In a five-page letter dated August 10, 2012, Jeanne Ireland, Deputy Commissioner, Legislation, stated: “FDA completed an updated assessment of the amount of caffeine that people in the Unites 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.
“For healthy adults, caffeine intake up to 400 mg per day (mg/d) is not associated with general toxicity, cardiovascular effects, effects on bone and calcium balance (with consumption of adequate calcium), changes in adult behavior, incidence of cancer, or effects on male fertility.”
Brewed coffee contains about 135 milligrams of caffeine per 8 ounce serving, while soda pop contains about 35 mg per 12 ounce serving.
FDA indicated that it is continuing to monitor the safety of caffeine, but that “available studies do not indicate any new, previously unknown risks associated with caffeine consumption.”
Good news
Commenting on the letter, Justin Prochnow, shareholder with Greenberg Traurig, LLP, told NutraIngredients-USA: “This letter is pretty good for energy drinks and energy supplement companies.”
FDA’s Ireland also wrote that the Agency expects that “the Drinks Draft Guidance, once finalized, will help both the FDA and industry draw a line between beverages and liquid dietary supplements.”
However, Prochnow said he didn’t expect the final guidance to change very much from the current draft guidance.
“Just because a company labels a product as a dietary supplement doesn’t mean that FDA will consider it a supplement,” he said. “There’s a list of factors that FDA will look at: Are you using words like ‘water’ or ‘juice’ or ‘milk’, in which case this probably puts you closer to a beverage. The serving size and the packaging is also important.”
The Colorado-based lawyer noted that he thinks it is unlikely that caffeine-containing products will be the specific target for action, but more likely that other ingredients, such as taurine, guarana, and ginseng, will be the focus of any attack on larger, beverage looking, supplements.