FDA warns public against purchase, use of Ever Bilena’s lip & cheek stain night berry

Robie de Guzman   •   March 17, 2021   •   925

MANILA, Philippines – The Food and Drug Administration (FDA) has warned the public not to purchase and use cosmetic product, Ever Bilena Lip and Cheek Stain Night Berry, which it said contains microbial contaminants.

In an advisory, the FDA said the product, based on its test, was found to contain microbial contaminants beyond the 1000 cfu/g set by the agency, and as published in the ASEAN Cosmetic Directive (ACD).

***FDA Advisory No.2021-***

The Food and Drug Administration (FDA) warns the public from purchasing and using the…

Posted by Food and Drug Administration Philippines on Monday, March 15, 2021

“The aforementioned adulterated product is found to be non-compliant with the existing standards, and, thus, pose potential hazards to the consuming public,” the FDA said.

The use of adulterated cosmetic products may result in adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure, it added.

In a statement posted on social media, Ever Bilena said its currently conducting testing of the said product to validate the FDA’s findings.

“We are doing our own internal testing, results should be out in 7 days. Simultaneously, we are also engaging with a 3rd party lab for their findings,” it added.

It also clarified that the FDA advisory only pertains to batch #19A03QW of lip & cheek stain night berry variant.

“We would like to inform everyone that all of our products go through quality control before they are go signaled for distribution to the market. Each Ever Bilena product is subjected to microbial testing prior to release to trade. Everything released from the warehouse is FDA compliant,” the company said.

Duterte orders FDA to deal with illegal sale, distribution of ivermectin

Robie de Guzman   •   April 21, 2021

MANILA, Philippines – President Rodrigo Duterte has directed the Food and Drug Administration (FDA) to take the lead in dealing with illegal traders of anti-parasitic drug ivermectin amid push to use this to treat COVID-19, Malacañang said Wednesday.

“To ensure the safety and welfare of the public and at the same time avoid any unnecessary conflicts, the Food and Drug Administration (FDA) has been directed to take the lead in determining the course of action against the illegal trading/dispensing of Ivermectin,” Presidential Spokesperson Harry Roque said in a statement.

“The Philippine National Police (PNP) cannot arbitrarily determine on their own which drug/s should not be on the market. All operations to apprehend or seize goods must be done in coordination with the FDA,” he added.

Roque, however, clarified that the FDA is only ordered to stop the sale or trade of ivermectin for veterinary use that has been repackaged as human grade, including those that have no been determined by competent authorities as safe to be used in humans.

“Having said this, we advise the public to seek the advice of medical practitioners before taking medicines and/or supplements,” he said.

“The President is closely monitoring the developments concerning ivermectin here and abroad. He has even directed the Presidential Management Staff (PMS) to give him weekly updates on ivermectin studies and FDA-related clearance,” he added.

The FDA earlier granted two hospitals compassionate special permit for ivermectin.

The agency, however, reiterated that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

The agency also emphasized that a compassionate use permit is different from certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

The FDA likewise stressed that only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer. Doctors who will use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis.

The FDA also said that distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the country for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

Ivermectin products registered for human use in the country were in topical formulations under prescription use only.

FDA open to probe into alleged delays in EUA, CPR issuances to local drug manufacturers

Marje Pelayo   •   April 21, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) welcomes the intention of the members of the House of Representatives (HOR) to investigate the process on the issuance of permits for drugs specifically the ones that show potential in combatting coronavirus disease (COVID-19).

During the Laging Handa briefing on Tuesday (April 20) FDA Director-General Eric Domingo stated that the agency has a set of standards on issuing approval on applications for Certificate of Product Registration (CPR) and Emergency Use Authorization (EUA).

“Mayroon naman tayong set ng policies at mga standard na sinusunod bago mag-approve po ng isang gamot kasama na ang safety, quality, and evidence on efficacy,” Domingo said.

Domingo said the investigation will help the FDA explain the measures it applies in expediting the country’s access to medicines, diagnostic kits, and other medical needs.

This,  after House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy filed House Resolution (HR) 1711 that calls on the Committee on Good Government and Public Accountability to look into the policies and guidelines for the registration, utilization, [manufacturing], distribution, and sale of drug products “which appear to be detrimental to public interest”.

Earlier, Velasco also urged the FDA to speed up the process of acquiring permits for local drug manufacturers after the government opened opportunities for the local pharmaceutical industry to boost the country’s response against COVID-19 in addressing the need for vaccines and medicines crisis.

During the briefing, Deputy Speaker Dy pointed out that there seems to be a problem with the process.

“Nakita natin na parang arbitrary kung paano nila pinapakinggan ang WHO or ‘yung iba mabilis ang approval, ‘yung iba matagal,” she said.

“Noong nakausap ko ang mga local pharmaceutical companies natin, they can make the tocilizumab, the remdesivir, pero it seems na nahihirapan silang magpa-register dito mismo sa ating bansa,” she added.

“Marami naman tayo mga foreign clinical trials na pwede nating gamiting basis. Iba kase yung available na siya sa market. Tandaan mo pag sinabi mong compassionate special permit these are for those na malubha na sa ospital. Papaano yung pang prophylactic niya? Paano yung pang prevention niya? Yun yung gusto nating patingnan sa FDA. Baka pwede nilang tingnan sa portion na ito and to make it available,” Dy further said.

For the part of the FDA, Domingo said any investigation would give the agency an avenue to explain their side on the matter.

“We welcome this para pa-explain natin sa ating mga mambabatas kung ano ang ating mga proseso at saka kung ano na ang nagawa natin sa FDA simula ng pandemic,” he said.

FDA issues advisory on sale of unregistered drug Lianhua Qingwen Jiaonang

Robie de Guzman   •   April 19, 2021

 

MANILA, Philippines – The Food and Drug Administration (FDA) has advised the public against the sale and distribution of unregistered drug Lianhua Qingwen Jiaonang with Chinese characters.

In its advisory, the FDA said there is still an “incessant sale and distribution” of the product, which were verified as unregistered.

 “As per continuing surveillance, there is still an incessant sale and distribution even through social media platforms, such as Facebook, of Lianhuan Qingwen Jiaonang with Chinese characters, which were verified as unregistered by the FDA,” the agency said.

The FDA added that only the Lianhuan Qingwen Jiaonang with English text and details provided in the advisory was issued with a certificate of product registration and approved to be sold/marketed in the Philippines.

“The agency cannot guarantee the quality and safety of the product with the Chinese text due to these have not undergone evaluation by the FDA and these came from unlicensed sources or establishments. The consumption of such violative product may pose potential danger or injury if administered,” it said.

Lianhuan Qingwen Jiaonang is a traditional Chinese drug that some people believe can cure COVID-19, but health experts said this drug should only be taken with a doctor’s prescription.

“All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product, otherwise regulatory actions and sanctions shall be strictly pursued,” the FDA said.

Under the country’s Food and Drug Administration Act of 2009, the manufacture, importation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is prohibited.

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