Vaping News: Flavor Pods/Cartridges Ban

Jan 3, 2020

Our industry has been making headlines more than ever over the past year, and all of this press has culminated in a new ban on flavor pods and pre-filled vape cartridges across the country. Many were taken by surprise as it seemed like the media had been quiet for a while in regard to vaping, but, nonetheless, what's done is done.

So, what does this new law mean for vapers? And, why exactly did it happen in the first place? We’re going to give you all of the information that you need regarding this law and what it means for you as a vaper or a vape business owner.

Why the Ban Occurred in the First Place

So, before we get into the nuances of the ban, let's explain what brought us to this point. In June of 2019, the U.S District Court ruled in favor of anti-tobacco organizations, moving FDA regulation for e-cigarettes to May of 2020 instead of its previous August 2021 date. The reason behind this was an acute rise in youth vaping over the past two years.

Then in August of 2019, there were news reports about numerous deaths and hospitalizations caused by a “mysterious vaping illness” that produced severe respiratory systems such as chest pain and coughing. In the following month, the Trump administration publicly announced that it was preparing a ban on flavored e-cigarettes to reverse the concerning epidemic of youth e-cigarette usage.

Since then, the CDC determined that most of the illnesses and deaths were traced back to black market THC vape cartridges that illegally contained a Vitamin E derivative that was harmful to the lungs when inhaled. The CDC has somewhat reaffirmed the fact that the illnesses were linked to THC vapes. Still, many legislators around the country were quick to blame the vaping industry. 

What it Means for Vapers

So, how does this ban affect you? Well, in fact, it’s pretty straightforward. January 2^nd, 2020 the Trump administration announced its plan to ban flavored vape cartridges and pods. Pre-filled pods and cartridges containing Tobacco and Menthol flavoring will still be allowed on the market. Again, this ban pertains to the pre-filled cartridges and pods only. This means that bottled vape juice is still perfectly legal, regardless of the flavor. Enforcement will begin within the next 30 days. So, you won’t be able to purchase flavored vape pods, but you can still purchase pre-filled vape pods that come in menthol or tobacco. 

Vapers can still go to their local vape shops or shop online for bottled e-liquid flavors that are compatible with refillable standard tanks or pod-based tanks.

What it Means for Vape Business Owners

The real victims here are vape companies and stores whom are marketing pre-filled flavor cartridges and pods. Now, the only way these companies and stores are are allowed to sell their product is if they offer it in menthol or tobacco flavors. Enforcement will begin within the next 30 days.

Companies that manufacture their own bottles of e-juice for refills, and for stores that sell refillable e-liquids too, can continue to sell them to anyone over the age of 21 in states, cites or counties that do not have a vape ban.

It is Clear that There is a War on Vaping…

This new law will certainly impact smokers that have transitioned to pre-filled cartridges. The new law will also negatively affect many companies and stores. However, as vapers switch to open pod systems, the adjustment period may not be a long as some of us out there think. Only time will tell, of course.

FDA pre-market regulations begin this May, meaning for some vape companies and individuals, there’s still much uncertainty for which products the FDA will allow to be marketed. Though very unfortunate that this law was enacted, for the time being vapers will still be able to use, and business can be able to manufacture and sell vape hardware (e-juice, refillable electronic cigarettes, box mods, mech mods, RDAs and open pod systems). 

U.S. District Court Ruling: Manufacturers must submit PMTA’s for ENDS products by May 12, 2020.

November 20, 2019

The U.S. District Court of Maryland made a ruling recently giving importers and manufacturers of ENDS (electronic nicotine delivery systems, such as e-cigarettes) until May of 2020 to send marketing applications to the FDA (Food and Drug Administration). The 10-month time limit is applicable to tobacco products that are currently available for purchase as per an August 8th, 2016 rule which lengthened the FDA’s regulatory jurisdiction to have every tobacco product included. As such, e-cigarette manufacturers now have less than a year to submit market approval applications if they want to keep selling ENDS.

Manufacturers of e-cigarettes have been selling products so far without approval from the FDA. The administration announced in 2016 its considerable rule that lengthened its regulatory jurisdiction on such products. At first, the FDA issued a deadline for 2022, forcing current organizations to submit approval applications to the FDA. The FDA inquired about reasons why applicant organizations felt that they should still be able to sell such products legally. The FDA expedited the deadline to 2021 after various studies showed an acute rise in the amount of teens that vape. Dissatisfied with the 365-day difference, a lawsuit was filed against the FDA by anti-tobacco organizations who claimed that the administration’s lax deadline was a threat to public health. As this lawsuit unfolded, the FDA suggested a 10-month period for application submission and a 365-day approval deadline. The judge acknowledged that the 120-day submission deadline that the plaintiffs asked for was unreasonable and was not enough time for applicants to put together enough data for the FDA. This ruling took away any administration discretion with reference to those deadlines.

Reacting to the court order, Norman E. Sharpless, the FDA’s acting commissioner, claimed that the administration was prepared to expedite the assessment of new tobacco products - including e-cigarettes - while intending to deal with the rise of youngers vaping using all the regulatory tools they had. In spite of the approaching deadline, the judge noted that those organizations had the money and resources to quickly finalize the necessary applications. With that said, in a memo filed on June 2019, the FDA stated that it had obtained more than 400 premarket applications as of May 2019 - 99% of which didn’t meet the fundamental criteria. As such, it will take more than money to get approval for these products.

