The Child Nicotine Poisoning Prevention Act (CNPPA) of 2015 will take effect on July 26th, 2016. CASAA is recommending that members ask retailers if they know whether they will be carrying products that will be compliant with this new law. Details on this issue are below in our “legislative update” section.
On May 10th, 2016, The Food and Drug Administration officially published their “deeming regulations” in the Federal Register. The official publication started the 90-day countdown to the effective date (August 8th, 2016) and various compliance deadlines. Despite the fact that CASAA has been sounding the alarm about this day since 2010, the advance awareness of the deeming regulations has not made their finalization any easier to digest by the community. The past month has been an emotional rollercoaster for our membership and the community at large. If left unchallenged, the impact of the FDA deeming regulations will be devastating to both the vapor industry and public health. It would be an understatement to say that CASAA is deeply concerned about, and critical of, the FDA’s decision to move forward with these regulations.
In the past several weeks, efforts to push back against the regulations have started to take shape. But it should be made clear that the operative word here is “started.” CASAA acknowledges that developing useful regulation that will replace what the FDA is implementing requires a sustained effort over many years. The legal, political, and public awareness process is a long one, and our participation must be deliberate and thoughtful.
There are legislative strategies at work which we discuss later on in this newsletter.
Multiple lawsuits have been filed which seek to challenge specific provisions of the new FDA regulations. CASAA has pledged our support to one lawsuit in particular (here) that was filed on behalf of The Right to be Smoke-Free Coalition (RSF) and ten other complainants. Within the past week, this lawsuit has been combined with another suit (here) filed on behalf of Nicopure Labs, LLC.
Public relations campaigns such as the No More Casualties campaign are also being developed to better inform the public about the significant beneficial contribution that vapor products are making to public health.
It is critical for advocates to understand that different angles of attack are vital. It seems to be in our nature as humans to want to “back a winning horse,” so to speak. However, we are not talking about a race here. Amending existing laws and regulations and developing new ones that are beneficial to consumers, industry, and public health is a long and thoughtful process.
Traditionally, this section is reserved for deliberate misinformation campaigns which are intended to confuse the public and policymakers about the risks associated with vaping. However, the vaping community has recently become painfully aware of misinformation originating from within its own ranks. Specifically, many members of the community have been misled to believe that the effort to gain co-sponsors for HR 2058 is a lost cause and, as such, should not be promoted.
On the contrary, HR 2058 continues to gain cosponsors and is part of a long-term effort to change the 2007 predicate date applied to new tobacco products by the Food, Drug, and Cosmetics Act. In fact, with the addition of Representative Collin Peterson (D-MN), HR 2058 is now considered a bipartisan bill. Moreover, although not specifically addressed by this legislation, urging support for this bill is important in our messaging efforts to change hearts and minds in Congress about the critical need to develop appropriate regulation for vapor products.
While it is unlikely that HR 2058 will advance successfully through the legislative process this year, it is wildly inaccurate and irresponsible to suggest that support for this bill is a “lost cause.” The simple truth is that support for this legislation will carry over to 2017 when the language (possibly with some additional language) is reintroduced and renumbered. CASAA also believes that it is unwise to put all of our resources behind one legislative strategy, especially when they are not mutually exclusive. Accordingly, CASAA will continue to offer support for not only HR 2058, but also for the Cole-Bishop Amendment to the Agricultural Appropriations Bill.
FDA Deeming Rumors
Speculation abounds regarding compliance deadlines and what this will mean for vapor retailers and manufacturers. Consumers are increasingly becoming aware that August 8th, 2016 is the effective date of the deeming regulation. Although three very important things happen on this date, they are unlikely to impact consumer access to vapor products in a substantial way.
First, August 8th 2016 is the start of the 24-month grace period for manufacturers to file their premarket tobacco applications (PMTA). For any new vapor product to be introduced to the market after August 8th, manufacturers will be required to file a PMTA with no grace period to allow for marketing before the application is granted. What this means is that as a practical matter, there will be no new products on the market after August 8th. August 8th, 2018 is the deadline for PMTAs for any product not on the market prior to February 15th, 2007.
