SC upholds FDA’s regulatory power over tobacco products

Facade of the Philippines’ Food and Drug Administration. INQUIRER/MARIANNE BERMUDEZ

MANILA, Philippines — The Supreme Court (SC) has upheld the regulatory authority of the Food and Drug Administration (FDA) over tobacco products.

In its decision, the SC pointed out that “all products affecting health – including tobacco products – are within” the FDA’s jurisdiction.

“Tobacco use, as well as exposure to secondhand smoking, pose hazards that cause death and disease among people,” the SC said in its decision dated July 13, 2021, but which notice of judgment was only released on June 7.

“It is within the [FDA’s] competence and mandate ‘to ensure safety, efficacy, purity, and quality of health products which, based on the definition under the law, clearly includes tobacco products,” it also said.

“A contrary reading, in that the [FDA] could regulate cosmetics due to its effect on health but not tobacco products, would be illogical,” it added.

The SC decision affirming FDA’s regulatory authority over tobacco products stemmed from the petition for review filed by the Department of Health (DOH) and FDA in 2012.

The DOH and FDA filed the petition as it sought a review of a ruling handed down by the Regional Trial Court Branch 255 in Las Piñas City in early 2012.

According to the SC, the lower court, acting on a petition filed by Philippine Tobacco Institute, Inc. (PTI),  had “nullified certain provisions” of the rules and regulations of Republic Act No. 9711 or the FDA Act of 2009 concerning its regulation of tobacco products and the tobacco industry.

The SC reversed this as it affirmed in its 2021 decision the FDA’s regulatory authority over tobacco products.

“The inclusion of tobacco products in the coverage of the Implementing Rules is not only supported by the text of the law, but also by pertinent congressional deliberations,” the SC pointed out.

The FDA’s regulatory authority over tobacco products also adheres to the country’s obligations under the WHO Framework Convention on Tobacco Control (WHO FCTC).

“The [FDA] is an attached agency of the [DOH]. As such, the regulatory authority over the health aspect of tobacco products not only falls within its mandate but more so within its competence and expertise,” the SC also said.

“Respondent (PTI), representing major transnational tobacco companies in this country, proposes an interpretation of our law that will effectively remove them from petitioners’ regulation. Its desired interpretation allows for tobacco companies to be principally regulated by the IAC [Inter-Agency Committee]-Tobacco, of which they happen to also be members. This not only leads to an absurd result, but it is also contrary to law and our international obligations,” it added.

The SC noted that the WHO FCTC “requires state parties to protect their tobacco control policymaking from tobacco industry interference.”

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