The U.S. Food and Drug Administration confirmed on Friday that toxic cough syrups linked to children&#8217;s deaths in India had not been shipped to the United States.
The World Health Organization has said India has a &#8220;regulatory gap&#8221; in screening locally sold syrup medicines.
The U.S. FDA said it was aware of news reports of devastating, ongoing diethylene glycol and ethylene glycol contamination in children&#8217;s cough and cold medicine in India.
Indian authorities advised the public to avoid two more brands of cough syrup on Wednesday following the deaths of 17 children under age five, linked to a toxic ingredient.
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The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials said. The deaths were all linked to the Coldrif medicine brand, which was banned after a test confirmed the presence of the chemical on October 2.
India&#8217;s health authority, the Central Drugs Standard Control Organization, informed the U.S. regulator that these products were not exported from India to any other country, the FDA said.
The FDA also said it remains vigilant to prevent contaminated drugs from entering the U.S. and asked manufacturers to ensure that drugs marketed in the U.S. are safe and of the highest quality.
(Reporting by Sneha S K in Bengaluru; Editing by Pooja Desai)

Cough Syrup

Cough Syrups Linked To Child Deaths Not Shipped To U.S., FDA Makes Clear

Health

India

Prescription Drugs

World

Louisiana sued the FDA this week for allowing the unfettered mailing of abortion drugs across the country.
The suit, <a href="https://storage.courtlistener.com/recap/gov.uscourts.lawd.213952/gov.uscourts.lawd.213952.1.0.pdf">filed</a> Monday by Louisiana Attorney General Liz Murrill, accused the FDA of enabling leftist activists to mail abortion pills into states like Louisiana, where chemical abortions are illegal. Murrill asked the court to strike down the FDA’s approval during the Biden administration of mail-order abortion pills.
“Every year, doctors and activists in states like California and New York mail a U.S. Food and Drug Administration (FDA)-approved abortion drug called mifepristone to thousands of Louisiana residents for the express purpose of causing abortions in Louisiana that are blatantly unlawful,” the suit said. “This extra-territorial mailing of abortion drugs is illegal under state law—and it is the direct result of the Biden Administration’s 2023 agency action expressly facilitating this scheme. That action is the subject of this lawsuit.”
In 2023, the Biden administration changed the Risk Evaluation Mitigation Strategy (REMS) for mifepristone, the drug used in over 60% of all abortions, allowing it to be sent through the mail.
Mifepristone works by starving an unborn child to death by cutting it off from the necessary nutrients provided by its mother. A different drug is then taken to induce labor and expel the deceased baby.
Murrill argued in the suit that the FDA’s regulations for mifepristone are “arbitrary and capricious” and violate the Comstock Act, a federal law that bans the mailing of abortion drugs. Joining the suit was Rosalie Markezich, a woman who says her boyfriend ordered illegal abortion pills from California and was then pressured into taking them to end the life of her unborn child.
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In response to a request for comment on the suit, the Department of Health and Human Services said that it does not comment on pending litigation. HHS did point The Daily Wire to its commitment to conducting a study on the reported adverse effects of mifepristone.
“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined [FDA Commissioner Marty Makary] in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight,” HHS Secretary Robert F. Kennedy Jr. <a href="https://x.com/SecKennedy/status/1973866621245567344">said</a> earlier this month.
The suit comes after pro-life advocates were <a href="https://www.dailywire.com/news/pro-lifers-demand-answers-from-trump-admin-after-shocking-abortion-pill-approval?author=Leif+Le+Mahieu&amp;category=News&amp;elementPosition=undefined&amp;row=0&amp;rowType=Vertical+List&amp;title=Pro-Lifers+Demand+Answers+From+Trump+Admin+After+‘Shocking’+Abortion+Pill+Approval">shocked</a> last week after the FDA approved a new generic mifepristone pill. Fifty-two Republican senators sent a <a href="https://justthenews.com/sites/default/files/2025-10/2025.10.09%20-%20Letter%20from%20Senator%20Graham%20et%20al%20to%20HHS%20and%20FDA%20re%20Mifepristone.pdf">letter</a> on Thursday to the FDA and HHS urging them to scrap the regulations that allow the mailing of abortion drugs.
The FDA has said that it was required by law to approve the new generic drug and noted that it was conducting a review of the Biden guidelines. On a press call on Wednesday, SBA Pro-Life America President Marjorie Dannenfelser said she was skeptical of that reasoning.
“This standard only seems to apply to this particular drug. It [has] certainly not been the standard for other drugs where there were questions that needed to be asked, that needed to get answers from those that were developing the drugs,” she said.

