FDA Warns Companies to Stop Selling Potentially Dangerous, Unapproved Eye Drops
Video Credit: Wibbitz Top Stories - Duration: 01:30s - Published
FDA Warns Companies to Stop Selling Potentially Dangerous, Unapproved Eye Drops
FDA Warns Companies to, Stop Selling Potentially Dangerous, , Unapproved Eye Drops.
Gizmodo reports that the United States Food and
Drug Administration (FDA) has warned several companies
to stop selling unapproved eye drop products.
On September 12, the FDA announced that it had
issued warning letters to eight companies
regarding the potentially dangerous products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The FDA has also expressed concerns over silver
compounds found in some of the products, which can
turn people's skin or eyes blue with long-term use.
According to the FDA, some of the eye drop products
were allegedly manufactured at facilities that have
failed to meet standard safety and quality guidelines.
The FDA is particularly concerned that these
illegally marketed, unapproved ophthalmic
drug products pose a heightened
risk of harm to users because drugs
applied to the eyes bypass some
of the body’s natural defenses, Food and Drug Administration, via statement.
The FDA is particularly concerned that these
illegally marketed, unapproved ophthalmic
drug products pose a heightened
risk of harm to users because drugs
applied to the eyes bypass some
of the body’s natural defenses, Food and Drug Administration, via statement.
Gizmodo reports that the companies
have 15 days to respond with their
plans to correct the alleged violations.
If the companies fail to respond, the FDA could
take further action to either seize or stop the
manufacturing of the products in question.
When we identify illegally marketed,
unapproved drugs and lapses in drug
quality that pose potential risks,
the FDA works to notify the
companies involved of the violations, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo.
We will continue to investigate potentially
harmful eye products and work to ensure
violative products stay off store shelves
so that consumers can continue taking
the medicines they need without concern, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo.
We will continue to investigate potentially
harmful eye products and work to ensure
violative products stay off store shelves
so that consumers can continue taking
the medicines they need without concern, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo
Supreme Court Upholds , FDA Regulation on Popular , Abortion Drug Mifepristone.
On June 13, the Supreme Court ruled against a group of
doctors who challenged the Food and Drug Administration's
(FDA) regulations on the abortion pill mifepristone.
CBS reports that the case once again highlighted
abortion access following the conservative
majority decision to overturn Roe v. Wade in 2022.
The court ruled unanimously that the group of
anti-abortion rights doctors and medical associations
lacked the legal right to challenge the FDA. .
However, the court also did not address
whether the FDA's decision to relax the
rules for mifepristone's use were lawful. .
The latest ruling was authored
by Justice Brett Kavanaugh. .
Under Article III of the Constitution,
a plaintiff's desire to make a drug
less available for others does
not establish standing to sue. , Justice Brett Kavanaugh writing for the court, via CBS.
Nor do the plaintiffs' other
standing theories suffice.
Therefore, the plaintiffs lack
standing to challenge FDA's actions, Justice Brett Kavanaugh writing for the court, via CBS.
CBS reports that the ruling does not impact other
challenges to the FDA's standing on mifepristone,
while preserving access to the popular abortion medication.
In 2016 and 2021, the FDA took steps to widen access
to mifepristone, which has been taken by over
5 million patients since first being approved in 2000.
Those steps included allowing the drug to be taken up to 10
weeks into a pregnancy, reducing the number of in-person
doctor visits and permitting it to be sold through the mail.
Credit: Wibbitz Top Stories Duration: 01:30Published
Microdose Chocolate , May Cause Seizures, FDA Warns.
The FDA says that several people in
four states have gotten sick after eating Diamond Shruumz chocolate bars.
Severe symptoms experienced by the victims include "seizures, central nervous system depression, agitation, abnormal heart rates, hyper/hypotension, nausea and vomiting," CBS News reports. .
The chocolate, which is sold across the country, landed six of the eight victims in the hospital. .
The company's website says that the chocolate
is manufactured with a "primo proprietary blend
of nootropic and functional mushrooms.".
In 2022, the FDA called nootropics "a term widely used to market unapproved products as 'smart drugs' and 'cognitive enhancers.'".
On June 7, the FDA warned parents to
keep their kids away from the chocolate
which is marketed as candy. .
Parents and caregivers should consider
discussing the information in this
advisory with their children and take
extra care to avoid this product being
consumed by younger people. , FDA, via statement.
Half of the victims were in
Arizona, CBS News reports. .
While these products claim to
contain only natural ingredients
and no scheduled drugs, there is
clearly something toxic occurring, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release.
We've seen the same phenomenon
of people eating the chocolate bar
then seizing, losing consciousness,
and having to be intubated, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release
Credit: Wibbitz Top Stories Duration: 01:30Published
FDA Reverses Ban , on Juul E-Cigarettes.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
In that time, Juul has maintained
its position as the second-most
popular e-cigarette in the U.S.
