It seems as though we have been waiting for years for the FDA to finally release its proposed regulations for electronic cigarettes. It is not clear to me what has taken so long. But the need for these regulations is great.
The problems caused by the FDA's dragging its feet are highlighted by today's CDC report showing that calls to poison control centers related to exposure to nicotine contained in e-cigarette liquids have increased dramatically and have reached a level of 215 calls per month nationally.
According to CDC director Dr. Tom Frieden: "E-cigarette liquids as currently sold are a threat to small children
because they are not required to be childproof, and they come in candy
and fruit flavors that are appealing to children."
An earlier study noted that e-cigarette cartridges for some brands may leak, which may lead to nicotine exposure.
The CDC concludes that: "Health care providers, e-cigarette companies and distributors, and the
general public need to be aware of this potential health risk from
The CDC also recommends that: "Developing strategies to monitor and prevent future poisonings is
critical given the rapid increase in e-cigarette related poisonings."
The Rest of the Story
There is no magic in figuring out a way to prevent future poisonings. Basic quality control and child safety standards are necessary, and the FDA is the government agency with the ability to promulgate these regulations. The problem is that the FDA, for a reason that is not apparent to me, has still not released its proposed regulations.
Several quality control and child safety standards are critical:
1. All e-cigarette liquids should be packaged in childproof containers.
2. Quality control methods need to be put in place to ensure that e-liquid containers or cartridges do not leak.
3. E-cigarettes should have warning labels noting that they must be kept away from children and that care must be taken because of the presence of nicotine in the e-liquids, which could be harmful to children if touched, ingested, or inhaled.
No advanced engineering practices are necessary to accomplish this simple task.
In addition, a very simple but critical step that the FDA needs to take is to regulate battery safety. There is no need for batteries that exploded. Overcharge protection does not take rocket science.
The rest of the story is that the FDA has spent so much time trying to take e-cigarettes off the market that it has delayed action on the most important measure it could take to protect the public's health: adopting basic quality control and manufacturing standards for e-cigarettes.
With more than 250 brands on the market, consumers need to know that any brand they purchase meets certain basic quality control and safety standards. They need to know that the amount of nicotine on the cartridge labels are accurate, that the battery will not explode, and that the e-liquids are in childproof containers that will not leak.
There is no political challenge in promulgating such regulations. No one opposes such safety and quality control standards.
So what is the FDA waiting for?
I recognize that the FDA was initially not well-equipped to deal with this issue and that there is a steep learning curve associated with becoming familiar with these products. However, organizations such as the American E-Liquid Manufacturing Standards Association (AEMSA) have developed standards that the FDA could easily adapt. These standards include childproof caps, tamper evident packaging, safety and health warnings, vendor age verification, nicotine quality standards, and nicotine level verification.
I also understand that the FDA is not comfortable commenting on the content of pending regulations or substantive issues such as why OMB failed to approve the draft regulations. However, I'm aware of no law or principle that would preclude the FDA from simply announcing the anticipated date on which the regulations will be released. I'd settle for the month. Or even the year.