WASHINGTON -- One of the most talked about issues of the U.S. Food and Drug Administration’s (FDA) recently announced “deeming” regulations on cigar, pipe and electronic cigarettes has been the predicate product date.
The predicate date (also known as the grandfather date) refers to part of the 2009 Tobacco Control Act that allowed tobacco products on the market before Feb. 15, 2007, to be “grandfathered” in (meaning manufacturers did not have to submit a premarket tobacco application—or PMTA—to the FDA). Equally important, manufacturers would have the option to submit less costly substantial equivalence (SE) applications for new products that were similar or substantially equivalent to a product on the market as of February 2007.
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Many have called for the FDA to adjust that grandfather date for newly deemed products, pointing out that the e-vapor industry was relatively nonexistent in 2007, meaning vaping products could remain on the market only through the very expensive PMTA pathway.
That didn’t happen.
“The FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99% of all vapor products on the market as a result of the Feb. 15, 2007, predicate date,” said the Smoke Free Alternatives Trade Association (SFATA) in a press release. “Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.”
Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), has repeatedly said the FDA does not have the authority to change the predicate date. Only Congress can … and is trying to.
Weeks before the final deeming regulations were announced, the House introduced a rider included in the Agricultural Appropriations Bill (known as the Cole/Bishop Amendment) that would move the predicate date from Feb. 15, 2007, to the date deeming goes into effect (Aug. 8, 2016).
The issue is far from settled: A similar amendment was nixed last year, and Zeller said the FDA and the Obama administration oppose any legislation that would change the grandfather date.
Here’s how the issue might play out:
Option 1: Predicate Date Remains Feb. 15, 2007
Numerous vaping advocates and manufacturers have decried the steep cost of the PMTA process. While the FDA had initially estimated each PMTA would take 500 hours, those estimates went up significantly in the final regulations.
“The FDA now estimates that filing a PMTA will take over 1,700 hours per product, which brings the estimated cost for a single application up to over $1 millions,” said Gregory Conley, president of the American Vaping Association. “In all reality, the true cost of a PMTA is likely to exceed several million dollars.”
That’s several million dollars per application. During a media briefing, Zeller acknowledged that most manufacturers will need to submit multiple PMTA applications.
“Will each SKU require a separate application?” he said. “It will depend on how many flavor combinations survive down the road. But it’s possible that, yes, each flavor/nicotine combination would be its own new product.”
This is especially problematic for vaping and e-liquid manufacturers specializing in multiple flavors and nicotine strengths. Michael Siegel, a professor of Community Health Sciences at the Boston University School of Public Health, pointed out that given the FDA’s own “gross underestimate” of $330,000 per PMTA, a manufacturer with 20 e-liquid flavors in three nicotine strengths would be looking at $19.8 million in order to comply.
“Quite clearly, this is a cost that only a very small number of manufacturers can afford,” Siegel wrote in his Tobacco Analysis blog.
“The grandfather date is huge,” said David Sweanor, an adjunct professor of law at the University of Ottawa’s Center for Health Law, Policy & Ethics. “You essentially banish the category if you use that earlier date. I don’t think any of the innovative companies can come anywhere close to covering the cost.”
Option 2: Congress Moves the Grandfather Date
Thomas Briant, executive director of Minneapolis-based NATO, talked about the Cole/Bishop Amendment at the NATO Show in April.
“If that change is enacted, the deeming regs would not require a PMTA to be filed on the hundreds or thousands of cigar products, pipe tobacco products, e-cigarette and vapor products that were on the market the day the deeming regs go into effect,” he said. “Everybody’s grandfathered.”
This, Zeller said, would have “an enormously adverse impact on public health and the ability of the FDA to do its job.”
“It will exempt all of these products from any premarket review,” he continued. “Worse, those unreviewed products will be able to serve as predicates for new products coming down the road. We don’t think that this makes sense from a public health perspective.”
Briant and others disagree with this sentiment, pointing out that, like cigarettes, smokeless and roll-your-own products that were grandfathered in back in 2009 (when the Tobacco Control Act was passed), newly deemed products would be under FDA authority.
“All those products would be subject to all of the regulations that currently apply to cigarettes, roll-your-own and smokeless,” Briant said at the NATO Show. “They would also be subject to any regulations the FDA adopts in the future.”
In fact, Siegel pointed out that moving the grandfather date doesn’t fully fix the problem of how costly it will be for the e-vapor industry to innovate moving forward.
“The only way out of this disaster would be for Congress to enact legislation that prevents the FDA from requiring PMTAs for vaping products and forces the FDA instead to develop actual safety standards for these products,” Siegel said. “While the Cole/Bishop Amendment is a step in the right direction, it is still problematic because PMTAs would still be required for new products. We need to encourage innovation, not stifle it.”
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