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Vocalek

A idea for regulating e-cigarettes

Rating: 2 votes, 3.00 average.
by , 09-11-2011 at 02:54 PM (1325 Views)
I've been giving this some thought. The hardware is going to be tremendously difficult to regulate. Any modder can come up with improvements and sell the hardware separately from liquid as a novelty item.

The Tobacco Act seems to have been invented with the idea of putting up a gazillion roadblocks to making any product improvements, which is a big problem when the product you are dealing with isn't an agricutuaral product but rather a gadget. Technology changes much more rapidly than plants do.

Legally speaking, regulating the liquid as a tobacco product is only possible by focusing with complete tunnel vision on the phrase "derived from tobacco" in the Tobacco Act. I don't believe the law was meant to apply to a chemical extracted from tobacco. If so, then the pills being sold by Star Scientific as a supplement would need to be regulated under the tobacco act. They contain an alkyloid extracted from tobacco, anatabine.
Star Scientific: A Struggling Tobacco Company Sitting on a Healthcare Gold Mine? - Seeking Alpha

The FDA doesn't even want to regulate Star Scientific's BDL (for "barely detectable levels) Ariva and Stonewall orbs as tobacco products, and they actually contain compressed powdered tobacco!
Star Scientific Receives Notices from FDA: Ariva-BDL(TM) and Stonewall-BDL(TM) Not Subject to Regulation Under FDC Act Chapter IX » Star Scientific

So here is an idea:

What if the FDA were to regulate the liquid, and only the liquid, but not as either a drug or a tobacco product. In Sweden, snus is regulated as a food product.

The FDA is already regulating Johnson Creek smoke juice in this way. See section headed "FDA": Frequently Asked Questions - Johnson Creek Smoke Juice

JC registered their lab with the FDA when they opened. FDA conducts inspections to make sure conditions are sanitary and safe. All FDA would need to do to complete the picture would be to modify the food labeling regulations to instruct e-liquid manufacturers to specify the % of nicotine in each container (whether that be a bottle or a pre-filled cartridge) and to add a Hazard warning label: CAUTION - Nicotine is poisonous and addictive.

FDA could also require that containers that contain nicotine be distributed with child-proof caps, but allow the seller to include a regular cap to be substituted by the customer if no children are present in the household. Kaiser does this with my prescriptions. They come in a bottle with a child-proof cap, but I only have to fight with it one time. They also include a snap on/off cap for me to substitute for the CPC.

FDA also regulates PG as a separate product:

WHAT DIFFERENTIATES USP AND FOOD GRADE GLYCOL FROM TECHNICAL GRADE GLYCOL?

Propylene Glycol USP is closely regulated by FDA in all aspects of manufacturing, testing, inspection, distribution, and warehousing. Glycol USP is subject to FDA rules requiring registration and listing, and glycerin FCC as well as USP are also subject to Good Manufacturing Practices, a series of appropriate procedures prescribed by FDA, while the technical grade is not under such regulatory control.

FDA requires all domestic owners or operators of all establishments that manufacture or process glycerin USP to register and list, unless specifically exempted (21CFR §207.20). For glycol USP of foreign origin, the foreign manufacturer and the importer share the responsibility of FDA compliance (21CFR§207.4). The Agency’s definition of "manufacturer" includes the original producer as well as re-packagers and/or distributors (21CFR§207.4). Additional information on drug registration and listing instructions is available from FDA at http://www.fda.gov/cder/drls/introduc.htm#top.

Further, under FDA regulations, the quality and purity of USP and FCC glycerin products must be supported by systematic and complete record keeping on the part of the manufacturer. For example, every shipment of USP and FCC glycerin must be referenced to a lot number, which permits tracing back to the plant in which the product was produced. These requirements are designed to assure a level of product integrity that cannot be achieved strictly by reliance only on physical and chemical testing.

Technical grades of glycerin, on the other hand, are not subject to the same FDA regulatory oversight. Although produced by similar processes, the technical grades of glycerin do not have to comply with USP and FCC requirements or with FDA regulations. This quality grade of glycerin must conform only to the specifications and terms agreed upon in the transaction between buyer and seller.
Propylene Glycol

The FDA could then notify Chinese manufacturers that if they want to continue exporting e-cigarette liquid and cartridges to the U.S., they will need to comply with FDA food standards for the products.

I believe that the QC issues with hardware tend to be self-correcting via caveat emptor. Word gets around and folks start switching to products that work better.

What do you think? Have I covered the bases? Would this take care of the safety concerns of users?
cigarbabe likes this.

