The FDA’s new commissioner, Scott Gottlieb, is being urged by Senator Ron Johnson (R-Wis.) to consider repealing the newly established rules which were finalized under former President Barack Obama’s administration.
In May 2016, the rules were put in place and manufacturers of electronic cigarette products were given 12 months from the date the rules to effect to request exemption from product approval standards. They were given 18 months to submit applications proving the product has an equivalent already on the market. Alongside the above time frames, manufacturers were also given 24 months to submit pre-market approval applications.
Enforcement of the rules has been delayed by three months to give the new administration time to review the rules which are currently being challenged in court.
Sen. Ron Johnson said, “Based on some estimates, these applications could cost manufacturers, many of which are small businesses, more than $1 million to complete, that is a cost that these businesses cannot afford”.