Tag: U.S. Food and Drug Administration

Reason Foundation: Vape Ban Will Boost Smoking

Photo: jedsadabodin
Guy Bentley
Banning many e-cigarettes from the market could harm public health, warns Guy Bentley, director of consumer freedom research at the Reason Foundation, ahead of the deadline for the U.S. and Drug Administration to decide the fate of millions of premarket tobacco product applications (PMTAs).
In a commentary published on the Reason Foundation’s website, Bentley says that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, the better off we’ll all be.
Today, the FDA is expected to announce which electronic nicotine delivery devices (ENDS) will be allowed to remain on the U.S. market. The sheer volume of PMTAs—the agency has received more than 6.5 million applications—means that there may not be decision on every product, but the FDA’s announcement will likely cover the majority of the vape market.
To remain on the market, every vapor products must prove to the FDA that it is “appropriate for the protection of public health. Because the process is expensive and complex, larger companies enjoy a big advantage over their smaller competitors. Experts expect considerable consolidation in the vapor market after today’s announcement.
Most of the vapor products that are likely to be banned are the non-tobacco flavors that have proved popular among America’s 15 million vapers. Bentley pointed to a recent study on the effects of San Francisco’s ban on flavored tobacco products, which showed an increase in high school smoking following prohibition. He also cited research by the Centers for Disease Control and Prevention revealing that sweet or fruity flavors are not the primary reason why youth vape.
On the positive side, argues Bentley, if the FDA approves some e-cigarettes today, it will help put to rest the arguments about whether these products are beneficial to public health. Many studies suggest that vaping is considerably less harmful than smoking. It has also proven effective in helping people quit smoking traditional cigarettes. Public Health England has famously found e-cigarettes to be 95 percent safer than smoking, for example.
An FDA seal of approval for some cigarettes would force policymakers and antismoking advocates to justify their crusades against products that the agency deems to play a role in improving public health.
The majority of vapor products are likely to be banned today, however. In most cases, it won’t be because they are inherently riskier than approved products but because the applicants were unable to navigate the FDA’s complex regulatory system, according to Bentley.
The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.
September 9, 2021
FDA Announcement on ENDS Marketing Expected Today

Photo: Grispb
The U.S. vaping industry is about to change fundamentally. Today, the U.S. Food and Drug Administration must decide whether millions of electronic nicotine delivery systems are “appropriate for the protection of public health.” Products that don’t meet its standard will have to come off the market or risk enforcement by the agency.
To date, vapor companies have operated without many of the restrictions on sales and marketing governing traditional cigarettes. But the FDA has come under increasing pressure from politicians and public health groups in recent years to limit the sale of vapes, largely over concerns about the products’ popularity with teenagers. E-cigarette companies argue that flavored vapes can help smokers switch to less-damaging nicotine products.
Due to the cost and the complexity of submitting a premarket tobacco product application, industry observers expect only a handful of applications, submitted by wealthiest companies, to survive the vetting process. Many vaping products are produced by smaller companies that lack the resources to thoroughly answer FDA’s scientific questions about safety, according to Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. “Large companies such as Juul only sell a handful of types of e-cigarettes, but have the financial resources to stack their applications to make them more likely to be cleared by the agency,” he told Politico.
The FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants’ market share. Juul Labs alone controls over 40 percent of the e-cigarette market.
The agency has already rejected a significant share of the estimated 6.5 million applications it received from more than 500 companies. On Aug. 9, the agency issued a “refuse to file” letter to JD Nova Group, notifying the company that the applications it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
In a statement, the FDA said the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
On Aug. 26, the agency issued marketing denial orders (MDOs) for about 55,000 flavored ENDS products from JD Nova Group, Great American Vapes and Vapor Salon. In a news release, the FDA explained that the applications from the three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use of such products.
According to Filter, the FDA on Aug. 31 denied an additional 800 flavored vaping products due to incomplete applications. The companies had reportedly planned to submit additional information after the Sept. 9, 2020, deadline. The FDA did not make a separate announcement of these denials on its website.
September 9, 2021
CTFK Urges FDA to Deny All PMTAs for Flavored Vapes

Photo: Brian Jackson
The Campaign for Tobacco-Free Kids (CTFK) reiterated its call for banning all flavored vapor products following the U.S. Food and Drug Administration’s denial of marketing applications for about 55,000 flavored e-cigarette products.
While welcoming the FDA decision, the CTFK noted the denial involved only a small percentage of the flavor products under review by the FDA. “
“The FDA’s action covers just a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with a significant market share or that are most popular with kids, such as Juul, the number one youth brand,” CTFK President Matthew L. Myers wrote in a statement.
“Today’s action will be effective in reversing the youth e-cigarette epidemic only if FDA also denies the applications for all flavored e-cigarettes (those with flavors other than tobacco), as well as high-nicotine products like Juul that put kids at risk of addiction.”
According to the 2020 National Youth Tobacco Survey, 3.6 million kids use e-cigarettes, including nearly one in five high school students. The CTFK blames flavored e-cigarettes for this situation. Eighty-three percent of youth e-cigarette users report using flavored products, and 70 percent of youth users say they use e-cigarettes because of the flavors, according to the organization.
“To protect our kids and end the youth e-cigarette epidemic, the FDA should not authorize the sale of any flavored or high-nicotine e-cigarettes,” wrote Myers.
The FDA must decide whether to grant marketing applications for e-cigarettes by Sept. 9.
August 27, 2021
SBA Wants FDA to Ask Judge for PMTA Extension

Photo: Grispb
The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.
In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.
In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.
Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.
“Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”
The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.
The SBA is a federal agency represents the views of small business to the various branches of government.
June 10, 2021