Although the FDA's proposed regulations on electronic cigarettes have been out for a few weeks already, it remains to be a hot topic among opponents and proponents on the industry. In fact, FDA Commissioner Margaret Hamburg wrote a letter to NYT to clarify the proposals.
Independent Researcher, consultant and CASAA Scientific Director Carl V. Phillips said that this letter is indeed a clarification of the ignorance the federal agency has on electronic cigarettes.
In the letter, Hamburg said that once finalized, the policies will require ecig companies will be required to submit their report on the levels of harmful as well as probably harmful chemicals/chemical compounds emitted by the products.
She said that they cannot enact a rule on restricting and reporting ecig emissions until the foundational rule making is made complete.
FDA Tobacco Regulatory Process
Under this process, harmful and potentially harmful chemicals or HPHC rules will require to test their products as well the smoke emission of products. It is not clear whether vapors from ecigs would have to be tested too.
This was not mentioned in Tobacco Control Act while the deeming ecig regulations repeatedly refer to HPHC rules with no clarification. Phillips stated that it easier answering a question when it is about processed tobacco leaf with paper rather than disposable ecigs.
It is possible that the FDA wants the quantity of listed chemicals in the overall product with the battery included. It can also be assumed that the agency only wants to know the chemical list of eliquids, but the agency has not been straight or clear about it. FDA only emphasized that ecigs will be subject to HPHC reporting, but did not explain what this actually means.
Inappropriate, Senseless Regulations
Apparently, the FDA has not thought or considered the legal and scientific aspects of the ecig regulations. Moreover, Phillips said that the biggest flaw of the FDA proposal is that the HPHC reporting process has no benefit at all because it will only impose useless busy work.
For years, FDA has been gathering smokeless tobacco and cigarette information; but barely knows what to do with such information. They report about it, but unintentionally do not tell that products with lower quantities have lower harms as well.
The federal agency is expected to implement its oversight on banning some product SKUs with higher levels of certain chemicals. This, however, is not proven to be beneficial to the public.
Although some cigarettes could have lower levels of these chemicals, they are still very harmful. Yet, the smokeless tobacco products will almost be harmless. HPHC numbers will only be used as an excuse in banning certain products. Phillips said that this is just what the FDA wants to do.
With ecigarettes, this problem is worse. The particular HPHC chemicals list is not appropriate for electronic cigarettes. Most components are useless to measure while compounds and molecules that are of significance with ecigs are not included in the list. If ever the list is appropriate, there remains no evidence that higher levels in ecigs are indeed risky.
Hamburg said that FDA is committed to science-based policies on electronic cigarettes in order to better protect the public. With what FDA plans to do with ecigs, this seems unbelievable. Hamburg said that there will be four different studies to be done on ecigarette vapor; but there are already a lot of previous studies about vapors that can assure vapers that vapors are not harmful. The FDA is focused on the chemicals that matter not with ecigarettes.
Also, it appears that there is no part in the plan that will address the improvement of production. The FDA plan is 99% focused on banning ecigarettes in the market through the immense expenses involved in the busy work of regulations.