Concerns as FDA tags face mask product ‘misbranded’

August 16, 2022 - 7:28 PM
FDA_misbranded face mask
A KF94 face mask tagged by the Food and Drug Administration Philippines as "misbranded" as seen from its advisory on Aug. 10, 2022. (Photo from FDA Philippines' website)

Some social media users aired questions and concerns after a regulatory body warned the public against buying a particular face mask.

The Food and Drug Administration Philippines on August 10 released an advisory warning consumers about product “KF94 (IN FOREIGN CHARACTERS),” which it said is “misbranded.”

It included an image of the item for the public’s reference.

The “misbranded” product is a KF94 face mask sold in transparent plastic with the big gold label of “94.”

A quick image search on popular shopping apps shows that various online sellers currently sell the face mask variant at cheap rates.

“The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the misbranded medical device product,” the regulatory body said in Advisory 2022-1494.

It cited a provision from the Food, Drug and Consumer Act (as amended by Republic Act 9711), which notes the following:

A device shall be deemed misbranded if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. 

Merriam-Webster defines “misbrand” as “to brand (as a food item or drug) falsely or in a misleading way.” It is specifically used “to label in violation of statutory requirements.”

FDA Philippines said that “misbranded” products and its manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship are prohibited.

“In view of the above, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product, otherwise, regulatory actions and sanctions shall be strictly pursued,” it added.

The warning didn’t amuse some Filipinos who admitted to already purchasing the item either online or through market stalls.

“Paubos na nga,” a Facebook user commented, attaching a picture of the face mask in her possession.

“Kahapon nga lang dumating parcel ko hahaha,” another online user wrote.

“Kung kailan dami ko stocks, bakit ngayon pa,” shared a different Pinoy.

Others questioned why the regulatory body was only able to issue the warning now, when face masks have become a necessity two years into the COVID-19 pandemic.

“Why only now that it is already widely distributed?” a Facebook user asked.

Some hoped that FDA Philippines would also warn the sellers and distributors of the product.

“Food and Drug Administration Philippines, sana po hindi lang kami ‘yung pinaalahanan niyo, sana paalalahanan niyo din ‘yung may obligasyon niyan sa pagsasala para ‘di makalusot papasok ng PILIPINAS, o baka may factory na ‘yan dito sa loob ng PILIPINAS? Hayssssssssss,” a Facebook user wrote.

The FDA is mandated to ensure the safety, efficacy or quality of health products, which include food, drugs, cosmetics, devices, biologicals, vaccines and other consumer products that may have an effect on health, which require regulations as determined by the regulatory body.

Its goal is “to protect and promote the right to health of the Filipino people by ensuring the safety, efficacy, quality, and purity” of consumer products and “to establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems.”