The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule Tomorrow, May 18, 2023, from 9 a.m. to 2 p.m.
The proposed rule is open for public comment until Sept. 6, 2023.
The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.
A state senator in Alabama introduced a bill last week that would make it illegal for minors to be in possession of vapes, according to a release from the Drug Education Council.
The bill, introduced by Senator Vivian Figures, received bipartisan support and was “co-sponsored by 100 percent of the state senators present,” according to the release.
The bill is an amendment to Section 28-11-14 of the Code of Alabama 1975, reports WRBL. It makes in unlawful for any individual under the age of 21 to purchase, use or transport any “electronic battery-powered device capable of being used to deliver the following:
The bill also says that “a violation is committed upon mere possession” of any vaping device, regardless of what is in it, according to the release.
No potential penalties were announced as of this writing.
On Friday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to 10 companies that collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.
The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”
The companies that received MDOs include:
FDA is not disclosing the names of the other two companies that received MDOs to protect potential confidential commercial information (CCI).
The FDA added the premarket tobacco product applications (PMTAs) submitted for a variety of flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol.
“It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO,” said Char Owen, president of the American Vapor Manufacturers Association.
She said some of the companies targeted Friday had just one or two storefronts and were genuinely trying to help adults stop smoking through the use of flavored products, according to the Washington Post.
“It’s tough out here because you’re dealing with lives and businesses,” Owen said.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
Avail Vapor has asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the Food and Drug Administration to Avail products.
In its petition, known as a Writ of Certiorari, Avail asks the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decisionmaking was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
The Supreme Court has not yet decided whether it will hear Avail’s case.
The Ministry of Health in Vietnam has called for stricter control of e-cigarettes and heated tobacco products that are not licensed in the country, reports VnExpress International.
In a recent document addressed to various government ministries and committees, the ministry asked for increased communication about the dangers of such products and for stronger measures to be taken against their purchase, sale, and trading.
Despite not being allowed in Vietnam, these products are becoming increasingly popular and are widely available on the internet. According to statistics from the World Health Organization, a growing number of Vietnamese students are using e-cigarettes, with 2.6 percent of those aged 15-17 vaping in 2019, and a 2022 survey revealing that 3.5 percent of those aged 13-15 use e-cigarettes.
There have been reports of students being poisoned by nicotine and liquids used in these products. The ministry also highlighted the risk of these products leading to social problems and addiction-related crime.
Israel’s health ministry discussed the possibility of banning the marketing of electronic cigarettes, according to i24 News.
The ministry said, “options are being examined due to two difficult cases and the widespread phenomenon,” referring to the increase of youth using e-cigarettes.
The ministry is considering the possibilities of banning the marketing of electronic cigarettes altogether, banning only those flavored or requiring dissuasive images on packaging.
The governor of Oklahoma signed a bill last year that removed fines for those under the age of 21 years old caught illegally purchasing or possessing vaping and other products. Earlier this week, Stitt signed a new law reinstating those fines.
On Monday, Stitt signed H.B. 2165 into law, which reintroduces fines for those under 21 years old caught possessing, purchasing, trying to purchase or using fraudulent identification to try to buy vaping and other tobacco products, reports Charlie Minato of Halfwheel.
Anyone caught violating the law must attend a tobacco cessation program and could be required to complete community service. If they do not, they could be fined up to $50 for the first offense and $100 for any subsequent offense.
In addition to restoring fines as a form of punishment, H.B. 2165 would also restore the ability of local cities and municipalities to issue their own penalties, something that was removed last year.
In 2020, Stitt signed a bill to raise the minimum age to purchase vapor, e-cigarettes and other tobacco products to 21 years old.
The new law goes into effect on Nov. 1, 2023.
The U.S. Food and Drug Administration says it is on track to finish reviewing premarket tobacco product applications (PMTAs) for the most prevalent e-cigarettes by the end of the year, reports CSP.
The FDA has reviewed 52 percent of covered applications as of March 31. Covered applications are for new tobacco products on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar and reach 2 percent or more of total retail sales volume per NielsenIQ reports, according to CSP.
Based on the latest status report, the FDA plans to have 53 percent of covered applications acted on by June 30, 55 percent of covered applications acted on by Sept. 30 and 100 percent of covered applications acted on by Dec. 31.
