Innovative electronic cigarettes, vaporizers and smokeless tobacco products introduced since 2007 likely will not face retroactive U.S. Food and Drug Administration regulatory standards.
A bipartisan amendment inserted Tuesday into the fiscal 2016-17 U.S. House agriculture appropriations bill changed the regulatory predicate — or product introduction — date for those products from Feb. 15, 2007, to 21 months after the effective date of FDA deeming regulations.
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What makes Feb. 15, 2007, so significant is that the vast majority of e-cigs and vaporizers were introduced into the marketplace after that date, including top-selling e-cig Vuse, made by the R.J. Reynolds Vapor Co.
The amendment was approved 31-19. U.S. Rep. David Price, D-N.C., the only North Carolina representative on the subcommittee, voted against the amendment.
If the bill is passed by Congress, those innovative products will not fall under pending additional FDA regulations that could be formalized any day.
Supporters of the amendment — including co-sponsors Reps. Tom Cole, R-Okla., and Sanford Bishop Jr., D-Ga. — say having a later predicate date makes “common sense” since there are studies that show e-cigs and vaporizers offer a reduced-risk alternative to traditional cigarettes.
“We shouldn’t be making it more difficult to buy a vapor product than a traditional cigarette by approving a more onerous and expensive regulatory path,” Cole said.
Bishop said the Feb. 15, 2007, date is “inappropriate” as a starting point for substantially equivalent measurement.
“To treat these products worse than a traditional cigarette would be a gift to Big Tobacco,” he said. “We don’t want to limit these products’ ability to compete.”
The amendment may have gained overall support because it also requires the FDA to establish marketing, retail and labeling standards for e-cigs and vaporizers, and to ban the use of those products by those under age 18. Most states, including North Carolina, already prohibit the sale of the products to minors.
The bill already contained a controversial carve-out for traditional large and premium cigars from FDA regulation if the agency wants to receive fiscal 2016-17 funding from the bill. An amendment filed to strip the language from the bill was defeated 34-14.
When asked about the approval of the amendment, FDA spokesman Michael Felberbaum said the agency “does not comment on proposed or pending legislation.”
Analysts said it is likely that the change in predicate date could further delay the implementation of new regulations that have been awaited for more than two years.
The typical e-cig is a battery-powered device that heats a liquid nicotine solution in a disposable cartridge and creates a vapor that is inhaled. A vaporizer can be supplied and reused through the insertion of a liquid capsule.
FDA officials have sought federal approval that new and enhanced smokeless tobacco products be “substantially equivalent” to products already in the marketplace as of Feb. 15, 2007.
The FDA defined substantially equivalent, or “deemed,” as “being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.”
Supporters of the previous predicate date say it would provide better oversight of existing e-cigs and vaporizer products that haven’t had to adhere to stricter health-risk standards, as well as tighten product standards in terms of limiting or eliminating candy and fruit flavorings available in vaporizers.
Rep. Debbie Wasserman Schultz, D-Fla., said she opposed the amendment because “it’s only a way to keep people addicted to nicotine in a more benign way.” She also cited her concerns about what is in the liquid nicotine in many vaporizer products.
Analysts, economists and advocates have said that tighter FDA regulations and the Feb. 15, 2007, predicate date could create a significantly more expensive approval process that could dry up the e-cig and vaporizer marketplace outside Reynolds American Inc., Philip Morris USA and their affiliates.
Wells Fargo Securities analyst Bonnie Herzog predicts that e-cigs ($1.5 billion) and vaporizers ($2 billion) combined will exceed $3.5 billion in sales in 2015, and overtake traditional cigarette sales within the next 10 years.
Scott Ballin, a past chairman of the Coalition on Smoking or Health, said he was surprised by the margin of the approval.
“I think that members of Congress are beginning to comprehend the idea of the continuum of risk that demonstrates that noncombustible products, including electronic nicotine delivery systems, are 95 percent lower in risk than the deadly cigarette and can help smokers quit their deadly habit,” Ballin said.
“I also believe that almost everyone agrees that much more needs to be done to prevent youth initiation of any tobacco or nicotine product.”
A group of 31 anti-tobacco advocate groups sent a letter to the subcommittee Monday stating its concerns that changing the predicate “would significantly weaken the FDA’s ability to take prompt action to protect children from the thousands of fruit- and candy-flavored e-cigarettes and cigars that have flooded the market in recent years.”
Gregory Conley, the president of the American Vaping Association, said the vote is “fantastic news for public health and small businesses.
“However, this is only the start of what will likely be a multimonth fight to keep this provision in the overall budget bill,” Conley said.
Resource : http://www.journalnow.com/business/business_news/local/e-cigs-vaporizers-smokeless-tobacco-products-may-gain-grandfather-exemption/article_b58f4df2-acab-59e5-82c5-584a57d646d3.html
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