Ending nearly ten years of debate, the US Food & Drug Administration has now announced that, like every other tobacco product, electronic cigarettes will be stringently regulated for safety and quality.
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1. The new regulations are broad.
Lots of eLiquids (probably the majority) contain nicotine, and usually that nicotine is derived from tobacco plants, hence the FDA’s authority to regulate e-cigarettes. But the agency’s new requirements will go far beyond eLiquids.
2. They apply to all “electronic nicotine delivery systems.”
Electronic nicotine delivery systems (ENDS) range from convenience store “cig-a-likes,” which closely resemble traditional cigarettes to tanks and mods that no one would confuse for a smoke. “System,” though, is the key term in the FDA’s definition, and it includes the devices and components used to vape. On its website, the FDA provides a list of “components and parts” that will now come under the agency’s review:
- eLiquids and the vials in which they are stored
- batteries (with or without variable voltage)
- digital displays and lights that allow users to adjust a device’s settings
- tank systems
In short, any component intended, or that one could reasonably expect, to be used in the human consumption of a tobacco product is covered. The new rule also automatically includes any products created in the future that meet the law’s definition of “tobacco product.”
3. This kind of authority was built into the law from the start.
When the Tobacco Control Act went into effect in 2009, giving the FDA power to regulate the tobacco industry, cigarettes, loose-leaf tobacco and smokeless forms of tobacco (like chewing tobacco and snus) were automatically covered, since those types of tobacco were prevalent at the time.
Now that the e-cig industry has taken off (although signs show that the popularity of e-cigs is waning), the FDA has invoked a clause in the law which allows it to “deem” newer products as “tobacco products” and restrict their sale and distribution.
4. Kids can’t buy e-cigs anywhere.
While most states (New York included) have already placed restrictions on the sale or marketing of electronic cigarettes to minors, the FDA’s new rule takes care of the few remaining exceptions (Michigan and Pennsylvania), making it illegal under federal law to sell e-cigarettes to people under the age of 18. That’s true for brick-and-mortar stores, as well as mail order and online retailers.
Photo ID will be required for any one under the age of 27.
The rules also make it illegal to sell e-cigarettes in vending machines, unless the vending machine is located where a retailer can ensure that people under 18 are prohibited from entering at any time.
5. Free samples are prohibited.
6. You can’t market e-cigs as safer than cigarettes.
At least not until we have compelling scientific evidence that e-cigs actually are safer than traditional cigarettes. In the future, any determination that an e-cigarette constitutes a “modified risk tobacco product” will be made on a case-by-case basis. At this time, e-cig manufacturers can’t advertise their products as “smokeless” or “smoke-free,” either, since e-cigarettes (unlike, say, chewing tobacco) require the heating of a tobacco product and the inhalation of something into the lungs.
7. Warnings are required.
E-cig marketing materials and product packaging must now bear an “addictiveness warning,” reading:
WARNING: This product contains nicotine. Nicotine is an addictive chemical.
On a case-by-case basis, the FDA may allow some e-cig products that don’t contain nicotine to use a more-moderate warning, which would read: “this product is made from tobacco.”
Whereas warnings on cigarette have to occupy 50% of the product’s packaging, e-cigs are being regulated more like chewing tobacco. The warnings will need to take up at least 30% of an e-cigarette’s packaging, both back and front. 20% of e-cig advertising materials will have to be occupied by the warning.
While not specifically required, the FDA says that additional warnings (including one about the risk of nicotine poisoning) may go some way in helping an e-cig manufacturer demonstrate that their product is “appropriate for the protection of public health.” In other words, an application for approval may go smoother if those warnings are included.
In most cases, these warning requirements won’t preempt (or cancel out) the additional, usually more stringent, warnings required by some state or local laws.
8. It will cover most batteries.
According to the final rule’s full text (available at the Federal Register), “FDA […] remains concerned about reports of exploding batteries.” Batteries that come packaged with e-cigs, or components designed to be used in electronic nicotine delivery systems, easily fall under the FDA’s new authorities, meaning many lithium-ion battery manufacturers will be required to submit their products for safety testing.
But lots of lithium-ion batteries, often sold individually, can be used in a wide range of applications, e-cigs being only one. The agency admits that regulating these products may be more difficult, and has limited its approval efforts to “batteries that are co-packaged with other parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with ENDS.”
9. It includes software, too.
The FDA’s definition of “component or part” includes “programmable software.” While the agency’s final rule provides little information on how this detail will be implemented, it could suggest that FDA reviewers will be analyzing the software used to stop some lithium-ion batteries from over-heating.
10. This is going to take a while.
The FDA’s ban on sales to minors, which again only affect a few states without their own laws, will go into effect on August 8, 2016, as will the agency’s prohibition on offering free samples and incorporating e-cigs in vending machines.
Beginning on May 10, 2016, when the FDA released its final rule, most e-cig manufacturers will have two years to submit their product applications for review, and the FDA will have an additional year to analyze the application. During those three years, the manufacturer will still be allowed to sell its product.