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FDA warns against purchase, consumption of unregistered food supplements

by Marje Pelayo   |   Posted on Tuesday, June 25th, 2019

Image by Ben Kerckx from Pixabay

MANILA, Philippines — The Food and Drug Administration (FDA) warns the public against purchasing and consuming the following food supplements being sold in markets that are without registration certificates from the agency.

Some of these unregistered food supplements include:

  1. Vitacio Maca Root Extract Complex, 500mg
  2. Doctor’s Best, Best Probiotic 20 Billion CFU
  3. Probiotic Pearls Women’s Digestive & Yeast Balance
  4. Puritan’s Pride Chewable Chlorophyll with Natural Spearmint Flavor
  5. Scivation Xtend Bcaas, Mango Flavor
  6. Bioherbs Healing Tiki-Tiki
  7. Nature’s Bounty Acidophilus Probiotic 100 Million Organisms
  8. Colloidal Silver
  9. Lemon Grass Iced Tea Calamansi With Honey
  10. Lemon Grass Iced Tea Stevia, Sugar Free

The advisory came after the FDA verified through post-marketing surveillance that the above mentioned food supplements “are not registered and their Certificate of Product Registration (CPR) have not yet been issued pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”.

“Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers,” the advisory reads.

Thus, the FDA warns that “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.”

The public is advised to always check the FDA’s website – www.fda.gov.ph – for products registered with the agency.

To report any sale or distribution of unregistered food supplement, consumers are advised to contact the FDA Center for Food Regulation and Research through email at cfrr@fda.gov.ph or call (02) 857-1900 loc. 8115 and 8112\ or through the agency’s online reporting facility or the eReport can be accessed at www.fda.gov.ph/ereport.

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34 of 400 samples of pork products tested positive of African Swine Fever – BAI

by Marje Pelayo   |   Posted on Friday, July 19th, 2019

Boxes of pork items from Poland intercepted in Cebu on June 27 | Courtesy: BAI

MANILA, Philippines – The Bureau of Customs (BOC) has intercepted a number of pork products from Hong Kong and China at Ninoy Aquino International Airport (NAIA) in between June 19 to 28.

The items didn’t have sanitary and phytosanitary clearances from the Bureau of Animal Industry (BAI) and could have been infested by the deadly pig virus African Swine Fever (ASF).

China is one of the 19 countries from where entry of pork and pork-based products are banned.

From a total of 400 samples that BAI examined, 34 tested positive of ASF and these products could have caused infestation in the country’s hog industry if they were not intercepted.

Germany was the latest addition to the list of countries where entry of pork products to the Philippines was banned.

Though there were no reports yet of ASF-infestation in Germany, the Philippines included it in the list after a German company exported pork products to the Philippines along with some 250 kilograms of pork from ASF-hit Poland.

The said shipment was intercepted in Cebu on June 27 which included 27 boxes of pork items from Poland.

That incident, according to Agriculture Secretary Manny Piñol, was a clear violation of the country’s Quarantine Law thus resulting in the ban of pork products from Germany.

“Nakikiusap ako.(‘Im appealing to you) Please understand, these are extraordinary times. We cannot take the risk,” Secretary Piñol said.

“Kasi tingnan mo, Germany napaka-respectable na bansa nyan. It’s export country known for its high standards, nasingitan tayo, (You see Germany is a highly respected country. It’s exports are known for its high standards but some banned (pork) slip past their screening,)” he explained.

Piñol stressed that ASF infestation would compromise the country’s P260-B worth of hog industry.

Some of the Philippines’ neighboring countries have already declared an outbreak of ASF such as Vietnam and Cambodia.

In May, the Food and Drug Administration (FDA) has asked store owners to self-recall pork products from China that covers those manufactured since the start of the import ban.

Still, Piñol assures the Philippines’ hog industry remains ASF free. – with reports from Rey Pelayo

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Medical marijuana can be legalized with proper provisions – Health reform advocate

by Marje Pelayo   |   Posted on Friday, December 21st, 2018

 

Marijuana plant (Reuters image) | Cannabis Oil

MANILA, Philippines – Opinions are divided about the legalization of medical marijuana in the country.

Under the Philippines law, marijuana is considered a dangerous and illegal drug.

It requires a special permit from the Food and Drug Administration (FDA) to be able to use it for medication.

But a health reform advocate believes that legalizing medical marijuana can be possible in the country but under proper and detailed regulations.

