FDA Is Not “Suspending Enforcement” of Cigar, E-Cigarette Regulation

Earlier today The Washington Post published an article titled, FDA suspends enforcement of stricter standards for e-cigarette, cigar industry.

While that would be a big win for both industries, it is not true.

The article begins:

The Trump administration has suspended enforcement of a rule finalized last year that imposed strict oversight over electronic cigarettes and cigars for the first time.

That’s even more wrong. In short, the rule is still in effect, the only thing that has changed is any future deadlines for compliance have been pushed back three months.

Shortly after this article was published, The Washington Post changed its article from “suspends enforcement,” to “delays enforcement.” That small change makes the article correct.

As we reported yesterday, the U.S. Food & Drug Administration (FDA) asked for and was granted a three-month extension to a lawsuit brought by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipes Retailers Association (IPCPR).

It’s the second time in the last two months the agency requested was granted an extension. When it requested the first extension, the three cigar trade groups requested that any additional extension to the court case should result in an equal delay to any future deadlines as part of the deeming regulations.

In other words, if FDA has more time to respond in court, cigar manufacturers should have more time to respond to FDA.

Attorneys for the government and groups negotiated out a second extension last week and it was agreed that the three-month extension would apply to both the court case and any future deadlines. Yesterday, Judge Amit P. Mehta issued the order making the extensions official.

What’s key is that in no part of the motion or the order does FDA use language suggesting it will “suspend enforcement”—furthermore, all rules that are already in effect, like those prohibiting new cigars and a ban on free samples, remain in effect. Suggesting that enforcement has been “suspended” would imply that already existing rules are no longer in effect, something that is simply not true.

FDA has not yet officially announced what it is doing as part of the delay. It is expected to publish a guidance document in the federal register within the coming days.

The Washington Post article says e-cigaretes and vapor products are included in the extension, something that isn’t set in stone. While an industry source told halfwheel it believes e-cigarettes will be included in the extension, both the motion and the order specifically mention “for cigar and pipe tobacco products for 3 months.”

It’s likely FDA would want to apply the order to all products to avoid further litigation from the e-cigarette and vapor industries, but there’s nothing in the court documents reviewed by halfwheel that supports that statement.

In court documents, FDA stated the reason for the extension is because of new personnel at the agency.

Judge Mehta’s order is below:

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.