Second, sales to minors will be prohibited in all 50 states. Although it is not clearly spelled out in the deeming regulations, online retailers will be required to use some sort of age verification process in order to prevent sales to minors through the mail. This will possibly include using a “signature on delivery” service provided for a fee by major carriers (FedEx, UPS). If you are accustomed to ordering your products online, you can expect to pay more now. Although signature on delivery is not a requirement -- yet -- online retailers may decide that requiring this service is the best way for them to be compliant. Unfortunately, this means that anyone under 21 will be unable to receive online purchases as these sign on delivery services were developed to accommodate alcohol shipments.
Third, although not something that has an immediate impact on consumer access, it is important to point out that the federal government now considers vapor products to be “tobacco.” Many in the community are speculating about how this definitional change affects state law. The rule of thumb to keep in mind is that states will need to update their definitions of tobacco in the various parts of their code on their own. Changing the federal definition of “tobacco” does not automatically change the definition for states.
CASAA’s Testimonials Project, has collected over 10,000 stories and continues to grow. We are working toward collecting testimonials with more detail so that we can provide state specific numbers to state and regional advocacy organizations that will assist them in their advocacy efforts.
Although not a CASAA project, The Vape a Vet (VAV) Project has been providing vapor products for free to veterans and active duty service members for three years now. Sadly, the FDA deeming regulation is having a negative impact on VAV and making it more difficult to provide this lifesaving resource to our nation’s bravest. When considering where to send your donations, please keep VAV in mind. You can learn more about the project and how to donate here.
Register to Vote before your state’s deadline! . . . and then, make sure you vote! Exercising your right to vote is vital to any advocacy effort. Engagement from voters carries weight with lawmakers as they consider input on legislation that comes before them. Lawmakers are not be able to see how you vote, but they will certainly check to see if you are voting.
Although a lot of focus has shifted to the FDA deeming regulations, it is critical that consumers and vapor businesses are aware of other federal and state laws that will be taking effect soon.
Probably the most important law for consumers and retailers alike to be aware of is the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) which takes effect on July 26th, 2016. Consumers and retailers need to understand that there are specific testing protocols which are described in Title 16 CFR, §1700.20. Although child-resistant packaging exists in other parts of the world, it may not meet US Federal guidelines. In order to sell bottled e-liquid after July 26th, 2016, it must be sold in child-resistant packaging that is compliant with the US Code of Federal Regulations (CFR).
The Consumer Products Safety Commission (CPSC) has sent letters to several retailers notifying them of the new law and what they need to do in order to be compliant. You can read the letter here and share it with retailers in your area that may not be aware of the new law.
Reminiscent of 2016’s state budget drama, the 2017 budget has failed to be completed by the June 30th deadline. Although the legislature has sent a completed appropriations package to Governor Wolf, the revenue portion of the budget remains incomplete. An estimated 400,000 vapers in the Keystone State should be aware that there are two tax proposals for vapor products that are on the table. For more details, please see our active call to action for Pennsylvania here.
On May 4th, 2016, Governor Jerry Brown signed into law a package of bills that will affect how vapor products are sold and where they can be used. SBX2-5 and SBX2-7 will take effect on or before January 1st, 2017. Among other things, this legislation will raise the minimum legal purchase age for all tobacco products, which will include vapor products, from 18 to 21. The use of vapor products will also be prohibited in the same places where smoking is currently banned.
The new California laws raises an important point for all vapor consumers to understand in regards to the FDA deeming regulations. Even though the federal definition of “tobacco product” now applies to vapor products and devices reasonably expected to be used in the delivery of nicotine, in most cases, this will not automatically affect various state laws. We can expect a great deal of proposed legislation as many states seek to amend their laws in order to subject vapor products to existing tobacco regulation. The federal definition does not preempt state laws with regard to enacting stricter regulations on “the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products.”
Effective July 1st, 2016, ALL ONLINE SALES TO CONSUMERS IN UTAH ARE PROHIBITED.
On May 16th, 2016, Governor Peter Shumlin signed into law H.171 (Act 108) which prohibits the use of vapor products in the same places where smoking is banned. However, thanks to the consistent and repeated efforts of advocates in Vermont, the bill was ultimately amended to include an exemption for vapor shops and vapor lounges.
