Delay the FDA: A Petition You Really Need to Sign

A Citizen Petition has been filed by NJOY LLC, and supported by several other groups and businesses, requesting the FDA delay the deeming regulations deadlines by 24 months, and issue “final guidance or regulations describing the recommended or required contents of premarket submissions” for e-cigarette product marketing orders from the agency.

CASAA has issued a call to action asking vapers to get involved. The difference between this kind of petition and a typical “slacktivist” petition like those on Change.org is that a Citizen Petition is a legitimate process described in the Code of Federal Regulations.

There is a separate site businesses can use to comment on the petition.

A Citizen Petition lets members of the public — including businesses, like NJOY — ask the FDA commissioner to "issue, amend, or revoke a regulation or order," or "take or refrain from taking any other form of administrative action." By law, the agency must respond within 150 days. Citizen Petitions are often used by pharmaceutical companies to ask the FDA to delay generic drug applications — and they work.

This Citizen Petition is part of a coordinated effort by vape businesses, associations, and consumer groups to push the Department of Health and Human Services (DHHS) to provide relief to the vaping industry. The FDA is part of the DHHS. New FDA Commissioner Scott Gottlieb is thought to be sympathetic to the vaping industry. This gives him a reason to take action.

In late April, a letter from vaping business owners to the DHHS asked Secretary Tom Price to “take action now to suspend or indefinitely delay” the remaining deeming deadlines. That was a joint effort from all the major national vaping associations, and it was signed by more than 2,000 small- and medium-sized vaping businesses, from vape mods to vape juice manufacturers, to every vape business in between.

The bottom line is that we need to use every legitimate tool for complaining, arguing, and demanding that the federal government delay, amend, or kill the unjust and impossible deeming regulations. The Citizen Petition is a good one. The larger the number of names on the petition, the easier it will be for Gottlieb to agree.