Functional Foods Under Fire

Functional Foods Under Fire

WASHINGTON--Functional foods and beverages may be drawing increasing consumerinterest, but they are also attracting a wary eye from the mainstream media andgovernment regulators.

In the past month, several articles have looked at the functional foodmarket, most prominently in The New York Times. In the newspaper's May 27article, "Stressed Out? Bad Knee? Relief Promised in a Juice," authorsJulian Barnes and Greg Winter explored a market that has doubled to $4.7 billionfrom 1997 to 2000. In the article, they touched on the Food and DrugAdministration's (FDA) role in regulating functional beverages ("Officialssaid that they had not meddled with most products because there had been noreports of consumers being seriously hurt by them"); the leaders in thecategory (such as Pepsico's SoBe, AriZona Beverage Co. and Snapple); and theup-and-comers trying to get their share of the pie (including Coke's partnershipwith Procter & Gamble to create Elation, a senior-targeted beveragecontaining 1,500 mg of glucosamine).

After the article came out and was picked up nationally on news wires, JohnBello, founder of SoBe (www.sobebev.com),told Insider, "There's not a lot of science behind a lot of thisstuff. But at the levels [of herbs] being used in [functional beverages], it'snot a big issue."

However, that is not to say that these drinks are not health-minded. Theauthors focused on herbal ingredients, rather than other nutrients such asvitamins and calcium, in these functional beverages. "Most of the herbs weuse are GRAS [generally recognized as safe] anyway, so what's the problem?"Bello questioned, adding that SoBe does not put efficacious amounts of herbs inits products because it wants customers to drink two or three a day. "Wedon't want people to worry about getting over-supplemented [from onebeverage]."

Just over a week after the Times story hit, FDA held a pressconference discussing its most recent warning letters sent to marketers offunctional beverages. The letters were a follow up to those sent last Februaryto the industry, which stated that some of these novel ingredients, includingbotanicals, were not GRAS approved.

During the press conference, Christine Lewis, director of the Office ofNutritional Products, Labeling and Dietary Supplements, reiterated thatingredients added to conventional foods must be pre-approved as food additivesor meet GRAS standards. "As a result of our concerns, we have begun aprocess of issuing warning letters," said Lewis, who added that three suchletters 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 saidthat letters would be sent to several other non-compliant companies.

In the letters, ginkgo and Siberian ginseng (eleuthero) were highlighted asingredients that were not prior sanctioned or GRAS for use in products. "Weare uncertain of a basis for concluding that echinacea was prior sanctioned orGRAS for use in products," Lewis said. She added that some nutrient contentclaims were being inappropriately used and that food may be viewed asconventional even though it contains novel ingredients. "From ourperspective, [this is] a very important part of protecting the integrity of theconventional food system."

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

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

Also of concern was the use of claims on these products, such as ginkgobiloba's effect "to sustain memory" on the Morning Organic Ginkgo'slabel. FDA even chastised Fresh Samantha for using the word "fresh" inits name because the Super Juice with Echinacea was pasteurized. An FDAspokesperson told Insider that if companies do not respond to this latestbatch of letters, the agency might take actions that include seizing product.

Hansen's Rodney Sacks noted that his company is concerned that FDA islimiting the choice of consumers by going after smaller companies rather thanlarger players such as SoBe. "Obviously, we are convinced that the safetyof our product is not an issue," he said. "The way the agency issingling out companies is unfair and raises questions about their motives. Therehave been, and continue to be, millions of bottles of [functional drinks] sold,and I'm not aware of any safety issue."

Indeed, many industry members claim the long history of use underscores theuse of these products as safe additions to foods. "FDA is again abusingfood additive law in much the same way it did with herbs before the passage ofDSHEA [the Dietary Supplement Health and Education Act]," said Rob McCaleb,president of the Herb Research Foundation. He added that ingredients such asginseng and echinacea have a long history of safe consumption as whole foods,teas and dietary supplements.

FDA appears to be setting boundaries to differentiate between ingredientsused in dietary supplements and those used in food. "FDA isn't saying thatcompanies can't market these products, only that they can't sell them in thismanner," said Marc Ullman, partner in New York-based Ullman, Shapiro &Ullman. "However, why this has been made an enforcement priority is beyondme. FDA has been woefully lax in enforcing DSHEA, which it has attempted toexplain away as being understaffed and only addressing pressing safety issues.But they're misleading consumers about safety concerns with theseproducts."