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Stick to science on THR regime

It was as if . . . it were as if we felt no fear, as if we were already dead and had nothing to lose by dying. Or perhaps it was because we had lived life so well, and loved life so much, that we fancied ourselves immortal, overwhelming the powers that be with the force of our passion for science. — Flatliners

It’s the science – validated, unadulterated, stupid!

The Food and Drugs Administration must 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, according to a medical expert on smoking cessation.

“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 his organization 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?” Dulay posed.

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

“I reviewed the pre-application documentary evaluation 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 October 6 and 8, 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 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 regulation 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 depended 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 one million Filipino vape users who found it hard to quit cigarettes and have switched to what the growing evidences 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 pointed out.


A bright leaf against a pall of gloom

Two top economic officials of the Duterte administration have jointly called for private sector support to local tobacco growers and raise revenues for leaf-producing provinces affected by the economic crunch by hiking its purchases of local produce.

Finance Sec. Carlos Dominguez III and Agriculture Sec. William Dar s aid the strict quarantines imposed to contain Covid-19 had also hindered the flow of food and other agricultural goods, including tobacco, the latter being one of the hardest hit crops since it is a non-food commodity.

The two economic officials cited a study indicating that “only 30 percent of the total local tobacco production are bought from the farmers while the rest are imported” by cigarette companies.

Republic Act 10351 requires manufacturers or sellers of tobacco products to procure at least 15 percent of their tobacco leaf raw material requirements from locally grown sources.

Ped Xing sought the position of the biggest industry player in the country on the matter, and PMFTC inc. responded enthusiastically to the call, throwing its all-out support to the plan.

PMFTC Inc. is the local affiliate of Philip Morris International,

In an exclusive corporate brief for Ped Xing, PMFTC communications director Dave Gomez said:

”We share your concern on the plight of our local tobacco farmers, and we agree that immediate assistance must be extended to the affected farmers and their families.

We assure your good office that PMFTC remains fully committed to spur economic activities in tobacco-farming communities to help sustain the economic development of the country.

Last year, PMFTC manufacturing operations bought 43 percent of its leaf purchases from local farmers (directly and indirectly through suppliers), to cater both domestic and 15 export countries.

Notably, the industry volume continues to decline due to the annual increases in excise taxes and the proliferation of illicit cigarettes.

Estimated volume of the local cigarette market decreased from 108.9 billion sticks in 2012 to 70.49 billion sticks in 2019 or a 35-percent decline in seven years.

Despite these developments, PMFTC remains committed to purchasing a substantial size of our local tobacco leaf through our suppliers.

While dependent on tobacco industry dynamics and the government’s excise tax policies, we anticipate spending approximately $130 million for more than 45,000 tons of Philippine green tobacco leaf over the next three years.

Meanwhile, PMI reported third-quarter profit of $2.31 billion.

The New York-based firm said it had profit of $1.48/share, translating into $1.42/share, adjusted for pretax gains.

The results exceeded Wall Street expectations with seven analysts surveyed estimating earnings at $1.36/share.

The tobacco product manufacturer posted a revenue of $20.44 billion in the period with adjusted revenue at $7.45 billion, also surpassing WS forecasts.

Four analysts surveyed expected $7.26 billion. It expects full-year earnings in the $5.05/share to $5.10/share.

Behold God’s glory and seek His mercy.

Pause and pray, people.

Publication Source :    People's Journal