Appeals Court Keeps Abortion Pill Mifepristone Available, But With Restrictions

‘Blatantly Unlawful’: Red State Challenges FDA Over Mail-Order Abortions

Abortion

Abortion Drug

Biden Administration

Department of Health and Human Services

Louisiana

Pro-Life Movement

Social Issues

U.S.

Last month marked 25 years since the Food and Drug Administration approved the abortion drug mifepristone, then called RU-486, for use in the United States.
On September 19, Health and Human Services Secretary Robert F. Kennedy, Jr., and the FDA Commissioner Marty Makary, sent a letter to 22 pro-life state attorneys general informing them that the agencies will perform a review of the drug’s safety.
Such a review is long overdue and should result in the revocation of the FDA’s approval of mifepristone or, at minimum, the restoration of important protections around the drug’s prescription.
Since sending that letter, the FDA unexpectedly approved a generic form of the chemical abortion drug. RFK, Jr., and Dr. Makary have regulatory tools at their disposal that could begin the process of removing these dangerous drugs from the market. It is time for them to take decisive action.
The FDA first approved mifepristone in 2000 under a regulation known as Subpart H which allows for the expedited approval of drugs that treat “serious or life-threatening illnesses” and that provide a “meaningful therapeutic benefit to patients over existing treatments.” Mifepristone meets neither of these requirements.
First, mifepristone does not “treat” a “serious or life-threatening illness.” Pregnancy is not an illness and killing an unborn child is not treatment.
Second, chemical abortion does not now, and certainly did not then, provide a “meaningful therapeutic benefit . . . over existing treatments.” As a 2006 <a href="https://advancingamericanfreedom.com/mifepristone-resource-congressional-staff-report-the-fda-and-ru-486-lowering-the-standard-for-womens-health/" target="_blank" rel="noopener">congressional report</a> on mifepristone’s approval explained, “it appears that no concurrently-controlled trials comparing medical and surgical abortion were required by FDA, because the Agency already knew that medical abortion—i.e., abortion by RU-486—is unambiguously inferior to surgical abortion with respect to safety and effectiveness.”
Nor, as the same report lays out in detail, did the FDA rely on studies of sufficient rigor to meet Subpart H’s requirements.
How could the FDA so blatantly disregard its own rules? Because the approval of chemical  abortion was <a href="https://humanlifereview.com/playing-politics-with-the-abortion-pill-a-quarter-century-of-abuse-of-power-at-the-fda/" target="_blank" rel="noopener">political from the start</a>.
In his <a href="https://url.avanan.click/v2/r01/___https:/advancingamericanfreedom.com/mifepristone-resource-judicial-watch-special-report-the-clinton-ru-486-files/___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6Nzo4ZDhkOjI3ZDY5MjU2MWJkOTU4OTZlNjNjYmUwMDI3ZmZjODA5NGMzNmZjYzNiYWU2NDk5MGYxZDE0MmIzNGE0Y2JiNjA6aDpUOk4" target="_blank" rel="noopener">first official act</a> as President, Bill Clinton directed HHS to promote the introduction of the abortion drug into the American market. Over the next seven years, the Clinton administration worked to have the patent rights transferred to the Population Council, which then sought the FDA’s approval.  That transfer of patent rights was necessitated by the fact that the French company that owned the patent was unwilling to introduce the drug to the American market without indemnification of liability for the harms it would foreseeably cause.
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Upon approval of mifepristone, the FDA implemented certain limitations on the drug’s prescription to provide at least some protection to women. <a href="https://url.avanan.click/v2/r01/___https:/storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.137.0_20.pdf___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6Nzo3MWI3OjEzNTE0ZGZhZjY0OTJkZGEwMzg2NmU3ZDRhYjFjYjlhZjQ2MDZiMzc2MzEyMDEzZjNkMmQ4NzgyYTJhOTEwNDY6aDpUOk4" target="_blank" rel="noopener">Specifically,</a> the abortion drug could only be prescribed to women who were less than seven weeks pregnant, women were required to visit the doctor three times, and abortionists were required to report all adverse events.
