Senate President Vicente Sotto III said Monday the Food and Drug Administration should consider the huge difference between combustible cigarettes and heated tobacco products in drafting the guidelines for the regulation of the electronic nicotine delivery systems.
“They are better than cigarettes. We have to admit that, especially heated tobacco. There is a big difference, even in terms of second-hand smoke from cigarettes. The heated tobacco does not have a second-hand smoke, but the actual cigarettes have,” Sotto said during the Senate deliberations on the budget of the Department of Health sponsored by Senator Pia Cayetano.
FDA, an attached agency of the DOH, was tasked to draft the general guidelines for the implementation of Republic Act No. 11467 and Executive Order No. 106 which allow the sale, distribution and taxation of HTPs and electronic cigarettes or vapes.
Sotto said the FDA’s proposal to prohibit certain ingredients such as glycerol and propylene glycol in HTPs and e-cigarettes may restrict the availability of these electronic devices in the country which would be contrary to the enabling law.
“I understand we need to properly regulate electronic nicotine delivery systems or ENDS and heated tobacco products or HTPs. However, it appears that certain ingredients considered essential for these products are proposed to be prohibited. These are aerosol formers for these products, so if they are banned, the products will not work anymore. If there is no aerosol to inhale, it will make these products unusable. In other countries they are not banned in e-cigarettes,” he said.
Sotto clarified that the regulation of HTPs and e-cigarettes in the Philippines was not meant to encourage the youth and non-smokers to take up these devices but to provide smokers with alternatives to traditional cigarettes.
“What we want is for smokers to try heated tobacco or e-cigs, because the research or study shows that once you switch from cigarettes to heated tobacco particularly, about 80 percent would not return to smoking,” he said.
Sotto said a case example is his brother and the other cast of noon-time TV variety show Eat Bulaga who were mostly smokers. “When they turned to heated tobacco more than a year ago, none of them have gone back to [smoking cigarettes]. So I believe in the study,” he said.
“I was in London over a year ago and I saw the difference which was huge,” Sotto said in bilingual.
He said this being the case, the FDA should not make it more difficult for HTPs and e-cigarettes to compete against traditional cigarettes.
Sotto also noted the concerns raised by some sectors particularly the e-cigarette consumer groups over the FDA’s initial draft guidelines on vapor products and HTPs. “What is the basis for the draft guidelines?” he asked.
Senator Pia Cayetano said she was informed by the FDA that it held public consultation that included representatives of different companies. She said the primary basis of the FDA’s guidelines was supposed to be the enabling law passed by Congress.
“Is there any other countries in the world that impose similar guidelines?” Sotto asked. He said the drafting of rules and regulations and guidelines by some government agencies became a source of concern among the authors of the laws. “It has been a big issue with us. Because some agencies appear to go beyond their enabling law, what the enabling law provides,” he said.
Sotto then asked Cayetano to guarantee that the draft guidelines would remain faithful to the enabling law.
“Yes, Mr. [Senate] President, the director-general [of FDA] is nodding his head with thumbs up. I will remind them that we are very conscious of their not exceeding their authority. They should just be guided by the law,” Cayetano said.
Cayetano said she would also ask the FDA to address the concerns about prohibiting the ingredients used in HTPs.
She said it is also important to make sure that the youth would not have access to these innovative products.
“Our biggest concern is the youth and what I learned when I went to London was that the reason they can really push for e-cigs [in London] is because they have already been successful in preventing the youth from smoking cigarettes. So now even the e-cigs is not something that they desire to try unlike in the Philippines where we have not yet cut that desire for the youth to engage in smoking,” Cayetano said.