As the chances of regular order for appropriations bills slips away, we are still very interested in the report language that accompanied the Agriculture appropriations bill. As you likely know, the Food and Drug Administration, while organizationally a part of the Department of Health and Human Services, is funded through the Ag approps bill. Report language, which is not legally binding but nonetheless followed by government agencies, includes many important policies.
One paragraph, in particular, caught our eye (thanks, Laura!). It directs FDA to update, and, if necessary, publish "new guidance inclusive of additional categories of menstrual products not currently covered by the existing guidance." The guidance, issued in 2005, applies to menstrual tampons and pads. Even then, the guidance clearly did not cover all available menstrual products; today, more products are on the market.
Tampons are labeled with their absorbency (light, regular, super) which is based on the industry’s syngina test, referenced in the 2005 guidance (syngina, by the way, is an abbreviation of sorts for synthetic vagina). Other menstrual products, like the menstrual cup, internal condom, diaphragm and even fertility apps are regulated through the 510(k) process. New and potentially more eco-friendly products, like reusable tampon applicators are being cleared by FDA. However, as menstrual products become more high tech, FDA will have to have a far different approach to regulation than asking for the tensile strength of the tampon string.
While FDA has a number of priorities, not the least of which is the international pandemic of COVID-19 and its variants, we hope that FDA welcomes the opportunity to update its guidance to industry. The femtech industry is booming, and menstrual products are an important part of this market. We see a lot of opportunity for users, industry and regulators to come together to work towards a more modern framework for regulating menstrual products.