New Bill Would Change the FDA Grandfather Date

For the benefit of electronic cigarette users, there is now an opportunity to fight again, and it is likely to succeed.

Vice Chairman Tom Cole (R-OK) and Bishop Sanford (D-GA) introduced a new bill claiming it will change the grandfather date for FDA determinations. The bill is called the "2017 FDA Approval Clarification Act."

Changing the grandfather date will not alter the FDA's authority to approve products introduced after the new date, but it will allow all current products to remain on the market without applying for marketing approval. Existing products must still comply with the safety and marketing standards set by the agency.

“Vapor products provide a promising pathway for those seeking to quit smoking or reduce their smoking,” said Mr. Bishop. “This legislation will ensure that the FDA's regulatory process does not limit access to safer tobacco options for those who seek to use them.”

The new bill is very similar to last year's Cole-Bishop amendment. The most important feature of the legislation is that it eliminates the old date from 2007. The previous grandfather date forced any product introduced after February 15, 2007, to undergo a difficult approval process, including submitting a premarket tobacco application (PMTA) that could cost millions of dollars.

Last year's amendment was abandoned after Donald Trump was elected president because the president allowed the Republican Congress to not pass the budget at the end of the year. Legislation that does not take action during one congressional session must be reintroduced in the next session.

As with last year's Cole-Bishop effort, the current bill offers some compromises that some in the vape industry may not like. The bill mandates that the FDA regulate batteries and imposes product standards, labeling rules, and registration for retailers and manufacturers. There are also some advertising restrictions, likely to gain support from Democrats who are usually skeptical of vaping.

While allowing the FDA to maintain control over vapor products, it still has a positive effect for vaping advocates. To change the regulations, vaping advocates have engaged in extensive discussions and correspondence.