Energy Drink Safety Concerns Make Action On Labels Imminent – Consultant

Marketers of energy drinks should disclose caffeine content on product labels as well as warnings to protect consumers and prepare for possible labeling regulations, according to attorney Antonio C. Martinez, a government relations and regulatory affairs consultant.

Martinez, who specializes in food and drug law, health care law and patient and health care professional advocacy, said action should be taken before there is a major "red flag" health event and prior to mandated labeling.

"Ultimately, the industry recognizes that regulations requiring full disclosure on caffeine content are coming," Martinez said in a June 19 correspondence.

"Why would you hesitate to fully disclose the caffeine content in your product and warn consumers on the risks of over-consumption or known contraindications?" he asked.

Martinez's observations reflect a growing concern that certain subpopulations at risk from high caffeine consumption - such as children, adolescents, pregnant women and people taking certain medications - are not aware of the ingredients in certain energy drinks.

The issue is garnering considerable attention in Europe, where several countries have already enacted regulations to curtail the sale of the products.

In March, the German Federal Institute for Risk Assessment issued a report featuring recent human data on potential risks associated with energy drinks.

According to the ¹ report, "cardiac dysrhythmia, seizures, kidney failure and fatalities occurred after consuming energy drinks," though a causal relationship is still being assessed.

The institute has recommended that energy drink marketers provide clear warning labels on products, including references to possible adverse effects.

On June 12, attorney Ricardo Carvajal with Washington-based Hyman, Phelps & McNamara, addressed the German report on the firm's FDA Law Blog. In light of action taken in the European Union, he writes, "It would not be surprising to see an increased focus in the U.S. on potential health risks to certain subpopulations that may be presented by consumption of energy drinks."

Martinez said he has consulted with several energy drink marketers interested in disclosing caffeine content on their products, though they tend to be more hesitant about posting warning labels.

"My professional advice to beverage makers is this on caffeine: Transparency and full disclosure of caffeine contents equals responsible corporate behavior," Martinez said.

"You have to think about the fact there are vulnerable populations, adolescents who are drinking these, people who are taking medication and don't make the connection that it's like drinking two cups of coffee or more."

In addition to protecting consumers, caffeine disclosure and proper warnings and contraindications on labeling have relevance from a product liability standpoint, he pointed out.

"Beverage makers stand to be held liable for failing to disclose information that otherwise would render the product harmful if not consumed safely by a consumer," he added.

Martinez recommends trade associations take a proactive stance, approaching FDA on the subject and working alongside the agency to develop formal regulations for labels.

The marketing of certain energy drinks has been a point of contention for state and federal regulators. FDA officials are examining whether products marketed as food should be labeled as dietary supplements (² (Also see "FDA Lawyers Working To Defog “Clouding” Of Food/Supplement Boundary" - Pink Sheet, 22 Oct, 2007.), p 6).

Similarly, state agencies are becoming more active in labeling enforcement actions as the number health claims by supplement and food products proliferates (³ (Also see "State AGs Pick Up Enforcement Slack Amid Expanding Products And Claims" - Pink Sheet, 27 Nov, 2006.), p. 6).

New Jersey State Assemblyman Ralph R. Caputo presented a bill May 19 to ban sales to consumers under 18 years old of food, beverages or other products meant to be ingested or inhaled that allude to controlled dangerous substances in their advertising.

- Eileen Francis ([email protected])