is-vaping-safe

Four Vaping Facts You Need to Know

Vaping seems to be a hot topic these days. Is vaping safe? Is it better than cigarettes? Regulations surrounding vaping seem to change daily, yet more people than ever before are choosing to vape.

Here are four frequently asked questions that will help you to understand what it is and why it is always such a controversial topic.

1)  What is Vaping?

A vape, also called an electronic cigarette or an e-cigarette, is an electronic device that heats up a special liquid to create an inhalable vapor. These liquids are flavored to make the vapor taste and smell appealing. When someone is vaping, they are inhaling these vapors into their lungs. Since vaping involves inhaling aerosols into your lungs, it is not a surprise that people are wondering, “is vaping safe?”

Is Vaping Regulated by the FDA?

Since its inception, the vaping industry has grown massively and become increasingly popular over a very small window of time. With that, everyone within the business, including manufacturers, vape shops, and online sellers, has been subject to continuously changing rules, regulations, confusion, and misinformation. As everyone struggles to keep up, FDA regulations continue to be developed, revised, and enforced to balance the great demand for these products with public safety. We cannot stress enough how much these rules and regulations continue to change, so it’s essential to do all we can to stay informed.

Here are just a few of the ways FDA regulations continue to affect everyone throughout the entire vaping industry.

fda-regulations
vaping laws

What are the Current Laws on Vaping?

Keeping up with vaping laws is an ongoing struggle. Recently we’ve seen changes to the PACT Act that will additional restrictions on vape sellers. Add the fact that regulations and approved or restricted products continue to change state to state over time and it’s no surprise that confusion and misinformation are pervading the vaping market.

Vaping laws are changing even more rapidly today, especially in light of the Premarket Tobacco Application (PMTA) deadline being moved up to September 9th, 2020 – nearly two years earlier than originally planned. Promoting the future of the industry demands the vaping public stay informed on current vaping laws and their varied impacts across the US. As of December 2020, here are some notable details.

Is Vaping Safe – The Truth about Vaping

Vaping as an industry has grown over the past decade from something that essentially didn’t exist into a large industry that is heavily regulated by the government and sadly, also plagued by misleading information and unauthorized product. Numerous claims have been made about vaping, but the most pressing question for almost everyone is a simple one: is vaping safe? When it comes to any type of smoking, abstinence is always safest choice, but based on this UK Public Health Study, vaping is found to be significantly less harmful than combustible cigarettes. Here are a few important pieces of information about vaping, its potential hazards, and what you need to know about the practice and industry.

is vaping safe

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

On April 29, FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products – the leading cause of preventable death in the U.S. The two products standards that the FDA are planning on issuing in the next year are to ban menthol as a characterizing flavor in cigarettes and to ban all characterizing flavors in cigars. There is clear scientific evidence that establishes the addictiveness and harm of these products, and the FDA is taking urgent action to reduce tobacco addiction and curb the number of deaths.

According to studies, menthol increases the appeal of tobacco which then leads to regular smoking, particularly among the youth and young adults. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine. If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only address manufacturers, distributors, wholesalers, importers, and retailers. The FDA cannot enforce against individual consumers who possess or use menthol cigarettes and tobacco products but will assure that no unlawful tobacco products will make their way on to the market.

FDA Sends Out 13 Additional Warning Letters To Firms for Making and Selling Unauthorized E-Liquids

On March 12th 2021, the FDA issued another batch of warning letters to 13 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.

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.

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.

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.