Federal health officials Wednesday announced a crackdown on the sale of prescription cold, cough and allergy products that had never been proven to be safe and effective.
About 500 products that had never been formally evaluated by federal regulators will be removed from the market, the Food and Drug Administration announced. The move is the latest in a series of actions by the agency to stop the sale of a variety of products that were being sold without government authorization.
Although the agency had received some reports of complications from the products, such as irritability and over-sedation, officials said they did not know how widely the products might cause problems or even how commonly the products are used.
"Like a lot of things that are related to unapproved products, the problem is what we do not know," said Deborah Autor, the director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research.
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