FDA warns against use of cosmetic products containing harmful methanol

Marje Pelayo   •   December 4, 2020   •   207

MANILA, Philippines — The Food and Drug Administration (FDA) warns the public against purchasing and using a certain brand of unauthorized and adulterated cosmetic products which may cause harmful effects due to methanol content.

In an advisory issued on Thursday (December 3), the agency noted that the following products manufactured in Thailand, tested positive for the presence of methanol:

  • Nana Cleansing Alcohol 80% (Blue Liquid)
  • Nana Cleansing Alcohol 80% (Transparent Liquid)
  • Nana Hand Gel Alcohol 80%
  • Nana Hand Alcohol 80% 

Citing a report from the Association of Southeast Asian Nation (ASEAN) Post-Marketing Alert System (PMAS), FDA said methanol is an ingredient that is not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD).

The said products had been tested by the Food and Drug Administration – Thailand and results of the laboratory showed that they are not compliant to the standards set by the ACD.

Acute and chronic exposure to methanol by inhalation or ingestion, the FDA said, may result in visual disturbances leading to blindness and neurological damage specifically motor dysfunction.

Skin contact to methanol can also produce mild or severe skin problems to humans.

FDA warns against purchase, use of AiDeLai face masks

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday (January 15) warned against the purchase and use of AiDeLai face masks.

In an advisory dated January 8, the FDA said it cannot guarantee the safety and quality of the popular face mask brand because it has not gone through the agency’s evaluation process.

The regulator also warned establishments not to distribute, advertise, or sell the medical product until Product Notification Certificate is issued.

“Otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA mentioned.

The agency urges the public to always check certain products on their website www.fda.gov.ph before purchasing. MNP / Raymund David

No photo description available.

Philippines approves emergency use of Pfizer-BioNTech’s COVID-19 vaccine

Marje Pelayo   •   January 14, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday (January 14) granted emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine developed by US pharmaceutical giant Pfizer Inc. and its German partner BioNTech SE.

The approval followed issuance of Executive Order No. 121 s. 2020, which grants vaccines under development an EUA “where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency.” 

The FDA clarified, however, that the EUA does not mean that the vaccine would be available for use as the country has yet to settle an agreement for its supply.

“The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially,” the FDA explained.

Pfizer-BioNTech’s COVID-19 vaccine, which boasts a 95% efficacy rate, is expected to arrive in the country by February according to vaccine czar Carlito Galvez Jr., in a meeting with President Rodrigo Duterte on Wednesday evening (January 13).

“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” Director General Eric Domingo said.

“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” he added.

Domingo noted the adverse events that happened in other countries following the inoculation of the vaccine. 

Thus, he said, close monitoring of the COVID-19 immunization programs is necessary to ensure adverse reactions will be properly addressed.

“The roll out of the vaccine and use in more than five million people worldwide has identified severe allergic reaction in a few individuals,” Domingo said.

“Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” he added.

The FDA noted also that reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

DOH, FDA to tap PRC in determining liability of doctors involved in unregistered vaccination

Robie de Guzman   •   January 4, 2021

MANILA, Philippines – The Department of Health (DOH) on Monday said it will coordinate with the Professional Regulatory Commission (PRC) in relation to the investigation on doctors involved in the administration of unregistered vaccines against novel coronavirus disease (COVID-19).

DOH spokesperson Undersecretary Maria Rosario Vergeire said they will be working with the PRC in determining the possible liability of medical professionals who participated in unauthorized COVID-19 vaccination.

Vergeire also stressed that the unauthorized inoculation of the COVID-19 vaccine to some members of the Presidential Security Group (PSG) is now being investigated by the Food and Drug Administration (FDA) and that the response of concerned agencies will depend on the agency’s findings.

“The FDA and DOH is also would be coordinating with the Philippine Regulatory Commission para nga doon sa mga involved professionals na sinasabing pagbibigay nitong unregistered vaccine na ito,” she said.

The vaccination of some PSG members came to light after President Rodrigo Duterte revealed last week that some military men had already received a COVID-19 vaccine.

PSG commander Brigadier General Jesus Durante had confirmed that his unit obtained the vaccine but refused to disclose its source. He also clarified that the president was only informed of their move after the fact.

Durante also stressed that their decision to inoculate some members sans the FDA approval is based on their mission to protect the president’s health and safety.

The PSG drew both criticisms and support from various quarters over the issue, while the Palace lauded the group’s bravery in taking unregistered and possibly smuggled vaccines.

But for Health Secretary Francisco Duque III, the incident is now being investigated by the FDA, as well as by the National Bureau of Investigation, and the Bureau of Customs.

“Nire-respeto po natin ang mga opinyon ng sinoman at ang mahalaga po rito ay kung ano po ang kakalabasan ng imbestigasyon na ginagawa ng FDA,” he said.

“Huwag po natin pangunahan ang anomang resulta na ilalabas ng FDA, NBI at Bureau of Customs sa naturang imbestigasyon… Sila po ang lead agency patungkol sa imbestigasyon na binanggit ko,” he added.

The DOH, meanwhile, urged local government units to coordinate with the agency and strictly observe protocols in rolling out their respective COVID-19 vaccination programs.

“So that we can have a unified effort at hindi tayo magkaroon ng technicalities and also we can be able to monitor as well.  We have to remember the National Immunization Program rests on the mandate of the Department of Health,” Vergeire said. – RRD (with details from Correspondent Aiko Miguel)

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