FDA

Monday

David Mansdoerfer

MAHA must resist purity tests to survive

The Make America Healthy Again movement has already accomplished more in its first year than many reformers dared to hope. Major food companies are starting to phase out those artificial dyes. States are testing ways to remove junk food from SNAP benefits. The MAHA Commission delivered a refreshingly honest assessment of the childhood chronic-disease crisis. Vaccine schedules have been thoughtfully adjusted toward the shots with the broadest consensus, and federal attention is finally turning to ultra-processed foods, seed oils and environmental toxins. These are real, tangible wins we can build on. Yet there’s a quiet risk brewing within the movement: the temptation to slide into puritanism.

RFK

Saturday

Teresa Mull

The Trump administration is not pro-life. Why?

President Donald Trump is continuing his consistently inconsistent stance on abortion as his administration’s Justice Department has asked a federal court in Texas to dismiss a case aiming to increase regulations on mifepristone, an abortion pill shown in some rare cases to involve serious health risks. Trump has claimed many times in the past to be pro-life, even saying in 2016 that “there has to be some form of punishment” for abortions.

pro-life

Wednesday

Ben Domenech

Josh Hawley talks Trump’s first 100 days: pro-life ‘needs to be a priority’

Senator Josh Hawley of Missouri has been one of Donald Trump’s fiercest allies on Capitol Hill. But since his easy re-election last November, he’s also been someone within the Republican party who demanded public commitments from Trump’s nominees on several issues of importance to him – areas of concern that include the influence of big tech, the encroaching role of China and a promise on the part of nominees with little or no record on the abortion issue to support pro-life policies. Senator Hawley spoke to me on the 100th day of Trump’s second presidency about what he’s seeing on tariffs, foreign policy and China.

hawley

Thursday

Neal Pollack

RFK Jr.’s hill to dye on?

If you’re to believe media accounts of Robert F. Kennedy Jr.’s extraordinary Tuesday press conference, the Health and Human Services Secretary has “banned” eight toxic colored dyes from American food products. Milder accounts say that the agency has ordered Big Food to “phase out” these dyes by the end of 2026. No one legitimate will argue against food-dye restrictions and anyone who does is either reflexively anti-Trump to an absurd degree or is a paid food-industry shill. But the problem is that there were no food-industry shills present at the press conference. RFK Jr. has essentially asked the food companies to do the right thing by American consumers – by self-deporting. “We don’t have an agreement,” RFK Jr. said. “We have an understanding.

Food dye

Thursday

Spectator Editorial

The heterodox cabinet

As Inauguration Day approaches, the second Trump administration is staffing up. The president-elect’s picks are more or less what everyone expected, outside of a few curveballs. To be honest, the lack of outrage from Trump critics is the big surprise: apparently Trump Derangement Syndrome is a passing fever; even many who’ve argued against him seem to see some logic in the administration of outsiders he’s been signaling he’ll pick for years. In Washington, where almost nothing changes from administration to administration, these cabinet picks might actually be able to effect some meaningful disruption. In almost every role that matters, Trump has opted for a nominee who has been an extreme critic of the very body he or she is set to oversee.

cabinet

Wednesday

Cockburn

Juul developing age-restricted e-cigarettes

Juul, the once dominant e-cigarette company, is back with a new proposed product that it hopes will rescue it from the brink of bankruptcy: age-restricted vapes.   In their attempts to make smoking less accessible for minors, the company is prepared to make the simple pleasure a pain for everyone. Users first must buy a new e-cigarette that pairs with a phone app. They will then upload their government ID or a real-time selfie to the app and have a third-party database verify their identity. A unique Pod ID chip within the Juul device will detect counterfeit cartridges made by other companies, who have flooded the market with illegal fruity flavors that appeal to minors. To further combat the problem, the new device only comes with just one flavor—Virginia Tobacco.

juul

Wednesday

Chris Mondics

Meet the drug manufacturer taking the FDA to task for the opioid crisis

Francis Collins, then head of the powerful National Institutes of Health, got right to the point. In a closed-door meeting with pharmaceutical manufacturer Edwin Thompson, Collins demanded Thompson back off his campaign to drastically cut back the use of prescription opioids for chronic, long-term pain. According to Thompson, Collins admitted healthcare regulators knew there was no science showing opioids were effective for anything but acute, short-term incidents. There was at the same time credible research showing the longer a patient remained on opioids, the greater the risk of addiction. Some studies even suggested long-term use increased pain sensitivity. But on that day in 2019, none of that mattered to Collins.

fda edwin thompson

Tuesday

Teresa Mull

Is almond milk damaging the dairy industry?

