FDA Finally Moves on E-Cigs With Minimal Regulation
If there was any fear of the Food and Drug Administration on the part of the e-cigarette industry, those companies are now breathing a massive sigh of relief, while pro-regulation consumer groups are muttering in frustration.
The "vaper" industry has grown into a multi-billion dollar market over the last few years in the absence of regulation, and over the last year, the roaring rumors of impending regulation by the FDA have intensified greatly, with some speculating that the devices could soon reach the same level of restrictions as traditional cigarettes.
Instead, the FDA's proposed regulations, published late last week, are but a mere whimper.
The New Federal Rules
The proposed regulations, which were published for comment on Regulations.gov on Friday, are surprisingly mild, and include:
- Chemicals used in the devices must be disclosed;
- No free samples;
- No sales to minors;
- Manufacturers must get FDA approval before going to market;
- A health warning is required, advising that nicotine can be addictive.
Nowhere in the proposed regulations are the more restrictive rumored regulations that regular cigarettes face, which include bans on Internet sales, restrictions on advertising, or the use of sweet, fruity, or other flavors that some argue attract children.
States and Cities May Do More
A FindLaw survey shows a mixed reaction to the nicotine-laced vapor-dispensing devices.
According to the survey conductors' legislative research, 46 states have already proposed or enacted legislation related to e-cigarettes. Of those, at least 20 state have extended existing smoking bans (typically in public places, restaurants, or bars) to e-cigarettes or otherwise prohibited public use. Other states have passed resolutions encouraging federal regulation or tried to exempt the devices from smoking laws.
As for popular opinion, 43 percent of Americans feel that e-cigarettes should face identical regulations to traditional cigarettes, though out of those who have actually tried the devices (only 15 percent of adults), 55 percent say that e-cigs shouldn't face the same rules.
FDA Starting Slow
For now, it seems that the FDA has sided with "vapers," (the term coined to describe those who use the vapor devices) and proposed extremely lenient regulations, though manufacturers should take heed of possible additional regulation in the future, now that the FDA has classified the devices as "tobacco products," which are subject to the agency's regulation.
Perhaps the initially mild regulations were intended to prevent challenges to the agency's authority? In case you're curious, the statutory definition for "tobacco product," which gave the agency authorization to regulate cigarettes only a few years ago, includes anything derived from tobacco, which would presumably include nicotine.
- This Week in FDA Regulation: Plan B Pills, Menthols, and E-Cigs (FindLaw's In House Blog)
- This Week in FDA Regulations: 40 States Ask for E-Cig Rules (FindLaw's In House Blog)
- This Week in FDA Regulations: Roll-Your-Own, Trans Fat, Cosmetics (FindLaw's In House Blog)
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