Unique System Needed to Regulate Electronic Cigarettes
TORONTO -- No system imposed by the U.S. Food and Drug Administration (FDA) or Health Canada -- a similar government agency in our neighbor to the North -- can adequately address electronic cigarettes, Sara Sborovski, partner at law firm Gilbert's LLP, said during today's first webinar in the Smoke Free Alternatives Trade Association (SFATA) Summer Webinar Series.
"We need a unique system regarding whether e-cigarettes should be regulated as drugs or natural products," she stated. "E-cigarettes are one of the most innovating new industries right now and placing them under one large umbrella is not enough."
The difference between being classified a natural health product vs. a drug is huge, the attorney added. Being considered a natural health product is clearly the simplest way to FDA and Health Canada approval. In fact, if the product doesn't contain nicotine and makes no health claims, the path to approval can be simple, said Sborovski.
Natural health products can offer a recommended use, though. A statement such as "Eases the transition into a smoke-free environment" can be easily proven, the Toronto-based lawyer explained.
Conversely, if an e-cigarette contains more than 4 milligrams of nicotine per unit, it is automatically classified as a drug in Canada. Once considered a drug, an e-cigarette must be backed up by supporting clinical trials.
Even if this difficult litmus test is passed, a product classified as a drug only receives clearance for sale in one country. Hence, Sborovski advised manufacturers listening to the webinar to attempt to conduct clinical trials that multiple countries' health departments can approve.
Hallandale, Fla.-based SFATA was founded in 2011 and describes itself as "the voice of the electronic cigarette industry." The association will conduct two more webinars this summer, one regarding e-cigarette insurance essentials on July 23 and another on e-cigarette imports on Aug. 20. Click here to register.