The Food and Drug Administration (FDA), a government agency under the Department of Health (DOH) in the Philippines, has directed all food and dietary supplement manufacturers, distributors and advertisers, to remove the phrase, “No Approved Therapeutic Claim” from all product labels and advertisements and replace the phrase with a standard message in Filipino language, “Mahalagang Paalala: Ang (Name of Product) ay Hindi Gamot at Hindi Dapat Gamiting Panggamot sa Anumang Uri ng Sakit.” This message informs the public that the product is not a medicinal drug and should not be used to treat symptoms of any disease. The FDA’s reiteration of this requirement is in accordance with the decision of the Court of Appeals on 28 November 2014, which upheld the DOH-FDA Administrative Order 2010-0008.
In line with this requirement, audio advertisements and promotions should also carry the standard message in Filipino and should be clearly and audibly voiced over without being cut off in the last line of the advertisements or promotions regardless of its duration.
The DOH, being the foremost health authority in the Philippines, has an important role of protecting the welfare of the public. The use of the Filipino phrase is more appropriate as it gets the message across clearly to the public thereby avoiding misinterpretations of its meaning and creating public awareness. It also serves to warn the consumers against any deceptive therapeutic claims by some food and dietary supplement manufacturers and sellers in the Philippine market.
Opposition to Administrative Order 2010-0008 (“AO”)
On 18 March 2010, the DOH issued the AO setting forth directives changing the use of the phrase, “No Approved Therapeutic Claim” in all advertisements, promotional or sponsorship materials concerning food and dietary supplements in order to protect the consumers’ health and fostering their right to proper education to facilitate sound choice. The AO was published on 21 March 2010 in the Philippine Star and the Philippine Daily Inquirer, two newspapers of general circulation.
The Chamber of Herbal Industrial of the Philippines, an association of over sixty-five (65) companies in the Philippines (“the association”) engaged in the business of manufacture and distribution of herbal products, opposed to the AO, stating that the implementation thereof would cause irreparable damage to their business if the AO is strictly enforced. The DOH, however, denied the association’s request.
The association brought the matter to the Regional Trial Court of Manila in 5 May 2010 to seek for a temporary restraining order or write of preliminary injunction (WPI), which was then granted by the RTC. The DOH requested the RTC to dissolve the WPI but the RTC denied it. The DOH then filed a Petition before the Court of Appeals (CA) in Manila for a Certiorari under Rule 65 of the Rules of Court (“Petition”) to nullify and set aside the Orders of the RTC.
Police Power of the State
In its decision, the CA granted the Petition and set aside the Orders of the RTC believing that the AO was issued as a valid exercise of the police power of the State for the protection of the public which has the right to be informed of the nature and established curative effects of food supplements they buy. The purpose of the AO is to educate consumers that food supplements are not substitutes for prescribed medicines.
The CA also recognized that the DOH’s interpretation of how the disclaimer, “No Approved Therapeutic Claim”, is delivered in the vernacular should be given due respect, being the entity in-charge of health-related matters in the country.
The AO was issued by the DOH pursuant to Section 5/(O) of the Republic Act No. 9711, which gives the FDA, a government agency under the DOH, the power to prescribe standards, guidelines and regulations on marketing activities of health products.
Warning against Deceptive and Misleading Claims
The FDA usually monitors food and dietary supplements being sold in the Philippine market as alternative medicines for a wide range of diseases. These supplements often come in the form of herbal teas, juice, coffee, capsules and tablets. However, the therapeutic efficacies of these supplements are not usually established. Hence, the FDA is encouraging the public to be more vigilant so as not to fall prey to the fallacious and misleading claims by these products.