Electronic Cigarettes and the FDA

Opinion IconOn 14 January 2013, I created a petition on WhiteHouse.gov asking the Obama Administration to Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids. At the time I submitted the petition, WhiteHouse.gov required 25,000 signatures in one month to be considered for a response. The petition got the minimum number of signatures in the required timeframe. In fact, to date, it’s acquired 36,009 signatures. It took more than two years and four months to receive a response. The response was as I expected; a formulated response that basically says, go look at our proposed rules, and didn’t provide any additional information. Oh, and too bad, we’re going to highly regulate electronic cigarettes.

Regulation of Electronic Cigarettes by the FDA

By Mitch Zeller

Thank you for your petition on electronic cigarettes. First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them. Some background, which you may already know: The Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products — cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco — under the Federal Food, Drug, & Cosmetic Act. And while it didn’t apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation. We’ve issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of “tobacco product” and so they’d be subject to the FD&C Act when the proposed rule is finalized. Now the petition states that sections 905 and 910 of the FD&C Act would “ban all e-cigarettes,” and that’s not true. If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 — but this doesn’t mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products. There will be two primary ways for tobacco products to obtain that authorization: either an application for “substantial equivalence,” or an application for premarket approval. “Substantial equivalence” would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent — though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be “appropriate for the protection of public health” to allow the product to be marketed. We know that those applications may require time and resources to develop. That’s why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application — so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review. So why are we seeking to regulate these products in the first place? As we discuss in the proposed rule, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. There’s still a lot we don’t know about these products, and this rule will expand the amount of information available to the FDA and the public — that’s good for everyone. Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don’t know enough to make that call. This rule would help us to continue to analyze the potential benefits and risks of e-cigarettes, including their impact on nonusers and on the population as a whole. It’s important to remember that this rule isn’t final yet, though. We’re seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes. The opportunity to comment on FDA’s proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments. Related links:

Mitch Zeller is the Director of the Food and Drug Administration’s Center for Tobacco Products.

I’ve read most of  the proposed rule. It’s difficult to read because the proposed rule also includes rules for other tobacco products, such as cigars, that I have no interest in or use. The FDA has extended the comment period to 08 August 2014.

Rules I Agree With

  • I agree that electronic cigarettes, accessories and vape juices (e-liquids, e-juices) should not be sold to persons under the age of 18, which is the current legal smoking age. Many shops do this already and have been for quite some time.  If the FDA wants to increase the age for purchasing and using tobacco products to 21, I wouldn’t oppose it. I’d even support local laws that would cause a business to lose its business license, subject to large fines, and more severe penalties if it’s found to have sold tobacco products to minors and never allow them to get its license back. I must note that the vape shops I patronize in Las Vegas do not sell products to minors. Many have signs on their doors stating than entry into the store by minors is prohibited unless accompanied by an adult. Personally, I don’t think minors should be allowed in vape shops at all, alone or with an adult. But I do realize that it isn’t always practical for parents to do.
  • I support requirements for child proof containers for vape juices to prevent unintentional ingestion. Liquid nicotine is a poison and even the small concentrations contained in vape juices can be very harmful and even deadly to children.
  • I support regulations that stipulate labels on vape juice bottles contain a list of ingredients and a warning that the product contains nicotine and that nicotine can be addictive (if it does contain nicotine). Consumers have a right to know what ingredients are in their vape juices.
    • I don’t believe that providing a list of ingredients endangers trade secrets and recipes. The ingredients are only part of the recipe; the amounts of those ingredients in each bottle do not have to be disclosed, thereby protecting the recipe. Additionally, vape juice manufacturers could try to patent or otherwise protect their recipes.
    • For those packages that are too small to include all ingredients and other information, listing the ingredients on a product page of a website or providing a small card that provides the list of ingredients with the purchase should be sufficient. Consumers should not need a high powered magnifying glass to read product information on the bottle.
  • I support product analyses and testing: chemical testing and certifications for vape juices and UL certification for hardware (mechanical and more advanced electronic mods) and registration of tobacco products, including vape juices with the FDA. This can only make these products safer for consumers.
    • The costs associated with chemical analyses, UL certification and FDA registration are extremely high. The costs of complying with the proposed FDA rule will likely cause most, if not all, small businesses to exit the market, leaving the market to large tobacco conglomerates and other large companies that have the capital to enter the market. This will stifle competition and innovation. The products that many vapers prefer will disappear from the “legal” market. Consumer choices will be significantly reduced. The entry costs need to be at a level that will allow small businesses to stay in business and compete in an open market.
  • I partially agree with the ban on sales of electronic cigarettes, accessories and vape juices in vending machines unless the vending machine is located in a facility that restricts the access of minors.
    • There are vending machines that sell lottery scratch off tickets that require age verification (driver’s license or other state issued identification card). These machines, which are sometimes located in convenience stores, require that the IDs have a bar code, QR code, magnetic stripe or other scannable identifier that contains identity and age verification data. As I am involved with the gaming and gambling industry, I have personally tested some of these types of vending machines and have found that the age verification technologies they include are reliable. I suggest that these types of vending machines can be used to sell any form of tobacco product in facilities that cater to persons of all ages.

