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Views Differs on FDA's Ability to Police Supplements


Thursday, April 03, 2008
Anti-Aging


By DAVID SCHEPP
THE JOURNAL NEWS
(Original Publication: March 18, 2007)

Three studies released in 2005 that warned that taking high doses of Vitamin E could significantly harm human health were the latest such reports that have questioned the safety of nutritional supplements.

The threat of serious health effects led Consumers Reports magazine to advise its readers to refrain from taking Vitamin E supplements to prevent disease, noting that people get adequate amounts from eating nuts and vegetable oils that are rich in the nutrient.

As a consumer-products testing organization the Yonkers-based publication periodically tests nutritional supplements.

A report in February on dollar-store multivitamins, for example, showed that eight failed to meet the label claim for one or more nutrients. What's more, three of them didn't dissolve properly.

Such reports concern Andrew Davis, senior vice president of the nutritional business unit at Wyeth, the maker of the nation's most popular line of branded vitamins, Centrum, the bulk of which are manufactured at the company's Pearl River plant.

Last year, the company derived about $400 million in revenue from its Centrum line, which include special formulations for people over 50, children and one designed to give busy adults an energetic boost.

Davis is equally alarmed by claims made by less-than-reputable supplement makers that promise their products can cure or prevent disease.

Wyeth would never make those sorts of claims, he said. "It's not appropriate to do that in the supplement industry," Davis said, adding that in many cases the data don't support such claims.

"We stick very much to the science and very much to the law," he said.

A decade ago, Americans bought into many of the claims made by supplement companies, which led to heady, double-digit growth for the industry.

Today, however, consumers have learned to be more skeptical. "There's been a little bit more of good consumerism going on," Davis said.

That's been good for Wyeth's business even if it means the company must work harder to sell its vitamins to those customers not already taking one, he said.

Unlike some skeptics, such as Consumer Reports, who call for more regulation of the industry to prevent outrageous claims, Davis said he believes that the law governing the sale of nutritional supplements, known as the Dietary Supplement and Health Education Act, or DSHEA, has enough teeth to do the job.

"It's really been a matter of the (Food and Drug Administration) taking the time to enforce what it has the power to enforce," he said.

"The laws are there to allow them to enforce, and they have chosen not to do it."

That's a view not shared by Nancy Metcalf, senior editor at Consumer Reports, who said regulation of the nutritional-supplement industry could best be described as sparse.

"DSHEA essentially deregulated them except for some very minimal requirements," she said.

As examples, she noted that manufacturers are under no obligation to prove that their products are safe or effective, and there is no entity responsible for overseeing the manufacturing process or whether the products contain the ingredients that they claim - "all of which are in place for over-the-counter drugs and prescription drugs," she said.

The lack of regulation is problematic not only for consumers but for dietary-supplement makers as well, Metcalf said.

Given all the problems with supplements, if you're an ethical manufacturer, how "do you convince consumers that you're not as bad as the bad guys?" she said.

To others with interests in the sector, such as retailer Brent Castagna, owner of Genesis Vitamins in Nanuet, the government's role in ensuring the safety of supplements is more driven by money and politics than a sincere desire to protect the public.

"No matter what anybody believes, that's what it's been for years and years, and that's what it's going to continue to be," Castagna said.

That said, there are ways consumers can become better educated.

"(But) listening to the latest headlines about a given supplement isn't the way to learn about the benefits it might provide," Castagna said. "If a person really cares to educate themselves on products, then they're going to do themselves a world of good."




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