The Center for Baby and Adult Hygiene Products (BAHP) in April asked the Food and Drug Administration (FDA) for a permanent exception, or alternately, a permanent extension of its 2015 Unique Device Identifier policy for Class II menstrual tampons.

Labels for these specified devices that bear a Universal Product Code (UPC) meet the UDI requirements under specific, established conditions. In its 2015 policy, the FDA recognized that retail stores selling these products did not all have appropriate technology to read and interpret UDIs comprised of both the Device Identifier (DI) and the Product Identifier (PI) in Automatic Identification and Data Capture form. The use of an alternate form of the UDI, which identifies and tracks devices in product inventories and commercial transactions, would facilitate recalls and other corrective actions once the products reached retail stores.

In its letter to the FDA’s Center for Devices and Radiological Health, BAHP outlined that the UPC and lot number successfully allow manufacturers, distributors, retailers and consumers to identify the product at the SKU—commercial configuration level, from the moment it is placed in the market and up to its consumption. It also is the method used by other governmental authorities in international markets where the products are sold.

Additionally, a recent survey completed by BAHP members showed that many retailers still do not have the appropriate technology to read and interpret standard UDIs. Further, it is not technologically feasible for their retail establishments to implement a new system capable of reading standard UDIs, and they cannot conduct a recall based on standard UDI product data.

Because menstrual tampons are single-use, over-the-counter, high-volume consumer products, BAHP believes FDA should treat them similarly to Class I menstrual hygiene products, such as pads and liners, that are considered to have met the UDI labeling requirements if they are marked with a UPC barcode on the label. If there is a need for product retrieval or recall, the current information on menstrual tampon packages (UPC and lot code number) would be the existing and proven mechanism for traceability and retrieval.

The alternative form of the UDI rule is due to expire on September 24, 2021. In its 2015 letter to BAHP member companies, FDA permitted those affected by the rule to extend the date within one year of the alternative’s expiration, or after September 24, 2020. In its request to FDA, BAHP said if member companies were to implement a standard UDI system for menstrual tampons, it would need at least 18 months to accomplish key milestones, including:

• Developing a new data architecture.
• Re-designing each unit box or package to accommodate the new UDI label.
• Modifying artwork mechanicals, purchasing, installing and validating new printing equipment on all package lines.
• Updating procedures.
• Training affected colleagues.