Vapor Industry law suit filed in D.C.
On behalf of the E-Vapor Industry, R2B filed the attached Complaint in the U.S. District Court for the District of Columbia on Monday challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the lawsuit are:
1. Right To Be Smoke Free Coalition (www.r2bsmokefree.org)
2. American E-Liquid Manufacturing Standards Association (www.aemsa.org)
3. American Vaping Association, Hoboken, New Jersey (http://vaping.info/)
4. Electronic Vaping Coalition of America, New Berlin, Wisconsin (http://evapingcoalition.org/)
5. Georgia Smoke Free Association, Fort Oglethorpe, Georgia (http://www.gasmokefree.org/)
6. Kentucky Vaping Retailers Association, Inc., d/b/a Kentucky Smoke Free Association, Louisville, Kentucky (http://www.kysmokefree.com/)
7. Louisiana Vaping Association, Chalmette, Louisiana (http://laecr.org/)
8. Maryland Vape Professionals, LLC, Baltimore, Maryland (https://vape-professionals.myshopify.com/)
9. Ohio Vapor Trade Association, Miamisburg, Ohio (http://www.ohvta.org/)
10. New Jersey Vapor Retailers Coalition, Roseland, New Jersey (http://www.njvaporcoalition.org/)
11. Tennessee Smoke Free Association (http://tnsmokefree.org/)
Also supporting the lawsuit are the Smoke-Free Alternatives Trade Association (http://sfata.org/), the Consumer Advocates for Smoke-free Alternatives Association (http://casaa.org/) and NOT Blowing Smoke (http://notblowingsmoke.org/).
In the Complaint, we argue the following:
(1) Count I – Violation of Administrative Procedure Act – Grandfather Date: FDA had the authority and the statutory duty to establish a new Grandfather Date for e-vapor products (ENDS) or apply its enforcement authority so that some ENDS manufacturers, including e-liquid companies, would have the opportunity to forego the Premarket Tobacco Application (PMTA) pathway and avail themselves of the option to submit Substantial Equivalence (SE) Reports. By not doing so, FDA violated the Administrative Procedures Act.
(2) Count II – Violation of Administrative Procedure Act – Pre-market Authorization Process: FDA was obligated to consider the continuum of risk of tobacco products and exercise flexible enforcement authority mandated by Congress, instead of a “one-size-fits-all” regulatory regime treating ENDS the same as cigarettes and other harmful products and forcing ENDS manufacturers into the PMTA process, which will all but ban the entire e-liquid and device categories. Accordingly, FDA’s application of the PMTA process to ENDS products violates the Administrative Procedures Act.
(3) Count III – Violation of Due Process and Equal Protection Clauses – Tobacco Control Act: In the Tobacco Control Act, Congress made clear that different tobacco products present different risks and that FDA should exercise its enforcement authority in a flexible manner. But if, as FDA argues, the Agency is mandated to enforce a “one-size-fits-all” regime to all products, including less harmful ENDS, than Congress did not provide FDA with the necessary tools and regulatory flexibility to achieve the Tobacco Control Act’s stated goals, which include allowing newer and safer products to enter the market. As a result, the Tobacco Control Act is unconstitutional under the Due Process and Equal Protection Clauses.
(4) Count IV – Violation of First Amendment and Administrative Procedure Act – Ban on Free Samples: FDA does not have a substantial interest in prohibiting access to free samples of ENDS products by – including taste testing e-liquids in vape shops. The complete ban on free samples does not directly advance the government’s interests. There were more narrow options available to FDA to advance their stated interest in preventing youth access while still allowing vape shops and others to market using free samples. Accordingly, the total ban on free samples violates the First Amendment and the Administrative Procedures Act.
(5) Count V – Violation of First Amendment and Administrative Procedure Act – Modified Risk Tobacco Products: The Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act, as applied to ENDS products – which do not produce smoke, combust e-liquid when used as intended, or produce aerosol that contains the harmful substances found in tobacco smoke – does not advance any purported government interests (which focus on traditional tobacco products), and captures commercial and non-commercial speech that is clearly not misleading (e.g., smoke free claims). By applying the MRTP provision and its extensive review process to ENDS products, FDA violated the Administrative Procedures Act and the prior restraint doctrine.
