Food and Drug Administration (FDA) Director Kenneth Hartigan-Go believes it is best to ban the product altogether.
The agency director said any effort to regulate Electronic Nicotine Delivery Devices (ENDs) or e-cigarettes would result in a waste of government funds and manpower. (READ: E-cigarettes: To ban or not to ban?)
In an interview with Rappler, Hartigan-Go cited the hurdles the agency will face should the government opt for product regulation. Below are some of these challenges:
(1) Smoking area vs vaping area
Since there is a ban on smoking in public places under the Tobacco Regulation Act of 2003, vaping — or e-cigarette use — would also need to be limited to certain areas.
Like smoke from tobacco, the aerosol mist that is emitted during vaping can also be a disturbance especially to non-vapers.
However, most vapers refuse to vape in designated areas for smoking. Claims that the harms of vaping are lesser than that of regular tobacco have prompted vapers to stay away from smoking areas.
The FDA is now faced with the regulatory challenge of providing vaping areas separate from areas for smoking.
"It's a chemical that enters the lungs. How do you classify that?" asked Hartigan-Go.
Product classification is one of the biggest challenges for any agency tasked to regulate e-cigarattes.
The two primary materials of the e-cigarette — the unit or the delivery device and the liquid or the e-juice — will both have to undergo testing to assure their safety. But tests vary per product classification.
A pharmaceutical drug, for example, requires documentation of the product's efficacy based on a clinical trial. A drug, however, has a "therapeutic endpoint."
If e-cigarette sellers make health claims, FDA would classify the e-juice as a drug and the unit as a medical device. The industry would then have to present a proof of concept — outlining the basics of the drug development to demonstrate its feasibility — and an ethical trial approval sought from an academic or medical research institution.
According to officers of the Philippine E-Cigarette Industry Association (PECIA), the domestic e-cigarette industry in its present form — given its size and its available resources — will be unable to meet the requirements needed if the product was categorized as a drug.
PECIA is currently composed of 95 small-scale e-cigarette sellers.
It is also possible that the product may be classified as tobacco, despite emitting vapor and not smoke. Should this be its official classification, e-cigarettes would be subject to the Sin Tax law as well as other tobacco control regulations.
Advertising restrictions will also apply.
However, the temporary restraining order issued by the Supreme Court makes the FDA unable, for the time being, to regulate any tobacco product.
(3) Do-It-Yourself (DIY) e-cigarettes
The inventive and ingenious minds of Filipinos have not overlooked the e-cigarette business.
Filipinos have started creating ENDs or e-cigarettes from everyday household materials, such as flashlights and empty gum containers.
Since e-juice content is mostly food additives coming from bakery supplies, some mix their own e-juices.
These DIY e-cigarettes would be nearly impossible to regulate, said Dr Hartigan-Go.
(4) Lack of scientific consensus
"How will you regulate something you know nothing of in terms of its safety profile?" asked Hartigan-Go.
There is currently a lack of scientific consensus globally – with studies contradicting each other and scientists rebutting each other’s claims – regarding the safety, benefits and harms of e-cigarettes.
The "Efficiency and Safety of an Electronic Cigarette as Tobacco Cigarettes Substitute" or ECLAT concluded after a 12-month study of a group of smokers made to use the device that, e-cigerattes helped reduce tobacco use.
The ECLAT study, however, is crticized for its "flawed methodology," lacking an additional control group that was not made to use e-cigarettes as a point of comparison to the "e-cigarette" group.
The lack of a generally accepted, peer-reviewed local study also inhibits FDA from pulling in data that can be the basis for any regulatory mechanism.
(5) Online sale
As various real-world affairs have either been duplicated or simulated online, trade has been possible in the World Wide Web for quite some time now.
There are e-cigarette sellers who have set up online shops for the convenience of consumers. This will make regulation all the more daunting for the FDA.
While the PECIA has banned the sale of e-cigarettes to minors by requiring identification cards indicating age from buyers, online sale to minors would be hard to monitor.
This year, the FDA is faced with the task of regulating industries that were previously not subject to any safety regulation specific to the industry. This includes regulating stem cell products which will be newly-registered by August.
In the country, e-cigarette shops have multiplied in number in the past two years. PECIA officers said they are willing to be subject to regulation.
The FDA has conducted a public hearing with industry players and members of the medical community on Wednesday, July 24. Clearer directives will be issued in a month's time. – Rappler.com
E-cigarette image from Shutterstock
Other e-cigarette image also from Shutterstock