On June 12th, 2016, the West Virginia legislature passed SB 1012 which enacts a 7.5¢ per milliliter tax on e-liquid regardless of nicotine content (§11-17-4b). West Virginia is only the fourth state to enact any extra tax on vapor products. The effective date of this law is July 1st, 2016 and the first payments to the Tax Commission are due on August 15th, 2016. Taxes are only being collected on product that is sold starting with July 1st. For businesses outside of West Virginia, it is unclear whether they will be required to register with the state as tobacco dealers for the privilege of selling into the state. The appropriate forms and procedures are still being developed by the Tax Commissioner. At this time, the best advice for businesses wishing to continue doing business in West Virginia -- other than consulting with legal council -- is to contact the tax commission.
Manufacturing regulations took effect on July 1st, 2016, affecting not only brick-and-mortar sales, but also online sales. For some in Indiana this has meant closing their businesses, while others face uncertainty as to how long they can remain open. In either case, the effect on consumers has been a loss of access to a significant portion of the diverse vapor industry.
The legal challenge to the Indiana regulations continues and politicians have promised to revisit the law in 2017. There is also debate over whether or not the law is sufficiently preempted by the FDA Deeming regulations. Unfortunately, substantial damage has already been done, and many in Indiana will not recover from the unnecessary and overreaching manufacturing standards that have gone into effect.
Although several anti-vaping bills were introduced this year, the legislature has concluded their session without passing any anti-vaping legislation.
On June 17th, the legislature concluded their session without passing any anti-vaping legislation.
US - Take action to change to the predicate date for vapor products newly deemed as tobacco by the FDA
Updated - 05.18.16 CASAA is urging our members to support both HR 2058 and the Cole-Bishop...
A 40% wholesale tax on vapor products is most likely back on the table as Pennsylvania legislators...
Although there are no active local alerts at the time of this writing, CASAA urges members to pay close attention to local efforts to restrict where vapor products can be used and sold. It is also possible that some municipalities and counties will seek to enact taxes on vapor products.
Members are advised to monitor activities of anti-smoking activist groups and be on the lookout for events like informational town hall meetings that are advertised as informing the public about e-cigarettes. These events are typically a precursor to anti-vaping legislation being introduced at the local level.
“A Billion Lives”
On May 11, “A Billion Lives” had its world premiere in Wellington, New Zealand. CASAA has had several opportunities to meet with and get to know Director Aaron Biebert and some of the crew working on this documentary. We are very excited the film has been released and now people will finally be able to see it. The film recently had its European premiere at the Palace of Culture in Warsaw, Poland on June 16. This was a special showing for the delegates of the Global Forum on Nicotine. Our Director of Scientific Communications, Brian Carter, attended the premiere and says “everyone, vapers and non-vapers alike, should see this film. The level of dogmatic bias, dishonesty, and self-serving motives by those in power in an attempt to destroy a safer alternative to smoking is truly staggering.”
The documentary will have its North American Premiere on August 6th, 2016 in Milwaukee, WI. Tickets went on sale July 6th. For details, please visit the A Billion Lives Facebook page. Be sure to give them a like on Facebook and a follow on Twitter.
Upcoming Events CASAA will be attending:
July 23rd - 24th: Vaping Convention Circuit - Pittsburgh, PA
August 5th - 6th: Vape Deadwood - Deadwood, SD
August 6th: A Billion Lives US Premier - Milwaukee, WI
August 12th - 14th: Oklahoma Vape Jam - Oklahoma City, OK
August 19th - 21st: The Vape Showcase - Dallas, TX
October 22nd - 23rd: Vaping Convention Circuit - Chattanooga, TN
Seminars at which CASAA presented:
June 17, 2016 in Warsaw, Poland - Global Forum on Nicotine This multi-stakeholder event (which last year had participants from 44 countries) includes policy analysts, regulators, academics, researchers, public health professionals, consumer advocates, and makers and distributors of alternative nicotine products – all with an interest in nicotine and its uses. Brian Carter, Director of Scientific Communications for CASAA, presented on the importance of non-nicotine pleasures (e.g., flavor, throat hit) for tobacco and e-cigarette users.