Senator Pia Cayetano

Uphold FDA’s regulatory authority over vapes, heated tobacco products

Senator Pia S. Cayetano has called on her colleagues in the Senate to uphold the Food and Drug Administration (FDA)‘s jurisdiction to regulate vapes and heated tobacco products (HTPs) in the market, saying that the agency’s mandate to protect public health is firmly established in two laws previously passed by Congress in 2020 and 2009.

In her interpellation on the controversial Vape Bill (SBN 2239) last week, Cayetano questioned the bill’s objective to transfer the government’s regulatory power over vapes and HTPs from the FDA to the Department of Trade and Industry (DTI).

Explaining the coverage of health products under the FDA’s jurisdiction, Cayetano noted that the FDA Law of 2009 included “health-related devices,” which refer to “any device not used in health care, but has been determined by the FDA to adversely affect the health of the people.” (Section 9-C of RA 9711).

“I think it is quite clear that in his previous statements, when his honor says that this product [e-cigarette] is ‘less harmful,’ then that is already an admission that it is a product that has health effects. Because why would you even mention the words ‘more harmful.. less harmful,’ if it’s not a health-related product?” Cayetano asked the bill’s sponsor, Sen. Ralph Recto.

“Moreover, if lotions, creams, and perfumes applied on the skin and other cosmetic products that come in contact with external parts of the body are regulated by the FDA, then what more for e-cigarettes, which are inhaled  by its users, sending harmful chemicals to the lungs and internal organs?” the senator further asked.

She also noted that under the Sin Tax Law of 2020, the FDA is clearly mandated to regulate, consistent with evolving medical and scientific studies, “the manufacture, importation, sale, packaging, advertising, and distribution of vapor products and heated tobacco products,” including the “sale to nonsmokers or persons below twenty-one (21) years old.” (Sections 144-B and 144-C of RA 11467)

In addition, she said that the FDA Law declared as policy that the State shall “protect and promote the right to health of the Filipino people,” and “help establish and maintain an effective health product regulatory system based on the country’s health needs and problems.” (Sections 3-A and 3-B of RA 9711)

The senator pointed out that Sen. Recto’s statements that e-cigarettes are ‘less harmful’ than conventional cigarettes amounted to a health claim, and an admission that these products are indeed ‘health-related devices’  that clearly fall under FDA’s jurisdiction as mandated by RA 9711.

Cayetano’s interpellation on SB 2239 is scheduled to resume this week.#

Senator Pia Cayetano
Solid legal ground: Senator Pia Cayetano says that FDA is mandated to regulate e-cigarettes by virtue of RA 11467 and RA 9711.

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