FDA permanently revokes Dengvaxia’s certificate of registration
by admin | Posted on Tuesday, February 19th, 2019
The Food and Drug Administration has permanently revoked anti-dengue vaccine Dengvaxia’s certificates of product registration (CPR) due to the continued failure of manufacturer, Sanofi Pasteur Inc. to submit post-approval commitment documents.
FDA Director General Nela Charade Puno on Tuesday cited in a statement the French pharmaceutical firm’s disregard of the agency’s rules and regulations as reason for its CPRs’ cancellation.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.
The revocation of the Dengvaxia’s CPR makes its importation, sale and distribution illegal in the Philippines, according to the FDA.
Dengvaxia’s CPR was initially suspended for a year since December 29, 2017 after Sanofi’s failure to comply with post-marketing requirements.
Prior to the lapse of the one-year suspension on December 17, 2018, Sanofi failed to comply with post-marketing authorization requirements. The company has since then suspended the sale and marketing of the vaccine. — Robie de Guzman
by Marje Pelayo | Posted on Wednesday, May 29th, 2019
MANILA, Philippines – Some local government units have begun inspecting grocery and retail stores in their areas for available pork and pork-based products amid African Swine Fever (ASF) outbreak in some European and Asian countries.
The Food and Drug Administration (FDA) on Tuesday (May 28) issued a recall order on all pork and pork-based items from local markets to prevent the possible spread of the deadly pig virus.
Dr. Paul Toletino Foronda, municipal veterinarian of Dinalupihan, Bataan posted on his Facebook page images of their initiative to remind grocery stores to self-recall the prohibited items from their respective shelves pending turn over to the FDA.
Foronda said they were able to convince store owners to pull out of more than 800 cans of ‘Ma Ling’ brand luncheon meat throughout their rounds.
Foronda wishes that they may be given authority to confiscate the banned items to keep consumers from buying them.
“We do what we can to help. Gusto sana namin mabigyan na kami ng order to dispose para mai-alis na agad ang risk (We wish to be given order to dispose so we could immediately remove the risk),” Foronda said.
The initiative is also being done in Parañaque City.
Meanwhile, supermarket owners said they might return the items to their suppliers.
They clarified, however, that similar items with manufacturing dates earlier than the August 2018 effectivity of the import ban can still be purchased in their stores.
“Makikipag-away na lang kami sa mga supplier namin (We have no choice but to deal with our suppliers),” noted Steven Cua, president of the Philippine Amalgamated Supermarket Association.
“Siempre, binili na iyan. Binayaran na. Isosoli ninyo pa sa amin. Ngayon kung meron silang ibang item hindi lang naman iyong item na karga nila, palit nalang. Swap (The items have been paid already. The suppliers might object if we return them. But we may ask to swap the banned items with other products),” he added.
Meanwhile, Agriculture Secretary Manny Piñol said they will request the Department of the Interior and Local Government (DILG) to direct the local governments to assist the DA and the FDA in confiscating the products as well as apprehending the violators. – (with reports from Rey Pelayo)
by Robie de Guzman | Posted on Tuesday, May 28th, 2019
MANILA, Philippines – The Food and Drug Administration (FDA) will release next week the list of “fake” vinegar products with synthetic acetic acid.
FDA officer-in-charge Eric Domingo said they are still testing vinegar brands suspected to be produced not from natural fermentation and biogenic ingredients but from synthetic acetic acid.
The FDA made the announcement following the call of the Department of Agriculture (DA) to release the list of the alleged fake vinegar products available in the market to ensure the safety of consumers.
A study conducted by the Philippine Nuclear Research Institute-Department of Science and Technology (PNRI-DOST) found that eight out of 10 vinegar products in the market are made from synthetic acetic acid and not from natural sources.
The research team explained that vinegar and other condiments from natural or plant-based sources are safer than those derived from petroleum-based sources.
“One can only imagine all the impurities and residues from the petroleum by-products, which can be the source of various degenerative diseases,” said Raymond Sucgang, section head of the PNRI Nuclear Analytical Techniques Applications Section.
The PNRI did not mention the brand names of the products used in the test but it assured that the results of the vinegar studies have already been submitted to the FDA.
Earlier, the DA advised consumers to exercise caution and discernment in buying vinegar from commercial establishments. The department also recommends that consumers buy natural vinegar made out of coconut sap and water, sugarcane, nipa and fruits which are readily available in the market.
For its part, the Department of Health (DOH) said once the PNRI study has been validated by the FDA, they will order the pull out of vinegar brands proven synthetic from local markets.
At present, there are a total of 274 vinegar brands duly registered by the FDA.
by Robie de Guzman | Posted on Tuesday, May 28th, 2019
MANILA, Philippines – The Food and Drug Administration (FDA) on Tuesday warned the public against the purchase and use of the counterfeit versions of some local and international beauty products.
On its Facebook page, the FDA posted a series of advisories against the counterfeit versions of the following products:
3W Clinic’s Fresh Lemon and Fresh Aloe Mask Sheet
RDL babyface Whitening Night Cream 5 in 1
RDL Face-off Fade-out Cream Day Cream
Maybelline New York The Magnum Volum’ Express Waterproof Mascara
M·N® Menow Generation-II Long Lasting Lip Gloss (Variant 34)
The FDA said the mentioned cosmetic products have been verified to be counterfeit, with the help of the brands’ respective distributors, retailers and traders.
The agency warned that fake products pose potential health hazards since these did not go through the required safety assessment and verification process.
The use of substandard and possibly adulterated beauty products, the FDA said, may result in adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock, and organ failure.
The FDA warned establishments not to distribute the said products as “regulatory actions and sanctions shall be strictly pursued.”
The agency likewise advised the public to be vigilant against cosmetic products that might not be duly notified with the FDA.
Before purchase, consumers may check if a beauty product has been notified with the FDA by searching about the item on their website.
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