The Center for Drug Evaluation and Research (CDER)
CDER is a division of the U.S. Food and Drug Administration (FDA), and is tasked to ensure that safe and effective drugs are available to improve the health of people in the United States. It regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Drugs and medical devices are defined as “articles (other than food) intended to affect the structure or any function of the body.” Under this broad definition, according to the CDER, “drugs” do not only include medicines but also fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens.
Tobacco products are explicitly excluded from the CDER’s definition of a “drug.” However, in 2011, the U. S. Court of Appeals for the District of Columbia ruled in Sottera, Inc. v. FDA, that nicotine-containing products that are marketed for “therapeutic purposes,” for example to quit smoking (cessation), can be considered drugs and thus regulated through the CDER. The key is what the product’s intended use is, which is defined by its marketing. If the intended use involves the diagnosis, cure, mitigation, treatment, or prevention of a disease, there is an argument the nicotine-containing product should be designated as a “drug.”
There are currently five types of FDA-approved nicotine-based therapies on the market as smoking cessation aids: the nicotine patch, gum, lozenge, spray (Rx only), and inhaler (Rx only). There are also two FDA-approved non-nicotine-based therapies (both by Rx only): bupriopion (Zyban) and varenicline (Chantix).
The process to become approved as a “drug” according to the CDER and the FDA is extensive and time-consuming. If you feel your product may qualify as a “drug” in that it is being marketed for smoking cessation or other therapeutic purpose, contact me and we can begin the application process and ensure your marketing and labeling campaign is compliant with the law. Also, if you are in need of a secure e-commerce payment gateway, our friends at Tasker Payment Gateways can get you set up!
Disclaimer: The information above is for informational purposes only and should not be construed as legal advice. It is not privileged and does not create any attorney-client relationship.
This post originally appeared at http://taskerpaymentgateways.com/fda-vape-regulations-are-you-selling-drugs