These restrictions did not make mifepristone safe, but they did reduce the risk of harm to women. For example, in-person consultations provided women with necessary procedures, such as ultrasounds, critical for recognizing ectopic pregnancies, which, if left untreated, are deadly.
In March 2016, the Obama FDA significantly <a href="https://url.avanan.click/v2/r01/___https:/storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.137.0_20.pdf___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6NzozMzQ4OjU0ZDdkY2E2NzEzOWExMDlmZTU0NzVjM2QwMTdkZmFjOGE1YzcxNzc3NTU2OWI3OTg4NzIxOGFlMjJhNjViYTc6aDpUOk4" target="_blank" rel="noopener">reduced</a> these protections, now referred to as a Risk Evaluation and Mitigation Strategy (REMS). Under the updated REMS, women could be prescribed mifepristone for abortions up to 10 weeks’ gestation and only needed to visit a doctor once, non-doctors were allowed to prescribe chemical abortions, and abortionists were only required to report fatal adverse events.
In 2021, the FDA “<a href="https://url.avanan.click/v2/r01/___https:/storage.courtlistener.com/recap/gov.uscourts.txnd.370067/gov.uscourts.txnd.370067.137.0_20.pdf___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6Nzo2ZGViOmVkNjQ0OWNmMjVmNWFiNzUyNDhjYzZkNGE2NzAxODU0ZTkyNjcwNGIzMDIzOWQyMGI0YWY5YjY2NjJkMDdlMzI6aDpUOk4" target="_blank" rel="noopener">removed</a> the ‘in-person dispensing requirement’” altogether.
In 2023, <a href="https://url.avanan.click/v2/r01/___https:/nrlc.org/nrlnewstoday/2024/03/guttmacher-says-abortions-increased-after-dobbs/___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6NzpjZjQ2OmNhNDQ5Mzc5ZWY2OGZhYjg5MjYyMDNlM2RhZGU5NGU3MDU2YjE3M2YwMzlhNjQwMGYwMmYzNmI2MTkyMWIyMDg6aDpUOk4" target="_blank" rel="noopener">63%</a> of abortions were chemical rather than surgical, and <a href="https://url.avanan.click/v2/r01/___https:/www.guttmacher.org/report/stability-number-abortions-2023-2024-us-states-without-total-bans-masks-major-shifts-access___.YXAzOmFhZjphOm86YmM2NTQ4Zjk3MDAzZTY4MjA0NDM5NzQyZjdmNzQ4NGU6Nzo0N2Q2OjFlMjhlNWE0NzQxODVlNWZiZDQ4YThmZWE5ODIzNTFkZTNlOWM3NWM5MGY4ZjJlOWI2NzY2YmM3ZGJmNDM4ZjI6aDpUOk4" target="_blank" rel="noopener">tens of thousands</a> of chemical abortions were shipped into pro-life states in 2024.
The FDA’s review of the dangers of mifepristone to women’s health is long overdue. A recent study by the Ethics and Public Policy Center suggesting that the adverse event rate for chemical abortion is much higher than FDA data suggests, is only the most recent in two and a half decades of evidence that the FDA’s approval of the drug is dangerous for women.
Armed with this and other data, the heads of HHS and the FDA have legal authority to <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-D/section-314.150" target="_blank" rel="noopener">call for a hearing</a> to determine whether the FDA’s initial approval of mifepristone should be withdrawn. This would be an important step toward removing dangerous chemical abortion drugs from the market, and allow the agency to delay approval of any other generic forms of mifepristone currently being considered.
For the past 25 years, mifepristone has been used to terminate innocent human life while injuring and harming women for life. The abortion drug’s reckoning is long overdue. The FDA’s recently announced review is a good first step, but pro-life Americans cannot rest until the dangerous chemical abortion pill is taken off the market and pre-born Americans are safe from its harms.
Marc Wheat is general counsel for Advancing American Freedom.
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The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.
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HHS Secretary Kennedy Holds News Conference On Synthetic Dyes In Food Supply

The FDA’s Review Of Abortion Drugs Is Long Overdue

Robert F. Kennedy Jr.

