar to many of the recommendations made in the Durbin/Blumenthal/Markey report. "We have shared our recommended guidelines with their offices," Al-Mondhiry said, adding the legislators' report was likely in very late stages when the CRN guidelines were released. "Maybe it impacted their report."
The CRN caffeine guidelines focus on full disclosure of total caffeine content from all sources, label advisories from conditions of use, intake and serving size suggestions, and restrictions on marketing in combination with alcohol. Among the small differences, the lawmakers' report highlights the marketing focus on children and teens under 18 as a concerning and major issue, while the CRN guidelines only mention children under 18 in its proposed conditions of use labelingany supplement with a total caffeine content more than 100 mg per serving should bear an advisory such as: "This product is not intended /recommended for children and those sensitive to caffeine." In fact, Al-Mondhiry said there is a big difference between young people under 18 and those over that age, and CRN does not currently see pervasive marketing of energy drinks to those under 18.
Effective April 1, the guidelines are intended as a basis for how companies should communicate with consumers on such products, and CRN recommends companies comply with the recommendations by April 1, 2014. "The guidelines are not mandatory," Al-Mondhiry reminded. She did report, however, a group of CRN member companies met several times with CRN staff to come to a consensus on the caffeine guidelines and the membership supports the finished publication.
For more information on CRN's guidelines for caffeine-containing supplements, visit CRN's website.
You can find the full energy drink report, What's All the Buzz About?, at Rep. Markey's website.http://markey.house.gov/sites/markey.house.gov/files/documents/2013-04-10_EnergyDrink_Report_0.pdf
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