FDA Issues Warning Letter to Foodmaker

WASHINGTON--The Food and Drug Administration (FDA) issued a strong warning letter to Robert's American Gourmet regarding two of its products, "Spirulina Spirals" and "Fruity Booty." The FDA informed the company that several herbal ingredients it was using were not GRAS (generally recognized as safe).

By using non-GRAS ingredients, said the FDA, the company violated food additive regulations. In addition, the company was charged with misbranding, drug claims and adulteration. The ingredients in question are cat's claw, echinacea, ginkgo biloba, kava kava, Spirulina and St. John's wort.

The FDA recommended that Robert's take "swift action" to rectify the problem and correct its labels. If the labels are not amended, warned the FDA, a regulatory action such as a seizure or injunction will follow.

"By putting herbs into potato chips, herbs are not protected by DHSEA," said Mark Blumenthal, founder and executive director of the American Botanical Council. "DSHEA says that dietary supplement herbs are not drugs or food additives, yet dietary supplements have to be consumed in dosage forms that are typical of a dietary supplement. A potato chip is a food, not a dietary supplement. Consequently, I suspect that FDA sees adding kava or ginkgo (biloba) to a chip is making the herb into a food additive, exempting it from dietary supplement status. And by law, a food additive must be approved for safety by FDA prior to its use."