http://www.digitaljournal.com/life/health/the-fda-pushes-purposed-rule-to-regulate-more-tobacco-products/article/391823

The FDA pushes purposed rule to regulate more tobacco products

Posted Jul 31, 2014 by Wendy Spickerman
U.S. Centers for Disease Control and Prevention has reported there are over 215 complaints each month about electric cigarettes.
A variety of cigarettes
A variety of cigarettes
Denis Charlet, AFP/File
In recent days, the ongoing news of health risks surrounding E-cigarettes was brought to my attention. Here you have a product, which turns nicotine and other chemicals into a vapor that is inhaled by the user. E-cigarettes provide a means to help those with long-standing addictions to nicotine.
However, the U.S. Centers for Disease Control and Prevention has reported there are over 215 complaints each month about electric cigarettes, better known as e-cigarettes or vaping. I was shocked when I found out these reported complaints involve children less than six years of age.
Symptoms Reported:
Sore Throat
Coughing
Dizziness
Headaches
Trouble Breathing
Nosebleeds
Chest Pain
Allergic Reaction
Currently E-vapor technology is widely unregulated with claims of inconsistency in product quality due to shipments from China and over 300 companies in the United States producing the product. You can read more in this press release, "New CDC study finds dramatic increase in e-cigarette related calls to poison centers" provided to me by a CDC spokesperson on April 21, 2014.
Furthermore, reports of vendors selling used protank wicks are being reported in the Buffalo, New York Area. "There are a few stores in Buffalo who sells re-built protank wicks as a choice. One store has them for $1.50 each and another for $1.00 each. This is an option, not sold as new."
This raises the question — how do you sell rebuilt heads and where are the burnt out heads coming from? Does this mean people are turning in old heads and companies are recycling them to resell?
As I looked into the matter further, I contacted the FDA to find out just what regulations were already in place and what types of regulations where they looking at to propose. With over 300 companies in the United States alone producing this product I was curious to see just what regulations might come into play and wondered how they would handle the situation with China produced products as well.
A spokesperson from the FDA provided me with this statement, "The FDA regulates electronic cigarettes that are marketed for therapeutic purposes as drugs or devices. The FDA intends to purpose a regulation that would extend the agency's "tobacco product" authorities, which currently only apply to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. This would extend to other categories of tobacco products that meet the statutory definition of "tobacco product" Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products."
One should know there are currently no electronic cigarettes that are FDA approved for therapeutic purposes and we still don't know about long term issues of vapor usage. Consumers may submit voluntary adverse event reports to the FDA for electronic cigarettes through the HHS Safety Reporting Portal.
The purposed rule from the FDA was sent in to the Office of Regulatory Affairs. At this point, I was looking into just how long the process of a purposed rule took and when it might be released to the public.
A spokesperson from OMB press office informed me, "It is the Office of Information and Regulatory Affair's longstanding policy not to comment on rules under review; under Executive Order 12866, OIRAA has 90 days to review rules, which can be extend."
I hope you have found this article to be informative and we will keep you posted on breaking news as it comes out. Why not share you thoughts on E-cigarettes. Do you believe the FDA should step in? Would you buy this product with a known used head?
More information has come out on June 20, 2014, Federal Register Notice: PDF .
Do you have data, research, or other information related to the proposed rule? FDA wants to hear from you. Learn more about this opportunity to comment by going to FDA Tobacco Products Your Voice Matters .