FDA RELEASES ADDITIONAL WARNING LETTERS TO 18 FIRMS ILLEGALLY MANUFACTURING AND SELLING VAPING PRODUCTS

On February 26th 2021, the FDA issued another batch of warning letters to 18 firms who have been manufacturing and/or selling unauthorized vaping products in the US. The below firms have not submitted the required PMTA(s) (Premarket Tobacco Application) on or by the 9/9/20 deadline, making respective products illegal to sell within the US due to lack of premarket authorization.

Report Funded by Bloomberg Lists Countries Affiliated With Big Tobacco

Released by the STOP partnership, the report was funded by a three-year grant of $20 million awarded by former New York mayor Michael Bloomberg. “This is the only product I know of where if you use it as advertised, it will kill you,” said Bloomberg about cigarettes in 2018, when he awarded the grant.

Study: Adolescent Brains May React Differently to Vapour Than Adult Brains

Led by Prof. Jibran Khokhar, University of Guelph researchers conducted the behavioral test (conditioned place preference, CPP) using adolescent and adult animals, to assess developmental differences in the rewarding effects of nicotine vapour.

“This is the first study to show that rodents find e-cigarette vapour rewarding in a conditioned place preference experiment,” said Khokhar, referring to animals’ preference for a chamber in which experimenters previously exposed them to a drug. “It also shows that adolescents find the nicotine vapour more rewarding compared to adults, and do so even at shorter exposures, which are not rewarding for the adults.”

Vape Safe

Vape Safe Backs PMTA Verified Mission to Support Adult Smokers and Trade with Verified, Unbiased, Factual Information to Make Informed Decisions.

PMTA Verified is backed by Vape Safe; a non-profit organization founded in 2016 by Emergency Room Physician Carlos Smith, MD, in conjunction with a group concerned citizens seeking information on a variety of alternative and emerging therapies. Finding little to no factual, verified information; Vape Safe was founded with an initial focus surrounding e-cigarettes, as the UK Public Health study released vaping demonstrated 95% less harmful than combustible cigarettes* but the information found in their areas told a very different story. What those early concerned citizens found were lies and propaganda.

Vape Safe’s mission is to disseminate honest, accurate, and verified** ENDS (electronic nicotine delivery system) industry information, so that consumers can make educated and informed decisions. These critical decisions need not be swayed by bias, political affiliation, or misinformation.  Because of this misinformation and frustration, the Vape Safe foundation founded PMTA Verified. For reference, it has been over 160 days since advancing the filing deadline and The FDA has still not released a list of accepted Pre-Market Tobacco Authorization.

As a practicing Emergency Medicine Physician for almost twenty years, I see and treat patients DAILY who suffer from the many deleterious health effects of combustible cigarettes. The dozens of toxins and carcinogenic constituents found within combustible cigarettes are culpable of these life-altering/lethal health effects. Interestingly, however, I have also seen patients who have curbed these harmful long-term health effects by abandoning combustible cigarettes and switching solely to e-cigarette use”, stated Dr. Carlos of Vape Safe.

PMTA Verified, backed by Vape Safe, is your trusted resource – not only for PMTA and regulatory updates in the vaping industry- but also for new and emerging therapies and alternative options to what is considered “traditional” in the US. Not backed by any agenda, only factual information to allow consumers to make their own informed decisions.

Interested in knowing what’s on the horizon for Vaping, CBD, THC, Psilocybin, and other emerging alternatives – and how the FDA is choosing to regulate? Stick with PMTA Verified as your trusted resource!

*Royal College of Physicians of Edenborough, published 2015

**PMTA Verified adheres to a strict policy of confirmation of all claimed acceptances. PMTA Verified is in no way affiliated with The FDA and serves as a clearinghouse of verified documentation.

US: CBP And FDA Seize Illicit Vaping Products at Dallas Airport

The seized products amounted to a total retail price of $719,453, and consisted of 42 separate shipments arriving from China and destined to various Texas counties. The shipments included individual disposable flavoured e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow.

Vaporesso Launches 

“Together We Can!” Campaign

Vaporesso, the major Chinese vape brand, has released an inspiring video entitled “Together We Can!” on its YouTube channel, notes a press release. The video, according to the press release, is intended to boost confidence and unity in the global vaping community. Further, the video highlights the company’s efforts to assist vape shop owners worldwide, amid heightened regulatory scrutiny and the COVID-19 pandemic.