 Rules I Do Not Agree With

  • I do not agree with prohibiting  the distribution of free samples.
    • I do not see the harm in providing customers with free samples or “tasting” bars, provided those samples are only distributed in facilities that restrict access of minors. If the customers want these offerings, why shouldn’t businesses be able to offer them?
    • Every vape shop I patronize has a vape juice bar or counter where you can sample the vape juices they have for sale. These vape juice bars allow consumers to find the flavor that suits them best without spending a lot of money on a variety of flavors to find the ones they like. Some vape shops provide small bottles of free vape juice or other inexpensive accessories during promotional events.

Other Thoughts about the Proposed FDA Rule

Registration Numbers

The FDA is seriously underestimating the number of Other Tobacco, E-Cigarettes, and Nicotine Product Manufacturers that will submit registration applications and the hours that it will take to process and respond to those applications. In Las Vegas alone, nearly 100 vape shops opened between 2012 and mid 2014; it’s not unreasonable to assume that thousands have opened across the country in that same time frame (not taking into account the hundreds or thousands of online only shops). Not all of them produce their own vape juice products, but many do. If, as a conservative estimate, 25% of those shops do manufacture their own lines of vape juice products, there will be millions of product registrations submitted, as each recipe (not just flavor) will require a separate registration.

Costs, Innovation and Product Availability

The cost for registering a product with the FDA may not be high, but the costs for product testing likely are. The proposed rule will require manufacturers of electronic cigarettes, components and vape juices to submit an “ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products.” This rule will require vape juice manufacturers to submit all vape juices for chemical analysis to identify any HPHCs their vape juices may contain. Vape juice manufacturers will have to submit each vape juice variant (recipe) separately. That is, if they offer a strawberry flavored vape juice with 4 nicotine strengths (6 mg, 12 mg, 18 mg, 24 mg) and 5 PG/VG ratios (60/40, 50/50, 40/60, 30/70, 20/80), they will have to submit 20 vape juice samples for analysis and submit 20 applications for registration for that vape juice alone. Most vape juice manufacturers have between 20 and 100 different flavors, some have more, that come in varying nicotine strengths and PG/VG ratios.

This will undoubtedly drive up costs. The actual cost for a 15 ml bottle of vape juices costs between $1.00 and $3.00 to make, including packaging. Add in some percentage of mark up for research and development (creating, testing and refining the recipe) and the total cost is likely between $2.00 and $4.00 per 15 ml bottle. Retailers typically charge about $10.00 to $15.00 per 15 ml bottle of vape juice. Analysis and registration costs will cause vape juices prices to skyrocket. Most small vape shops will probably cease to produce their own lines of vape juices, reducing consumer choices. Many shops also allow vapers to choose a custom level of nicotine and PG/VG ratio. If a juice manufacturer must register every variant of a particular juice, vape shops (online and brick and mortar) will no longer be able to offer customized vape juices.

