More flexibility in OTC labeling

Manufacturers of over-the-counter drugs now have greater flexibility in labeling inactive ingredients in OTC drugs based on a decision by FDA to grant two petitions.

In doing so, it formalized a practice that the agency has tacitly condoned for more than 15 years. Manufacturers now may use what FDA calls “over-inclusive inactive-ingredient labeling,” identifying ingredients that may or may not be present in a particular product.

FDA rejected a request to allow use of terms such as “may contain,” “may also contain,” or “and/or” in describing inactive ingredients. Instead, these inactive ingredients may be listed as part of the required alphabetical listing of inactive ingredients followed by an asterisk. An asterisk at the bottom of the inactive-ingredient section of the drug facts box would note “contains one or more of these ingredients.”

FDA made clear it expects a phone number to be included on packages bearing over-inclusive labels so consumers can find out if a particular ingredient is contained in the product. That would mean the lot number of the package would need to identify the inactive ingredient in the specific product.

FDA cautioned against “overzealous” use of over-inclusive inactive-ingredient labeling because it might lead to adulterated and/or misbranded products and could mislead consumers. Further guidance on limits to its use will be issued. In addition, such labeling should not be used for ingredients that are specifically required to be disclosed, such as allergens.

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