A coalition of pro-life advocates led by Live Action President Lila Rose on Friday urged Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to reverse the recent approval of an abortion drug. 
Over two dozen pro-life advocates petitioned the FDA following the agency&#8217;s Tuesday approval of Evita Solutions’ generic version of mifepristone, the drug used in over 60% of all abortions. The signatories say that instead of approving new life-ending drugs, the FDA should completely remove mifepristone from the market. 
“We urge you, in the strongest possible terms, to reverse this dangerous approval immediately,&#8221; the coalition wrote, according to a <a href="https://dw-wp-production.imgix.net/2025/10/FDA-Coalition-Letter_-Abortion-Pill-10.3.2025-1.pdf">copy of the letter</a> obtained by The Daily Wire. &#8220;Rather than expanding the license for these drugs, the FDA should acknowledge the clear evidence of harm and withdraw mifepristone from the market.&#8221;
“Every abortion is a violation of human rights, and every life lost is an irreplaceable son or daughter. The federal government must stop enabling this violence under the false banner of ‘healthcare,’” they added. 
Signers of the letter included Ethics and Public Policy Center President Ryan Anderson, Students for Life President Kristan Hawkins, and Concerned Women for America CEO Penny Nance.
On Friday, White House Press Secretary Karoline Leavitt said that the administration did not endorse the drug, but was required by law to approve Evita’s application because it was a generic offering of a drug already offered by two other pharmaceutical companies. 
The letter to Kennedy also laid out the brutal process that takes place after a mother takes a chemical abortion pill. 
“A chemical abortion consists of a two-step process. First, a pregnant mother will take mifepristone to starve her preborn child to death. Next, she will take misoprostol to induce labor contractions and deliver the baby&#8217;s dead body. At this stage in the first trimester, children developing in the womb already have a detectable heartbeat and brainwaves, and are beginning to move their arms and legs,” the coalition wrote. 
The coalition said that the approval contradicted a recent commitment from Kennedy to study the dangers of mifepristone. 
“Yet rather than pausing to examine the mounting evidence showing the harmful effects of mifepristone, the FDA has chosen to expand access to a drug that has already killed millions of preborn children and harmed countless women, undermining the very commitment that the Secretary publicly made to protect patients,” they wrote. 
Chemical abortions account for about two-thirds of all abortions in the United States and have ended the lives of at least 7.5 million unborn babies. At the same time, the mothers who take the pills often experience additional medical complications like hemorrhaging and sepsis. Studies showing the dangers of the drug have been manipulated to hide the harm, the coalition said. 
The decision has already triggered outrage from many Republican lawmakers. Senator Josh Hawley (R-MO) said he had completely lost faith in the FDA over the move, while over a dozen Republican representatives <a href="https://www.dailywire.com/news/republicans-demand-rfk-fire-rogue-actors-at-fda-who-approved-abortion-drug?author=Leif+Le+Mahieu&amp;category=News&amp;elementPosition=1&amp;row=0&amp;rowType=Vertical+List&amp;title=Republicans+Demand+RFK+Fire+%E2%80%98Rogue+Actors%E2%80%99+At+FDA+Who+Approved+Abortion+Drug">sent a letter</a> on Friday telling Kennedy to fire the “rogue actors” at the agency who approved the lethal drug.

