Friday July 29, 2016
What is Vaping?
According to the U.S. Food and Drug Administration (FDA), “Vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes are some of the many types of Electronic Nicotine Delivery Systems (ENDS).These products use liquid containing nicotine, as well as varying compositions of flavorings, propylene glycol, glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales.”
How will the new FDA regulations affect the Vaping industry?
The FDA's regulations took effect on August 8th 2016 therefore, e-cigarette companies will have two years to prove that having their products on the market are “appropriate for the protection of public health.” If companies reach that deadline, they will be permitted another year to sell their products, while applications are reviewed by the FDA.
Under the new FDA regulations, companies that sell hardware vapers separately may face serious complications as they attempt register all of the different parts. The regulations state that, “manufacturers will need to prove that every possible configuration of the different parts would still make a safe product, and notes that the FDA expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components.”
However, according to the FDA, “products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying its jurisdiction over tobacco products, drugs, and devices.”
The Arbour Advantage with Medical Device Compliance
Arbour Group is dedicated to bringing your organization all of the necessary tools for regulatory compliance. We assist medical device and pharmaceutical companies in maintaining regulatory compliance with the FDA and other international regulatory agencies. Learn how Arbour Group can help your organization maintain it's medical device compliance.