3 More Companies Receive PMTA Denial Orders

All of the premarket tobacco product applications (PMTAs) that have received marketing denial orders (MDOs) from the U.S. Food and Drug Administration have been for flavored products other than tobacco. On Aug. 31, the agency issued MDOs to three companies for only their other-than-tobacco flavored e-liquids, bringing the total number of companies known to have received MDOs to six. According to Filter, approximately 800 PMTAs were denied in the recent round of denials.

the FDA has issued a Refuse to File (RTF) on 4.5 Million products

The FDA has made significant steps in taking action on the unprecedented number of applications received by the Sept. 9, 2020 deadline. In accordance with that deadline, the FDA received applications for over 6.5 million products from over 500 companies. 4.5 of those million products were submitted by JD Nova Group LLC who received a refuse to File (RTF) letter from the FDA on August 9th for not meet the filing requirements for a new tobacco product seeking a marketing order.

JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate Environmental Assessment (EA). As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.

The FDA Issues Warning Letter To Visible Vapors LLC

On July 28th, 2021, the FDA issued a warning letter to Visible Vapors LLC for illegally marketing new tobacco products lacking premarket authorization. Simply put, this means that the firm did not submit any premarket tobacco product applications (PMTAs) for these products by the Sept. 9, 2020, deadline. While the warning letter issued today cites specific products such as Visible Vapors Irish Potato 100mL and Visible Vapors Peanut Butter Banana Bacon Maple (The King) 100mL, the company must ensure that all of its 15 million products comply with federal rules and regulations, which include the premarket review requirement.

The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law. From January through June 2021, the FDA issued a total of 131 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications for such products by the Sept. 9 deadline.

The FDA Has Delivered a total of 9 warning Letters in the month of june

In the month of June 2021, the FDA delivered a total of 9 Warning Letters to manufacturers and sellers of unauthorized ENDS products. These companies are or have illegally been selling ENDS products which do not have the necessary premarket authorization to be legally sold in the US (obtained only through PMTA submission to the FDA by the 9/9/20 deadline). Since January 2021, the FDA has issued a total of 131 Warning Letters.

June Warning Letters:

  1. TNT Vapors
  2. Tasty Vap Shop
  3. Custom Vapors Inc. dba VIP Custom Custom Vapors/ Premier Vape
  4. Pure Vapor USA LP
  5. Vape E’s Ltd
  6. E-Vaperz Spring Hill Location LLC
  7. Lincoln Vapor LLC
  8. The Vapor Shop
  9. Tiger Vapes

For a complete list of all ENDS Companies represented on the FDA’s Official PMTA Listclick here.

D.C. City Council Passes Flavor Ban, Excludes Hookah

A vote by the the City Council for the District of Columbia (D.C.) took place on Tuesday, 29th June to ban the sale of flavored vaping and other tobacco products in the District, including menthol cigarettes. It was the council’s second vote in favor of the legislation and it will now be passed onto Mayor Muriel E. Bowser, who supports the ban for health reasons.

The High Court Ruled In Favor Of The FDA Right To Regulate Electronic Cigarettes And Vaping Products.

In a win for the public health regime in the United States, the US supreme court rejects the vaping industry challenge to FDA Vaping Regulations. The court declined to hear the challenge, ultimately turning away an opportunity for the courts to put restrictions on the power of federal regulatory agencies.

CAPHRA: World Vape Day 2021 Largest Event Ever

A vaping group announced World Vape Day 2021 was an unprecedented success with social media engagement about the annual global celebration up considerably. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) estimates report a 125 percent increase in Twitter traffic about World Vape Day from 29 May to 2 June compared to the same period last year.

cbd-regulation

CBD Vaping Regulation – Why is it So Essential?

Vape products and e-cigarettes have been the topic of a lot of discussion and faced a whirlwind market with a lot of positive and negative press. State and federal governments have waffled back and forth on various regulations and attempts to study the industry and stay informed on how best to protect consumers while allowing the industry to thrive with very mixed success. While this has disappointed consumers and certainly discouraged investors and innovators in the industry, tobacco and CBD regulations are sorely needed.

Insufficient Studies of Long-Term Health Effects

Any new industry is difficult to regulate as the existing rules often do not apply to the new product, or the government officials might not understand the new idea well enough to make decisions on them. FDA regulators have to depend on scientific studies, with a heavy emphasis on independent studies, in order to make the right decisions. This definitely applies to proper CBD regulation, as studies are still being conducted. CBD vapes are still new we are still waiting on definitive studies on their possible long term health effects.

What Does Vaping Do to Your Lungs?

Vaping is out there. If you don’t vape, it seems like everyone else does, but if you do want to try vaping, it can be hard to find. The questions about whether or not one should try it are always out there, too. There are other questions, as well. The biggest few that people ask about when it comes to vaping are whether it is safer than smoking cigarettes, and what vaping laws govern it. Most importantly, what does vaping do to your lungs? Have the right information before you make up your mind.