Great American Farmers Market 2025

‘Every Abortion Is A Violation Of Human Rights’: Pro-Life Advocates Demand FDA Yank Abortion Drug

Live Action

The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United States.
The program is designed to encourage companies to invest in domestic drug production and research by offering faster approvals for products made with U.S.-sourced ingredients and tested within the country.
Earlier this week, the FDA held a public meeting to discuss its broader efforts to support U.S. pharmaceutical manufacturing, including the PreCheck program, which aims to help set up high-priority drug facilities more quickly.
The FDA said these steps will help strengthen the U.S. drug supply chain and bring high-quality, U.S.-made generic drugs to market more quickly.
More than half of the pharmaceuticals distributed in the United States are made overseas, according to the health regulator.
As of 2025, only 9% of companies that produce the key ingredients in drugs &#8211; known as active pharmaceutical ingredients &#8211; are based in the U.S., compared to 22% in China and 44% in India, the FDA said.
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&#8220;Over-reliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,&#8221; said George Tidmarsh, Director of FDA&#8217;s Center for Drug Evaluation and Research.
&#8220;It also slows down reviews and costs taxpayers more money,&#8221; he added.
The FDA also noted many important studies used to approve drugs &#8211; including tests to show that generic drugs work the same as brand-name ones &#8211; are now often done outside the U.S., which is weakening the country&#8217;s ability to lead in drug research and development.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)

Prescription drugs

FDA Launches Pilot Program To Fast-Track Review Of Generic Drugs Made In U.S.

Trump Administration

A group of 13 House Republicans led by North Carolina Congressman Mark Harris demanded Friday that Health and Human Services Secretary Robert F. Kennedy Jr. fire the bureaucrats responsible for the FDA’s “alarming” approval of a new abortion pill, according to a letter obtained by The Daily Wire. 
Harris told Kennedy that the FDA’s <a href="https://www.dailywire.com/news/pro-lifers-demand-answers-from-trump-admin-after-shocking-abortion-pill-approval?author=Leif+Le+Mahieu&amp;category=News&amp;elementPosition=2&amp;row=0&amp;rowType=Vertical+List&amp;title=Pro-Lifers+Demand+Answers+From+Trump+Admin+After+%E2%80%98Shocking%E2%80%99+Abortion+Pill+Approval">approval</a> of Evita Solutions’ generic mifepristone, the drug used in over 60% of all abortions, ran contrary to the Trump administration’s pro-life record. Harris and his co-signers suggested that “rogue actors” in the FDA were responsible for the decision. 
“The approval of a generic version of this dangerous drug not only contradicts the announced review but also runs directly counter to this Administration’s stated pro-life agenda,” the lawmakers <a href="https://dw-wp-production.imgix.net/2025/10/10.3.25-Letter-to-Sec-Kennedy-on-Abortion-Pill-Approval.pdf">wrote</a>. “It is clear that rogue actors within the FDA are working to undermine both the sanctity of life and the Administration’s commitment to protecting it.”
They said that Kennedy should look at removing the officials responsible for the decision. 
“For this reason, we respectfully urge that you consider the director of the Office of Generic Drugs, the director of the Center for Drug Evaluation and Research, and other bureaucrats responsible for this reckless decision as part of your reduction-in-force evaluations,” he wrote. 
Signing onto the letter were Reps. Josh Brecheen (OK), Keith Self (Texas), Eli Crane (AZ), Paul Gosar (AZ), Chip Roy (Texas), Mary Miller (IL), Andy Biggs (AZ), Barry Moore (AL), Scott Perry (PA), Ralph Norman (SC), Sheri Biggs (SC), and Ben Cline (VA). 
Mifepristone works by starving an unborn child to death by cutting it off from the necessary nutrients provided by its mother. A different drug is then taken to induce labor and expel the deceased baby from the mother. 
Harris said that removing the officials responsible for the decision would send a message that the administration still believes in defending innocent life. 
“As stewards of the taxpayers’ trust and defenders of the unborn, we must ensure that no federal office operates in open defiance of our values or the administration’s pro-life commitments. This is a critical moment to send a clear message that the lives of the unborn and the health of women will not be compromised by bureaucratic mismanagement or ideological activism.
Commenting on the approval, Health and Human Services Communications Director Andrew Nixon told The Daily Wire that the FDA “has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.”
Nixon added that applicants for generic drugs do not need to submit independent evidence proving safety and efficacy. He also noted that HHS is conducting a review of the “reported adverse effects” of mifepristone.
Only two other drug companies, Danco Labs and Genbiopro, were previously approved to distribute the life-ending drug. The FDA wrote to Evita Solutions on September 30 that it had “concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval.”
The announcement shocked pro-life advocates, who have continued to press for action to crack down on the widespread distribution of abortion pills across the country.

