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.

Pia: Congress has jurisdiction to tax e-cigarettes

Amid rising concerns in many countries about the health risks of electronic cigarettes and vapes, Senator Pia S. Cayetano reiterated that Congress has the jurisdiction to impose higher taxes on these products as a means to regulate their use.

 

The chairperson of the Senate Committee on Ways and Means, Cayetano made the assertion at the start of plenary debates on Senate Bill No. 1074, which seeks to raise ‘sin’ taxes on alcohol and vaping products. 

Responding to the questions of Senator Francis Tolentino, Cayetano clarified that Congress has already imposed taxes on e-cigarettes since the enactment of Republic Act 11346 earlier this year. 

Tolentino had asked Cayetano whether Congress can impose a tax on e-cigarettes, even if these products have yet to be given certification by the government through the Food and Drug Administration (FDA). 

“As to whether we can tax a product that’s not been given permission to be sold, let me point out that under RA 11346, we (lawmakers) have already taxed e-cigarettes,” Cayetano noted. 

“So this committee is not proposing a new kind of tax. It’s already recognized by Congress under its jurisdiction. This committee is just increasing that tax,” she added. 

Cayetano pointed out that taxation is “just one tool” that would help curb these new kinds of vices. She said other pro-health initiatives should be put in place to complement the sin tax bill. 

“Taxation is not the end-all, be-all. So we must help our health department come up with measures to provide a health approach to the problem of smoking and drinking,” she said, while expressing her plan to push for additional regulatory measures on e-cigarettes.

The senator said she is in the process of drafting a bill mandating the government to “look into the harmful effects of e-cigarettes,” which shall be referred to the Committee on Health. 

She also intends to draft a measure that would regulate the marketing and ban the advertising of e-cigarettes in the country. 

“Exposure to these products will be dangerous because the science is not yet clear about its dangers. I’m concerned for the young people in general as these products can easily entice them,” she explained. 

“Our goal is to reduce people’s consumption of these sin products, on top of generating more revenues to finance our Universal Health Care program,” she stressed.

A total of 42 countries worldwide have already banned the use of e-cigarettes, while 10 countries banned the use of heated tobacco products (HTPs) due to growing evidence that such products are dangerous to people’s health.

Earlier this year, the FDA gave manufacturers, importers, and retailers of e-cigarettes three months to register and comply with specific regulations before they could sell their products legally.

These include a license to operate and the issuance of a certificate of product registration. The three-month period is set to end this October. #

Senator Pia Cayetano: Taxation is “just one tool” to help curb new kinds of vices. She said other pro-health initiatives should be put in place to complement the sin tax bill. 

Pia on e-cigarettes: ‘Less harmful’ does not mean ‘safe’

If there was one clear takeaway from the Senate’s latest committee hearing on proposals to raise ‘sin’ taxes, it’s that electronic cigarettes (e-cigs) are “definitely” not safe and could pose risks to people’s health, Committee on Ways and Means Chair Senator Pia S. Cayetano asserted. 

The panel on Thursday (September 5) conducted its third public hearing on proposals to increase excise taxes on alcohol and e-cigarette products under Package 2+ of the Comprehensive Tax Reform Program or CTRP. 

The hearing, which focused on e-cigarettes, invited officials from industry, who expounded on the position that heated tobacco products (HTPs) and vape products are “less harmful” than conventional cigarettes. 

On the other side, various health experts, including officials from the Department of Health (DOH), the World Health Organization (WHO), and the Philippine College of Physicians (PCP), refuted industry claims, saying there is not enough evidence to prove that e-cigs are indeed safer for human health. 

WHO’s Country Representative to the Philippines, Dr. Rabindra Abeyasinghe (OIC), even likened using conventional cigarettes to jumping off a 10-storey building, whereas using e-cigarettes would be like jumping off a six-storey building. Either way, she said, the use of such products is “inherently toxic.” 

Both sides cited different studies and experiences from other countries, such as the United States, Japan, and the United Kingdom, where e-cigarettes have been commercially available longer than in the Philippines, and where extensive studies have been conducted on the impact of these products on people’s health. 

“One thing that I am prepared to say now is, [there’s no truth to such claims that e-cigarettes are safe]. Para sabihin mong less harmful, well, then what is the degree of harm that is acceptable?” Cayetano stressed.

Summing up the discussions after the hearing in a briefing with media members, the senator added that despite the authorization granted by the United States Food and Drug Administration (US FDA) to e-cigarette companies to market and sell e-cigs in the US, the latter were still not authorized by the regulatory agency to claim that their products are a “safer alternative” to conventional cigarettes. 

“There is no statement from the (US) FDA that it is safe. So let’s be clear about that. Nililinlang naman natin ang mga tao kapag sinasabi nating safe. Pati ang WHO, walang sinabi na safe ‘yan,” Cayetano said. 

Furthermore, the senator said one of the primary objectives in raising taxes on these products is to make sure that they don’t become readily accessible to children and young people, whom she said are the most vulnerable to e-cigarette use. 

“Suddenly, this tool that the industry is trying to promote as an alternative to smoking is now being taken up by young people who do not even smoke,” Cayetano pointed out during the hearing.

“I would like to hear from the industry how they intend to market their products, because I saw very disturbing modes of marketing [targeting the youth],” she added. 

The Ways and Means Committee is set to continue discussions on the tax measures on Wednesday (September 11). #

Senate Ways and Means Chair Pia Cayetano on taxing e-cigarettes as ‘sin’ products: You may claim that these are ‘less harmful’ but this is not equivalent to being ‘safe.’