Drugmaker Asks FDA , to Approve Over-The-Counter , Birth Control Pill.
On July 11, a French pharmaceutical company sought
regulatory approval to sell an over-the-counter
birth control pill in the United States.
NBC reports that HRA Pharma's application
comes amid legal and political battles
regarding women's reproductive health.
However, the company said the timing for
its application was unrelated to the Supreme Court's
recent decision to overturn Roe v.
Wade.
According to NBC, hormone based birth
control has long been the most widely
used form of birth control in the U.S. .
Since the 1960s, birth control has required
a prescription and a medical screening for
conditions that raise the risk of blood clots.
The French drugmaker argues that years of research suggest that women can safely screen themselves for those conditions and use the pill effectively.
For a product that has been available
for the last 50 years, that has been
used safely by millions of women,
we thought it was time
to make it more available, Frederique Welgryn,
HRA’s chief strategy officer,
via 'The Guardian'.
NBC reports that FDA approval
could come as soon as next year.
.
Reproductive rights advocates have reportedly been pushing for the approval of more over-the-counter contraceptives following the Roe v.
Wade decision .
.
Reproductive rights advocates have reportedly been pushing for the approval of more over-the-counter contraceptives following the Roe v.
Wade decision .
.
Now, the FDA likely faces intense political
scrutiny as it weighs a potentially
precedent-setting decision
Latest Weight-Loss Drug , Faces Shortages .
The United States Food and Drug Administration
(FDA) says that high demand has left the latest
weight-loss drug, Zepbound, in short supply.
'Newsweek' reports that the Eli Lilly product
is expected to experience limited availability
through Q2 of 2024 as surging demand has
outpaced the manufacturer's expectations.
We have experienced
an unparalleled surge in
demand for our type 2
diabetes and obesity medicines, Eli Lilly spokesperson, via 'Newsweek'.
We recognize this situation may
cause a disruption in peoples'
treatment regimens and are
working with purpose and
urgency to help meet
the surge in demand, Eli Lilly spokesperson, via 'Newsweek'.
The FDA said that Novo Nordisk's weight-loss
drug, Wegovy, is also experiencing a
widespread supply shortage with no end
in sight for the drug's limited availability.
By the year 2030, 'Newsweek' reports
that the weight-loss drug market is
expected to grow to about $100 billion.
We expect our investments
in manufacturing and supply
capacity to progressively increase
production of our medicines
throughout 2024 and beyond, Eli Lilly spokesperson, via 'Newsweek'.
Over the past year, manufacturer Eli Lilly
has already seen share prices rise over 102%.
The company has announced plans
to expand operations to meet increased
demand for its incretin products which are
used in the firm's diabetes treatments. .
Incretin mimics gut hormones
that regulate blood sugar
while also suppressing appetite
Credit: Wibbitz Top Stories Duration: 01:30Published
Experts' Tips on Taking, Supplements as Sleep-Aids.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
Melatonin has become a popular
supplement in recent years for being
a safe and effective sleep aid.
According to a 2023 study by the American Academy of Sleep
Medicine (AASM), nearly two-thirds of people in the
United States have tried using melatonin to help them sleep. .
It’s not something that is generally
harmful or toxic, which is probably
why people are tempted to take
more when a little bit doesn’t work, Dr. Milena Pavlova, neurologist at Brigham and Women’s
Faulkner Hospital and an associate professor of
neurology at Harvard Medical School, via 'Time'.
'Time' points out that supplements, such as
melatonin, are not regulated by the
U.S. Food and Drug Administration.
Similar to melatonin, over-the-counter antihistamines
like Benadryl have become a popular sleep-aid due to
containing doxylamine, which causes drowsiness.
However, doxylamine also comes
with a number of side effects,
including a potential hangover the next day.
The big problem with antihistamines
is they can make people extremely
groggy and really impair cognitive
function the next day, Dr. Indira Gurubhagavatula, professor of medicine
in the division of sleep medicine at the
University of Pennsylvania, via 'Time'.
While antihistamines can induce
drowsiness, they don't normally
result in quality, restorative sleep.
Experts suggest eliminating things that prevent healthy sleep, like alcohol and caffeine, while also incorporating physical activity into your daily routine.
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA to Outlaw Soda Ingredient , Already Banned Around the World.
Brominated Vegetable Oil (BVO) has been used as an emulsifier in various products
since the 1930s, ScienceAlert reports. .
Countries such as India, Japan and nations within
the European Union have banned BVO for years.
California also outlawed it in 2022.
Studies have indicated that BVO builds up in fat tissue when consumed and prevents iodine from properly functioning within the thyroid. .
