SC upholds FDA power to regulate tobacco products

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MANILA, Philippines — The Philippine Tobacco Institute Inc. (PTI) suffered another setback in the Supreme Court after the high tribunal upheld its 2021 decision to grant the Food and Drug Administration (FDA) regulatory authority over the health aspects of tobacco products.

In a July 23 ruling which has yet to be made public, the high court en banc upheld its earlier decision and denied the motions for reconsideration filed by PTI and Albay Rep. Edcel Lagman, the Supreme Court Public Information Office said in a statement on Tuesday.

“All products affecting health, including tobacco products, are covered by the FDA’s mandate to ensure the safety, efficacy, purity, and quality of health products,” the Supreme Court said.

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“Thus, the inclusion of tobacco products in the implementing rules of the FDA Act is in accordance with the law,” it added.

The case stemmed from the petition for declaratory relief that PTI filed before the Regional Trial Court (RTC) of Las Piñas City in 2011.

The company tried to stop the enforcement of the FDA implementing rules and regulations (IRR), alleging that rules improperly expanded Republic Act (RA) No. 9711, or the Food and Drug Administration Act of 2009, by classifying tobacco products as health products, placing them under the FDA’s regulatory authority.

PTI argued that under RA 9211, or the Tobacco Regulation Act of 2003, the Inter-Agency Committee on Tobacco (IAC-Tobacco) had exclusive jurisdiction over tobacco products, including their health aspects, and not the FDA.

It cited Section 25 of RA 9711, which specifically excluded tobacco products from the FDA’s jurisdiction.

In 2012, the Las Piñas RTC ruled in favor of PTI and nullified the provisions of the FDA IRR insofar as it included tobacco products and the tobacco industry in its coverage.

This prompted the Department of Health (DOH) and the FDA to file a petition for review on certiorari before the Supreme Court, which then overturned the RTC decision in 2021.

PTI challenged the high tribunal’s ruling, with Lagman also filing a motion for reconsideration as respondent-intervener.

“In denying the motions for reconsideration, the Court ruled that the IAC-Tobacco does not have sole and exclusive jurisdiction over tobacco products and the tobacco industry,” the high court said in its statement on Tuesday.

Under the Tobacco Regulation Act, the inter-agency committee is chaired by the trade secretary with the health secretary as vice chair and includes a representative of the tobacco industry as a member. PTI previously held the position of representing the tobacco industry in the committee.

According to the Supreme Court’s 2021 decision, the committee has limited jurisdiction over tobacco products and does not regulate all their aspects under RA 9211.