It appears the US Food and Drug Administration isn’t entirely oblivious to the benefits of e-cigarettes for smokers, as the FDA’s first-ever e-cigarette authorisation specifically cites the vaping product’s potential to help smokers either completely quit smoking or significantly reduce the amount that they smoke.
Here’s what the director of the FDA’s Centre for Tobacco Products, Mitch Zeller, said:
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavoured products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
Why The FDA’s Admission Matters
The FDA has established mutual recognition agreements (MRAs) in the EU and the UK. Beyond this, there seems to be no shortage of governmental bodies around the world that at least consider the FDA’s position on the wide array of products, foods, and medicines that the federal organisation regulates.
For Australians who aren’t entirely familiar with the FDA is or what the agency does, it’s essentially the US version of the Therapeutic Goods Administration (TGA).
As it stands, the FDA and Australia have a number of cooperative agreements. For instance, the FDA and TGA have a cooperative agreement regarding the exchange of information on GMP inspections of human pharmaceutical facilities.
Whether or not the FDA’s admission that e-cigs have the potential to help smokers will have any impact whatsoever on the Australian Government’s position on nicotine vaping products remains to be seen. However, much like the formal positions of the governments of the UK and New Zealand, it is possible that Australian politicians and citizens will cite the FDA’s admission as they advocate for the rights of Australian vapers.
The FDA Appears Behind The Times When It Comes To Vaping
First came vaping, and then came regulations. For quite some time, vaping was a largely unregulated industry. As it became clear that vaping was not a fad that would fade quickly, it seemed to catch the attention of more and more regulatory bodies and researchers around the world. In the US, vape companies flourished as vaping exploded in popularity. Now, the FDA appears set on regulating the industry.
In recent times, the FDA ordered ten companies to stop selling their e-cigarette products in the United States. While this may have come as a shock to some, the move appears to have been a long time in the making. The companies that the FDA told to remove their products from the market were told by the agency that their products lacked the necessary premarket authorisation. Meanwhile, many vaping products remain on store shelves across the country.
Australia Charts Its Own Path
The Australian Government has decided to chart its own path, opting to regulate e-cigarette use across the country by requiring vapers to have valid e-cig prescriptions to buy vaping products with nicotine in them. Nicotine prescriptions for e-cigarettes are not required in the US, UK, or NZ. Australia is truly on its path all its own when it comes to requiring prescriptions to vape with nicotine.
With a valid prescription, vapers can still buy nicotine e-cigarettes from overseas vape shops just like they have been doing for years. The new requirement makes it more difficult for Australians to vape with nicotine, as they must now consult a licensed GP to discuss how e-cigarettes may help them quit smoking or reduce the amount that they smoke. Even then, there’s certainly no guarantee that a doctor will prescribe nicotine for vaping, leaving much in question for former smokers who have already made the switch to vaping, those who are in the process of transitioning, and those that are considering the move.
In addition to overseas suppliers, Aussie vapers with valid prescriptions are also allowed to have their vaping prescriptions filled at local pharmacies.
Meanwhile, Australians who are of legal age can purchase cigarettes at stores across the country.
What do you think of the Australian Government’s decision to require vapers to maintain valid e-cigarette prescriptions while cigarettes remain accessible throughout the country without the need for a prescription?
