Will synthetic nicotine bypass FDA tobacco certification?
The vast majority of electronic cigarette oils and cigarette bombs use nicotine derived from tobacco, as do all drug nicotine products. There is no evidence that USP grade nicotine extracted from tobacco contains sufficiently high levels of “harmful impurities” that they pose an actual health risk to users. Claiming that Synthetic Nicotine has health benefits may itself lead to FDA enforcement.
The Tobacco Control Act (TCA) grants FDA regulatory authority over products containing “nicotine made from or derived from tobacco”. The agency’s presumption rules of 3016 apply the law to all e-cigarette related products containing nicotine and tobacco derived nicotine.
This is the way FDA claims to have an open system authorization for e-cigarette products and their filling products. Because they can fill tobacco equipment, the agency claims that they are part of tobacco products and therefore subject to TCA control. The agency may consider it smokeless nicotine and try to seek authoritative certification by describing it as an integral part of tobacco products.
Although the FDA may not have regulatory power over Synthetic Nicotine at present, there is an effective bill in the Senate (which has passed the house of Representatives) ordering the FDA to regulate the substance. If the bill is passed, or if the FDA chooses to regulate it itself, Synthetic Nicotine can be regulated as a drug rather than a tobacco product, which is much more expensive and strict than tobacco regulation. Congress that fails to pass the bill may amend the tobacco control act to include nicotine from any source, or as mentioned above, FDA may consider it a tobacco product.
Whatever action the federal government takes, enforcement at the state level does not depend on the tobacco control act or the presumption rules. As Stefan didak, a California e-cigarette expert, pointed out on twitter, even if the FDA does not require regulatory authority over Synthetic Nicotine, states can incorporate it into their own tobacco laws, and some states have already done so.
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