FDA warns manufacturers of danger of nutrient-, herb-enriched foods
Controversy rages over benefits and dangers of functional foods
Popular drinks that promise "power" or "wisdom" because of their added ginseng or ginkgo, cereals that claim they’ll "de-stress" consumers with St. John’s wort or kava kava, even pasta that pledges an immune system boost with added echinacea — all are being called to task for their health claims. Consumer advocates and now government officials are questioning the safety of "functional foods" — sometimes called "nutraceuticals" — that almost overnight have become a boom industry.
The U.S. Food and Drug Administration (FDA) sent a letter to food manufacturers warning them that they may be in violation of federal regulations for additives being combined with conventional foods. The FDA warned in a letter dated Jan. 30 that "some herbal and other botanical ingredients that are being added to conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with approved food additive regulations and may not be GRAS [generally recognized as safe] for their intended use."
Further, the FDA warned that claims characterizing a relationship between a substance and a disease- or health-related condition could be in violation of food safety laws unless specific evidence is presented supporting any such claims. "The FDA must review health claims and nutrient content claims prior to marketing. Manufacturers are encouraged to contact the agency regarding the regulatory status of ingredients and claims they intend to use for foods," the letter stated.
The grocery industry immediately scoffed at the food safety warnings. "There’s a new sheriff in town, and he just wants to let us know he’s here," says Gene Grabowski, spokesman for the Grocery Manufacturer’s Association in Washington, DC, referring to the Bush administration’s change of leadership at the FDA and elsewhere.
Nutraceutical ingredients must be safe
In a report issued last summer, the General Accounting Office (GAO) — the investigative division of the U.S. Congress — noted that while the FDA does regulate functional foods, the products "have no legal definition or separate regulatory category" from conventional foods. Ingredients in functional foods must be "generally recognized as safe" or "approved by the FDA," the GAO report stated.
Also of concern is the fact that some products do not have safety-related information printed on the labels, the GAO said in its report. "The agency has not issued policy guidance to clarify circumstances under which its believes that supplements can legitimately market in food form," said the GAO report. "Several companies told us they need clarity on this issue to guide them in the development and marketing of their products." The GAO also notes that, as of Feb. 29, 2000, the FDA had not received any reports of health problems associated with functional foods.
The FDA’s letter, written to more than 80 companies, was published several months after the Center for Science in the Public Interest (CSPI), a consumer advocacy group in Washington, DC, asked the FDA to ban the sale of more than 75 functional foods. The CSPI referred to the functional foods as the "snake oil" of the new millennium. CSPI officials labeled the FDA letter "a shot across the bow warning companies they will be sued if they sell products with ingredients not demonstrated to be safe."
"Look at the bottles of some of these drinks; they even look similar to the snake oil sold around the turn of the last century," says Eileen Heller, senior staff attorney for CSPI.
Conversely, she says, it’s likely that many of these products contain only tiny amounts of the botanicals they advertise, and then the issue becomes less one of health and more an issue of fraud. Worse than the possibility these products are making false promises, says Heller, is the possibility of real harm coming to consumers who ingest botanicals that "should be used as medicine, not as food."
The rapidly expanding functional foods market began with foods having generally recognized efficacy, such as orange juice with calcium and fiber-enhanced cereals. "But the latest fad takes this concept a step further: adding unproven, largely unregulated herbal dietary supplements to foods," notes Heller.
Heller says the problem with botanically enhanced foods is that "no one knows for sure if they are effective, or if they are dangerous, or if they might become dangerous if they are consumed in large quantities or eaten regularly over a long period of time."
She says there is particular concern about products containing St. John’s wort and kava kava because of their sedative effects. "These are medicines, and they should be treated as such," she says. "These could be particularly dangerous for children because we don’t have the science to show if these things are safe for kids, and we don’t think it is healthy to send a message to them that it is OK to eat medicine." She added that patients with diabetes and obesity-related conditions could be taking in more sugars than they realize, thinking they are eating or drinking something healthy.
