SC reaffirms: FDA has authority to regulate tobacco products

THE Supreme Court has reaffirmed that the Food and Drugs Administration has the authority to regulate tobacco products.

The Court en banc, through Senior Associate Justice Marvic Leonen, affirmed its 2021 decision and denied the motions for reconsideration filed by the Philippine Tobacco Institute Inc (PTI) and Albay Rep. Edcel Lagman.

The ruling stemmed from a petition filed by PTI challenging a provision in the implementing rules of Republic Act 9711, or the Food and Drug Administration Act (FDA Act) giving FDA the regulatory authority over all health products.

The law’s implementing rules also state that the Department of Health is responsible for regulating tobacco products through the FDA.

In its petition, PTI claimed that the Inter-Agency Committee Tobacco (IAC-Tobacco) has exclusive jurisdiction over tobacco products, including its health aspect, and not the FDA, as provided for in the 2003 Tobacco Regulations Act.

PTI filed the petition representing major transnational tobacco firms in the country.

The regional trial court ruled in PTI’s favor and held that tobacco products are beyond the FDA’s regulatory power.

But the High Court reversed the trial court’s ruling in 2021, prompting PTI to challenge the ruling.

Lagman also filed a motion for reconsideration as respondent-intervenor.

In its latest ruling, the SC ruled that the IAC-Tobacco does not have sole and exclusive jurisdiction over tobacco products and the tobacco industry.

It added that 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,” the SC held.

“It is also in accordance with the Philippines’ commitments under the World Health Organization Framework Convention on Tobacco Control (WHO-FCTC),” it added.

Under the WHO-FCTC, the country shall prioritize the protection of public health, including implementing tobacco control measures to reduce the prevalence of tobacco use and exposure to tobacco smoke.

The SC has yet to release a full copy of its ruling.

A significant victory