BVO has also been linked with heart and behavioral problems, ScienceAlert reports. .
Recent toxicology studies prompted
the Food and Drug Administration (FDA)
to propose banning BVO in November.
The proposed action is an example of how
the agency monitors emerging evidence
and, as needed, conducts scientific research
to investigate safety related questions, , James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
... and takes regulatory action when the
science does not support the continued
safe use of additives in foods, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
Over the years many beverage makers
reformulated their products to replace
BVO with an alternative ingredient, and
today, few beverages in the US contain BVO, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
The FDA's BVO reclassification will still need to
go through a review process before completion.
James Jones, FDA deputy commissioner
for human foods, said that regulations
for authorizing other food additives are
currently being reviewed by the agency...
... in order to automatically block
the approval of ingredients known to
cause cancer in animals or humans
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Warns These , Cinnamon Brands , Could Contain Lead.
NPR reports that the Food and Drug Administration
has issued an advisory that several brands
of cinnamon could potentially contain lead.
The six brands impacted by the advisory are: , La Fiesta, Marcum, MK, Swad,
Supreme Tradition and El Chilar. .
These brands are commonly on sale at
discount stores and were found to contain
between 2.03 and 3.4 parts per million of lead.
The FDA said that while no illnesses have been
linked to the products, it has recommended
a voluntary recall of the cinnamon brands.
It is important to note that the lead
levels found in the ground cinnamon
products listed above are significantly
lower than lead levels in cinnamon in
the recalled apple sauce pouches
removed from the market this past fall, FDA statement, via NPR.
The FDA added that the impacted products , "could be unsafe for prolonged use.".
NPR reports that long-term lead exposure
in children can lead to slower development,
brain and nervous system damage,
as well as behavioral and learning problems.
According to the CDC, while adults
can experience similar impacts, higher
amounts of exposure are necessary.
The FDA said that "historically, lead chromate has
been illegally added to certain spices" to increase
their weight and enhance their color, "which
increases the monetary value of the adulterated spices." .
FDA's leading hypothesis
remains that this was likely
an act of economically
motivated adulteration, FDA statement, via NPR
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Approves Marketing , That Cites Yogurt's Ability , to Reduce Diabetes Risk.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The petition sought to have the FDA allow the
company to market yogurt's ability to reduce
the risk of Type 2 diabetes without objection.
On March 1, the FDA confirmed that
it would not oppose the marketing
campaign, while including some caveats. .
Those caveats include that the marketing must
note that evidence is limited to eating two cups,
equal to three servings, of yogurt per week. .
NBC reports that Danone's petition is
part of a standard process which the
FDA calls "qualified health claims.".
While these claims do not require the FDA's
approval, companies often petition the
agency to define the specific language
necessary to avoid making false claims.
The petition reportedly cited yogurt's nutrient
profile of proteins, vitamins and low sodium.
The petition also cited studies which have supported
the link between regularly consuming yogurt and
reduced risk of diabetes and related conditions.
The petition also noted that
the evidence supports the health
effects of yogurt as a food rather
than related to any single nutrient
or compound and thus is
independent of fat or sugar content. , FDA announcement, via NBC
Credit: Wibbitz Top Stories Duration: 01:31Published
Donald Trump Says States , Should Decide Abortion Legislation.
On April 8, the former president set
the record straight about where he
stands on abortion rights, CNN reports. .
My view is now that we have abortion
where everyone wanted it from a legal
standpoint, the states will determine by
vote or legislation, or perhaps both. , Donald Trump, via Truth Social video.
And whatever they decide must
be the law of the land. In this
case, the law of the state, Donald Trump, via Truth Social video.
Many states will be different. Many will
have a different number of weeks, or
some will have more conservative than
others, and that’s what they will be. , Donald Trump, via Truth Social video.
At the end of the day, this is all
about the will of the people, Donald Trump, via Truth Social video.
Trump also said he was "proudly the
person responsible" for Roe v. Wade
being overturned in 2022.
He went on to say that the decision removed the issue from "federal hands and brought it into the hearts, minds and vote of the people in each state.".
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said that her organization was "deeply disappointed"
by what Trump had to say, CNN reports. .
Saying the issue is ‘back to the states’
cedes the national debate to the Democrats
who are working relentlessly to enact
legislation mandating abortion throughout
all nine months of pregnancy. , Marjorie Dannenfelser, Susan B. Anthony Pro-Life
America president, via statement.
If successful, they will wipe
out states’ rights. , Marjorie Dannenfelser, Susan B. Anthony Pro-Life
America president, via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
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