These costs will also stifle hardware  innovation. When I started using electronic cigarettes, I started with disposable “cigalike” electronic cigarettes. They cost about $10 per “cigalike” and lasted a couple of days. These disposable “cigalikes” were fine for a couple of weeks while I researched other types of electronic cigarettes. From there I moved up to “cigalike” electronic cigarettes that had rechargeable batteries and replaceable flavor cartridges. That is, the flavor cartridges screw on to the battery; when they are depleted, they are discarded and a new one replaces it. These cartridges cannot be refilled. I tried a couple of brands. These “cigalikes” were fine for a few months, but the flavor selections were limited and the flavor was lacking. That’s when I moved away from “cigalikes” to more advanced electronic cigarettes, or mods. These electronic cigarettes have larger batteries and tanks that can be refilled with vape juice. Some have removable, rechargeable batteries that are recharged in a battery charger. Some have variable voltage and/or variable power and other features. It’s these advanced mods (see examples below) that will be in danger of disappearing from the market.

Advanced Electronic Cigarette Mod

Photo by lindsay-fox

Advance Electronic Cigarette Mod

Photo by lindsay-fox

Big tobacco company products thus far are “cigalikes,” such as Njoy, Blu and Vuse brands (see examples below). Their target market is people who still smoke cigarettes and want to “quit” smoking. Their advertisements use the word “smoking” rather than “vaping,” which is the word most people who use electronic cigarettes use. They are not targeting people who already stopped smoking and use electronic cigarettes. I suspect that most people who have been using electronic cigarettes awhile do not use “cigalikes” and use the advanced mods, even if they are simple eGo style electronic cigarettes. High registration and testing costs for hardware will stifle innovation of new products and reduce the types of products consumers can purchase as big tobacco companies have shown no interest so far in manufacturing the advanced electronic cigarettes so many vapers prefer to use.

NJOY "Cigalike"Electonic Cigarette

Photo by lindsay-fox

Blu "Cigalike" Electronic Cigarette

Photo by lindsay-fox

Flavored Vape Juices

  • Do people lose the ability to enjoy fruit flavors, candy flavors, dessert flavors and other pleasing flavors or all of a sudden stop enjoying these flavors once they turn 18?
  • Why is it okay to manufacture, market and advertise flavored alcohol, such as chocolate stouts, apple and strawberry ales, flavored vodka, cinnamon infused whiskey, etc.? Don’t these flavors entice minors to drink?

The issue of flavored vape juices and cartridges is not addressed in the FDA’s proposed rule, so for now, electronic cigarette users can still vape their favorite fruit, candy and dessert flavors. However, there are forces working hard to eliminate those yummy flavors.

First, the FDA has already banned flavored cigarettes, except menthol cigarettes, and it’s been pushing to eliminate menthol cigarettes. There’s nothing preventing the FDA from introducing a new proposed rule banning flavors at some future time.

Second, opponents of electronic cigarettes demonize flavored vape juices and electronic cigarette cartridges, arguing that these flavors entice minors to try electronic cigarettes. Again I ask, do people suddenly dislike fruit, candy, gum, dessert and other pleasing flavors when they turn 18? And, why is it ok to create, sell and advertise (on TV) fruit, dessert and candy flavored alcoholic beverages? Don’t those encourage underage drinking?

Lastly, the FDA may not need to ban flavored vape juices and cartridges, at least not for a while. If the costs of entering or staying in the market are high, producers of high quality flavored vape juices will be forced out of the market because they cannot longer afford to compete. Big tobacco’s target audience is smokers, not former smokers who use electronic cigarettes. So big tobacco companies have no incentive to produce a variety of flavored vape juices and cartridges. Users of advanced mods could find themselves with fewer choices because of a contracting supplier base and lack of interest from big tobacco.

Conclusion

I’m not opposed to many of the things that the FDA’s proposed rule intends to regulate. The FDA’s proposed rule on electronic cigarettes, components, vape juices, cartridges and other accessories will not ban these things from the market. However, the regulations, as written, may cause serious effects on the emerging electronic cigarette industry.

  • Big tobacco will dominate and control the industry.
  • Small vape companies will be forced out of business because of the costs to register and “certify” products.
  • Thousands of people who work at these small vape companies will lose their jobs, adding to unemployment.
  • Consumers will have fewer product choices than they enjoy now.
  • Product innovation will be severely curtailed.
  • Products, including those that are relatively cheap to produce, will become much more expensive.

Regulation isn’t always a bad thing, but when it stifles innovation, makes it difficult for small companies to enter and compete in the market and reduces choices for consumers, regulation does as much harm than good.

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