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
Sales of alternative nicotine
products, like e-cigarettes, have
continued to grow in the past decade. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
Juul released a statement
following the FDA reversal, .
... saying the company looks forward to "re-engaging
with the agency on a science- and evidence-based
process to pursue a marketing authorization.".
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
'The Wall Street Journal' reports that Juul has argued
that the 2022 ban significantly disrupted the company's
finances, resulting in an investor bailout.
Currently, the FDA has only granted approval for 23
e-cigarette products, manufactured by only three
companies, to be marketed and sold to consumers
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Reviewing Data on MDMA , for Potential Approval of , Groundbreaking PTSD Treatment.
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
The news comes after decades of
psychedelic advocates urging regulators
to give the drug medical acceptance. .
On June 4, the Food and Drug Administration
(FDA) called on a group of outside experts
to review the latest MDMA research. .
The research suggests that when the drug is paired with talk therapy, it can help alleviate PTSD. .
However, regulators at the FDA have questioned the
reliability of the data, as well as the potential safety risks,
which include possible heart problems and addiction.
FDA approval could open the door for federal
approval to be granted as soon as this summer. .
Approval would make MDMA, often referred to as
ecstasy or molly, the first illegal psychedelic
to receive approval for mainstream medicine. .
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
It’s clear that MDMA-assisted
therapy would be a welcome
addition to the currently
available options, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'.
I’ve seen firsthand
how this treatment can
be lifesaving for some, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'
Credit: Wibbitz Top Stories Duration: 01:30Published
Cucumbers Are Recalled , in 14 States.
Fresh Start Produce Sales in Florida is
recalling cucumbers over possible salmonella contamination, 'Newsweek' reports.
The 14 states affected by the recall include Alabama, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and West Virginia.
Only large, whole cucumbers
are included in the recall.
Mini and English cucumbers
are considered safe to eat.
The Pennsylvania Department of Agriculture first informed Fresh Start that its product tested positive for salmonella.
The FDA is conducting whole genome
sequencing to determine if this sample
is related to an ongoing salmonella
outbreak investigation, Via recall notice.
Fresh Start believes it recalled the product before it could make it into consumers' hands.
Although these cucumbers are
unlikely [to be found] in the
marketplace, anyone with the
recalled product should not
consume it and should destroy
and discard it or return it to the
place of purchase for a refund, Fresh Start Produce Sales, via statement.
Consumers should check with their
retailer or place of purchase to
determine whether the recalled
cucumbers were sold where they shop, Fresh Start Produce Sales, via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
Trump Promises to Stop , All Electric Car Sales.
In an effort to be reelected
as President of the Unites States.
Trump is promising oil and gas execs that
he'll keep electric vehicles (EVs) from being sold in the U.S. if they make significant donations to his campaign, Gizmodo reports. .
Trump said that he'd lower tailpipe emissions targets and cut EV tax credits, among other things. .
"You won't be able to sell those cars," Trump said.
However, the EV market continues to grow, with
at least 1.5 million units expected to sell in 2024.
If Trump squashes EV sales in the U.S., it could anger some Republicans since the market has provided more jobs and investments in the South.
For example, Hyundai is investing
$13 billion in Georgia, a state Trump lost
in 2020, to produce electric vehicles.
Meanwhile, analysts predict EV sales will continue to rise despite Trump's efforts.
Although, his tactics could prove
to slow those sales dramatically. .
Ford Motor executive chair
William Clay Ford Jr. weighed
in on Trump's promises.
Our time frame as a company,
our planning time frame, is a lot
longer than election cycles, William Clay Ford Jr., via statement.
When we’re whipsawed back
and forth by politicians that
becomes really difficult for us, William Clay Ford Jr., via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
Walgreens Plans , ‘Significant’ Store Closures.
On June 27, Walgreens announced quarterly earnings
that were poorer than expected, NBC News reports.
The company's stock fell 15% in pre-market trading.
CEO Tim Wentworth issued a press release.
We continue to face a difficult operating
environment, including persistent
pressures on the U.S. consumer and the
impact of recent marketplace dynamics
which have eroded pharmacy margins, Tim Wentworth, Walgreens CEO, via press release.
Our results and outlook
reflect these headwinds, Tim Wentworth, Walgreens CEO, via press release.
Wentworth elaborated in an interview with CNBC.
The consumer is absolutely stunned by
the absolute prices of things, and the
fact that some of them may not be
inflating doesn’t actually change their
resistance to the current pricing, Tim Wentworth, Walgreens CEO, via CNBC.
On a call with analysts, Wentworth said that Walgreens' strategy will have to "include the closure of a significant portion of these underperforming stores.".
75% of our stores drive 100% of our
profitability today. What that means is
the others we take a hard look at, we are
going to finalize a number that we will close, Tim Wentworth, Walgreens CEO, via call with analysts.
The pharmacy chain currently
operates about 8,600 stores
Credit: Wibbitz Top Stories Duration: 01:30Published
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