"Functional" Foods Must Substantiate Claims

"Functional" Foods Must Substantiate Claims

WASHINGTON--The Food and Drug Administration (FDA) sent aletter to "functional" food manufacturers in early February statingthat foods and beverages must follow the guidelines mapped out under its Food,Drug and Cosmetic Act.

In an FDA Talk Paper, released to the public Feb. 5, the agencyreported that it sent the letter to restate the requirements for marketingconventional foods containing novel ingredients, including botanicals."Many ingredients intentionally added to a conventional food are foodadditives," wrote Christine J. Lewis, Ph.D., director of the Office ofNutritional Products, Labeling and Dietary Supplements, in the letter that wassent out. "Food additives require pre-market approval based on datademonstrating safety submitted to the agency in a food additive petition."She added that a substance is exempt from being classified as a food additive ifthe substance is generally recognized as safe (GRAS).

However, FDA is concerned that these novel ingredients "are neitherapproved food additives, nor generally recognized as being safe for these uses.This letter serves as a reminder to the industry of the longstanding legalrequirements governing conventional food products." According to theAssociated Press, FDA officials would not give examples of which ingredients areunder investigation since some are legal to use in foods in certain doses.

Congress's General Accounting Office (GAO) estimated that consumers spentapproximately $31 billion in 1999 on dietary supplements and "functionalfoods," including products such as AriZona Tea and SoBe beverages. FranciePatton, vice president of corporate communications at AriZona, stated that thecompany would comply with FDA's letter. For additional information of the FDAletter, visit www.fda.gov/bbs/topics/ANSWERS/2001/ANS01070.html.