FDA Sends Warning Letters to Functional Food Makers

WASHINGTON--On June 6, the Food and Drug Administration's (FDA) (www.fda.gov) John Foret sent out more warning letters to manufacturers who use dietary supplements in "functional" foods. This is a follow-up to letters sent by the agency last February to the food and beverage industry, citing that some of these novel ingredients, including botanicals, were not approved as GRAS (generally recognized as safe).

In a press conference to discuss this latest spate of letters, Christine Lewis, director of the Office of Nutritional Products, Labeling and Dietary Supplements, reiterated that ingredients added to conventional foods must be pre-approved as food additives or meet GRAS standards. "As a result of our concerns, we have begun a process of issuing warning letters," said Lewis, who added that three such letters went out June 4 and 5 to Needham, Mass.-based U.S. Mills, Corona, Calif.-based Hansen Beverages and Saco, Maine-based Fresh Samantha. She said that letters would be sent to several other offending companies.

In the letters, ginkgo and Siberian ginseng (eleuthero) were highlighted as ingredients that were not prior sanctioned or GRAS for use in products. "We are uncertain of a basis for concluding that echinacea was prior sanctioned or GRAS for use in products." Lewis said. There are also that nutrient content claims were being inappropriately used and that food may be viewed as conventional even though it contains novel ingredients. "From our perspective, [this is] a very important part of protecting the integrity of the conventional food system."

Of course, there are hundreds, if not thousands of companies who use botanicals in beverages and food, and FDA is not equipped to send out letters to each of these companies. "[These companies] should take note of this action and consider their own products," Lewis advised.

The particular products that were addressed in these letters were: U.S. Mills' New Morning Organic Ginkgo and Organic Ginseng Crunch; Hansen's Health Start Immune Juice; and Fresh Samantha Super Juice with Echinacea.

Also of concern was the use of claims on these products, such as ginkgo biloba's effect "to sustain memory" on the Morning Organic Ginkgo's label. However, FDA's labeling requirements became a little persnickety when it chastised Fresh Samantha for using the word "fresh" in its name even though the Super Juice with Echinacea was pasteurized.

FDA has asked the companies to notify the agency within 15 working days of the specific steps taken to correct each company's respective violations. Copies of the revised labels should also be submitted to FDA during this time.