A idea for regulating e-cigarettes
by, 09-11-2011 at 02:54 PM (1492 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:
Propylene GlycolWHAT 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.
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?