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Comments

  1. Cool_Breeze's Avatar
    double post
  2. Cool_Breeze's Avatar
    Hi Vocalek -

    I like your reasoning. I'd say write it up as a proposal rather than example, but that might be seen as an invitation.

    While it might address the concerns of users (defined as 'we'), I know not what all concerns that other outsiders might want addressed.

    Still, should discussion ensue wth authorities, your thoughts certainly bear merit.
  3. Vocalek's Avatar
    Some of the concerns that outsiders want addressed really amount to unproven fears. An example is the fear that flavors will attract children to use them. We have documentation that a sizeable percent of us adults no longer like the taste of tobacco and we suspect that switching to flavors helps to extingish urges to go back to smoking.

    There are only isolated reports of youth under age 18 using the products, and then only among young smokers looking for a way to quit. Even these reports have been second-hand (e.g. "My daughter says she has a friend that....") If youth are using these devices, I doubt whether flavors entered at all into the decision to give the products a try. Further research is needed. I believe that there is a danger that the products would be made less effective if flavors are banned based on conjecture alone.

    Some folks are so concerned about the dangers of poisoning that they would want to require that sealed, tamper-proof cartridges be the only way e-cigarette liquid can be sold. Yet, here we are 7 years after product introduction and there have been no massive cases of poisoning by e-liquid spills. Those of us who started out using the early models often ended up with juice in our mouths due to leaky cartridges, and we had no ill effects.

    Again, further research is needed before imposing restrictions on users being able to refill their own cartridges. I suspect that one factor in the product success might be the fact that the users have an extremely fine level of control over nicotine content never before seen in products that contain nicotine, but no tobacco. For example, using the patch, users are forced to drop their nicotine by 50% with each step. Gum comes only in 2 mg and 4 mg doses. What if some users need 6 mg? What if some need only 1 mg or even 0.5 mg?

    I believe it is too soon for government to step in regulate such things as flavors and nicotine content.

    I'm looking for a concensus among the consumers regarding what they consider to be reasonable and sufficient safety regulations. Additional regulations could be imposed after convincing evidence is compiled showing that public health is endangered by the absence of those regulations.
    cigarbabe likes this.
  4. cigarbabe's Avatar
    It would be fine if we could actually trust our government or the regulatory agencies but we know that we cannot. There needs to be a group with folks from all walks and perhaps industries including those who just vape not necessarily all vendors. Comprised of maybe tobacco research scientists without a ANTZ viewpoint and perhaps from tobacco or pharma possibly who believe in HR and maybe one anti everything just to be fair or at least to vote down time and time again.... heehee
    C.B.
  5. Vocalek's Avatar
    Good idea. I'll see if I can get some scientists interested in this idea.
  6. Stubby's Avatar
    I am all for reasonable regulation and have said so long ago. It would be good to know if the liquid is made under lab conditions or mixed in someones bathtub. That may seem like an over the top statement but with the large amount of venders out their at the moment there is no way of knowing.

    The manufacture of swedish snus is highly regulated and must meet certain standards or it's a no go. It would be nice to have that assurance with e-liquid.

    I do have some problems with the hardware, and in particular the battery mods. With very few exceptions (Pro Vape being the only one I can think of) the mods are very poorly done as far as safety goes. It appears the fad is for battery mods the brag about being all-machanical. Truth is that is not such a good idea. It may work fine for a mechanical swiss watch, not such a good idea with a battery. Having a mod with a mechanical switch with no backup safety measures is not an accident waiting to happen, it's an accident begging to happen. When something goes wrong, as in a atty short, stuck switch, uncontrolled battery discharge, or any other numerous things that can go wrong, things can very quickly turn very bad.

    Some regulation of the hardware would also be a good thing.
  7. sachavaca's Avatar
    jc changed to % ON BOTTLES
  8. Vocalek's Avatar
    I suspect that the industry started out by reporting mg/g because the NRT industry uses mg as a dosage identifier. Even cigarettes were using mg. But it turned out to be confusing, especially since most of the cartridges held nowhere near a gram of liquid. In Italy, one brand reports mg by how many mg are in the cartridge. Thus an entire research project was run using e-cigs with 7.5 mg of nicotine, which really works out to the equivalent of 24 mg. juice. I think expressing it as a percentage not only helps to avoid confusion for new users regarding "how much nicotine is in that cartridge" but also since 2.4% sounds a lot smaller, it is less frightening to people who know nothing whatsoever about nicotine.