Consumer Groups Urge Google to Not Ban Vape Apps

A total of 35 vape groups, amongst which the World Vapers’ Alliance (WVA), have spoken up against this request. “Google already showed its ability to protect kids from accessing content not suitable for minors. It is clear that they have the technical ability to protect children without depriving adults of information. For the good of public health and consumer freedom this anti-vaping crusade needs to stop. The health and wellbeing of millions of people around the world depends on it,” said WVA Director Michael Landl.

What Will USDA's Final Hemp Rule Mean for CBD and Delta-8 Users?

Two years after Congress passed the 2018 Farm Bill, which legalized hemp production in the United States, the U.S. Department of Agriculture (USDA) has published its final Hemp Rule. The new rule spells out the regulations of hemp production and processing for farmers and producers of hemp-derived products, including CBD and other cannabinoids extracted from the plant.

 

Innokin New Generation Vape Technology: Find “F” To Find the Code!

Innokin, one of the leading e-cigarette brands, recently announced the “Find F” campaign for a new product. Innokin has not revealed the product name and its full image yet, and temporarily indicate it as “Find F”. Interestingly, this product has a hidden function named ‘Fø’ that is locked. ‘F’ is described as a new generation vape technology that can be accessed via a secret gamer style code.

Four States Likely To Legalize Medical Marijuana Through Legislation This Year

Lawmakers in Alabama, Kansas, Kentucky, and South Carolina could legalize medical marijuana that could further generate hundreds of millions of dollars and business opportunities across the interstate supply chain. All four of these states are also deep in Republican country and voted for impeached former President Donald Trump in the 2020 Election

U.S. FDA Sends 11 Warning Letters for Illegal Products

The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.

The US FDA Finalizes Two Minimum Requirements For The PMTA

In a release on its website, the FDA explained that these two finalized foundational rules for the premarket review of new tobacco products, provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

U.S. FDA has Processed PMTAs for 4.8 Million Products

The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.

US Post Office to Publish ENDS Mailing Rules Feb. 19

The United States Postal Service (USPS) is scheduled to publish in the Federal Register its rules for mailing electronic nicotine-delivery system (ENDS) products tomorrow, Feb. 19. The unpublished rule states “that the prohibition on mailing ENDS will apply immediately ‘on and after’ the date of the final rule.” However, the Preventing Online Sales of E-Cigarettes to Children Act, which placed ENDS under the PACT Act, was enacted on December 27, 2020 and becomes effective 90 days after enactment (March 27, 2021)

FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline

The FDA set a strict deadline of Sept. 9, 2020 for the premarket tobacco application and as anticipated, received thousands of tobacco product submissions covering millions of tobacco products. All products submitted by the deadline can remain on the market for up to a year pending review from the FDA.

Following the deadline, the FDA began processing and reviewing the large number of applications and just 5 months on have stated that ‘the initial “intake” of submissions is nearly complete, and the acceptance, filing, and substantive review of applications is underway.’ This a lengthy process because of the additional challenges the FDA faced due the significant variety of tobacco products that are included in each submission, they ranged from one product per submission to tens of thousands of products within one submission. Even the amount of content in each submission varied greatly ranging up to 2,000,000 files with each file containing multiple pages of content.

Over the past 5 months the FDA processed applications for 4.8 million products from 230 companies. 84,000 products have been accepted and 3,100 products have received a refuse to accept. Due to level of interest and high demand from the public, the FDA plan to share a list of all products submitted once they have completed processing all applications submitted through the PMTA pathway.

The FDA have also begun the process of issuing warning letters to firms who have not submitted premarket applications and are continuing to sell their products on the market. To date, the FDA has sent warning letters to 30 firms selling electronic nicotine delivery system (ENDS) products, specifically e-liquids. Given the high number of applications and the variety of each submission, the FDA have stated that the likelihood of all applications being reviewed by Sept. 9 2021 is very low.

WHO Urged to Stop Spreading Misinformation About Vaping And COVID-19 Risks

Sadly, the WHO has become renowned for becoming aggressively anti-vaping, despite all the scientific data available in favour of e-cigarette use for tobacco harm reduction. CAPHRA Executive Coordinator and AVCA (Aotearoa Vapers Community Advocacy) director Nancy Loucas, has previously highlighted that the health agency’s position against e-cigarettes has been influenced and compromised by vested interests that provide funds to the organisation, as in this case.