Walang Certificate of Product Registration...Kape, chili sauce, noodles atbp.,'di safe kainin - FDA

ni Lolet Abania | September 4, 2021

Naglabas ng babala ang Food and Drug Administration (FDA) ngayong Sabado sa publiko at sa mga healthcare professionals hinggil sa pagbili at pagkonsumo o paggamit ng mga hindi rehistradong produktong pagkain at food supplements sa mga pamilihan.

Sa limang magkakahiwalay na advisories na inisyu ng FDA, ang mga produktong hindi nagtataglay at walang Certificates of Product Registration ay ang mga sumusunod:

• Lee Kum Kee Guilin Style Chili Sauce (in foreign language)

• Tasty Vegetables with Dark Orange Label in Glass Bottle (in foreign language)

• Pickled Vegetable with Boy Character and Bright Green Label in Glass Bottle (in foreign language)

• Taiwan Chili sauce with Male Character and Violet Label in Glass Bottle (in foreign language)

• Ji Xiang Ju Preserved Vegetable with Blue and Green Label in Glass Bottle (in foreign language)

• Fermented Vegetable with Orange Label in Glass Bottle (in foreign language)

• Preserved Vegetable with Mask Image and Red Label in Glass Bottle (in foreign language)

• Pickled Vegetable with Boy Character and Dark Pink Label in Glass Bottle (in foreign language)

• Pickled Vegetable with Violet Label in Glass Bottle (in foreign language)

• Food Product with Red and Yellow Label in Plastic Jar (in foreign language)

• Huo Lala Chili Oil with Red and Orange Label in Glass Bottle (in foreign language)

• Food Product with Tomato Image and Red Label in Glass Bottle (in foreign language) • Artificial Crawfish Flavored Stir Fried Noodle (in foreign language)

• Wrigley's Food Product with Sliced Orange Image in Plastic Bottle (in foreign language)

• Wrigley's Food Product with Orange Image in Plastic Bottle (in foreign language)

• Wrigley's Food Product with Sliced Melon Image in Plastic Bottle (in foreign language)

• Taisun Mixed Congee with Okinawa Brown Sugar (in foreign language)

• Yezhi Zun Milk-Like Beverage with Cow Image in Clear PET Bottle (in foreign language)

• Only for You Pursuing Delicious Food Green Mochi-Like Food Product in Black and Green Box (in foreign language)

• Sotero Coffee 10in1 Mix Tongkat Ali, Korean Ginseng, Maca Root

• SkinConnect Glutaglow Reduced L. Glutathione Dietary Supplement

• W.L. 24 Seven Dalandan Powdered Drink Mix

• W.L. 24 Seven Pineapple Powdered Drink Mix

• Mix Ramune

“Pursuant to the Republic Act No. 9711, otherwise known as the ‘Food and Drug Administration Act of 2009’, the 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,” pahayag ng FDA.

Ayon pa sa ahensiya, walang katiyakan na ang mga naturang produkto ay ligtas at may kalidad dahil hindi nila ito nasuri.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” sabi pa ng FDA.

Paalala rin ng FDA sa mga establisimyento at sa publiko na i-check ang FDA registration number ng isang produkto sa pamamagitan ng FDA Verification Portal.

Hiniling din ng ahensiya sa mga law enforcement agency at local government units (LGUs) na siguruhing hindi ito maibebenta sa mga pamilihan, anila, “To ensure that these products are not sold or made available in the market or areas of jurisdiction.”

Gayundin, hinimok ng FDA ang Bureau of Customs na tiyaking mapipigilan ang pagpasok sa bansa ng mga unregistered imported products.

Pag-aprub sa gamot vs. Alzheimer's, pinalagan, 2 members ng FDA nag-resign

ni Ronalyn Seminiano Reonico | June 10, 2021

Nagbitiw sa puwesto ang dalawang miyembro ng US Food and Drug Administration (FDA) advisory panel bilang protesta matapos aprubahan ng ahensiya ang gamot ng Biogen Inc's Aduhelm laban sa Alzheimer's disease sa kabila ng pagtutol ng komite.

Kabilang si Mayo Clinic Neurologist Dr. David Knopman sa panel member na nagbitiw sa puwesto noong Miyerkules.

Aniya, "I was very disappointed at how the advisory committee input was treated by the FDA.

"I don't wish to be put in a position like this again.”

Ang panel na binubuo ng 11 miyembro ay bumoto “nearly unanimously” noong Nobyembre laban sa gamot ng Biogen dahil wala umanong katiyakan na epektibo ito laban sa naturang sakit.

Noong Lunes, pinagkalooban ng "accelerated approval” ng FDA ang nasabing gamot dahil umano sa ebidensiyang nababawasan nito ang posibilidad ng pagkakaroon ng Alzheimer’s disease.

Noong Martes naman nagbitiw sa puwesto si Washington University Neurologist Dr. Joel Perlmutter na tumutol sa pag-apruba ng FDA sa nasabing gamot.

Edad 12 to 15, oks nang turukan ng Pfizer vaccine

ni Lolet Abania | June 8, 2021

Pinalawak na ang ibinigay na emergency use authorization (EUA) sa Pfizer na sasakop sa indibidwal na puwedeng mabakunahan ng COVID-19 vaccine.

Ayon kay DOH Undersecretary Maria Rosario Vergeire, binigyan ng EUA ang Pfizer para magamit ang bakuna sa mga edad 12 at pataas.

“While we welcome more vaccines that are approved for children and adolescents, due to limited vaccine supply, our vaccination strategy remains the same -- prioritize the vulnerable and adhere to our prioritization framework,” ani Vergeire.

“The general consensus of our vaccine experts is to revisit pediatric and adolescent vaccination once our vaccine supply has stabilized,” dagdag niya.

Sa isang report, inamyendahan ng Food and Drug Administration ang EUA na kanilang inaprubahan para sa Pfizer-BioNTech's vaccine upang maabot nito ang mga nasa edad 12 hanggang 15.

Nakasaad sa kopya ng Pfizer EUA sa FDA website na, “Amendment to include minors was issued on May 28.”

Una rito, inaprubahan ang Pfizer jab para gamitin sa mga indibidwal na nasa 16-anyos at pataas.

Matatandaang sinabi ni FDA Director General Eric Domingo na ang mga eksperto ay nagbigay ng “very favorable” o napakakanais-nais na rekomendasyon para sa paggamit ng Pfrizer vaccine sa mga menor-de-edad.

Noong March, ayon sa American pharmaceutical giant, nagpakita ang vaccine ng 100% efficacy laban sa COVID-19 sa mga adolescents na may edad 12 hanggang 15. Inihayag din ng Malacañang na ang mga Filipino teen-agers ay mababakunahan ng Pfizer vaccine kapag dumating na ang mga supplies nito.

Inaasahan namang mabibigyan ng 40 milyong doses mula sa nasabing kumpanya ang bansa ngayong taon.