Vaping has cut into Chantix’ sales too. Pfizer probably supports anything that might restrict vapor products, as the deeming regulations will. There is a belief among many vapers that the FDA Center for Tobacco Products (CTP) — the division of the FDA that regulates tobacco and consumer nicotine products — created the deeming regulations in part to protect the pharma companies that make cessation products like Chantix from competition by vape. While that is theoretically possible, vapers have to understand that the CTP doesn’t oversee or approve Chantix, or any cessation products made by pharma companies.
That responsibility belongs to the Center for Drug Evaluation and Research (CDER) — the part of the FDA that regulates pharmaceutical products. Mitch Zeller’s team at the CTP has no regulatory control over sales of Chantix or NRT products like nicotine gum, and CDER has none over e-cigarettes (or tobacco products that actually contain tobacco).
Approval as a drug by CDER takes many years and millions of dollars. Randomized clinical trials must be performed at the expense of the manufacturer. It is an even more difficult and expensive path to approval than the Premarket Tobacco Application route laid out in the deeming regulations. So even though vaping may well be as safe or safer — and probably even more effective — than NRT products or Chantix, comparing one to the other is apples and oranges. The processes for approval, and the regulatory bodies that oversee them, are different.
Still, it will always be maddening to vapers to see an FDA-approved product that is known to have serious side effects easily available and even recommended, while the FDA is working overtime to hammer nails into vaping’s coffin.
Rob Wilson / Shutterstock.com