G.R. No. 240764 , November 18, 2021
VENUS COMMERCIAL CO., INC., PETITIONER, VS. THE DEPARTMENT OF HEALTH AND THE FOOD AND DRUG ADMINISTRATION, RESPONDENTS.

FACTS

This case involves a challenge to the constitutionality of certain provisions of Republic Act (R.A.) No. 3720, as amended by R.A. No. 9711 (The Food and Drug Administration Act of 2009), and its Implementing Rules and Regulations. The specific provisions in question are Sections 12(a) and 30(4) of R.A. No. 3720 , as amended, and Section 2(b), paragraph 5, Article III of the Implementing Rules. The Concurring Opinion of Justice Caguioa focuses on expounding the view that the regulatory authority of the Food and Drug Administration (FDA) under the final sentence of Section 10(ff) of the law must be circumscribed by a holistic reading of the entire statute.

ISSUE

Whether the final sentence of Section 10(ff) of R.A. No. 3720 , as amended, which grants the FDA authority to regulate products that may have an effect on health, confers an overbroad and unconstitutional delegation of legislative power.

RULING

The Concurring Opinion concurs with the ponencia that the challenged provisions are not unconstitutional. It agrees that R.A. No. 3720 , as amended, satisfies the completeness and sufficient standards tests for valid delegation of legislative power. The opinion expounds that the FDA’s delegated authority under Section 10(ff) is not a blanket license to regulate any product perceived to affect health. This authority must be read in conjunction with the entire law to produce a harmonious whole. The legislative purpose of R.A. No. 9711 is to strengthen the FDA’s capacity to regulate specific categories of health products, as reflected in the establishment of Centers for “Drug,” “Food,” “Cosmetics,” and “Device” Regulation. The term “health products” in Section 10(ff) is primarily defined by enumerated categories (food, drugs, cosmetics, devices, etc.), and the final sentence must be interpreted to refer only to products of the same class or kind as those enumerated, which are within the FDA’s administrative expertise. Furthermore, Section 25 of R.A. No. 9711 expressly excludes from the FDA’s jurisdiction products already under the authority of other specialized agencies. Therefore, a holistic reading of the law provides adequate standards and limits to guide the FDA’s exercise of its rule-making power, preventing it from arrogating unto itself unlimited regulatory jurisdiction. Based on these premises, the Concurring Opinion concurs in denying the petition.