CSPI was joined in its plea by Connecticut’s attorney general, as well as herbal foods specialist Varro Tyler, PhD, professor emeritus of pharmacognosy from Purdue University in West Lafayette, IN. Among the dozens of items targeted by CSPI are some well-recognized products from manufacturers such as Snapple, Ben and Jerry’s, Procter and Gamble, and Arizona Teas. The manufacturers make a variety of claims for the products, including the following abilities:
- boost memory power;
- strengthen the immune system;
- improve energy levels.
Some products are marketed as nutritional enhancers, energy boosters, or stress relievers. Currently, the FDA allows companies to add ingredients that have been proven safe to other foods. Calcium-enriched orange juice is now available, for example. There also are salmon burgers with omega-3 fatty acids, cookies with antioxidants, margarine with an additive that lowers bad cholesterol, and cakes with extra fiber.
The Grocery Manufacturers’ Association argues that functional foods are safe and legal. "Functional foods are conventional foods," said Grabowski. "There are ample regulations to make sure they’re safe, and consumers are not misled through their labeling."
"I can’t for the life of me figure out what the CSPI and the FDA are so concerned about," says Stacey Bell, DrSc, chief scientist at Functional Foods Inc., a Belmont, MA-based company marketing snack powders specifically aimed at people with diabetes and those wishing to lose weight. Bell says that the term "functional foods" is "simply a marketing device, sexy words that don’t really mean anything, but they get peoples’ attention."
She explains that the FDA and the scientific establishment are "well aware that the value of foods goes far beyond simply providing protein or energy." What is being sold is what anyone could buy at a health food store or nutrition outlet, says Bell. "We’re taking science and moving it a step forward."
Well-known herb researcher Earl Mindell, RPH, PhD, author of The Vitamin Bible for the 21st Century (New York City: Warner Books; 1999) calls nutraceuticals "the most exciting breakthrough in preventive medicine." Since they are derived from natural products derived from food, they are filling a gap in deficient American diets, he says.
"Since only 9% of Americans eat five servings of fruits and vegetables a day, these supplements are playing an increasingly important role in our nation’s health," he says. Mindell notes phytochemical-enriched foods are simply alternative means of getting adequate nutrition. He cites these examples:
- snack bars enhanced with soy photochemicals to alleviate menopausal symptoms and to prevent prostate problems;
- nutraceutical-enriched margarines to lower cholesterol;
- phytochemical-enriched candy for children who won’t eat vegetables.
Some companies are marketing responsibly
Jeff Nedelman, president and CEO of Strategic Communications, a Vienna, VA, firm representing numerous companies in the functional foods industry, says not all manufacturers are producing apocryphal products. "There are many big companies that are very responsibly marketing functional foods, boutique foods, designer foods, whatever you want to call them — and they’re backed up by solid scientific data," he says.
Nedelman explains that more research on the efficacy of certain herbs and other nutrients currently being added to foods makes it easier for companies to satisfactorily address the FDA’s questions. At the same time, however, it could create a quagmire for some food manufacturers. "The FDA wants scientific data, but when it gets them, it decides the thing must be a drug rather than a food," he explains.
"It’s like walking a minefield to deal with the FDA, and that’s why many companies are conducting their research and test marketing their products through doctors. The FDA is much less likely to object if there are MDs out there vouching for a product," he says.
As an example, he uses Benecol, a cholesterol-lowering margarine-like spread marketed by Johnson and Johnson and used to lower cholesterol. Johnson and Johnson knew how to get the product out there, says Nedelman. "The Mayo Clinic did the research and it was published in the New England Journal of Medicine. The FDA wouldn’t resist that kind of scientific power."
Grocery industry analysts say designer foods have the potential to mushroom into a $250 billion empire — or half the estimated size of the current food industry.
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