Discover your next big idea at PACK EXPO Las Vegas
Experience a breakthrough in packaging & processing and transform your business with solutions from 2,300 suppliers spanning all industries. Click to learn more.

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.

Annual Outlook Report: Workforce
Hiring remains a major challenge in packaging, with 78% struggling to fill unskilled roles and 84% lacking experienced workers. As automation grows, companies must rethink hiring and training. Download the full report for key insights.
Download Now
Annual Outlook Report: Workforce
Conveying Innovations Report
Editors report on distinguishing characteristics that define each new product and collected video demonstrating the equipment or materials as displayed at the show. This topical report, winnowed from nearly 300 PACK EXPO collective booth visits, represents a categorized, organized account of individual items that were selected based on whether they were deemed to be both new, and truly innovative, based on decades of combined editorial experience in experiencing and evaluating PACK EXPO products.
Take me there
Conveying Innovations Report