Some history

Some time ago, it seemed that vaping was welcomed as a health alternative to smoking. But shortly thereafter, people began to see it differently. What was risky about tobacco smoking was still present in vaping products. Soon, the FDA determined that there was little difference. Vaping had similar effects and consequences. It was still addictive, and it was still assumed to be filled with harmful chemicals that no one should inhale. Vaping laws first changed one way, and then went another.

vaping-laws

Despite Regulatory Challenges, Vapor Retail Rises

The Vaping Industry has been facing ongoing major regulatory challenges. The first big hit was the Premarket Tobacco product application (PMTA) that was announced in 2016 for “deemed” tobacco products introduced into the marketplace between Feb. 15, 2007, and Aug. 8, 2016. The Food and Drug Administration (FDA) set Sept. 9, 2020, as the deadline for manufacturers to submit their applications. The most recent challenge has been the U.S. Postal Service ban on mailing vaping products. However, despite these major impacts on the Vaping Industry, the electronic smoking devices saw a 19.9 percent increase in dollar sales and a 24.5 percent increase in unit sales over the last 4 weeks of April. 

This Week The FDA Has Issued 9 Warning Letters To FIRMS FOR MAKING AND SELLING UNAUTHORIZED E-LIQUIDS

This week the FDA issued a total number of 9 warning letters to vapor companies 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. The regulatory agency issued the letters to the below firms between May 20 and May 27.

  1. Big Chief Vapor Products LLC
  2. Vape Lizard E-Juice LLC
  3. Blue Eyed Vapor
  4. Adirondack Juice LLC (Adirondack Vapor & Co.)
  5. Nicfixed LLC (Good Karma Vapor)
  6. Soul Vapor  
  7. Nelson Endeavors LLC (Liberty Vape Co.
  8. Premium eJuice USA LLC (Vapor Lab)
  9. Capitol Hill Vapor Co.

PMTA Verified Releases Press Release On The FDA's List of Deemed Tobacco Products

The 15-part list includes over 6 million deemed new tobacco products with pending Premarket Tobacco Applications. Listed products are authorized to remain on the market while applications continue to be reviewed by the FDA. PMTA Verified has compiled a comprehensive list of all ENDS (Electronic Nicotine Delivery Systems) Companies included on the FDA’s PMTA List.

According To The Yale School Of Public Health Flavor Bans Boosted Teen Smoking

In 2018, San Francisco approved a ballot banning the sale of flavored vaping products to discourage the youth from vaping. According to a new study done by the Yale School of Public Health, high school students’ odds of smoking conventional cigarettes doubled in San Francisco’s school district. The study is believed to be the first to look at how flavor bans affect youth smoking habits. 

THE FDA HAVE PUBLISHED THE OFFICIAL LIST OF ENDS THAT CAN BE LEGALLY SOLD IN THE US

The U.S Food and Drug Administration (FDA) have finally published the list of ENDS products that can be legally marketed in the US. The list is broken down into 15 files containing over 6 million individual products. The companies that have submitted their application by September 9th can continue to market their products up until the one-year mark depending on the FDA review of their application. Due to volume of products, PMTA Verified have made a simplified version of the list containing companies represented on the FDA’s official PMTA list. 

Click below for list of 360 companies that have filed a PMTA. 

Over The Past 30 days The FDA Has Issued 12 Warning Letters To FIRMS FOR MAKING AND SELLING UNAUTHORIZED E-LIQUIDS

Over the past month the FDA issued a total number of 12 warning letters to vapor companies 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. The regulatory agency posted the letters to the below firms between April 9 and May 7, however the FDA didn’t post the letters on its website until April 30 and May 18.

  1. B-X Vapor
  2. VaporBombCOM
  3. Rockey Top Vapor LLC
  4. Custom Vapes
  5. The Smokers Alternative
  6. Nicotine Nirvana
  7. FF Vapors LLC
  8. JP & SN Enterprise Inc (eCigs International)
  9. The Iron Crow LLC
  10. Sema International Inc.
  11. Central Iowa Electronic Cigarettes Inc.
  12. High Voltage Vaporz LLC

These companies must submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

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.

According to the FDA*, more than 8 out of 10 youth e-cig users use

flavored e-cigarettes.

 
With disposable device usage surging among youth e-cig users –

FDA: Where’s the Enforcement?

 
Over 90 days after the PMTA Submission Deadline (September 9th, 2020) and nearly a year (February 6, 2020) after the complete ban of flavored e-cigarette pods available for purchase in the convenience store and raising the minimum age from 18 – 21 years to purchase – where is the enforcement?

Many brands available online or in store today have been deemed problematic or downright illegal and should not be selling in the US Market with zero consequences. To date, the FDA has yet to release a complete list of accepted PMTA applications, or more importantly, those they denied for substantive review.

PMTA Verified advocates on behalf of adult smokers and in support of the reputable brand owners and manufacturers who have invested hundreds of hours and millions of dollars to submit their required Pre-Market Tobacco Applications to remain on the market and legally sell to adult consumers looking for an alternative.

The FDA’s lenience and lack of enforcement will lead to the exact detriments our government set out to avoid with these imposed regulations.
Repost and share to get the FDA’s attention and protect adult smokers’ rights while protecting youth and attracting new users!

*https://www.fda.gov/tobacco-products/youth-and-tobacco/youth-tobacco-use-results-national-youth-tobacco-survey