“Compassionate use sa FDA na iyong kunyari may sakit ka tapos hindi ka gumagaling dito and then iyong relative gusto. Doctor niya ang magre- request sa FDA at paratingin iyong gamut, let’s say, galing Canada para gamitin ito sa pasyente. Pero  tayo hindi pa tayo nagma-market by law hindi pa kasi approved ang medical marijuana,” explained Dr. Anthonay Leachon.

Dr. Leachon noted that unlike cigarettes which are consumed by smoking or sniffing, marijuana needs a special process when use as medication.

“Dapat po oil or tablet. May forms po depende po kung ano ang doablity pero definitely hindi ito hihithitin,” he said.

Dr. Leachon added that medical marijuana is only given to terminally or seriously ill patients such as cancer or HIV-AIDS patients.

Filipina nurse Wendy said she observed an improvement in her son’s condition since he started using cannabis oil.

Wendy’s son who has non-verbal autism and hyperlexia, a condition characterized by strong decoding skills and delayed comprehension.

With the help of cannabis oil, Wendy said her son’s social skills improved.

He has started communicating and does eye-to-eye contact.

Wendy currently lives in the United States where medical marijuana is legal.

Despite seeing its benefits, Wendy believes a thorough study is still needed on the effects of medical marijuana to the human body.

“I agree that CBD oil use needs further research investigation, testing to prove its benefits and if its 100% effective and safe. It’s fairly new to the industry. As for us, the only proof we need to see is Spam developing as fast as he is right now. It greatly improved his quality of life even though he’s just 4 as well as ours,” Wendy said over the phone.

Health undersecretary Eric Domingo said recommendations to legalize the use of medical marijuana is still under study by the Department of Health (DOH).

In fact, they have started consulting experts on the matter.

“We need to collect scientific evidence before an official position is made. In the meantime, FDA accepts applications for compassionate use of unregistered drugs,” Domingo said.

Recently, the FDA received three applications to use medical marijuana, however Domingo said, they failed to fulfill the criteria set by the agency. – Marje Pelayo (with reports from Aiko Miguel)

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Dengvaxia ban likely to extend for more than a year – DOH

by Marje Pelayo   |   Posted on Tuesday, December 11th, 2018

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

MANILA, Philippines – The Food and Drug Administration (FDA) is likely to extend the ban on marketing and sales of Dengvaxia, according to the Department of Health (DOH).

December 29 this year marks the first year since the license of French pharmaceutical giant Sanofi Pasteur was suspended; banning its sale of Dengvaxia in the country.

The DOH believes that since the controversy on the anti-dengue vaccine is not yet closed, the ban on sale of Dengvaxia still remains.

“Iyong one-year suspension ng Dengvaxia CPR is not yet lifted and I do not see it being lifted anytime soon. We still have a lot of pending issues with the vaccine and at this time we do not see it being registered and allowed for marketing in the Philippines…regulatory issues and cases in Court,” said DOH Spokesperson Usec. Eric Domingo.

It will be recalled that the FDA suspended Sanofi for not submitting its post-marketing authorization requirements which were supposed to prove that the products manufactured by the pharmaceutical company are safe to use.

Sanofi also couldn’t assure the safety of Dengvaxia, according to DOH.

The DOH noted that in November 29, 2017, Sanofi released a statement that Dengvaxia is not advisable to be administered to seronegative recipients —children or adults—who never had dengue infection prior to injection for the reason that their cases are likely to develop into severe dengue.

“It cannot be used without testing for children if they had dengue before. And there are no available testing kits commercially to do that. We don’t see naman any use for the vaccine at this time,” Domingo said.

The DOH also argued that the even regulatory agencies in the world that were granted with licenses to use Dengvaxia such as in Brazil, have set restrictions on the use of Dengvaxia on children who never had dengue infection prior to injection.

Hindi na rin sila magbibigay without screening,” Domingo said.

Based on the latest findings of the DOH, about 24 to 25 cases of dengue infection led to death due to severe dengue.

“We’ve seen talagang meron tayong patients who have, na ang mortality nila was due to severe dengue and I think probably from talagang seronegative patients iyon,” the health official said.

Meanwhile, the DOH is still waiting for the approval of Congress regarding the supplemental budget for vaccinees from the refund that Sanofi gave which reached P1.16-B.

Domingo said before the end of the year, the Office of the Solicitor General is likely to file a case against Sanofi Pasteur in line with the Dengvaxia controversy. – Marje Pelayo (with reports from Aiko Miguel)

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