(6) Count VI – Violation of Administrative Procedure Act – Definition of “Tobacco Product” and Application to ENDS: FDA considers a broad range of ENDS products to be regulated as tobacco products or “components or parts,” including software that operates devices, batteries, displays, tanks, etc. FDA intends to regulate these products as tobacco products despite the fact that they do not contain tobacco, are not derived from tobacco and are not components and parts of an actual tobacco product. There is nothing in the legislative history of the Act, and FDA has provided no supporting rationale, for why these items should be regulated as tobacco products merely because they are used to consume the product. Accordingly, FDA’s application of the Tobacco Control Act’s definition of “tobacco product” to certain ENDS is unreasonable and unlawful under the Administrative Procedures Act.
(7) Count VII – Violation of Regulatory Flexibility Act – Unlawful Cost/Benefit Analysis: The Regulatory Flexibility Act requires administrative agencies to consider the effects of their regulatory actions on small business entities. FDA failed to consider significant alternatives, including, but not limited to, the impact of any compliance period on the ability of small entities to successfully navigate the PMTA process given that FDA concedes that there are no long-term clinical studies or other data necessary to support such applications. FDA only considered several, modest alternatives focused on discrete issues like labeling burdens. The Agency did not make a reasonable, good faith effort to consider alternatives that would have an overall impact on all small entities. In short, FDA substantially overestimates the benefits of the Deeming Rule and underestimates the costs. Accordingly, the Court should take corrective action, set aside and remand the Deeming Rule to FDA, and defer enforcement until the Agency complies with the Regulatory Flexibility Act.
(8) Count VIII – Violation of Administrative Procedure Act – Unlawful Cost/Benefit Analysis: The Tobacco Control Act makes clear that FDA was required to adequately consider the costs and benefits of the Deeming Rule. As with the Regulatory Flexibility Act, FDA failed to consider regulatory alternatives, such as an extended compliance period, that would have significantly increased the chance that ENDS manufacturers would be able to comply with the PMTA process, thus avoiding what will be close to an effective ban on ENDS products. The Agency also failed to properly estimate key factors necessary to an adequate cost/benefit analysis, including the number of entities and products affected, as well as the number of PMTA applications that will be filed. For many of these numbers, FDA did not adequately explain or support its conclusions. As a result, FDA violated the Administrative Procedures Act and, therefore, the Deeming Rule must be remanded to the Agency so that a proper cost/benefit analysis may be conducted.
Compliance: Are you ready for August 8’th?
New deeming rules begin to take affect August 8’th. Is your business ready? Are your customers? Business owners can find a lot of information directly on the FDA.gov website. Trade associations at the federal level are also a great source of information and help. This is why we value our partnership with the Vaport Technology Association (VTA). Business owners should also be joining their state advocacy groups and trade associaiton if they have not done so already. The time is NOW.
VTA releases its Next Level Analysis on the Deeming Regulation
What the US should learn from the UK’s wisdom on e-cigarettes – Sally Satel
This is one of the better articles to come out recently discussing the data needed to submit for approval through the PMTA pathway the FDA has laid out in the current deeming regs. Very much worth the read.
From the article….
“…Added to this onus is the so-called “public health or population impact.” According to the FDA, “Manufacturers must, for each product, quantify the likelihood that nonsmokers will start using the product, the likelihood that former smokers will relapse back to nicotine use by using the product, the likelihood that nonsmokers who do start using the product will progress to cigarette smoking, the likelihood that former smokers who relapse back to nicotine use will then progress to smoking, the likelihood that consumers will use the product in conjunction with other tobacco products, and the likelihood that smokers who start using the product would otherwise have quit smoking.”
Vapor Technology releases comments on FDA deeming regulations.