MixCollage-03-Oct-2025-09-31-AM-5086

Republicans Demand RFK Fire ‘Rogue Actors’ At FDA Who Approved Abortion Drug

Pro-life advocates are demanding answers from the White House after the FDA approved a new abortion pill in a “shocking” decision earlier this week.
The FDA on Tuesday gave <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf">approval</a> for Evita Solutions to distribute mifepristone, a drug that is used to end the life of an unborn child in up to 63% of all abortions. After a pregnant woman takes mifepristone, her unborn child is cut off from the nutrients it needs to survive and is effectively starved to death. A different drug is then taken to induce labor and expel the deceased baby from the mother. 
The fatal drug has been increasingly available after the Biden administration allowed it to be mailed by doctors. Leftist activists ship the drugs illegally across the country with impunity. 
Senator Josh Hawley (R-MO) called the approval “shocking” and said he had lost faith in FDA leadership. 
“This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child,” Hawley <a href="https://x.com/HawleyMO/status/1973801164052574259">wrote</a> on X. 
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” he added. 
Rep. Mark Harris (R-NC) also questioned the move.
&#8220;Wow! The FDA just approved a generic version of the abortion pill, Mifepristone, a drug that ends a baby&#8217;s life 100% of the time and harms mothers. The FDA announced a new safety study just days ago, so why this new move now?&#8221; he <a href="https://x.com/RepMarkHarrisNC/status/1973841437730222548">wrote</a> on X.
Only two other drug companies, Danco Labs and Genbiopro, were previously approved to distribute the life-ending drug. The FDA wrote to Evita Solutions on September 30 that it had “concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval.”
Evita Solutions says on its <a href="https://www.evitasolutionsllc.com">website</a> that “medical abortion care is rife with medically unnecessary restrictions and social stigma in the United States” and that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live.”
Evita said that it expected to have the life-ending drug available by January 2026.
&#8220;Evita Solutions is now the third manufacturer (the second generic manufacturer) with FDA approval.  Availability of our product will expand patients’ options for medication abortion with an affordable product backed by decades of safe use,&#8221; it said in a statement.
In response to questions about the drug’s approval, Health and Human Services Communications Director Andrew Nixon told The Daily Wire that the FDA “has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.”
Nixon added that applicants for generic drugs do not need to submit independent evidence proving safety and efficacy. 
“HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks,” Nixon added. “The FDA does not endorse any drug product and directs prescribers to follow all labeling.”
The decision is already drawing backlash from pro-life advocates who have long warned about the dangers of the drug. Kelsey Pritchard, the director of state affairs for SBA Pro-Life America, called the decision “reckless.”
“This does nothing to help and fix the problem that we have with abortion drugs and mail-order abortion drugs, and instead puts a cheap drug on the market so that more unborn lives are taken and more women and girls end up in the ER,” she told The Daily Wire. 
Pritchard said that the Trump administration should reinstate restrictions on the mailing of mifepristone that the Biden administration loosened. 
“This decision is not MAGA. It is not MAHA, adding a new life ending drug to the market doesn&#8217;t make America greater or healthier, and this is not something that we would expect, especially at this time,” she added, calling for pro-life Republicans to call out the decision. 
Last month, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told Republican attorneys general that they were studying the safety of mifepristone. Some studies have shown that the drug is not only fatal to the unborn child but can also bring serious health risks to the mother.

