Congress Kills Vaping Bill While FDA Offers Reprieve
There’s good news and bad news: the US Food and Drug Administration stepped up and offered a reprieve on vaping regulations on the same day that Congress killed an amendment that would reset the predicate date for vape products.
The San Diego Tribune is reporting that the Cole-Bishop Amendment, which was meant to curb the FDA’s so-called “deeming” regulations on vaping, died in Congress this week after it failed to get the necessary votes to be attached to the rider list during budget negotiations. The bill, which would have moved the FDA’s predicate date from August 8, 2008, to August 8, 2016, was defeated by a coalition of Democrats and Republicans that was lead by Representative Nita Lowey, the Democrat from New York, who is a ranking member of the House Appropriations Committee.
Lowey, it should be pointed out, received $18,900 from Regeneron Pharmaceuticals as well as the National Association of Realtors, who have both contributed to anti-vaping candidates in the past.
The move to kill the bill was welcomed by the lobbying group, the Campaign for Tobacco-Free Kids, which in a press released stated that the budget agreement: “delivers critical victories for America’s kids and health over the tobacco industry by rejecting proposals to greatly weaken FDA oversight of electronic cigarettes and cigars and slash funding for the CDC’s programs to reduce tobacco use.”
The group also said that: “By rejecting these special-interest giveaways to tobacco companies, this agreement preserves the FDA’s ability to protect kids from the huge assortment of candy-flavored e-cigarettes and cigars that have flooded the market in recent years and threaten to addict a new generation.”
But while the lobbying group is happy about the rejection of the Cole-Bishop amendment, vaping activists are furious.
Gregory Conley, who is president of the American Vaping Association, released his own statement on the decision made by Congress, stating that: “the FDA’s deeming ban is set to take effect less than three months before Senate Democrats have some of their toughest election fights in years. Just as vapers helped re-elect Senator Ron Johnson, vapers will vote out Senators who stand by idly as harm reduction products are yanked from shelves.”
Conley also took direct aim at Democrats, asserting that: “Democrats are setting themselves up to experience a reality check on vaping in the November 2018 mid-term elections.”
Unless Congress takes steps to revive the Cole-Bishop Amendment, the only alternative to rolling back the onerous regulations facing the vape industry is the bill introduced last week in the House by Representative Duncan Hunter. This bill would reclassify vape products as harm-reduction products that would have its own rules and regulations instead of being regulated as tobacco products.
While Congress is set on refusing to make room for vaping, the FDA has given the industry some breathing space.
On the same day that Congress rejected the Cole-Bishop bill, the San Diego Tribune reported that the FDA pushed back the registration deadline for vape manufacturers.
The date, which was set for June 30, will now be pushed back three months to September 30, and “hopefully more is to come,” a sentiment held by Conley.
The reprieve is important, particularly for the small businesses that make up the bulk of the vape industry; the registration date is the precursor to an expensive approval process that is estimated to cost businesses upwards of $200,000 per vape liquid per nicotine level, which will result in fees that could easily total more than one million dollars.
For a small business, that amount of money is hard to part with, particularly since the vape market has been in existence for ten years without over regulation. In many cases, vape businesses have stated that to have to register so early would cause them to go into bankruptcy, since the money is required in order to process the application.
Other deadlines under the FDA’s suite of regulations were also delayed three months, but the most important deadline was the need for registration.
This also calls into question the seriousness of the FDA and the PMTAs: because each PMTA must be reviewed and processed with either an acceptance or rejection within 180 days, is it even feasible that the FDA would have the manpower and the resources within its budget to properly assess the thousands of applications it will receive from the vape industry? While many vape businesses would close if the PMTA requirement stands, there are dozens of other companies that would go forward with the application process. And with the introduction of Big Tobacco into the market, the amount of applications will be steady for the next few years.
The FDA is not currently staffed to reach its mission and goals of reviewing and processing applications because the Trump Administration has yet to even secure Scott Gottlieb’s approval from Congress to become the FDA Commissioner. The approval is important, because until Gottlieb is installed in the office, the FDA is in a hiring freeze, meaning that a backlog of PMTAs has already begun.
With the three-month delay it is hoped that the FDA will come to see its own predicate date as too harsh for the vape industry and will consider, on its own, an amendment to its own deeming rule. Because vaping is now considered by many countries, including the United Kingdom, to be a harm reduction method, it makes more sense to regulate it accordingly, and this delay in the application deadline requirement may signal that the FDA is ready to listen.
The vape industry has pinned its hopes for a bright future on President Donald Trump and his administration; former President Barack Obama was less than sympathetic to the industry and was in office when the FDA regulations went into effect. With Trump’s election, a new nominee to head the FDA and the U.S. Surgeon General’s office, both of whom are believed to be more willing to learn about vaping and give the industry a chance, it seems that a new dawn has risen for the industry.
Lindsay R. Tobias, who is an FDA policy analyst, summarized the action by the FDA best when saying that: “This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.”
While the vaping industry has had both good and bad news in the last week, it is safe to say that vaping advocates and the community surrounding them are not yet ready to let this fight end.