FDA warns public vs several unregistered food products

Aileen Cerrudo   •   September 13, 2019   •   916

The Food and Drug Administration (FDA) has warned the public against the purchase and consumption of several unregistered food products.

According to the FDA, they have verified through post-marketing surveillance that the products are not authorized and have not been issued with Certificates of Product Registration (CPR).

Because of this, the FDA said they cannot guarantee the safety and quality of the following products:

  1. JC PILI CENTER CLASSIC TURMERIC LEMONGRASS POWDERED TEA
  2. JC PILI CENTER CLASSIC TURMERIC MALUNGGAY POWDERED TEA
  3. JC PILI CENTER CLASSIC TURMERIC PANDAN
  4. CULINARY EXCHANGE PREMIUM ORO 100% PURE COFFEE
  5. CRUNCH TIME Flavorites, Fiery Glaze
  6. CRUNCH TIME Flavorites, Hot & Spicy
  7. CRUNCH TIME Flavorites, Soy Garlic
  8. CRUNCH TIME Flavorites, Creamy Cheese
  9. TSARAP’ TO! Cheesedog (250g)
  10. TSARAP’ TO! Tocino 230g (8.11oz.)
  11. TSARAP’ TO! Cheesedog 1kg (35.27 oz.)
  12. TSARAP’ TO! Cheesedog 500g (17.63 oz.)
  13. MIXMATE GINGERALE
  14. OK ® MINI PILLOW WAFER CHEESE FLAVOR SNACK
  15. MONIEGOLD GUMMY TAMARIND & PLUM
  16. BARRIO FIESTA JUMBO ROASTED PEANUTS SPICY
  17. PREMIO BRILLO CAFFE ARABICA MEDIUM DARK ROAST
  18. CARL’S SPECIAL FISH CRACKERS (TENDER & CRUNCHY)
  19. CARL’S SPECIAL FISH CRACKERS (TENDER & CRUNCHY) Hot & Spicy
  20. MAGIC VINEGAR
  21. ENG SENG FOOD PRODUCTS SPECIAL TOWER PASTILLAS
  22. AURO CHOCOLATE RESERVE 2016, 70% DARK CHOCOLATE
  23. CRACKLE SNACKS SALTED EGG
  24. Y. FARM DRIED DRAGON FRUIT
  25. DIZON’S FARMS FRESH HABIT COMLD PRESSED JUICE – JUST BEAT IT
  26. LEMON GRASS ICED TEA

The FDA has warned establishments against selling these products.

“All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products,” according to the FDA.

They also advised the public to always check if a food product or food supplement is registered with the FDA through their website (www.fda.gov.ph).—AAC

 

Duterte ‘puzzled’ over FDA advice on Sinovac use for health workers – Palace

Robie de Guzman   •   February 24, 2021

MANILA, Philippines – President Rodrigo Duterte was perplexed by the recommendation of the Food and Drug Administration (FDA) not to use the Sinovac COVID-19 vaccine on health workers who are frequently exposed to patients with coronavirus disease (COVID-19), Malacañang said Wednesday.

Presidential Spokesperson Harry Roque said the president has asked FDA Director-General Eric Domingo to explain such recommendation after the agency’s issuance of an emergency use authorization (EUA) to Sinovac.

“Si president po mismo, nagtataka bakit nga ganuon nga ang naging EUA ng FDA at pinatawag po talaga si Dr. Domingo ng huling cabinet meeting… Naiparating ng president ang pagtataka kung bakit may ganitong colatilla,” Roque said.

Domingo explained that the vaccine’s efficacy rate on healthcare workers is 50.4% based on Sinovac’s clinical trials conducted in Brazil, making it not the best vaccine suited for healthcare workers treating coronavirus patients.

The FDA chief, however, stressed that this is only a recommendation and healthcare workers are not prohibited from receiving Sinovac if they chose to.

“Nirerespeto po ni president ang mga opinion ng mga experts kaya let the colatilla remain,” Roque said. – RRD (with details from Correspondent Rosalie Coz)

DOH, FDA to probe Mon Tulfo’s alleged use of unauthorized COVID-19 vaccine

Robie de Guzman   •   February 24, 2021

MANILA, Philippines – The Department of Health (DOH) and the Food and Drug Administration (FDA) on Wednesday said they would investigate reports on the use of smuggled vaccines against novel coronavirus disease (COVID-19).

The DOH issued the statement following the admission of Special Envoy to China Ramon Tulfo that he received coronavirus jabs from China’s Sinopharm, which has not yet been authorized for use in the country.

Tulfo on Tuesday said he got inoculated with illegally procured vaccine last year with some Cabinet officials, a lawmaker and some of President Rodrigo Duterte’s security team.

