SEATCA

Southeast Asia Tobacco Control Alliance

SC: FDA Has Power to Regulate Health Aspect of Tobacco Products

30 July 2024

By Supreme Court of Philippines

The Food and Drug Administration (FDA) has regulatory authority over the health aspect of tobacco products.

This was the ruling of the Supreme Court En Banc, through Senior Associate Justice Marvic M.V.F. Leonen, as it affirmed its 2021 Decision and denied the motions for reconsideration filed by Philippine Tobacco Institute, Inc. (PTI) and Representative Edcel C. Lagman.

Under Republic Act No. 9711, or the Food and Drug Administration Act (FDA Act), the FDA has 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.

PTI challenged this provision in the implementing rules. It claimed that the Inter-Agency Committee Tobacco (IAC-Tobacco) has exclusive jurisdiction over tobacco products, including its health aspect. 

The Regional Trial Court ruled in PTI’s favor and held that tobacco products are beyond the FDA’s regulatory power.

The Supreme Court reversed the RTC in its 2021 Decision, prompting PTI to challenge the ruling. Rep. Lagman also filed a motion for reconsideration as respondent-intervenor.

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.

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

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 Supreme Court Public Information Office will upload a copy of the Decision in G.R. No. 200431 (Department of Health v. Philippine Tobacco Institute, Inc.) once it receives the same from the Office of the Clerk of Court En Banc. (Courtesy of the Supreme Court Public Information Office)