Although there is currently no FDA regulation authorizing the addition of gingko biloba to food, most supermarkets and health food stores carry teas and fortified waters (if not other potable or edible products) containing the ingredient.
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In most cases, a manufacturer will not find existing clearances in FDA’s food additive regulations for functional ingredients. For example, there is currently no regulation authorizing the addition of gingko biloba to food. A very significant commitment of time and resources would be needed to obtain a new food additive regulation covering gingko biloba or similar ingredients. This often makes GRAS status a more attractive regulatory option.
GRAS status can be based either upon common use in food prior to 1958 or upon “scientific procedures,” for example, toxicological studies or other scientific information. GRAS status based on scientific procedures generally requires the same quantity and quality of safety data as FDA would require for the evaluation of a food additive. Additionally, some amount of the data supporting GRAS status must be published or otherwise publicly available.
Thus, GRAS status is not always easy to establish. The advantage of GRAS status is that it avoids the need for a lengthy evaluation at FDA through the food additive petition process.
If a substance is properly deemed GRAS under its intended conditions of use, it may be legally added to food without FDA’s review or concurrence. Some manufacturers have voluntarily filed successful GRAS notifications with FDA covering functional ingredients. These include notifications covering lycopene, phytosterols and various fish oils as sources of omega-3 fatty acids. GRAS notifications focus on the safety of the ingredient, so it is not necessary to describe in detail how the ingredient functions.
FDA sends occasional warning letters to manufacturers of teas and other products containing functional ingredients questioning their regulatory status. A warning letter of this type may state in fairly mild terms that FDA is “not aware of a basis for concluding that [functional ingredient] is prior sanctioned or is GRAS for use in [tea/juice] products.” A recipient of such a letter should expect to explain to FDA how a proper GRAS conclusion has been reached or, if this is not possible, reformulate the product without the ingredient in question.
Manufacturers might be forgiven for thinking it should be legal to add small amounts of functional ingredients to foods when these same ingredients are readily available at higher doses in pill or capsule form as dietary supplements. Unfortunately, common use in dietary supplements simply does not go far toward establishing GRAS status for a functional ingredient’s use in conventional foods.
What has emerged is a regulatory climate that is challenging for both FDA and for the food industry. FDA would like all food manufacturers to follow strictly the agency’s views on the criteria for GRAS status. However, FDA must prioritize its enforcement activities so as to focus on situations that pose a risk to public health.
This may leave some in the food industry guessing about how well-supported a GRAS conclusion should be for a seemingly safe functional ingredient. Clearly, substances should not be added to food unless they have a solid, favorable regulatory status. Unfortunately, however, during the time it takes to generate and publish safety data, a competitor might introduce the same ingredient, establish a dominant market position, and possibly even exhaust the public’s appetite for the ingredient.
David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.
