Making Sense of FDA Regulations for Vapers
This year, the FDA released its final deeming regulations regarding ENDS, or electronic nicotine delivery systems. The release of these regulations, while a long time in the making, has the vape industry reeling to make sense of it all. While vapers and the public alike try try to decipher the recently released 500 page document, myths and facts swirl about about what the actual impact will be on the burgeoning vapor industry. One thing is definitely true, vaping in the United States will never be the same again.
FDA Regs Past – A Look at the History
To truly understand today’s FDA regulations, we have to go back. Today’s ecig regulation all started with the Tobacco Control Act. Signed into law in 2009 by Barack Obama, the TCA gave the Federal Drug Administration the power to regulate the tobacco industry.
Any new tobacco products on the market, or rather, any tobacco products on the market after the FDA’s predicate date of February 15, 2007, must undergo an FDA approval process before being able to be legally sold in the UNited States. Any tobacco products that were on the market before the FDA predicate date, also known as the grandfather date, are exempt from undergoing the same approval process as new tobacco products.
Since 2009, cigarettes, roll-your-own tobacco and smokeless tobacco have all been regulated by the FDA. This year, in 2016, electronic cigarettes, hookah, pipe tobacco, cigars, dissolvables, and any future tobacco products also fall under the FDA regulatory power.
Two years ago, in 2014, the FDA released their proposed deeming regulations for electronic cigarettes.
Since then ecigarette advocacy groups such as CASAA, SFATA, and AVA gave been working tirelessly to understand and fight against unfair overreach by the FDA. Also, during that time, groups such as the American Lung Association, the Campaign for Tobacco Free Kids, and others have been fighting to prevent vaping from spreading and to limit access to vaping technology, often by promoting fear based campaigns that do not fully appreciate vaping’s potential to reduce the harms of tobacco smoking. These public health groups are fighting to eliminate the very technology that could be used as a tool to improve the lives and health of millions of smokers.
FDA Regs Present – Where Do We Stand?
And so here we are, 2016. After waiting for two years, the FDA final deeming regulations were released May 10, 2016 setting off a firestorm of political action and conversation about what the regulations mean for the industry. Vapers, fearing the worst have begun to stock up on supplies. Rumors abound on social media, and no one seems to have all the right answers about the changes regulation will bring, not even the FDA. Schell Hammell, vape shop owner and vaping advocate, shared some of her recent experience at a panel at The Vape Exhibit in Las Vegas, noting that even the FDA itself gave conflicting answers during different phone calls.
A few things about the state of the FDA Regulations are clear. On August 8 2016, 90 days after the release of the final deeming regulations, the market freezes. Vaping manufacturers cannot release a new tobacco product, nor can they alter their existing products. Also effective August 8th, all eliquids must be made in sanitary conditions, ecigarette and ejuice manufacturers must not make any modified risk claims, and there will be no ecigarette or ejuice sales to minors under the age of 18.
Electronic cigarette manufacturers, should they intend to continue producing, must begin registration of their products as a “new tobacco product”. The FDA has allowed a six month delay for smaller manufacturers, as they have acknowledged the fact that it may take smaller vaping businesses longer to allocate the time and resources to the FDA application process. Within the next six months, manufacturers will also need to provide a detailed ingredients listing to the FDA. Gregory Conley and Schell Hammell have both recommended to smaller eliquid manufacturers to start reaching out now to their flavoring suppliers to ask them to submit their ingredients to the FDA’s Master File.
Free sampling is also banned beginning August 8th, although eliquid retailers may be able to work around this by charging a nominal fee to test eliquids. A few things have not been banned by the FDA, including vape expos and online sales. Warning labels are not required as of August 8, 2016, but will be required in the future.
Finally, August 8th, 2018 will be the prohibition date. Any and all electronic cigarette and eliquid products that have not been approved by the FDA will not be allowed on the market without a PMTA (Pre-Market Tobacco Application) or without demonstrating SE (Substantial Equivalence).
Cole Bishop and HR 2058 – Change the Grandfather Date!
The original predicate date set forth by the FDA is February 15, 2007. According to the regulations as currently written, any tobacco or nicotine products that came onto the market after that date are considered “new” tobacco products. Much of the advocacy in relation to the FDA Deeming Regs have been in support of adjusting the predicate (aka grandfather) date. Vaping technology is a relatively new phenomenon. Virtually none of the electronic cigarette products on the market today were present in 2007. By changing the predicate date, the vaping industry may be able to ease the transition to FDA Regulation by allowing some products to remain on the market without submission of the PMTA.
