The FDA has regulated cigarettes, smokeless and loose tobacco since 2009 under the Tobacco Control Act. In 2016, the FDA finalized a rule for the regulation of all tobacco products, making it illegal to sell e-cigarettes, cigars and hookah tobacco to anyone under 18 and requiring retailers to check photo ID for anyone under the age of 27. This rule also mandated manufacturers to submit clinical data by 2018 for newly regulated products (such as, cigars and e-cigarettes) in order to be able to continue selling these products in the market place.
There are 3 main rationales for this new mandate. First, tobacco companies determine the bioavailability for their products the same way pharmaceutical drug delivery companies have been required to provide bioavailability for their products. Second, the constantly evolving landscape of flavors and device changes by e-cigarette manufactures which, recent data suggests, can influence the user’s size of puff and frequency of use, and thereby user nicotine levels. Lastly, there is the perception that e-cigarettes are a “safer” alternatives to combustible tobacco products. Data will be required to support these claims in the now-regulated environment.
Industry has been slow in conducting these clinical trials. Their delay may be in part to the hope the current administration might rescind this requirement. The FDA has also been criticized for not providing clear guidance to what types of studies need to be conducted.
Since 2016, the FDA has moved forward on two new fronts:
- Asking the industry to reduce nicotine content in tobacco products, to make them less addictive
- Encouraging the development of innovative nicotine-replacement therapies, to wean smokers off combustible cigarettes
These new initiatives are problematic for a couple reasons. The drive to reduce nicotine content would require manufacturers to re-formulate their products which could take years to enact and potentially be derailed by lobbyists. Additionally, reducing nicotine in tobacco products may result in smokers breathing deeper and more frequently in order to increase nicotine exposure.
New plans push back deadlines by which e-cigarette manufacturers are required to provide information on current and future products in order to gain FDA approval, shifting the requirement from 2018 to 2022.
The other FDA initiative for the development of nicotine replacement therapies may provide “additional opportunities” for new and improved OTC products that could help smokers quit. This might include e-cigarettes or other nicotine delivery products.
With all of these changes, KCAS is committed to provide custom bioanalytical services to support and navigate the constantly changing regulatory landscape. Our high and low sensitivity nicotine assays can be utilized to provide reliable and defendable data to keep within FDA compliance and keep your products on the shelf.
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