1. Authorities

Beers, RTDs, Whisky
Philippines

This section provides an overview of the Authorities involved in setting regulations and managing compliance with the food product in scope.

Food and Drug Administration [1]

The Food and Drug Administration (FDA) is renamed from the Bureau of Food and Drugs (BFAD) under the Republic Act 9711 [2], otherwise known as “The Food and Drug Administration Act of 2009”. The Republic Act 9711 is an Act strengthening and rationalizing the regulatory capacity of the FDA by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resource complement, giving authority to retain its income, and amending certain sections of the Republic Act no. 3720, as amended, and appropriating funds thereof. The FDA is mandated to ensure the safety, efficacy, or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health.

Food and Drug Administration (FDA) functions, powers, and duties under the Republic Act 9711 [2]

(a) To administer the effective implementation of this Act and of the rules and regulations issued pursuant to the same; 

(b) To assume primary jurisdiction in the collection of samples of health products; 

(c) To analyze and inspect health products in connection with the implementation of this Act; 

(d) To establish analytical data to serve as a basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality, and fill of container; 

(e) To issue certificates of compliance with technical requirements to serve as the basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding the operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA; 

(f) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality; 

(g) To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person; 

(h) To issue cease and desist orders motu propio or upon verified complaint for health products, whether or not registered with the FDA provided, that for registered health products, the cease-and-desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed; 

(i) After due process, to order the ban, recall, and/or withdrawal of any health product found to have caused the death, serious illness, or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization; 

(j) To strengthen the post-market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products; 

(k) To develop and issue standards and appropriate authorizations that would cover establishments, facilities, and health products; 

(l) To conduct, supervise, monitor, and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA; 

(m) To prescribe standards, guidelines, and regulations with respect to information, advertisements, and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act; 

(n) To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and 

(o) To exercise such other powers and perform such other functions a8 may be necessary to carry out its duties and responsibilities under this Act." 

Among others, the FDA is also mandated to enforce the provisions of the following laws: 

• RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008 
• RA 6675, or The Generics Act Of 1988, 
• RA 10918, or The Pharmacy Law, 
• RA 9211, or The Tobacco Regulation Act of 2003 
• RA 7394, or The Consumer Act of the Philippines 
• RA 7581/10623, or The Price Act 
• RA 10611, or The Food Safety Act of 2013 
• RA 8172, or The ASIN Law 
• RA 8203, or The Special Law on Counterfeit Drug 
• RA 8976, or The Food Fortification Law 
• RA 9165, or The Comprehensive Dangerous Drugs Act 
• RA 9257, or The Expanded Senior Citizens Act of 2003  
• PD No. 881, or The Household Hazardous Act 
• EO No. 51, or The Milk Code of the Philippines 
• RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012 
• PD 856, or The Code of Sanitation of the Philippines 

Bureau of Customs [3] 

The Bureau of Customs (BOC) stands as the second-largest revenue-generating agency under the Department of Finance. Originally established with the primary goal of collecting duties and taxes for the national government, BOC has transformed over the years into an agency dedicated to fostering economic growth and ensuring national security through its commitment to trade facilitation, border control, and revenue collection.

Bureau of Internal Revenue [4]

The Bureau of Internal Revenue is under the supervision and control of the Department of Finance and its powers and duties include the assessment and collection of all internal revenue taxes, fees, and charges, and the enforcement of all forfeitures, penalties, and fines connected therewith, including the execution of judgments in all cases decided in its favor by the Court of Tax Appeals and the ordinary courts. The Bureau gives effect to and administers the supervisory and police powers conferred to it by this Code the National Internal Revenue Code of 1997 and other laws. 

1.1 References

1. The Philippine Food and Drug Administration 

Home - Food and Drug Administration

2. Republic Act 9711 

https://www.fda.gov.ph/wp-content/uploads/2021/04/Republic-Act-No.-9711.pdf

3. The Philippine Bureau of Customs website 

https://customs.gov.ph/the-philippine-bureau-of-customs/

4. Section 2 of the National Internal Revenue Code of 1997

https://www.dbm.gov.ph/wp-content/uploads/GAA/GAA2015/GAA%202015%20Volume%20I/DOF/C.pdf