For years consumers have dealt with conflicting reports about the effectiveness of such nutritional supplements as fish oil, saw palmetto and St. John's wort.
But a recent investigation by the New York state Attorney General's Office highlights a more basic question facing the public: Do the supplements contain what their labels say they do?
Last week, New York authorities accused four major retailers — GNC, Target, Walgreen's and Walmart — of selling fraudulent herbal products, all of them popular store brands. Ginseng pills that were examined contained only powdered garlic and rice. Ginkgo biloba, St. John's wort and valerian root tested negative for the herbs on their labels.
Though retailers agreed Thursday to pull the products off the shelves after threat of legal action, industry leaders argue the New York office botched the results by using DNA testing instead of a more accurate chemical analysis.
As this fight plays out, one thing is clear: Consumers are on their own.
There's no official government seal of approval to prove the authenticity of supplement labels. Though the U.S. Food and Drug Administration requires manufacturers to test their products to ensure they are safe and accurately labeled, there are too few government inspectors to enforce those rules.
Even the makers of supplements acknowledge as much. Paula Bickford, a professor of neuroscience at the University of South Florida in Tampa and a researcher at James A. Haley Veterans Hospital, is a co-founder of Tampa-based Natura Therapeutics, which she said requires all its ingredients be certified by a third-party company.
But she doesn't have a lot of confidence in all products when she's shopping the supplement aisle.
"The problem the FDA has is that there are lots and lots of companies," she said, "and not enough people to inspect them."
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Supplements are exempt from the strict regulatory oversight faced by prescription drugs, because of a 1994 federal law that was the defining act for the industry. But the law does give the FDA the authority to regulate how supplements are made and sold as part of what's known as good manufacturing practices or GMP, said Steve Mister, president and chief executive officer of the Council for Responsible Nutrition, a trade association of supplement companies.
Mister said the FDA makes unannounced, periodic inspections of plants, making sure those companies run tests to identify every batch of material that comes in. "You can't just accept that it's ginseng," Mister said. "You have to test to ensure that it is ginseng."
But the FDA says it does only about 480 inspections a year, he said. That represents a small piece of the estimated $30 billion supplement industry.
The New York investigation came after a 2013 report in the New York Times on labeling fraud in the supplement industry. The University of Guelph in Ontario had found as many as a third of herbal supplements tested did not contain the plants on their labels.
Mister and other industry representatives said the New York office's genetic testing could be misleading since DNA can be damaged in the manufacturing process. A chemical analysis would have been more accurate, he said. "It's an unfair black eye," Mister said.
The New York report showed the four retailers' supplements were loaded largely with cheap, harmless fillers like powdered rice, asparagus and houseplants. Still, the questions raised by the new report also point to how easy it could be for supplements spiked with dangerous chemicals to reach consumers, too.
The FDA can order products to be pulled from shelves only after they've injured consumers. Since 2007, the FDA has caught companies selling nearly 575 supplements illegally spiked with prescription drugs or potentially dangerous chemicals, according to the agency's website.
A variety of third-party testing companies offer seals of quality to supplements. But none of them stands out as the official self-policing agency, so consumers must do their homework on those companies, too.
"You have competing seals right now," Mister said. "Each of them would like to grow to the point that they become the seal for the industry."
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Fred Sancilio, founder of Miami-based Ocean Blue Supplements, which makes omega-3 supplements, said chemical analysis of each ingredient in a supplement can be costly — sometimes as much as three times the cost of the raw material itself.
"If you run these tests, the prices of vitamins go through the roof," he said.
That's why Sancilio said he's suspicious of cheap supplements sold on store shelves and through Internet sites. He said cheap products may include ingredients imported from China. (His products sell for about $30 for a two-month supply. That's roughly in line with, for instance, a GNC-brand fish oil supplement.)
To Sancilio, imports from China are a cause for concern. He recalled an anecdote in which a company testing imported vitamin A from China could not detect any vitamin A. The problem? The shipping container had been incorrectly translated, from "a vitamin" to "vitamin A."
"There's nobody testing it," he said.
Mister said companies are supposed to test products, no matter where they come from. But he, too, said he would be wary of low prices for normally expensive supplements, such as $5.99 for a bottle of CoQ10, an antioxidant.
"If you shop the aisle, you get a sense of what most products are selling for in that category," he said. "If you see something drastically cheaper than the general prices, that would be a red flag."
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Experts note that consumers intent on taking supplements can practice some caution in what they take. Some health food stores suggest customers read the label for additional ingredients; as a rule of thumb, there should not be much more than the active ingredients.
At the Palma Ceia Village Health Market in Tampa, employee John Staryk said he advises customers to look for names of companies that have been in the industry for years, such as Country Life. He has been asked about fraudulent supplements and can tell customers only to research the products they are considering.
"It's been a smear on the industry," he said.
Contact Jodie Tillman at [email protected] or (813) 226-3374. Follow @jtillmantimes.