The court-ordered deadline for FDA review of PMTAs was Sept. 9, 2021, but the agency did not meet that deadline and now has to file regular status reports on progress. The next status report is due by July 24.
The Australian government today announced that it will ban the importation of all nonprescription vaping products – including those that do not contain nicotine. The new legislation is being billed as containing the most significant tobacco and vaping control measures in the country in a decade.
The announcement today clarifies last week’s announcement of a crackdown on illegal vaping. This time the government said it would now include a total ban on nonprescription vaping products.
To tackle youth vaping, minimum quality standards for vapes will be introduced including restricting flavors, colors and other ingredients. Vape products will require pharmaceutical-like packaging, and the allowed nicotine concentrations and volumes will be reduced.
All single-use, disposable vapes will be banned, according to The Guardian.
Speaking on ABC’s Q&A on Monday night, Australia’s health minister, Mark Butler, said that the tobacco industry was trying to create a “new generation of nicotine addicts” through vaping and that he was “determined to stamp out this public health menace.”
The move follows an inquiry into vaping reforms led by the drugs regulator, the Therapeutic Goods Administration (TGA), with submissions from health professional bodies, public health associations, individual health professionals and university researchers that overwhelmingly support tightening border controls.
Many public health experts and bodies submitted to the inquiry that border controls should also be placed on non-nicotine vaping products to prevent mislabelling and exploitation of import loopholes. It follows manufacturers falsely labeling products containing nicotine as “nicotine-free” to get around import restrictions, leaving children easily able to buy vapes, often unknowingly inhaling nicotine and becoming addicted.
The government will also work with states and territories to end vape sales in convenience stores and other retailers. Prescriptions for nicotine vaping products for smokers trying to quit tobacco will be made easier to obtain, with stronger standards around the vaping products that can be bought in pharmacies so people can be assured of the content of the products.
Butler said he will expand on the reforms in a speech to the National Press Club on Tuesday, where he is expected to say vaping has become “the biggest loophole in Australian history” and announce that the following Tuesday’s federal budget will include AUS$234 million in funding for tobacco and vaping reforms, the biggest since plain packaging of tobacco products was introduced.
The government watchdog group Protect the Public’s Trust filed a complaint with the Department of Health and Human Services over what it says are scientific integrity violations involving the impact of vaping.
The complaint states the U.S. Food and Drug Administration is promoting public health messages on vaping that appear to be unsupported by its own research and scientific findings, according to Center Square.
Protect the Public’s Trust stated the FDA was making “scientifically unfounded statements about the vaping industry” contrary to its own research, adding the agency’s own data appeared to contradict the FDA’s public stance on vaping products.
Protect the Public’s Trust said an FDA report found that “only a subset” of the many harmful compounds found in cigarettes are found in vapes and “at much lower levels” than those in cigarette smoke. That FDA report found that menthol-vapes were helping adult smokers quit cigarettes better than fruit, candy or traditional tobacco flavors.
In the complaint, Protect the Public’s Trust stated that FDA Commissioner Scott Gottlieb presented vaping as comparable to smoking traditional cigarettes because “several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some [vaping] products.”
The FDA didn’t respond to an email seeking comment.
But the FDA declared that “Vaping is not harmless. It carries real health and safety risks, including addiction and other negative health effects.”
“Many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes. However, there is not yet enough evidence to support claims that e-cigarettes and other ENDS [Electronic Nicotine Delivery System] are effective tools for quitting smoking,” the FDA stated on its website.
Protect the Public’s Trust stated there has been a pattern of the government not following “the science.” Protect the Public’s Trust also claimed in December 2022 that the Centers for Disease Control and Prevention failed to track side effects of taking the COVID-19 vaccine.
“Once again, it appears that federal public health leadership has chosen to sacrifice scientific integrity and the public’s rapidly disappearing trust on the altar of political and special interest agendas,” said Michael Chamberlain, director of Protect the Public’s Trust, in an email to The Center Square. “While we were promised that health officials would follow the science, what we have observed instead is a disturbing trend of ignoring or disregarding scientific research and data that don’t fit their particular biases.”