• A new bill introduced in the U.S. House of Representatives would require a “high caffeine” warning on beverages that contain more than 150 milligrams of caffeine, as well as require manufacturers to declare the amount of caffeine in their products.
  • Representative Robert Menendez introduced H.R.2511, the Sarah Katz Caffeine Safety Act, stating that (Law360 subscription required) “the bill is about transparency and safety,” aimed at preventing tragedies such as the death of Sarah Katz, a college student who died after drinking a highly caffeinated beverage. As we previously blogged, Katz’s parents filed a lawsuit alleging that Panera Bread Company’s “Charged Lemonade” caused their daughter’s death and that the beverage contained anywhere from 260-390 mg of caffeine, depending on the size of the beverage.
  • The bill would require menu items in chain restaurants containing at least 150 mg of caffeine to bear a statement such as “high caffeine” on the menu. In addition, the bill amends Section 403 of the Food, Drug, and Cosmetic Act to consider foods and dietary supplements containing more than 10 mg of caffeine as misbranded unless the label includes the amount of caffeine in the product, a statement of whether the caffeine is naturally occurring or an additive, and an advisory statement regarding FDA’s daily recommended limit of caffeine for healthy adults.
  • The bill also directs FDA to define “added caffeine” and review the status of caffeine and other stimulants as generally recognized as safe (GRAS). Specifically, FDA would be directed to consider:
    • Whether caffeine should be considered GRAS;
    • The safety of caffeine or other stimulants, either alone or in a blend;
    • The safety of guarana, taurine, and similar substances in food and dietary supplements with added caffeine;
    • Thresholds for the amount of caffeine or blends of caffeine and other stimulants; and
    • Whether any regulations relating to caffeine in food and dietary supplements should be issued or updated.
  • Finally, the National Institutes of Health would be required to conduct or support a review of the effect of caffeine consumption in vulnerable populations, and FDA and CDC would be required to conduct a public education campaign on caffeine safety.
  • FDA’s webpage on caffeine indicates that 400 mg a day is “not generally associated with dangerous, negative effects,” but that the level of sensitivity can vary widely.
  • Keller and Heckman will continue to monitor this bill and other developments regarding caffeinated beverages.