The DOH warned the public that the use and distribution of smuggled vaccine is illegal.

“Ito po ay makakasama sa imbestigasyon and all of these things kapag nakita natin na hindi naayon sa mga batas na meron tayo dito sa ating bansa will be considered illegal,” Health Undersecretary Maria Rosario Vergeire said in a virtual briefing.

“Kung sinoman po yung mga kababayan natin, distributors or suppliers na nagbibigay ng mga bakuna na wala pang emergency use authority ay magkakaroon ng appropriate investigation and if there would be violations, magkaka-sanctions po,” she added.

Vergeire also stressed that vaccines need to undergo regulation and secure emergency use authorization (EUA) to ensure its safety and efficacy.

FDA Director General Eric Domingo said Sinopharm has yet to file an application for an EUA.

“As of now, wala pa pong nag-a-apply sa amin. ‘Yung Chinese Government, sumulat po sila kay Secretary (Carlito) Galvez informing him na wala silang local na distributor dito at hindi ko alam kung ano ang kanilang magiging applications po and strategy,” Domingo said.

Presidential Spokesperson Harry Roque, meanwhile, said that Malacañang will leave the investigation on the issue to the FDA.

He, however, stressed that taking illegally procured COVID-19 vaccines is not a policy of the Duterte administration.

“Wala pong ganiyang polisiya dahil kung may ganiyan pong polisiya, siguro commercial quantity na ang kumalat noong mga bakuna na hindi naaprubahan. Pero inaantay po talaga natin ang aksiyon ng FDA sa mga bagay-bagay na ito,” Roque said.

To recall, some members of the Presidential Security Group (PSG) were revealed to have taken unauthorized coronavirus vaccine shots in December.

The FDA and the National Bureau of Investigation are undertaking separate investigations into the matter.

Domingo said the PSG has yet to respond to FDA’s inquiry into their illegal inoculation. – RRD (with details from Correspondent Rosalie Coz)

FDA, nilinaw na maaari pa ring gamitin ang Sinovac vaccine para sa healthcare workers

Robie de Guzman   •   February 23, 2021

MANILA, Philippines – Nilinaw ng Food and Drug Administration (FDA) na maaari pa rin namang gamitin ang Sinovac vaccines sa healthcare workers dahil may maibibigay pa rin naman itong proteksiyon para sa mga hindi exposed o walang contact sa mga pasyenteng may COVID-19.

Ginawa ni FDA Director General Eric Domingo ang paglilinaw matapos nitong ihayag noong Lunes na hindi inirerekomenda sa healthcare workers na exposed sa COVID-19 patients ang Sinovac dahil nasa 50.4% lamang ang efficacy rate nito batay sa resulta ng pagsusuri sa bansang Brazil.

“Recommendation lamang naman yun halimabawa ayaw na niyang hintayin yung ibang bakuna and then willing naman siya to take the vaccine knowing na ang possible efficacy nito sa situation mo is 50% and you’d rather take it now rather than 1 or 2 months from now kung kelan darating yung bakuna pwede naman yun. Hindi naman namin sya ipinagbabawal na gamitin,” ang pahayag ni Domingo.

Paliwanag ni Domingo, bumababa ang bisa ng bakuna kapag madalas na nakakasalamuha ng isang tao ang pasyenteng may COVID-19.

“Ang tao naman kasi iba iba ang situation natin, iba iba rin ang ating suceptibility, saka iba iba yung exposure natin, so depende po yan sa situation. Maaring mas bumaba ang efficacy ng isang vaccine kung tayo ay nasa situation talagang nasa harap natin araw araw yung covid virus, at the exposure is continuous and at high level,” ang paliwanag ng opisyal.

“Maaaring kahit mabakunahan ka ng first dose pero hindi ka pa nakaka-mount ng enough response to ward off yung infection kasi nga masyadong regular iyong exposure sa to the covid-19 virus,” dagdag pa niya.

Binigyang-diin din ng pinuno ng FDA na bagaman naghihintay pa rin na maipalathala ang mga datos ukol sa clinical trial ng Sinovac ay may mga sapat namang batayan para masegurong ligtas itong gamitin.

Posible rin aniyang mapalawak pa ang grupo o edad na pwedeng tumanggap ng naturang bakuna dahil hindi pa tapos ang ginagawa ritong clinical trial.

Tiniyak din ni Domingo na maaari pang marebisa ang mga probisyon sa ibinigay na emergency use authorization ng Pilipinas para sa Sinovac COVID-19 vaccine. – RRD (mula sa ulat ni Correspondent Joan Nano)

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