"Alert Gum" Highlights Uncertain Regulatory Status of Caffeine

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Registrar Corp is an FDA consultancy firm that focuses on U.S. FDA regulations for food and beverages and helps companies modify their food, beverage, or dietary supplement labeling to comply with U.S. FDA regulations.

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The addition of caffeine to other types of food products is not covered by the regulation. So… is caffeine added to gum (or potato chips, or jelly beans) considered GRAS?

In April 2013, Wrigley launched Alert Energy Caffeine Gum with much fanfare. However, the U.S. Food and Drug Administration's (FDA's) concerns about the added caffeine in foods caused Wrigley to take its Alert Energy Caffeine gum, which has the same amount of caffeine as half a cup of coffee, off the market. Wrigley announced that "it had stopped new sales and marketing of Alert Energy Caffeine Gum 'out of respect' for the F.D.A." Registrar Corp, an FDA consultancy firm, assists companies with issues related to labeling and ingredients.

This situation highlights the recent focus on the avalanche of caffeinated foods entering the U.S. marketplace. Food manufacturers have been adding caffeine to a variety of foods: potato chips, jelly beans, energy drinks, to name a few. FDA issued a statement applauding Wrigley for its decision and announcing the agency's intent to work "with industry, the scientific and medical community, and all interested parties to address the issues posed by added caffeine in foods and beverages."

The heart of the issue lies in how FDA regulates substances added to food. "Food additives" are those substances added to food that have not been generally recognized as safe (GRAS). Food additives must be approved by FDA through the food additive petition process and are then codified into regulation. GRAS substances are those substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of their intended uses. This can be established through a widespread history of consumption for food use. Alternately, it can be made through scientific procedures, requiring the same quantity and quality of scientific evidence as would be required to obtain approval of the substance as a food additive. GRAS substances may be self-affirmed by the manufacturer or affirmed by FDA and written into regulation. A company may also submit a GRAS notice to FDA to inform the agency of their determination that a substance is GRAS. FDA specifically affirmed caffeine as GRAS for "cola-type beverages" with a tolerance level of 0.02%. The addition of caffeine to other types of food products is not covered by the regulation. So… is caffeine added to gum (or potato chips, or jelly beans) considered GRAS? If not, one could argue that the addition of caffeine to these products makes it an "unapproved food additive" and therefore the product is adulterated.

When announcing its decision, Wrigley stated "we have a greater appreciation for its [FDA's] concern about the proliferation of caffeine in the nation’s food supply. There is a need for changes in the regulatory framework to better guide the consumers and the industry about the appropriate level and use of caffeinated products." FDA has stated its intent to take "a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on health, particularly vulnerable populations such as children and youth, and if necessary, will take appropriate action." Food manufacturers will need to be prepared to affirm the safety of caffeine at the levels found in their products.

Registrar Corp helps food and beverage exporters to understand and comply with U.S. FDA regulations. Registrar Corp welcomes food and beverage companies to attend a seminar on U.S. FDA Food and Beverage Labeling Regulations as part of the Akademie Fresenius Conference at the Atrium Hotel Mainz in Mainz, Germany on June 18-19, 2013.

Companies contemplating the development of products containing food additives (i.e. caffeine) may want to contact a regulatory specialist, such as Registrar Corp. Registrar Corp's Label & Ingredient Review service will inform companies of the regulatory status of their ingredients so that they may determine whether it will be permitted by FDA. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

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David Lennarz

Liviana Callahan
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