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Suansing calls “deplorable” FDA’s premature issuance of vape, HTP regulations

NUEVA Ecija First District Rep. Estrellita Suansing called “premature” and “deplorable” the Food and Drug Administrations’ (FDA) issuance of the administrative order regulating vapes and heated tobacco products (HTP) amidst unresolved issues raised by stakeholders and the call for a House probe on FDA’s receipt of funds from foreign anti-tobacco group.

“Despite the unfinished public consultation on the FDA’s draft guidelines and numerous unresolved matters raised by legislators and stakeholders alike, prompting all three lawmakers present to call for more hearings, the FDA, through the Department of Health, still proceeded to issue their regulations, without any prior notice or resolution. For whatever reason, it’s as if the valid concerns raised were deliberately ignored,” lamented Rep. Suansing.

Suansing was pertaining to Administrative Order No. 2020-0055 dated 1 December 2020, which was released and posted on the FDA website on 4 January 202. The order provided the FDA’s regulatory framework for the manufacture, distribution, importation, exportation, sale, offering for sale, advertising, promotion, sponsorship, and/or use of vapor products and HTPs.

On October 6 and 8 last year, the FDA conducted public consultations on its draft guidelines on the regulation of vapor products and HTPs, respectively. The hearing on HTPs, attended by Rep. Suansing, Ilocos Sur Rep. Deogracias “DV” Savellano, and Valenzuela Rep. Wes Gatchalian, was however cut short after FDA officials refused to answer Rep. Suansing’s question on FDA’s receipt of private funding intended to implement anti-tobacco and anti-vaping polices from foreign private groups.

The FDA initially denied receiving foreign funds but when confronted with actual donor declarations from Bloomberg’s official website by Rep. Suansing, a ranking official admitted to receiving such grant.

Rep. Suansing said she tried to pursue the question about the foreign grants but an official told her that “he was ordered not to answer me. He said FDA leadership will instead coordinate with my office to discuss the grants separately.”

“With this stubborn refusal, I could not allow the so-called consultation to proceed given the potential conflict of interest. Arguably, these foreign grants could have pushed the policy direction of the FDA in drafting these regulations,” Rep, Suansing stressed.

Suansing noted that in addition to receiving funds from the Bloomberg Initiative, the FDA also admitted to soliciting and accepting funding from another anti-tobacco and anti-vaping organization, The International Union Against Tuberculosis and Lung Disease (The Union).

“How then can the public put faith in the integrity of these consultations when the government regulator itself has admitted to receiving funding from groups that seek to ban the products the regulator should be regulating,” she said.

Rep. Suansing called this unexpected issuance “deplorable” as it was made despite the fact that there was no formal notice of termination of the public consultation and the call for a Congressional investigation on FDA’s receipt of foreign funds.

She also said that instead of allowing local policies to be influenced by foreign vested interest group, regulators should look into the actual experience of other countries like Thailand and the United Kingdom.

“Take the case of Thailand and the United Kingdom for example. Each has taken a different approach in tobacco regulation with the former implementing a prohibitive stance on smoking alternatives, while the latter embracing tobacco harm reduction principles. The rate of smoking in the UK has been steadily decreasing in contrast to Thailand where smoking rates remain stagnant,” Rep. Suansing said, referring to the conclusion of a policy study done last year by R Street Institute—a nonprofit, nonpartisan, public policy research organization.

On 2 December 2020, Rep. Suansing and Rep. Savellano filed House Resolution No. 1396, directing the House Committee on Good Government and Public Accountability with the specific intent to conduct an inquiry on the questionable receipt of private funding by the FDA and other government agencies and institutions in exchange for specific and pre-defined policies directed against a legitimate industry and in complete disregard of the rights and welfare of consumers. According to Rep. Suansing, “the Resolution was filed in order to ensure the integrity of government proceedings and reaffirm the public’s trust in our government regulators”.

“The initial denial and subsequent admission bring into question the objectivity, impartiality, and credibility of the FDA in drafting these Guidelines and overseeing the implementation of these regulations. The potential conflict of interest these foreign funds creates cannot be ignored and must first be resolved in order to preserve the integrity of the proceedings. ”