Late last night Tony Abboud, National Legislative Director for the VTA, released the following statements and initial thoughts the FDA Deeming Regulations released 5/5/16. Please follow the ink below to read the full document.
The GSFA fully supports the VTA and their course of action. Stay tuned for additional releases.
We are also encouraging shop owners and employees to print out the document to share with your customers. Consumers will be coming into your shops with questions. We owe it to them to give them good advice and pint them in the right direction.
Link to VTA press release.
Are you registered to vote in GA?
Voter registration deadline is Monday 2/8/16. GA is already reporting record early registration ahead of it’s March 1 Presidential Primary. Please make sure you are registered to vote if you are a GA resident. Your vote does matter and when we are fighting for our vaping rights and emailing reps they do check to see if you are a registered voter.
Don’t wait. It’s easy. Below is the link for online registration.
HB-907 – Pending GA Legislation that will damage our industry.
There is a new house bill that has come up in GA. Text of the bill can be found here…….
GS House Bill – HB907
This regulation is under the guise of safety and public health but it is far from it. The following is from our GSFA President, Bill Funderburk.
FIRST THOUGHTS ON HB 907
On its face, the alleged purpose behind the new proposed Georgia Vaping Regulation law sounds reasonable to the average person–ensure quality and cleanliness of vapor products. That is how the legislators were recruited. Unfortunately it is a horribly drafted piece of legislation. It was drafted by a group out of Indiana whose sole goal is to get a monopoly on the eliquid market. The group is also tied to the casino industry and involves some deep pocket supporters. Because it was drafted by Casino lobbyists, the security measures reflect those in place for Casino operators.
The real victims will be the millions of Georgia smokers and vapers. The net effect would be to drive out smaller companies, drive up retail prices, and shrink the options available. Why would we want to do that to a product that gives smokers a chance at a better life? Why would we want to compromise on tobacco harm reduction.
As the only trade association representing the Georgia vaping industry, we have to fight this. Our member shops and the vapor industry here employ thousands of Georgians and brings in millions of dollars. Our products have changed lives for the better. That piece of legislation would be very costly to and/or put many small companies out of business. We don’t want to amend it we want it scrapped. If the legislators believe changes are necessary, WE as the native Georgia Vapor Industry should have been involved.
Again the flawed premise behind this legislation sounds good–it is like the old “we’re protecting the children” arguments that always peddled by politicians.
Here are a few notes I quickly jotted down about the pending legislation:
1. The law is biased toward other versions of the same product: sealed ciga-like electronic cigarettes are exempted. The liquids used in them are basically the same as the version regulated. Do users of them not deserve the same security, safety and cleanliness? They were exempted so as not to rile big tobacco and keep them either out of this fight or in collusion. They probably did not want to poke the sleeping bear.
2. The hidden cost of “random” testing could put a small company under. How many “random” tests? What are they testing for? What science are they using? Who decides and based on what regarding the ingredients in an eliquid.
3. Why is there more legislation regarding the “security” of a manufacturing lab than the cleanliness of the facility–“casino level security”? Standards not required of other industries who sell known health damaging products? These security measures aren’t applied to compounding pharmacies, tobacco companies, nor chemical companies, yet somehow they should be applied to E-liquids? A product that has been shown to be at least 95% safer than smoking?
4. The storage of 30 ml samples of every batch of eliquid manufactured would cripple a smaller company. Most Georgia E-liquid manufacturers make very small batches. A requirement to store 30 ml out of every 300 ml batch would drive up costs exorbitantly. Who loses? The smoker who contemplates using vapor as an alternative.
5. Where is the need for the legislation? The requirement for child resistant packaging is already national law. Have there been any people sickened by poor quality E-liquids in Georgia? NO. Has there been new research exposing risks from poorly mixed E-liquids? NO. Who benefits from the legislation? Not Georgia vapers and smokers, and definitely not the Georgia vapor industry.
More importantly any regulations should be national in scope. Which will soon happen. The FDA is very near issuing regulations for vapor products. The proposed Georgia legislation will adversely affect interstate commerce. Another can of worms we shouldn’t get in to.
