FDA Bans 223 Over-Counter Medications : Drugs: Ingredients are found ineffective in treating certain ailments. The action is part of an extensive review of 300,000 non-prescription products.
WASHINGTON — In a broad cleanup of ineffective over-the-counter drugs, the Food and Drug Administration today banned 223 ingredients in medications to treat everything from acne to dandruff.
Major products affected by the latest ban include anti-dandruff products like Tegrin Lotion, which can no longer include allantoin, and Packers Shampoo and Packers Soap, which can no longer include pine tar. The anti-diarrheal product Donnagel can no longer include atropine sulfate, hyoscyamine sulfate and scopolamine hydrobromide.
The FDA said it took the action because drug manufacturers submitted no proof that the ingredients work.
Among the substances banned: juniper tar and pine tar in dandruff products, dehydrated garlic and various enzymes in digestive-aid products, aspirin in external medications and prune concentrate in stimulant laxatives.
Other ingredients affected by the ban include some used for allergies, boils, cold symptoms, digestive problems, ingrown nails, constipation, oral health problems, pain, skin problems, nail biting, thumb sucking, smoking and swimmer’s ear.
The FDA emphasized that some of the ingredients have been found effective for other conditions. For example, aspirin was banned as an external pain-reliever, but it continues to be considered effective in internal pain relief products.
Some manufacturers have already stopped using some of the ingredients because FDA advisory panels reported there was insufficient evidence to judge their effectiveness.
The ban, which affects 19 classes of non-prescription drugs and takes effect in six months, comes one week after the FDA proposed to ban 111 ingredients in over-the-counter diet products.
Both moves are part of the FDA’s lengthy, ongoing review of the effectiveness of about 300,000 non-prescription products. That review was started in 1972, and consumer groups have criticized the FDA for moving too slowly to pull ineffective ingredients from the market.
