From the Coalition of Handcrafted Entrepreneurs….Senator Hatch from Utah has entered the cosmetics regulatory reform debate in a significant way, by introducing his own legislation, which he is calling the “FDA Cosmetic Safety and Modernization Act” It has been assigned the bill number, S.2003.
This is a much different bill than the Feinstein-Collins plan. Under Senator Hatch’s bill, small businesses would be exempt from registration if they are home based or have less than $1 million in “net” revenue. While “net” is not defined in the bill, it is a term that typically incorporates the deduction of certain costs of operation from the overall or “gross” amount of revenue a business takes in. In this way, Senator Hatch’s bill continues to recognize the importance of protecting small business from impacts that could harm their ability to grow.
Like the Feinstein-Collins bill, the Hatch bill does require small business to comply with the adverse event reporting requirements and also would obligate producers to provide contact information so that consumers can contact the manufacturer in the instance of an adverse event. The bill also has a GMP requirement, but, if adopted, would require the Secretary of Health and Human Services to come up with special guidance for small business and extra time for compliance. The bill also calls for research into the safety of cosmetic ingredients.
Significantly, Senator Hatch’s bill is silent on many of the other components of the Feinstein–Collins effort such as ingredient uploading, safety substantiation, and perhaps most significant, fees.
Congress’ plate is pretty full for the remainder of the year with budget and tax related issues so we don’t expect to see near term action on this, but we will continue to monitor.