OMB Reviews FDA Deeming Regulations
The long-awaited deeming regulations of the US Food and Drug Administration (FDA) on the topic of electronic cigarettes are currently being reviewed by the Office of Management and Budget (OMB).
Although the regulatory agency had promised to make these regulations public last month (October 2013), they had to be reviewed by the OMB first, and the government shutdown delayed this review. The OMB is a division of the executive branch of the US government, that is to say it is a White House department, and its function is to oversee the implementation of all executive functions of the federal government. Proposed revisions of regulatory standards must pass through its review process before being publicly announced.
Once the OMB hurdle is passed and the proposed regulations are publicized, further delays are likely. It is expected that a period of time will be set aside for public comment, which may last anywhere from 2 to 6 months. At the end of that period, there may be changes in the rules put forward. Then companies will be given a window of time to implement compliance, expected to last six months to a year, according to food and drug legal expert David B. Clissold, as reported by Crystal Phend in MedPage Today.
The whole process of regulating e-cigarettes has been fraught with delays for years, ever since the courts ruled against the FDA's bid to regulate them as therapeutic devices in 2010. Since then they have been deemed tobacco products, but not regulated in the same way as combustible cigarettes. The absence of regulation has aroused the ire of some in the smoking ban movement, and has allowed for "wild card" development of the industry. Now that a number of large companies producing combustible cigarettes have moved into the e-cig business as well, the market is changing radically. Some have feared that strict regulation may "give the entire industry to Big Tobacco," squeezing out small companies that cannot afford the expenses of compliance. But everyone agrees that some kind of regulation is needed, and is indeed long overdue.
One feature that is certain to be included in the regulation is a ban on sale to minors. The industry has been policing itself in this regard, according to some, but others feel that the introduction of candy-like flavors is an attempt to attract underage customers. Several states have banned sale to persons under 18, but bills requiring this restriction have been defeated or vetoed in some states, and opposed by some heath advocacy groups and anti-smoking campaigns, who fear that such state bans could actually have a reverse effect, making e-cigs more attractive to youngsters. The consensus among such advocates seems to be that the age ban should be imposed at the federal level.
Other features of the regulation are expected to be standardization, ingredient listing, manufacturing requirements, labeling and branding guidelines, and perhaps provisions restricting internet sales.
In any case, the proposed new rules are expected to be available for public comment very soon, perhaps by the end of the year.