FDA Releases Long Awaited Deeming Vape Regulations
THIS IS A DEVELOPING STORY AND WE WILL KEEP YOU UPDATED AS WE LEARN MORE.
UPDATE: 6:28am PST via the Associated Press:
WASHINGTON - Hundreds of electronic cigarette brands will have to seek federal permission to stay on the market under new rules that have the potential to upend a multi-billion dollar industry attempting to position itself as an alternative to traditional cigarettes.
The Food and Drug Administration on Thursday released long-awaited rules that bring the burgeoning industry under federal oversight. Among other steps, the FDA rules limit e-cigarette sales to minors and require new health warnings. In a move vigorously opposed by manufacturers, the agency said manufacturers would have to seek permission to remain on the market under a multi-tiered system. Those that don’t submit the required information could have their products taken off the market.
UPDATE: 6:46am PST
Link to the full 499 page FDA document can be found clicking here.
UPDATE: 7:17am PST
This a final rule from the FDA and, as per page 8 of the document above, it regulates "e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software".
UPDATE: 7:36am PST
There are several rulings that go into effect 90 days after the publication of the FDA's final rule (it is assumed that means as of today) which includes regulations for retailers that require purchasers of vapor products to be at leat 18 years of age. However, it appears that there is an extending period of compliance for manufacturers (page 18):
"According to this revised compliance policy, for newly deemed products that are on the market on the effective date of this final rule and were not on the market on February 15, 2007, FDA is providing a 12-month initial compliance period for manufacturers to submit (and FDA to receive) an SE exemption request, an 18-month initial compliance period for manufacturers to submit (and FDA to receive) SE applications, and a 24-month initial compliance period for manufacturers to submit (and FDA to receive) a PMTA."
UPDATE: 7:43am PST
All products that were introduced to the market after February 15, 2007 will require approval by FDA through either SE (substantial equivalence) or through (premarket tobacco product application).
UPDATE: Commentary 7:50am PST
We have received a lot of questions asking how this will impact the large amount of vape brands that we work with and their e-liquid products that are in ZampleBox. At this time, we must continue to await more legal commentary to better answer those questions.
We've also commentary from our members and perspective members anticipating a rise in demand as vapers "stock up" on product and whether we plan to increase prices as a result. No, we plan to keep our prices the same until there is something that increases our cost.
UPDATE: 8:27am PST
"The requirements and costs of a PMTA may vary based on the type and complexity of the product. Variations in the ratio of ingredients, such as propylene glycol and glycerin, would indicate that products have different levels of each of these ingredients. As stated in section 910(a)(1)(B) of the FD&C Act, any change in an ingredient level, as with additions or removal of ingredients, yields a new tobacco product."
UPDATE: 9:02am PST
SFATA has issued the following statement in regards to the FDA final deeming rule:
WASHINGTON, D.C., May 5, 2016 — The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and managing the interests of the vapor industry, today issued the following statement regarding the Food & Drug Administration’s (FDA) final deeming rule on e-cig and vapor regulations:
“As the Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products, the FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99 percent of all vapor products on the market as a result of the February 15, 2007 predicate date.
“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.
“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.
“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.
“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that Congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers. The only viable option at this time is to change the predicate with federal legislation, such as H.R. 2058 (aka Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee, so that a more reasonable substantial equivalency pathway to market is created."
UPDATE: 10:46am PST
A petition to overturn the FDA regulations has started. To sign the petition, click here.
We will be updating the blog post throughout the day as we learn more. This is a developing story. We absolutely understand that the following weeks will be a period of anxiety for the entire vaping community (vapers, employees, business owners, etc). I kindly ask that we all remain calm and not rush to conclusions before we have all of the facts. Then, we must unite together with a very loud voice and speak out to the public to ensure that vaping remain widely accessible so that more people can find success living tobacco-free lives. Send this post to friends & stay tuned. Please feel free to leave comments below.
~ Tony Mandarano
CEO / ZampleBox
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