Organizations can review the FDA’s latest guide, which was released in the summer of 2019, regarding PMTAs (premarket tobacco product applications) for ENDS (such as vape pens, e-liquids, and e-cigarettes). The guide offers a guideline for businesses who want to market ENDS products so that they put together a PMTA. With the information submitted, the FDA would be able to assess the benefits and dangers of a product to public health. The guide is comprised of several components, including:

• (1) Products applicable to the guide;
• (2) Rundown of the FDA’s ENDS regulations;
• (3) Content necessary for an ENDS PMTA and suggestions for demonstrating APPH (public health protection suitability), and;
• (4) Basic ENDS PMTA review procedures.

The FD&C Act (Food, Drug, and Cosmetic Act) regulates ENDS federally. As per this act’s 910 section, individuals and organizations intending to promote a new tobacco item must adhere to the 905(j) pathway and present either:

• (1) a report informing the administration of the product’s exemption as per the FD&C Act, or;
• (2) a report to acquire a substantial equivalence determination.

If the new product is judged as inequivalent to an asserted and identified product, organizations need to present a PMTA and get a marketing order prior to any promotion of the product.

When a PMTA Is Necessary and Applicable Products

The guide is applicable to a few ENDS product categories: e-liquids, e-cigarettes, and the packaging of those two products as one when they are distributed or sold to consumers. For instance, an e-liquid sealed and packaged to be distributed or sold to customers would fit under the FDA’s enforcement guidelines and need to meet PMTA requirements.

Review of PMTA for ENDS

Once the business submits its PMA for ENDS, the FDA will perform a preliminary assessment to establish if the application contains everything requested. Upon acceptance of the PMTA, a filing review will be processed by the FDA, where it will establish if the content is sufficient, ready for filing, and prepared for a substantive review. As per the FD&C Act, after the FDA obtains a thorough PMTA for the ENDS and it is filed, the administration has 6 months to perform a nominal evaluation to either deny or approve the PMTA. While this review is taking place, the FDA might ask for deficiencies to be clarified or request extra details to supplement the PMTA. The administration might also assess nonclinical research, clinical studies, and manufacturing sites to inspect the validity and accuracy of details offered in the PMTA. In doing so, that they can verify that the manufacturing process and product itself meets all relevant standards. In the guide, the administration states that it will enforce protocols for the manufacturing of tobacco products.

PMTA of ENDS Contents

A thorough PMTA for ENDS needs to be comprised of necessary details as per the Act’s 910(b)

• (1) section. In the guide, the FDA offers a suggested classification of these details, which should entail, at the least:
• (1) basic information – including a cover letter – outlining any earlier FDA compliances for the new product;
• (3) a content index;
• (3) Descriptive details that convey important aspects of a new product, which includes a rundown of its design and formulation, the nicotine level, directions for use, any limits on distribution and sales suggesting that its advertising will be APPH-compliant, and certain e-liquid and e-cigarette suggestions (such as battery wattage/capacity and package type/quantity);
• (4) an environmental evaluation;
• (5) suggested labeling that can reduce the dangers associated with the use of the product (such as a warning for e-cigarette’s battery deficiency, as per storage conditions);
• (6) samples of products; and
• (7) comprehensive scientific research and findings of studies conducted.

The administration suggests that organizations offer details on ways to reduce the dangers identified with ENDS batteries, and address the changes of use/misuse that could result in explosions, fire, and overheating.

The administration is concerned about how these ENDS products are marketed towards people under the age of 18 (such as how specific flavors of e-liquids cater to the tastes of minors). In the guide’s press release released by the administration, they said they would take steps to reduce the toxicity of tobacco products, make them less alluring, and less addictive with a strong focus on children. Not too long ago, the FDA showed signs of following through with this promise by looking into e-cigarette ads for youth.

The FDA commissioner encouraged organizations to utilize the guide for application submissions, particularly since there is not an approved e-cigarette on the market.

To view the complete FDA PMTA guidance for all ENDS products, click here.

Share on Facebook     Share on Twitter     Share on Google+

---

FDA will extend the PMTA deadlines for marketing newly regulated non-combustible products to August 8, 2022!

July 28, 2017

Today, FDA Commissioner Gottlieb announced a stunning shift in the US Government’s approach to regulating tobacco products. Dr. Gottlieb announced that FDA is embarking on a new and comprehensive approach to regulating nicotine – and reducing addiction. This initiative will create a multi-year roadmap that will cause greater public awareness that nicotine is not the cause of death and disease, and nicotine products exist on a continuum of risk. That’s right, FDA has finally recognized the continuum of risk and that “cigarettes are the most harmful form of nicotine delivery.” AND, THAT SWITCHING TO LOWER RISK PRODUCTS CAN PROVIDE PUBLIC HEALTH BENEFITS! Here’s the headline: FDA will extend the PMTA deadlines for marketing newly regulated non-combustible products to August 8, 2022!

Read the official FDA press release here.

They will also allow marketing to continue after that new PMTA submission deadline date in 2022 as long as your PMTA application is under review! (previously, you only had a year... even if they had not even looked at your application yet). So, that means we have nearly 5 years to complete PMTA applications, but applications will still be required and those applications may be in a very different form than what the assumptions have been thus far. This extra time is significant for vapor manufacturers and retailers, alike. It means we can now see a future for our businesses we didn’t see yesterday. Here is an example of testimony that came in from SFATA member companies immediately after the announcement this morning. SFATA members Michael and Carla Bowers first words were, "I guess we can renew our leases now.”

Share on Facebook     Share on Twitter     Share on Google+

---