FDA is sole regulator of tobacco products’ health aspects – SC

The Food and Drug Administration (FDA) has the exclusive authority to regulate the health aspects of tobacco products, the Supreme Court rules on July 23, 2024. A person smoking tock image INQUIRER FILES

MANILA, Philippines — The Food and Drug Administration (FDA) has the exclusive authority to regulate the health aspects of tobacco products, the Supreme Court said Tuesday.

In an en banc ruling dated July 23, the SC denied the motion for reconsideration filed by the Philippine Tobacco Institute, Inc. (PTI), which asserted that the Inter-Agency Committee Tobacco (IAC-Tobacco) has lone jurisdiction over tobacco products, including its health aspect.

The high court’s decision also aligns with Republic Act No. 9711, also known as the FDA Act, which states that the FDA has regulatory authority over all health products.

The law’s implementing rules further state that the Department of Health (DOH) is mandated to regulate tobacco products through the FDA.

READ: Return of FDA regulation for vape products pushed

However, the PTI challenged this, arguing that IAC-Tobacco has the regulatory authority over tobacco products.

The Regional Trial Court ruled in favor of PTI but the SC reversed it in a 2021 decision, reaffirming the FDA’s role in the regulation of tobacco products.

Eventually, the PTI and Albay Rep. Edcel Lagman filed separate motions for reconsideration before the high court. Lagman made his move as a respondent-intervenor.

The SC, in its July 23 ruling, said IAC-Tobacco does not have sole and exclusive jurisdiction over tobacco products and the tobacco industry.

READ: Vapedemic kills 22-year-old; DOH-FDA should regulate, not DTI

In a statement, the SC stressed: “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.”

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

The SC decision affirming the FDA’s regulatory authority over the health aspects of tobacco products was an apparent nod to calls of various health experts to transfer the regulatory jurisdiction of vape and other tobacco products to the FDA.

In a Viber message sent to reporters, Health Secretary Teodoro Herbosa said the DOH welcomes the SC ruling.

“We see this Decision by the Supreme Court as a triumph of justice in favor of health for our people. We thank the wise Justices of the Supreme Court for this landmark decision,” Herbosa said.