doesn’t fall under the FDA’s current rules for vaping products.
Synthetic nicotine a new trick
The agency has said in an online FAQ that it’s possible that synthetic nicotine “would not be regulated by the FDA as a tobacco product,” adding that it will decide on a case-by-case basis.
However, Sward and Myers believe that the FDA still has approval power over these products. Even if it isn’t derived from tobacco, synthetic nicotine remains a new drug that ought to be regulated, they argue.
“It is clear to us that even if the Center for Tobacco Products does not have jurisdiction over these products, the Center for Drug Evaluation can assert jurisdiction over these products as unapproved drugs — but hasn’t,” Myers notes.
The way companies have been touting their synthetic nicotine products appears to justify treating the substance as a drug, Linda Richter, PhD, vice president of prevention research and analysis for the Partnership to End Addiction says.
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“A lot of the companies that are selling these synthetic nicotine products are saying, ‘Hey it’s purer than nicotine that comes from tobacco, it’s got these great ingredients and it’s not going to harm you. They’re kind of promoting it through health benefits, which puts it under the drug regulation authority of the FDA,” Richter points out.
Even better would be for Congress to intervene regarding synthetic nicotine, Myers says.
“The best possible solution would be for Congress to clarify the definition of a tobacco product to specifically include these products,” Myers adds. “Otherwise, FDA will be playing whack-a-mole from now to kingdom come.”
Overall, the FDA has been timid in the face of continued opposition from the vaping industry, and needs to step up its efforts, according to Myers and Sward.
“They’ve had more than three months past their deadline from the federal judge to deal with these products, and it’s very disheartening that they have not so far,” Sward says.
“The clear takeaway is that as long as flavored products are for sale, kids will get them. The only way to protect kids from flavored products is to make it illegal to sell them,” she concludes.
However, the FDA might simply be outgunned and overwhelmed, Richter says.
“I just don’t know that it has the staff and the funding to keep up with this extremely well-funded industry, especially given that there’s plenty of people within the government who don’t think the regulations should be as strong as they are,” Richter says.
“Then you turn to a product like vaping that is presented as somewhat healthier, so you have a lot of people within Congress and regulators who say, hey, let’s be careful how much we restrict those because it might deter people from quitting smoking. That’s the murkier landscape that allows a lot of this to go on,” Richter concludes.
Prevention tips
The Partnership to End Addiction points out how important to be aware of the available nicotine products and how their manufacturers work around the existing restrictions that seek to protect youth from the harms of tobacco and nicotine. To help prevent your child from using, try the following:
- Be aware and stay up to date on the latest trends in nicotine products, what they look like and how they are used, so that you can know if your child is using them.
- Model healthy behavior for your child by not using or condoning the use of any nicotine products.
- Connect with your child, have honest conversations with them and talk regularly about nicotine, other substances and how using them can damage their health and well-being.
- Clearly convey that you expect them not to use these products, monitor their activities, and intervene when necessary in a health-promoting, rather than in a punitive way.
- Make sure they know they can come to you for help if they are struggling and possibly using nicotine or other substances to cope.
- Know about the factors that can increase your child’s risk of using, such as mental health issues, and address these early with the help of a qualified health professional.