NEW YORK -- Having rushed to get in-demand herbal supplements onto their shelves, retailers are now pausing, along with consumers and doctors, to consider how safe and effective these products actually are.
Concerns about the minimally regulated herbal industry were highlighted in a symposium sponsored by Good Housekeeping magazine, whose April issue featured an article called "If It's on the Shelf, It's Safe . . . Right?" In the article, medical researchers evaluated the efficacy and potential dangers of such popular remedies as gingko biloba, echinacea and St. John's Wort. Their findings ranged from cautiously favorable to scathing.
Good Housekeeping is published by Hearst Communications, based here.
At the symposium, former Food and Drug Administration commissioner and current dean of Yale Medical School David Kessler attacked the practice, common in supermarkets and drug stores, of linking supplements with the pharmacy.
"My question is where do you draw the line? Will you sell anything that makes any claim?" he asked. "It certainly seems that way when you walk into a pharmacy."
Retailers contacted by SN said supermarkets have a responsibility to make sure their suppliers are reputable and to avoid making their own claims in order to move merchandise.
Bob Teas, the pharmacist at Pratt Discount Foods, Shawnee, Okla., which carries a sizable assortment of vitamins and supplements, said consumers should consult their doctors and buy only recognized brands that do lab testing to verify the contents of their products.
"A legitimate company won't do anything without documentation," he said. "Supermarkets have to act responsibly and present the information in a straightforward way without any hype," said a health and beauty care category manager for a Northeastern chain. "We don't make any claims in our advertising, but despite the fact that we don't actively push herbal supplements, we can't keep enough of them in stock. Some supplements, like St. John's Wort, fly off the shelf."
She added that unless a retailer makes specific statements about the properties of remedies it sells, the onus ultimately is on the supplier.
"Manufacturers have their own liability insurance," she said. "It's like the Tylenol scare. The stores with contaminated Tylenol could not be held responsible because the product had not been tampered with in the supermarket."
At the symposium, Good Housekeeping announced the results of a study rating various St. John's Wort products made by well-known manufacturers. Researchers had found a 17-fold difference in potency between the brands containing the smallest and largest amounts of the active ingredient, hypericum. Labels did not indicate any discrepancy.
"The upshot of this is that consumers can't be guaranteed that they will get the same amount of the active ingredients if they switch brands," said Deborah Pike, the magazine's health editor. "There is no way to tell if consumers are taking too much or too little of an ingredient.
"This puts an enormous burden on the retailer. They should caution the consumer and say while there is some evidence, you need to do more research."
Marketing standards for herbal supplements, as well as for vitamins and other nutriceuticals, are dictated by the Dietary Supplement Health and Education Act of 1994, a relatively loose set of guidelines that essentially allows for self-regulation.
Supplement makers are not required to go through the FDA's stringent food and drug vetting processes, and the agency does not have the power to review supporting scientific evidence a manufacturer cites in claiming a product is safe and effective. While manufacturers cannot tout a vitamin or supplement as a cure for a specific condition, they can claim a product affects a "function or structure" of the body.
Many would like to see the FDA take a larger regulatory role.
"Everybody in our company is concerned about some of the claims made by manufacturers because they are not regulated or proven like traditional medicines. The current law definitely is not enough to protect consumers," said the HBC category manager.
"While I'm not qualified to say what the law should be, manufacturers need to back up their statements with facts. Maybe herbal remedies need a few more clinicals behind them."
Debbie Trinker, director of regulatory affairs and corporate counsel for Boca Raton, Fla.-based Rexall Sundown, a top player in the industry, argued that the current guidelines are working.
"Manufacturers have to follow good manufacturing practices. Reputable manufacturers include all the necessary information for safe supplement use on their labels," she said, adding that "FDA approval does not always guarantee the safety of a product. There have been several prescription drugs previously approved by the FDA that were later taken off the market due to safety issues."
Pratt Discount Foods' Teas agreed.
"There are some generic products I won't carry because they are not good, even though they have been approved by the FDA. Having the FDA regulate herbs is not the answer," he said.
Safety questions aside, he added, the agency's involvement would lead to higher costs for consumers. "The FDA would force companies to submit to 10-year double-blind tests and spend $300 million on research. Consumers would then pay $1 a pill as they do for traditional medicines."