WASHINGTON - The Food and Drug Administration said today hundreds of ingredients in over-the-counter medications don't work, and products making those claims will have to change their formulas or labels.
Some of these remedies are pretty common. For instance, every medicine chest in America has probably held a bottle of calamine lotion. Mom said it was good for bug bites and poison ivy. It'll make the itch go away.
Prove it, says the FDA.
Calamine is among 415 ingredients which the agency says are not shown to be effective. Under the proposed rules published by the FDA, calamine, a pink mixture of zinc oxide and ferric oxide, could be sold as a "skin protectant" but not as an "external analgesic."
In other words, it may protect the skin, but it doesn't make it feel any better.
"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.
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 nation's medicine chest 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. A year ago it banned another 111 products. Today's action could take effect in 60 days, giving parties time to send comments to the government.
"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.
A lot of the ingredients on the FDA's list seem to be the stuff of old wives' tales. For example, 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.
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.
None of the ingredients the agency proposes to ban are considered unsafe, and manufacturers could leave them in the products as long as they are treated as inactive ingredients, Gilbertson said.