US bans fruit, mint vaping cartridges to curb youth use

Robie de Guzman   •   January 3, 2020   •   532

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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FDA reiterates COVID-19 vaccination non-mandatory

Aileen Cerrudo   •   December 4, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) reiterated that vaccination will not be mandatory once a COVID-19 vaccine becomes available in the country.

FDA Director General Eric Domingo said the national government will prioritize the poor in the immunization campaign. The government aims to vaccinate 60 million to 70 million Filipinos in order to reach herd immunity against the virus.

Domingo also reminded the public that minimum health standards should still be practiced even after the availability of a vaccine. He also said that the agency, along with the Department of Health (DOH), is already planning the process for the COVID-19 immunization program. AAC (with reports from Aiko Miguel)

Duterte authorizes FDA to issue emergency use of COVID-19 vaccines

Robie de Guzman   •   December 3, 2020

MANILA, Philippines – President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for COVID-19 vaccines and drugs that are expected to be made available in the Philippines next year.

Under Executive Order (EO) No. 121 signed on Dec. 1 and made public by Malacañang on Wednesday, Duterte granted authority to the FDA director general to issue EUA for COVID-19 drugs and vaccines, subject to provided conditions.

The EO stated that an EUA on a COVID-19 vaccine or drug shall be issued and remain valid only when all of the following circumstances are present:

  • Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
  • The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; and
  • There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treat9ing COVID-19

An application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or public health program implementer, the EO read.

The FDA shall then convene a panel of experts on drug and vaccine development to review available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. The panel will then submit its report and recommendations to the FDA director general.

“In evaluating applications for EUA, the FDA director general shall have the power to implement reliance and recognition processes for emergency use of drugs and vaccines,” the order stated.

“For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization), US-CDC, or other internationally recognized and established regulatory authorities,” it added.

An EUA issued pursuant to the order shall be valid within the duration of the declared public health emergency due to COVID-19, and may be revoked or revisited by the FDA director general.

FDA director general Eric Domingo earlier assured they will not compromise public safety with the sped-up process.

The Philippine government is looking to administer the vaccines to at least 70 million Filipinos under an immunization program that may be carried out within three to five years. – RRD (with details from Correspondent Rosalie Coz)

US FDA authorizes first COVID-19 kit for self-testing at home

Robie de Guzman   •   November 18, 2020

The US Food and Drug Administration (FDA) announced it has approved the first novel coronavirus disease (COVID-19) diagnostic test for self-testing at home.

In a statement issued on Tuesday, the US FDA said it has issued an emergency use authorization (EUA) for the COVID-19 All-In-One Test Kit, made by Lucira Health, for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.  

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the US FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Stephen Hahn.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he added.

The FDA said the test works by swirling the self-collected sample swab in a vial that is then placed in the test unit.

“In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” it added.

Individuals with positive results are advised to self-isolate and seek additional care from their health care provider.

While those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

The kit may also be used in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

The test is currently authorized for prescription use only, the FDA said.

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