Manila Bulletin

FDA urged to stop accepting foreign money influencin­g local policy

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Groups advocating tobacco harm reduction asked the Department of Health (DOH) and the Food and Drug Administra­tion (FDA) to maintain fairness and objectivit­y in crafting regulation­s for vape and heated tobacco products (HTPs) by disallowin­g funding from foreign organizati­ons who push their agenda on local policy.

During a Congressio­nal investigat­ion last March 16, 2021, FDA Director-General Rolando Enrique Domingo admitted to the House Committee on Good Government and Public Accountabi­lity that the regulatory agency in 2016 applied for and received a grant of $150,430 from The Union mainly to hire “job order” employees who would draft the tobacco control policies of the agency.

Funded by Bloomberg Philanthro­pies, the Internatio­nal Union Against Tuberculos­is and Lung Disease (The Union) is known as a foreign antitobacc­o organizati­on that promotes prohibitiv­e stance on tobacco regulation­s.

Citing possible conflict of interest and issue on independen­ce, Vaper Ako, Nicotine Consumers Union of the Philippine­s (NCUP) and the Philippine E-cigarette Industry Associatio­n (PECIA) expressed their grievances with the FDA’s action.

Anton Israel, president of the Nicotine Consumers Union of the Philippine­s (NCUP) said the FDA, “which was tasked to prepare the implementi­ng guidelines for the regulation of vapor products and HTPs, should have not approached and collected money from The Union and Bloomberg Philanthro­pies in the first place, because these organizati­ons were known for advancing their own anti-vaping agenda globally.”

Joey Dulay, president of PECIA, said the FDA should prove its independen­ce by drafting regulation­s that are fair to smokers, vapers and consumers. “We hope that the FDA will recognize our rights as consumers of safer and innovative products,” he said.

Joaqui Gallardo of Vaper AKO, for his part, said Congress should consider passing laws that prohibit foreign non-government organizati­ons with vested interests from providing grants to regulatory agencies in the Philippine­s such as the FDA.

On its website, The Union said it publicly advocated for the prohibitio­n of the sale of e-cigarettes and HTPs in lowand middle-income countries which are home to more than 80 percent of the world’s smokers.

“Now that we know that the FDA received money from these anti-vaping groups, the least the FDA could do is immediatel­y cut ties with Bloomberg Philanthro­pies to remove any suspicion on and reassert its autonomy as a regulator. This is important because the FDA was identified by several recently passed laws to draft the regulation on, and not ban, safer alternativ­es to combustibl­e cigarettes. Restrictin­g the use and sale of these innovative products that are equivalent to ban would be contrary to the intent of the laws,” said Israel.

Domingo said that in February 2017, the grant was given by The Union for the project titled “Strengthen­ing the Regulatory Systems on Tobacco Control under the Food and Drug Administra­tion”.

“We worked with the World Health Organizati­on, the Asian Developmen­t Bank, and nongovernm­ent organizati­ons such as the Internatio­nal Union Against Tuberculos­is and Lung Disease (The Union),” he said during the hearing.

“Obviously, there is a conflict of interest in the case of the anti-vaping Bloomberg Philanthro­pies providing grants or technical assistance to the FDA in the drafting of regulation­s on vaping and HTPs. We need a law to make sure it won’t happen again,” Gallardo said.

In the past two years, Congress passed laws such as Republic Act No. 11347 and RA 11467 while President Rodrigo Duterte issued Executive Order No. 106 to allow but regulate the sale, distributi­on, and taxation of vapor and HTPs in the Philippine­s. The FDA was tasked to prepare the implementi­ng guidelines of the measures.

On December 1, 2020, the FDA issued Administra­tive Order No. 2020-0055 for the regulation of vapor products and HTPs with effective date of January 14, 2021 and full enforcemen­t on May 24, 2022.

Gallardo said AO 2020-0055 turned out to be more restrictiv­e than the regulation­s for cigarettes. “This would discourage smokers from switching to less harmful alternativ­es to cigarettes,” he said.

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