Many people think that the industry has a few more months before we start seeing products being pulled by the FDA from American shelves. Well, it turns out that we’re already seeing it happen.
The way the regulation works is that only products created prior to August 8, 2016 have the remaining months before the government comes for then. Anything concocted in the last two years is already fair game.
The feds have actually come after some products in the past. But the US FDA just put out a press release noting that they’ve sent letters to four companies covering 44 different e-liquids.
The companies must immediately pull their products from the market as they haven’t been approved by the FDA. Most of the products banned are e-liquids containing nicotine salts. Salt Nic is a relatively new thing, so it’s an unsurprising move.
The products subject to the warning letters were introduced or modified after Aug. 8, 2016 – the effective date of the final rule that extended the FDA’s authority to all tobacco products. Any new tobacco product that does not meet the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements is adulterated and/or misbranded and may not be legally marketed without authorization from the FDA. The agency has several tools to enforce the requirements of the FD&C Act and regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.
FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market for not having required marketing authorization | FDA