‘Base vape, heated tobacco regulations on science, not fiction’

MANILA, Philippines — A medical expert has urged the Food and Drug Administration (FDA) to base the proposed vape and heated tobacco regulations on science and not on fiction in the wake of the beleaguered agency’s admission that it received funding from foreign anti-tobacco organizations.

“Science, and there is an abundance of curated and peer-reviewed studies out there, should be the basis of regulation. Not political or ideological agenda,” said Dr. Lorenzo Mata Jr., president of Quit for Good, a group that advocates sustainable ways to quit the smoking habit.

The FDA has conducted a couple of public consultations where it was compelled by members of Congress to admit receiving funding from The Union and Bloomberg Initiative, US-based philanthropies working to eliminate use of any tobacco product. The admission triggered calls for a full-blown congressional inquiry into the FDA and its receipt of foreign grants.

Mata noted that they participated in the FDA public consultation “hoping for a robust and substantive discussion on science not fiction. We were treated to a farcical consultation, a mere tick-the-box exercise for the sake of simply holding one.”

“We have been advising the FDA that regulation should be based on the risk profile of products. The greater the risk to one’s health, the stricter the regulation, not the other way around. The World Health Organization has in fact conceded before the Philippine Congress that e-cigarettes are substantially less harmful than cigarettes. So why regulate them the same as cigarettes?” he said.

For Joey Dulay, president of the Philippine E-Cigarette Industry Association, alternative nicotine delivery systems are treated even harsher than cigarettes.

“The vaping industry is being treated unfairly. We are not the enemy here. Combustible cigarettes that bring 88,000 deaths per year are our common enemy. Why is vaping treated worse than smoking?” he said.

Stressing his point, Mata cited one of the requirements under the FDA guidelines.

“I reviewed the pre-application documentary evaluation (PADE) provision and I am sorry to say that it is not a different pathway as the FDA claims it to be for HTPs (heated tobacco products) and vapor products. This is exactly the same process a drug or a medical product would go through. These products are not pharmaceutical products or anything close to it. So PADE should not be applied to HTPs or vapor products,” he said.

Some of the provisions on the FDA proposed guidelines, according to Dulay, “are almost impossible to comply with.” He said, “Small players will be driven out of business and new players will find it extremely difficult to enter the sector.”

The FDA conducted online public consultations on the guidelines for e-cigarettes and HTPs last Oct. 6 and 8, 2020, which Deputy Speaker and Ilocos Sur Rep. Deogracias Victor Savellano and Nueva Ecija Rep. Estrellita Suansing moved to suspend after the FDA admitted receiving grants from foreign anti-tobacco advocates The Union and Bloomberg Initiative.

Mata noted that there is “obviously a conflict of interest here. We are therefore constrained to believe that the industry is unfairly being treated by FDA in this regard, the reason now for these almost impossible guidelines. Everyone here is asking for fairness and for the protection of the interest of everyone concerned, especially for those whom these products were intended for.”

“This is shameful and scandalous. A Philippine regulatory body receiving money from American businessmen to draft a set of regulations they cannot even get passed in their own country,” he said.

“Tobacco prohibition did not work in the US and they want it imposed in the country with over 2 million Filipinos dependent on tobacco for their livelihood,” he added.

Mata said, “It’s a sorry state for an industry that is trying to provide 16 million Filipino smokers a viable alternative so they can be freed from the clutches of the deadliest product in the market, combustible tobacco.”

“What about the 1 million Filipino vape users who found it hard to quit cigarettes and have switched to what the growing evidence says is the better alternative? Does the FDA want them to go back to smoking cigarettes?” Dulay asked.

“These are the views we want to offer to the FDA, if only they would genuinely listen to stakeholders,” Mata said.