Why is the PMTA so feared? Because in order to meet the requirements of the FDA rules, vaping manufacturers will need to produce a clean, consistent product that is backed by numerous scientific studies. Unfortunately, the studies required by the FDA are so open-ended and difficult to demonstrate that getting a product approved would be nearly impossible. Not to mention that each flavor of an eliquid would be considered its own separate product. And with the financial cost of filing the PMTA expected to be in the neighborhood of one million dollars per product, well, it is easy to conceive why vape manufacturers would argue that the PMTA process is unfair, onerous, limiting, and likely to stifle innovation. Another route to FDA approval that is one the table is called Substantial Equivalence (SE). Substantial Equivalence would be a pathway to avoid the significant cost of the PMTA (although would still likely be in the hundreds of thousands of dollars). If a vaping manufacturer wanted to release a new product, you can demonstrate that it is essentially the same as a tobacco product already on the market and gain FDA approval through SE.
Both the Cole Bishop Amendment and HR 2058 are motions to change the grandfather (predicate) date for the regulation of electronic cigarette products. By changing this date, more products will be allowed to enter the market and the vaping industry will be allowed to continue to provide a variety of electronic cigarette device and eliquids to vapers. Vape advocacy groups urge all vapers and concerned parties to contact their elected officials and ask them to support both Cole Bishop and HR 2058.
Cole Bishop Amendment
Here is an excerpt from the Keller and Heckman law firm regarding the Cole Bishop Amendment:
“The Deeming Regulation, as proposed, would treat all deemed products in essentially the same manner as the currently regulated products under a one-size-fits-all regime, subjecting the newly covered products to the same requirements including, among other things, facility registration, product and ingredient disclosures, Harmful and Potentially Harmful Constituent (HPHC) testing and reporting and, critically, the premarket authorization requirements for “new” products. Under the Tobacco Control Act, any regulated tobacco product not marketed on or modified after the February 15, 2007 grandfather date is a “new” product that requires FDA marketing authorization – via either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market.
The Cole-Bishop amendment to the 2017 Agricultural Appropriations bill would change the grandfather date specifically for deemed products from February 15, 2007 to the effective date of the Deeming Regulation (i.e., most likely sometime in 2016). If this amendment becomes law, any nicotine-containing e-vapor products on the market as of the effective date of the final rule would be grandfathered and, although such products would still have to comply with the rest of the Tobacco Control Act, could avoid the lengthy and expensive PMTA process. Grandfathered products could also serve as predicate products for future SE Reports for new products intended to be marketed after the new grandfather date.”
The Cole Bishop Amendment also includes some language that will require the FDA to create standards regarding batteries, limit vapor product advertising, prohibit vending machine sales, add labeling requirements, and require ecig retailers to register their establishment with the FDA.
H.R. 2058 is another motion to change the grandfather date. Americans for Tax Reform reports on H.R. 2058.
“H.R. 2058 moves up the 2007 date to the date of the announced “deeming regulation,” which is likely to occur later this year. This would permit products that have hit the market since 2007 to remain on the shelves, pending approval. This is important for a number of reasons. First, nearly every vapor product on the market today did not exist in 2007. The thousands of e-liquids and countless versions of electronic cigarettes available to smokers looking for an effective way to quit would be banned pending FDA approval without a change to the Federal Food, Drug, and Cosmetic Act or subsequent Tobacco Control Act of 2009, which established the 2007 date.”
This bill is still being heard in Congress, and again, advocates urge vapers to reach out to their elected Congress officials to ask them to support this measure as well.
Johnson Letter – Another Important Objection
Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee feels that the FDA is making the wrong move for public health by remaining so restrictive on electronic cigarettes. While not many studies have been performed in the US, scientists in the UK are beginning to show the risk of vaping to be significantly less so than the risk of smoking combustible cigarettes. Senator Johnson has sent a letter to the FDA voicing his opinion and calling for some answers from the FDA. An excerpt of the letter reveals the important questions he is asking of the FDA, that as of today remain unanswered. From Senator Johnson:
“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences. The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.
In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:
- The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”
- Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.
- How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?
- Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.
- Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why?
- If so, please provide that data.
- Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?
- Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.”
Although the Senator’s letter called for an official response to be provided by May 31, 2016, as of the time of this writing the FDA has provided no such response.
FDA Regulations Future – Will Vaping Be Saved?
Vaping advocates continue the fight to preserve vaping technology and its lifesaving potential. Experts expect much more litigation regarding regulation, and many remain hopeful that the grandfather date will be moved so the effect on the industry is lessened. But much remains uncertain. The FDA regulation will create a definite slowdown to the ever changing vapor market, but in every challenge is an opportunity for those who are willing to look hard enough. Regulation will force a maturing of an industry who is suffering an image problem and some growing pains. Additional studies will demonstrate what vapers already know, that vaping is less risky than smoking and can be a great help for smokers trying to get away from tobacco, but who aren’t able make the switch all on their own. Although the FDA regulations as they currently stand will shrink the market, those who remain will get the chance to provide a superior product. It is important to remain positive, since the FDA regulation will go into effect in any case. In order for vaping to be saved, vapers must become vigilant and more involved than ever in advocacy and political action so that vapor technology will remain accessible and affordable for the greater good of the public health.
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