Senate Hearing Examines AI Industry’s Use Of Copyrighted Works To Train AI Models

Pro-Lifers Demand Answers From Trump Admin After ‘Shocking’ Abortion Pill Approval

The U.S. Food and Drug Administration (FDA) announced on Tuesday evening that it&#8217;s cracking down on deceptive pharmaceutical ads, issuing thousands of warning letters and about 100 cease-and-desist notifications.
“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” FDA Commissioner Dr. Marty Makary said in a statement. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”
A press release from the agency said current law requires pharma ads to &#8220;present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; not create a misleading overall impression; properly disclose financial relationships; and include information regarding major side effects and contraindications.&#8221;
That rule, which the FDA did not adequately enforce during the Biden years, will be &#8220;aggressively&#8221; enforced now, the release says. Additionally, the FDA is closing the “adequate provision” loophole created in 1997, which companies have used to &#8220;conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.&#8221;
Television ads are not the only promotional content being scrutinized and regulated. Social media posts, which often feature an influencer talking up the drug, rarely mention &#8220;potential harms,&#8221; or they fail to disclose that the influencers are being paid.
&#8220;[W]hile 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms,&#8221; the FDA said, citing a 2024 review in the Journal of Pharmaceutical Health Services Research. &#8220;Moreover, 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.&#8221;
In the thousands of letters sent to drug companies, the FDA warns, &#8220;You are hereby directed to remove any noncompliant advertising and bring all promotional communications into compliance.&#8221;
&#8220;This notice also serves to demand compliance with the [Federal Food, Drug, and Cosmetic] Act and FDA implementing regulations and requires companies to remove any and all DTC (direct-to-consumer) prescription drug advertising that violates the law,&#8221; the letter adds.
Robert F. Kennedy Jr. &#8212; the head of Health and Human Services (HHS), which oversees the FDA &#8212; has long been a critic of Big Pharma ads. He said in a statement issued Tuesday that &#8220;pharmaceutical ads hooked this country on prescription drugs.&#8221;
&#8220;We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising,&#8221; he continued. &#8220;Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
While Kennedy was running for president in 2024, before he endorsed President Donald Trump, he said he would &#8220;issue an executive order banning pharmaceutical advertising on television.&#8221;
&#8220;We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television,&#8221; RFK Jr. said on X in 2024. &#8220;Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.&#8221;

