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FDA Hearing Will Review Rules for `Functional' Foods
Published on Thursday, October 26, 2006 by the McClatchy Newspapers
FDA Hearing Will Review Rules for `Functional' Foods
by Michael Doyle
 

WASHINGTON - It's time to taste-test some new rules for "functional" foods, federal officials declared Wednesday.

These are foods that pack a special punch, or at least so their labels suggest. Grocery store shelves abound with them.

Snapple "Moon" tea offers kava kava to "enlighten your senses." Odwalla's "Serious Energy" drink contains "energy sustaining herbs" such as gotu kola. Ben & Jerry's "Raspberry Renewal" smoothie includes "energizing" ginseng.

While enhanced foods proliferate, critics grow more alarmed, enough so that federal regulators will give everyone a chance to weigh in with a public hearing. This could be the bureaucratic equivalent of empty calories. Alternatively, it could fuel a move toward stricter labeling standards.

"We believe that it would be in the best interest of public health to begin a dialogue with industry, consumers and other stakeholders regarding the regulation of these products," the Food and Drug Administration said.

Functional foods have extraneous but supposedly beneficial ingredients added. It could be as simple as orange juice fortified with calcium. It could be as esoteric as Trader Joe's "Green Tea with St. John's wort," with hints of elevated moods to come.

Americans are gobbling them up. Functional food sales increased from an estimated $11.3 billion in 1995 to $16.2 billion in 1999, a 2000 study by the then-General Accounting Office noted. Propelled by savvy marketing and health-conscious baby boomers, functional food sales were projected to reach $49 billion by 2010.

"Increased consumer demand is causing the food industry to add more and larger amounts of substances to food," the FDA noted, citing the work of other experts.

Jim Belcher, the owner of Katrina's Natural Ranch Market in downtown Fresno, Calif., agrees.

"They're adding calcium to everything these days, it seems," he said.

But estimates and regulations alike can be squishy, because there's no official definition of "functional food." The FDA's reach also is limited.

Claiming that soy protein may reduce the risk of heart disease requires formal FDA review. However, describing Odwalla's "Think Drink" with gingko biloba as a beverage "with two brain-boosting botanicals used . . . to stimulate thinking centers of the mind" does not.

Critics worry that this ambiguity cracks open a regulatory loophole.

Federal agencies "provide limited assistance to consumers in making informed choices and do little to protect them against inaccurate and misleading claims," the GAO warned in its 2000 study of functional foods.

A petition previously filed by the Center for Science in the Public Interest, a nutrition and health advocacy group, cited the Odwalla and Snapple drinks, among others, as the kinds of functional foods that need more oversight. Neither Odwalla, based in Dinuba, Calif., nor Snapple, based in New York, could be reached to comment Wednesday on the proposals for tighter regulation. As a general rule, though, industry officials are leery of new regulations.

"Functional foods are just that: foods," Stacey Zawel of the Grocery Manufacturers Association declared after the 2000 GAO study. "They already have to meet stringent food-safety regulations."

Food and Drug Administration officials said Wednesday that "we are confident" the existing rules are adequate. Nonetheless, citing the center's petition and the GAO study, officials set a public hearing for Dec. 5 in the FDA's offices in Washington's Maryland suburbs.

"There are a lot of people out there being duped," Belcher said. "What I'm really concerned about are the big companies that say something like, `If you drink this, you'll walk on water.'"

Several questions are ripe for debate.

Currently, companies don't need FDA approval before marketing new functional foods if the ingredients themselves generally are considered safe. The Center for Science in the Public Interest is urging regulators to require such prior approval.

The public hearing also will consider other questions, including whether functional foods require a formal definition and unique regulations, and whether food industry experts should evaluate the claims made for functional foods.

© Copyright 2006 McClatchy Newspapers

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