FDA Labels Scores of Concotions Worthless
WASHINGTON (AP) _ The government, in an effort to purge the nation’s medicine chest of snake oil, has declared a carnival of over-the-counter remedies worthless.
Horsetail and huckleberry may have their uses, says the Food and Drug Administration, but no one’s ever proved they’re effective in treating digestive problems. And it arrived at a similar judgment Wednesday against 413 other ingredients.
A lot of the stuff - turpentine oil for fever blisters, sublimed sulfur for lice, creosote for poison ivy - has long since faded from use, just as the old wives’ tales that promoted them finally withered away.
But many concoctions remain on the drug store shelves. And while the FDA says none is unsafe, it wants the public to know that, at least for specific claims of effectiveness against this or that problem, the evidence is lacking.
For example, calamine lotion can be marketed as a skin protector, but its label cannot claim that it relieves the itching of poison ivy or bug bites, the FDA said.
″We are taking this action because no proof has been submitted to FDA that shows the ingredients are effective for the conditions claimed,″ FDA Commissioner David Kessler said in a written statement.
This is the third and largest sweep of over-the-counter products that the FDA has conducted in the last couple of years, as the agency roots through the inventory to throw out stuff that doesn’t live up to its claims.
Many of these have been around since before 1962, when federal law started requiring manufacturers to prove products were safe and effective before putting them on the market.
Two years ago, the FDA made a similar move against 223 ingredients for which it had no evidence of effectiveness, and a year ago it banned 111 more products. Wednesday’s action could take effect in 60 days, giving interested parties time to send their comments to the government.
There was some initial confusion over what effect this would have on the non-prescription drug industry.
″It’s going to affect literally thousands″ of products, said William Gilbertson, who is in charge of the FDA’s review of over-the-counter medicines.
But Meg Grattan, a spokeswoman for the Nonprescription Drug Manufacturers Association, said effects on that group, which represents about 95 percent of the industry, will be negligible.
″We’ve not been contacted by anybody who has real problems with this,″ she said.
Little wonder. Presumably, there won’t be much industry hysteria over the FDA’s declaration that oral drugs for treatment of menstrual symptoms can no longer claim these as active ingredients: alfalfa leaves, blessed thistle, dog grass extract or Venice turpentine.
Still, Ms. Grattan said the association does not have a list of the products that could be affected by the FDA’s action, and Gilbertson said the agency doesn’t have one either.
He said keeping track of products is harder than examining ingredients.
″There are over 300,000 products out there,″ said Gilberston, who is a pharmacist. ″There are less than a thousand ingredients in those products.″
For example, aspirin is an ingredient, and there are hundreds of brands of aspirin.
Once this ban takes effect, it does not mean drug stores will have to remove the products from their shelves, Gilbertson said. It just means the manufacturers no longer will be able to ship the products across state lines.