The Food and Drug Administration banned 223 ingredients in over-the-counter drugs Wednesday, saying manufacturers had offered no proof they were effective for problems they were supposed to treat.
The ingredients ranged from pine tar in dandruff fighters through dehydrated garlic in digestive aids to aspirin in medications for external use.The FDA did not ban the ingredients entirely, just in certain uses. For example, aspirin may still be used in products for pain relief taken internally, because it has been shown to be effective pain reliever.
The over-the-counter drug industry said most of the ingredients already had been withdrawn, but some familiar drugstore and supermarket products still will be affected, the agency said.
For example, Tegrin Lotion, sold for use against psoriasis, may no longer contain allantoin. Also Packers shampoo and soap may not contain pine tar, and Donnagel, used to treat diarrhea, may no longer include atropine sulfate, hyoscyamine sulfate and scopolamine hydrobromide.
The ban becomes effective in six months. The agency said none of the ingredients posed a safety problem in any of the banned uses.
The ruling is part of an 18-year-long review of about 300,000 nonprescription products that were on the market in 1972.
As part of its effort to complete that review, the agency last week proposed to ban 111 drug ingredients in over-the-counter diet products. Most companies have stopped using those ingredients, industry officials said.
Manufacturers have been on notice since May that the agency wanted to ban the list of 223 ingredients, and most have reformulated their products, said Jack Walden, a spokesman of the Nonprescription Drug Manufacturers Association.
``Overwhelmingly, this is a housekeeping action,' he said. ``The industry long ago came into compliance. ... It affects products now on the market very, very little.'
Dean Siegal, a spokesman for Block Drug Co. Inc., which makes Tegrin Lotion for psoriasis, said the company has been reformulating its product and expects to have a new one out soon. ``This is not new news,' he said.
But Walden said that some companies disagree with the FDA's assertion that the action was being taken ``based on the absence of substantive comment or failure to submit new data.'
``Some of our companies disagree that they failed to submit data and are in contact with FDA on this matter,' Walden said.
He did not identify those companies, the products or ingredients.
Other banned ingredients are used in, among other things, topical acne drug products, antiperspirant products, cough and cold medications, laxatives, nail biting and thumb sucking deterrents, poison treatments and drug products used to help people stop smoking.
Within a few months, the agency expects to be about halfway through the massive review of nonprescription products it began in 1972, said spokeswoman Bonnie Aikman.