FDA urged to stop accepting foreign money influencing local policy

Published April 21, 2021, 3:10 PM

by Manila Bulletin

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.

Food and Drug Administration (FDA) (FACEBOOK / FILE PHOTO / MANILA BULLETIN)

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 anti-tobacco 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 low- and 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 non-government 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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