FDA Shines a Spotlight on Caffeine

In the wake of deaths and hospital admissions arising from the energy drink craze, the FDA is examining the safety of caffeine added to foods, beverages and dietary supplements. The agency is also investigating the legality and safety of beverages containing both alcohol and caffeine (“combo drinks”).

What is Caffeine?

Caffeine is a mild stimulant that millions of Americans consume in beverages enjoyed for increased wakefulness, alertness, pleasure and sociability. It is a naturally occurring chemical in coffee, tea, chocolate and kola nuts. Yet caffeine has come under increasing attack by some public health advocates and writers, often without regard to whether the caffeine is naturally occurring or a synthetic version created in laboratories.

Nutrition Facts Panel

The Nutrition Facts Panel on U.S. food labels is required to include specified dietary information for nutrients. Caffeine is not a nutrient. If caffeine is not naturally occurring but is added to a food, then it must be included in the listing of ingredients required on food labels. Caffeine is generally recognized as safe by the FDA when used in cola-type beverages up to a level of 0.02 percent or 200 parts per million. Some soft drink and energy drink manufacturers voluntarily list caffeine levels in their products.

Regulatory Status

Because of energy drinks, combo drinks and caffeine being added to foods, the FDA is re-examining the regulatory status for products containing caffeine. It will likely act slowly. In the meantime, regulatory uncertainty has placed a cloud over caffeine. This has discouraged food and beverage manufacturers from introducing new products which may be perfectly safe for adults.

For example, in 2013, Mars-owned Wrigley Company pulled chewing gum with 40 milligrams of caffeine (equivalent to a half cup of coffee) off the market. The product did not violate any FDA regulation but the FDA put pressure on the company to withdraw the gum from the market. The FDA’s rationale was that a proliferation of new food products with added caffeine may present over consumption risks.

It should be noted that caffeine is a permissible ingredient in many over-the-counter and prescription drugs regulated by the FDA.

Health Effects

Many studies have shown health benefits from moderate consumption of caffeine, especially from coffee, such as increased memory, better athletic performance and lower risk of Type II diabetes, Alzheimer’s and Parkinson’s diseases. Overconsumption can cause irritability, restlessness, insomnia, increased heart rate, higher blood pressure and irregular heart rhythms.

However, regulators should not forget that people do not consume food and beverages solely for nutrition or disease prevention. Coffee and tea provide pleasure and opportunities for socialization. How many children want a vanilla cake for their birthday instead of a chocolate one?

Coffee and tea have been consumed worldwide for centuries with beneficial effects. Overzealous attacks on caffeine could damage long standing consumer acceptance of these products.

FDA Priorities

The agency should work closely with the National Institutes of Health, the medical profession and the food and beverage industry to develop and publicize uniform information on recommended levels of caffeine for adults and children.

This information must not be complicated or confusing. Public health advocates have been successful in communicating that women should only drink one alcoholic beverage (measured in ounces depending on the type of alcohol) as compared to two beverages for men because of the differences in the way the genders metabolize alcohol.

The FDA needs to allocate resources and cooperate with other governments to assure that all synthetic caffeine, whether produced domestically or overseas, is produced in sanitary conditions with rigorous quality assurance processes to prevent contamination and fraudulent substitution of ingredients.

Of course, if the FDA determines that specific energy drinks, supplements and combo drinks are unreasonably dangerous for adults then a complete ban or reformulation can be considered. The analysis should be based on the products’ ingredients as a whole and caffeine should not be singled out unless its content level is the sole cause of the unreasonable danger. Also, restrictions on marketing and sales to children, just like with alcoholic beverages, can be appropriate measures for products which are not unreasonably dangerous for adults to consume but may harm children.

Finally, to address the FDA’s proliferation concerns discussed above, if food manufacturers deliberately add synthetic caffeine to their products (within any new limits the FDA may establish or not) they should be required to disclose the amount on the food label not just the fact that caffeine is one of many ingredients.

Since naturally occurring caffeine levels are variable depending on the coffee or tea variety and the brewing method and equipment; a coffee manufacturer should not be required to disclose a specific number of caffeine milligrams per serving – only a range.


Coffee and tea drinkers as well as chocolate lovers who consume moderate amounts of naturally occurring caffeine should not be the concern of regulators. Rather the FDA should focus its attention on synthetic caffeine added to foods and beverages, especially if the synthetic caffeine is being imported from countries with inadequate food safety processes.