The Food and Drug Administration (FDA) just released draft guidelines concerning the definition of “milk,” saying that producers of alternative milk beverages derived from plants and nuts (non-mammals) can keep calling their products “milk” because, basically, they’ve been doing it for a while and the public likes it that way. The draft guidance explains “that the public already refers to plant-based milk as milk while also acknowledging the plant source it comes from, such as ‘almond milk’ and ‘soy milk,’” according to Fox Business. “Consumers reportedly favor the term ‘milk’ over plant-based ‘drink,’ ‘beverage’ or ‘juice,’ according to internal and third-party focus groups the FDA cited.” Not everyone agrees with the FDA.

Sunday

Taylor Millard

It’s time to allow over-the-counter birth control

Birth control may finally become available over the counter in the United States. HRA Pharma, a French drugmaker, hopes the FDA will approve its application for sale of the Opill brand after seven years of tests. You’d think Opill was some new kind of drug, except it’s been prescribed to women for decades. “For a product that has been available for the last fifty years, that has been used safely by millions of women, we thought it was time to make it more available,” commented HRA’s chief strategy officer to the Associated Press. HRA Pharma started lobbying for OTC status in 2016 after purchasing the drug rights from Pfizer. And HRA isn’t the only drug company playing a regulatory game of limbo. Cadence Health planned to start a trial for its drug Zena last year.

birth control

Saturday

Matt McDonald

Am I still fully vaccinated?

Am I ‘fully vaccinated’? For the last few months I was sure I was — but recent events are making me doubt myself. Take Monday, when President Biden rolled up his sleeve and presented his unusually hirsute arm for his third Pfizer shot. This followed some federal health advice last week that people over 65, as well as 18-to-64-year-olds with ‘underlying health conditions’ or ‘jobs that increase their risk of developing severe COVID’, are eligible for a third dose of Pfizer. ‘The booster line is if you're fully vaccinated — the bottom line is that if you're fully vaccinated and — you're highly protected now from severe illness, even if you get COVID-19,’ explained the President with his trademark clarity.

vaccinated

Tuesday

Richard Koenig

What to do when Joe Biden falsely promotes the COVID vaccine

Janet Woodcock, MD Acting Commissioner of the Food and Drug Administration 10903 New Hampshire Ave Silver Spring MD 20993-0002 Dear Dr Woodcock, You’ve got a problem. An executive is making unsupported promotional claims for a biological product, indeed one that has yet to be formally licensed by your agency. Doubtless you have dealt with such a violation before. When a pharmaceutical company tries to stretch an efficacy claim beyond the data, you can put a stop to it. You have tools: warning letters, fines, threats of criminal prosecution. But the current situation is a bit thorny. The executive is your boss’s boss. That would be President Joe Biden.

cdc vaccine

Tuesday

Ross Clark

Who really needs a third Pfizer shot?

Do Americans need a third booster shot of the Pfizer vaccine? The question is the subject of a remarkable row between the drugs company and the government — the former of which is putting together an application for emergency use authorization for a third dose and the latter of which has so far proved unwilling to sanction it. The Department of Health and Human Services issued a statement after a meeting on Monday saying: ‘At this time fully-vaccinated Americans do not need a booster shot.’ For its own part, Pfizer cites evidence from Israel which, thanks to a deal with Pfizer, was able to get ahead in its vaccination program in return for the country effectively being used as a giant human laboratory.

third shot pfizer

Monday

Dr Kristina M.L. Acri

Criminal gangs are making billions from fake medical supplies during COVID

While it’s great news that Pfizer, BioNTech, AstraZeneca and other pharmaceutical companies are developing vaccines to prevent people from getting the coronavirus, we should remember that international criminal entities are taking advantage of the fear, uncertainty and desperation created by the coronavirus pandemic to expand their illicit footprint. Since early June, Customs and Border Protection has seized more than 107,000 FDA-prohibited COVID-19 test kits, 750,000 counterfeit face masks, thousands of EPA-prohibited anti-virus lanyards, 11,000 FDA-prohibited chloroquine tables and more than 67,000 ACCU-CHEK test strips. When demand outstrips supply, it creates an environment in which substandard and counterfeit medical supplies proliferate.

fake medical