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December 24, 2021

Buyer Beware: Packaged Salads Recalled in 19 States

Fresh Express has recalled products from 19 states while the Food and Drug Administration (FDA) investigates a deadly outbreak related to the packaged salads that killed at least one person.

The company announced in a press release that products from its factory in Streamwood, Illinois, are potentially contaminated with the bacteria Listeria monocytogenes. The Michigan Department of Agriculture conducted a random sample and found one packaged salad containing the bacteria.

Recalls were made in the following states: Connecticut, Illinois, Kentucky, Maryland, Maine, Indiana, Rhode Island, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Wisconsin, North Dakota, Minnesota, Michigan, Iowa, and Massachusetts.

According to FDA, the recalled products include all use-by-date fresh salad packages with the product codes of Z324 through Z350.

The FDA announced a probe into a “multistate outbreak” linked to the Fresh Express products.

According to FDA Deputy Commissioner for Food Policy and Response Frank Yiannas, ten people infected with the outbreak strain have been reported from eight states while one person has died.

“We will continue to work with our partners and with Fresh Express to determine the source of this outbreak,” Yiannas said. “We remain committed to transparency and providing updates as we learn more during our continuing traceback investigation.”


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Fresh Express Announces Recall of Fresh Salad Products Due to Potential Health Risk

December 19, 2021

FDA Permanently Allows Abortion Pills By Mail [Video]

The Food and Drug Administration (FDA) decided that Americans can permanently receive abortion pills by mail, lifting a restriction that required individuals to get the pills in person from a physician.

The move comes amid the likelihood that the Supreme Court will overturn Roe v. Wade, a 1973 decision that made abortions legal in the U.S.

Abortion pills enable patients to undergo a medical abortion at their homes up through 10 weeks of pregnancy. Patients first take mifepristone, which stops the pregnancy from continuing, and then up to 48 hours later, they take misoprostol, which causes uterine contractions.

However, 19 states have already banned telemedicine visits for abortions. Five states, including Missouri, Arkansas, and Louisiana, have outright bans on using telemedicine for abortion pills, while the other 14 — which includes Texas, Mississippi, and Alabama — require patients to visit a physician in person. 

Planned Parenthood put out a statement on the FDA’s announcement, calling the decision a “victory for public health and equity.”

“We’ve seen very clearly in the past two years that the logistical hurdle of unnecessary travel to health centers during a dangerous pandemic only creates more barriers to care, especially for people of color and people with low incomes,” said Alexis McGill Johnson, the president and CEO of Planned Parenthood. “Abortion is time-sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion.”

“With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”


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FDA says abortion pills can be sent by mail

September 19, 2021

FDA overwhelmingly rejects Pfizer booster for anyone 16 and up

An advisory panel for the Food and Drug Administration resoundingly voted against giving Pfizer-BioNtech’s COVID-19 booster shots to those 16 and up. The panel agreed to distribute them only to people aged 65 and those at high risk of severe illness.

Members overwhelmingly voted against the recommendation for everyone 16 and older, citing concerns about the lack of evidence showing boosters are safe and effective for young people.

“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit.

The recommendation only applies to those who received the Pfizer vaccine and does not impact those who received Moderna or Johnson & Johnson.

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FDA advisory group rejects Covid boosters for most, limits to high-risk groups

September 14, 2021

Resigning FDA advisers say COVID-19 boosters unnecessary for most

An international group of scientists says that current evidence doesn’t indicate a general need for COVID-19 vaccine booster shots. The group includes two senior Food and Drug Administration (FDA) officials who are reportedly resigning from their positions over a disagreement with the Biden administration on COVID-19 boosters.

The researchers published their findings in The Lancet on Monday, arguing that the data is too insufficient to implement a widespread booster protocol.

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” the authors wrote. “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

Among the researchers are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause. Gruber will step down in October, and Krause will follow suit in November.

Source:

COVID-19 vaccine boosters unnecessary for most, say FDA advisers reportedly resigning over issue

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