Caffeine is being added to many new foods and beverages, but there may be limits to this trend. Although the Food and Drug Administration has so far shown little inclination to curtail the use of added caffeine, manufacturers would be prudent not to interpret this current inaction as carte blanche to add the substance to their products. The warning bells have been gently set off by at least one new study, which suggests that excessive caffeine consumption may be a growing problem for some. And although there is currently little indication of an imminent regulatory crackdown, that could change if the problem of caffeine abuse grows. However, food and beverage manufacturers can take certain steps in order to reduce their risk of both regulatory action and product liability lawsuits. Caffeine occurs naturally in coffee, tea, cocoa, as well as in several other plant ingredients, such as guarana, herba mate, and Kola nut, used in some conventional foods and dietary supplements. Aside from foods that naturally contain caffeine, the FDA has acknowledged that the substance is generally recognized as safe (GRAS) when added to cola-type beverages up to a limit of 0.02 percent. FDA has not approved caffeine for use in any other foods or beverages. However, manufacturers have recently begun adding caffeine to a host of other products, including sports drinks, energy drinks and gels, caffeinated waters, and fruit juice. While manufacturers may have 'self-affirmed' the GRAS status of such uses, the basis for this determination is not always public. Other novel uses of caffeine may also be on the way. It was reported earlier this year that a food scientist has developed a process for microencapsulating caffeine and adding it to doughnuts and other baked foods. Although caffeinated doughnuts are not on the market yet, the inventor was reportedly shopping his invention to major companies. This more widespread use of caffeine in food may have been fed by recent scientific studies that have suggested possible health benefits from caffeine consumption. These studies have found evidence that caffeine may help protect against gallstones, cavities, type 2 diabetes, and Parkinson's disease. The view of caffeine as entirely innocuous may also be encouraged by the popularity of gourmet coffees and coffee shops, now on virtually every street corner. However, reports are beginning to emerge of caffeine abuse. A review of records from a regional poison control center in Chicago by Danielle McCarthy, MD, found 265 cases of caffeine intoxication, including 31 hospitalizations and 20 ICU admissions. The average age of the patients was 21. Most were sickened by caffeine, usually in the form of dietary supplements, medications, and energy drinks, though some cases also involved alcohol or illegal drugs. Symptoms of caffeine intoxication included insomnia, heart palpitations, tremors, sweating, nausea, diarrhea, chest pain, and neurological symptoms. In March 2006, the governors of 5 states and the mayors of 17 cities signed proclamations, declaring March the National Caffeine Awareness Month, to call attention to the dangers of caffeine intoxication. The American Medical Association and some consumer groups have called for mandatory labeling of the amount of caffeine present in foods and beverages. And just last week, PepsiCo and the Coca Cola Company announced that they will begin declaring the amount of caffeine per serving on cans and bottles of their flagship sodas. Unlike FDA, Health Canada advises consumers to limit their caffeine intake to 400 to 450 mg per day, the equivalent of about three 8 fl oz cups of brewed coffee, and less for women of child-bearing age and children. In the US, over-the-counter drugs containing caffeine are required to bear a warning statement. However, to date, FDA has said little about new food products containing caffeine. The agency does not require that foods be labeled to indicate the presence of caffeine (except that added caffeine must be listed as an ingredient) and does not recommend a specific limit on caffeine consumption. But this may not always be the case. As well as the recent reports on caffeine abuse, another indication that the issue could soon come to the forefront was concern raised by some participants at an FDA public meeting on 'functional foods' held in December. Manufacturers that wish to add caffeine to food products other than colas can protect themselves from future regulatory action by obtaining an opinion from qualified experts that their proposed use of caffeine is GRAS. This is especially recommended if children may consume the food to which caffeine is added. A GRAS opinion will estimate total dietary intake of caffeine under the intended conditions of use, taking into account caffeine from other sources. One consequence of the new food applications for caffeine is that previous estimates of caffeine dietary intake may not accurately reflect current intake levels, particularly for high-end consumers. It should be remembered that most GRAS determinations are limited to the specific use of a substance in a specific food. For example, a GRAS determination that a certain level of caffeine is safe in sports drinks does not mean it is safe for all uses. A helpful discussion of GRAS status can be found in FDA's guidance document Frequently Asked Questions About GRAS (Dec. 2004) (available here.) Manufacturers can also reduce their risk of both regulatory action and product liability lawsuits by alerting consumers to the presence of added caffeine. Added caffeine is required to be listed in the ingredients declaration, and manufacturers may also want to consider identifying natural ingredients, such as guarana, that contain caffeine (e.g., "Ingredients: … guarana (contains caffeine) …") and/or declaring the presence of added caffeine on the principal display panel. Robert Hahn is a Principal and Mark Itzkoff is Of Counsel with Olsson, Frank and Weeda, a Washington, D.C. law firm representing companies in the food, drug, medical device, and agriculture industries.