US bans fruit, mint vaping cartridges to curb youth use

Robie de Guzman   •   January 3, 2020   •   507

Washington – The United States Food and Drug Administration on Thursday banned the sale of unauthorized flavored cartridge-based e-cigarettes, including fruit and mint, in an attempt to reduce their use among children and youth.

The decision, in which companies have 30 days to cease manufacture, distribution and sales, aims to reduce the “troubling epidemic” among youth, although for some sectors it is seen as a step back from the original plan of the President Donald Trump administration to ban all flavors.

“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes,” said Health and Human Services Secretary Alex Azar in the FDA statement.

On September 11 last year, Azar announced that the Trump administration planned to ban the sale of flavored e-cigarettes except tobacco after the first deaths linked to their use were made public.

At that time, Trump, in statements from the Oval Office with Azar and other officials, said that vaping is a problem that especially affects “innocent children.”

In October, Juul, the largest manufacturer of e-cigarettes in the US, announced it was suspending sales of most of its flavors in the country ahead of the ban, although it anticipated that it would continue to manufacture tobacco and menthol flavors.

The same month, The Washington Post reported that the Trump administration was considering allowing the sale of some flavors so as not to put at risk the re-election of Trump, whose campaign team has warned of the electoral impact that the plan to ban all flavored e-cigarettes would have amid possible job losses and voter backlash.

The report said Trump’s campaign chief Brad Parscale warned that the plan to reduce vaping among young people could hurt Trump in the 2020 election.

Groups working in the industry also created a pushback campaign called #IvapeIVote and #WeVapeWeVote.

In its statement, the FDA cited federal survey data to show that young people are particularly attracted to flavors such as fruit and mint, more so than to tobacco or menthol.

According to local media, 55 people have died across 27 states due to a lung illness linked to vaping. EFE-EPA

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COVID-19 vaccine approval in PH possible in April 2021 – FDA

Robie de Guzman   •   September 25, 2020

MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.

During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.

“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.

“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.

In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.

“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.

Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.

“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.

The DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the sharing of their earlier trial results.

Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.

The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)

US donates hygiene kits, handwashing stations to Manila City gov’t

Robie de Guzman   •   September 17, 2020

MANILA, Philippines – The government of the United States on Thursday donated hygiene kits and handwashing stations to the city government of Manila in support of the Philippine capital’s fight against the coronavirus disease (COVID-19) pandemic.

In a statement, US Ambassador Sung Kim said he visited the Delpan Quarantine Facility in Tondo to handover 5,000 hygiene kits and 16 handwashing stations to Manila Mayor Francisco “Isko Moreno” Domagoso.

Kim said the hygiene kits could provide additional protection against COVID-19 through the provision of items essential to practicing good personal hygiene.

The kits contain face masks, soap, laundry detergent, dishwashing liquid, and toothbrushes.

“The U.S. government is a friend, partner, and ally of the Manileños in facing this pandemic. The American people are pleased to support the City of Manila’s efforts to fight COVID-19,” Kim said.

To complement the donation, the U.S. Agency for International Development (USAID) said it will continue to collaborate with the Manila City Health Office to help ensure that citizens can access quality tuberculosis services during the pandemic as well as to support the rollout of the Department of Health’s “Coordinated Operations to Defeat Epidemic (CODE)” strategy to contain the pandemic.

USAID recently donated two ventilators to the Tondo Medical Center as part of the 100 ventilators that the U.S. government handed over last August 28 to the Philippine government.

To date, the U.S. government has donated over P1 billion ($22.6 million) to support the Philippines’ COVID-19 response.

FDA warns against purchase of unregistered food items including popular liver spread brand

Marje Pelayo   •   September 17, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) on Wednesday (September 16) issued a warning against the purchase and consumption of several unregistered food and food supplements including a popular brand of liver spread.

According to its advisory dated August 26 and released only on September 16, the following products have no certificate of product registration issued and therefore unregistered in the agency:

  • Reno Brand Liver Spread
  • Miracle White Advance Whitening Capsules Food Supplement
  • Turcumin 100% Natural & Standardized Turmeric Curcumin
  • Desa Spanish Style Bangus In Corn Oil
  • Samantha’s Dips And Sauce Spanish Sardines Paste Sauce

“Since these unregistered food products and food supplements have not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety,” the advisory said.

The FDA cited the provision of the Food and Drug Administration Act of 2009, which states that “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.”

The agency also warned establishments not to distribute, advertise or sell the said violative food products until a proper certificate of registration is issued.

Otherwise, they could face regulatory sanctions.

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