6. Legal costs to the State: the implementation of this law will most assuredly result in costly and lengthy litigation. On its face several sections are unconstitutional. It happened in Indiana, it will happen here. Legal costs that should not be born by our Georgia citizens.
As you see, those are identifiable issues based on a very quick reading. In the coming days, our members and supporters will further analyze this legislation.
I have attached a couple of articles that will help you guys realize what we are up against. We need you on our side.
Thank you for your attention and assistance. We must act on behalf of a great industry and all of our Georgia smokers and vapers.
Join the discussion and get involved. See our public Face Book group for more details.
Child Nicotine Poisoning Prevention Act of 2015 – S.142
Here is a link to the text of S.142 (passed in the U.S. Senate December 2015, and by voice vote in the U.S. House of Representatives 1/11/2016) and the relevant Code of Federal Regulations (CFR). If signed by the President, this will be the first Federal legislation EVER in the U.S. directed specifically towards the electronic cigarette industry.
To require special packaging for liquid nicotine containers, and for other purposes.
Title 16 CFR (1700.15 & 1700.20): https://www.gpo.gov/…/…/CFR-2012-title16-vol2-sec1700-15.pdf
Credit to Kevin Skipper – Vista Truth
E-cigarette hysteria is hazardous to your health
This is a great opinion piece written by Dr. Richard Carmona, former US Surgeon General and current NJOY board member. This is the type of article we should be sharing and spreading within our community. Too many times our passion as vapers gets the best of us and we share the negative stories so we can make snarky comments and bash them. It makes us feel a bit better but in the end we are just spreading the misinformation and helping our opponents agenda. Take a minute to read through Dr. Carmona’s article and share this to your favorite Facebook group, twitter it from on high and spread the news.
BATTERY SAFETY 101
Generally all modern electronic cigarettes are powered by a re-chargeable battery. Most of these batteries are lithium-ion like those found in cell phones, remote controlled toys, computers, and many tools. As such, they need to be treated with respect. Everyone has heard or seen horror stories of cell phones exploding under pillows or on car seats. Yes, that really happens—although rarely.
Good battery practices will protect both equipment and provide personal safety! Batteries should only be charged with a charger of the correct output rating. Charging a battery at a higher rate than specified could lead to battery corruption, fire, or explosion.
Mechanical mods are vape devices that have no safety circuitry. Before using mechanical mods or building “do it yourself coils”, a vaper should understand ohms law and basic electronics.
For personal safety, please observe these battery tips:
> Use correct battery—one rated for specific application
> Use the correct charger for the battery
> Only charge batteries on a hard, flame-resistant surface or within a vented metal charging box
> Plug charger in first before inserting/connecting battery
> Allow batteries to cool before charging
> After charging, allow battery to cool before use
> Monitor batteries during charging
> Never use batteries below 3.2 volts
> Immediately discard any swollen or distorted batteries
> Always inspect your batteries for nicks and tears on the skin. This can cause serious damage and should be re-wrapped or replaced.
> If a battery becomes hot to the touch, starts smoking, or hissing, lay it down and get away from it
> NEVER carry loose batteries in pockets or purses, use an insulated battery cover
> Buy batteries from reputable sources—some lesser quality batteries have been re-wrapped to look like better batteries
> When using dual batteries, “marry” the two batteries—always use the same two together from day 1
> Only use good quality chargers—you get what you pay for has never been more true.
> Always properly dispose of old batteries.
When in doubt or if you have questions, drop by a reputable shop. They can answer your question and give you some great advice on vaping safely. Some shop can re-wrap damaged batteries and inspect them for you.
Vaping is a bit different for everyone and there are lots of options available to you. High power devices and mechanical mods are NOT recommended for beginners. A truly good shop will explain your options and not push certain devices on you. They will take the time to answer your questions and show you how to use the device. Knowledgeable staff should be able to explain battery safety and give you a great start.
This information can also be found in our “Resources” section. http://www.gasmokefree.org/battery-safety/