Finally The FDA’s Regulation Proposal Will Be Announced
Finally The FDA’s Regulation Proposal Will Be Announced
The New York Times has recently published an article claiming that “The FDA Will Propose New Regulations For E-Cigarettes” today at 9AM.
The article gives an insight into what the FDA is planning, but even after the proposal “federal officials and advocates say it will take at least another year for the rules to take effect — and possibly significantly longer if affected companies sue to block them.”
[blockquote cite=”Sabrina Tavernise, NY Times” float=”left” align=”left”]F.D.A. officials gave journalists an outline of the new rules on Wednesday, but required that they not talk to industry or public health groups until after Thursday’s formal release of the document.[/blockquote]
Though the article was an interesting read, it was also lengthy. That said, I’ll break the article down and give the key points to the expected proposal.
The new regulations would ban the sale of e-cigarettes, cigars and pipe tobacco to Americans under 18, and would require that people buying them show photo identification to prove their age. Require producers of cigars and e-cigarettes to register with the F.D.A., provide the agency with a detailed accounting of their products’ ingredients and disclose their manufacturing processes and scientific data. Producers would also be subject to F.D.A. inspections. The new blueprint was also notable for what it did not contain: any proposal to ban flavors in e-cigarettes and cigars, like bubble gum and grape. or any move to restrict the marketing of e-cigarettes. companies would no longer be able to offer free samples, and e-cigarettes would have to come with warning labels saying that they contain nicotine. Companies would also not be able to assert that e-cigarettes were less harmful than real cigarettes unless they got approval from the F.D.A. to do so by submitting scientific information. In the proposed restrictions on sales to minors, vending machines in public places where minors are allowed would no longer be able to carry them. A ban on Internet sales to minors, already in place for cigarettes, would extend to e-cigarettes and cigars. companies would have to apply for F.D.A. approval for their products, but would have two years after the new rules are finalized to do so. Companies can keep their products on the market in the meantime.The new regulatory proposal is open to public comment for 75 days, and then the agency will make final changes, a process that will take months.
After reading over comments on Reddit about this article, Greg Conley of CASAA broke it down even further, which after reading is pretty scary.
TLDR version: Two years after these regulations go into effect, any e-cigarette product then on the market containing nicotine or any e-cigarette product marketed to be used with nicotine will be BANNED if the manufacturer does not submit a costly application to the FDA. New products will not be permitted to enter the market without FDA approval. FDA is woefully and inadequately prepared to handle this.
This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will work to the benefit of large tobacco and e-cigarette companies with Wall Street investors that don’t make the products used by 98% of this subreddit’s users, while potentially shutting down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.
This is actually worse than I expected.
Two years after the regulation is written, e-cigarette companies will have to put in ‘new tobacco product’ applications for any product released to the market after February 25, 2007.*** This is not mere registration. This is a lengthy and expensive process. If you don’t file an application, your product is banned. If you file an application and the FDA finds that your product shouldn’t be on the market for one of a variety of reasons (including their favorite, ‘You failed to submit adequate evidence of x, y, and z.’), it can be pulled from the market.
After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products. http://www.gao.gov/assets/660/657451.pdf
For just a sample of what a “new tobacco product” application is like, see here. This a document from when the FDA refused to even file (let alone approve) four “new tobacco product” applications : http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined: http://pastebin.com/5nGxZYac
This is bad news for e-cigarette consumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.
*** There is also something called “substantial equivalence” which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.
Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers.
(Going to edit this post a bit with some links as the night goes on)
~ Gregory J. Conley, JD, MBA Twitter: @GregTHR Bio: http://heartland.org/greg-conley (609) 947 – 8059
Once the proposal is released to the public, I will share it immediately. Your comments are welcome.