Trump FDA Announces Major Crackdown On ‘Misleading’ Pharma Ads

Big Pharma

Politics

NASHVILLE — Banana Taffy, Dragon Drink, Hawaiian Fruit Punch. Those aren’t smoothies or soft drinks. Those are a sampling of the variety of vapes that continue to enter the United States illegally from China in 2025.
Cases of the brightly-colored devices lined the booths at this year’s Alternative Products Expo in Nashville, Tennessee. Some vape devices featured LED screens. Some were stackable, allowing up to three flavors, enabling the user to concoct their own mixture of candy-like vape flavors. Other vapes were stylized as designer purses. One wholesaler employee pitched a pastel vape device that doubled as a fidget toy.
And as of 2020, all of them were illegal.
<div id="attachment_966933" style="width: 453px" class="wp-caption aligncenter"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-966933" class="wp-image-966933 size-large" src="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6-443x576.jpg" alt="" width="443" height="576" srcset="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6-443x576.jpg 443w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6-231x300.jpg 231w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6-768x999.jpg 768w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6-1181x1536.jpg 1181w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_6.jpg 1516w" sizes=" (max-width: 443px) 100vw, 443px" />A promotional flyer for the Alternative Products Expo in Nashville, Tennessee.</div>
While American manufacturers like JUUL only sell vapes in menthol and tobacco flavors — the only legal flavors in the United States — wholesalers skirt Food and Drug Administration (FDA) regulations by importing vape products from China. These unregulated Chinese vapes are flooding the United States, despite warning letters and threats of seizure by the FDA. At the Alternative Products Expo, wholesalers promoted their illegal, Chinese vape products completely out in the open.
The Chinese company <a href="https://www.kangvapecig.com/">Kangvape</a> prominently displayed its TC8000 vape. The booth stocked the flavors Cool Mint, Miami Mint, Pineapple Coconut, Vintage, Virginia Tobacco, and Watermelon Ice. A flyer advertised an additional 23 flavors, including Rainbow Paradise.
Kangvape also sold its Speedy Beast vape in 20 flavors — none of which included tobacco or menthol. Instead, the Speedy Beast boasted the exotic-sounding Blue Laffi Taffi, Ruby Delight, and Tropical Starburst.
These are being openly hawked with no concern for past threats of action. The FDA <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nfv-llc-dba-nfdvapes-and-nic-fix-doctor-673307-12122023">cited</a> the Rainbow Paradise flavor of the TC8000 in a warning letter from December 2023. Another FDA warning letter from April 2024 <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/highfi-vape-682420-04302024">noted</a> the illegal Kangvape Onee Stick. 
<div id="attachment_966947" style="width: 429px" class="wp-caption aligncenter"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-966947" class="wp-image-966947 size-large" src="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-419x576.jpg" alt="" width="419" height="576" srcset="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-419x576.jpg 419w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-218x300.jpg 218w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-768x1055.jpg 768w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-1118x1536.jpg 1118w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4-1490x2048.jpg 1490w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_4.jpg 1496w" sizes=" (max-width: 419px) 100vw, 419px" />ZColors by ZLAB is another Chinese vape company that sells its products in the United States.</div>
FDA Commissioner Marty Makary said cracking down on illegal vapes is a “top priority” for the agency, The Daily Wire previously <a href="https://www.dailywire.com/news/top-priority-fda-to-crack-down-on-illegal-chinese-vapes">reported</a>.
“Eighty-five percent of the vaping products sold in the vape stores are illegal according to the FDA’s list,” Makary said. “We don’t even know what’s in some of these vaping products.”
There are only 39 vape products that have been authorized by the FDA.
An FDA spokesman says a federal task force is facilitating actions against illegal products.
“FDA has taken numerous actions against unauthorized new tobacco products from international firms, including e-cigarettes that are most popular with youth,” the spokesman told The Daily Wire.
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The FDA reports that it has seized millions of dollars’ worth of illegal products. In January, the agency seized $7 million worth of vape products, including the brand Geek Bar, which an FDA press release <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/more-7-million-worth-illegal-e-cigarettes-seized-federal-operation" target="_blank" rel="noopener">stated</a> “may appeal to youth.”
The seizures haven’t scared Kangvape. The company sold dozens of boxes of Geek Bar vapes at the Expo, featuring flavors ranging from Banana Taffy Freeze to Blue Razz Ice.
Federal action appears to have had little impact on Chinese vapes in general. The Expo featured wholesalers that have received FDA warning letters and seemingly ignored them.
One such wholesaler, Safa Goods, was a sponsor of the Expo. Its name appeared on Expo nametags, as did advertisements for two other illegal vape brands, Beri Crush and Raz LTX.
The warning letter to Safa, <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safa-goods-llc-665079-10052023">sent</a> in October 2023, cited the illegal vape product EB Design BC5000 Blue Razz Ice. Safa’s booth didn’t advertise the EB vapes. But it did sell the illegal vape Raz LTX 25K, which was <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vapejuicecom-709722-05302025">cited</a> in an FDA warning letter from May 2025.
The Raz LTX 25K is a <a href="https://mipod.com/blogs/mipodblog/what-happened-to-raz-dc25000-vapes?srsltid=AfmBOor8Y9qvgdp0D6RivbJ6vGd7lvXcRpp2AeXAOV_R7DvF28cbEUfl">rebrand</a> of the Raz DC25000, which has also been cited in multiple FDA warning letters. Safa’s Expo booth sold the flavor Mango Loco, which was <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thesmokeplugcom-709720-05302025">named</a> in an FDA warning letter from May 2025.
<div id="attachment_967009" style="width: 452px" class="wp-caption aligncenter"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-967009" class="wp-image-967009 size-large" src="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-442x576.jpg" alt="" width="442" height="576" srcset="https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-442x576.jpg 442w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-230x300.jpg 230w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-768x1000.jpg 768w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-1179x1536.jpg 1179w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7-1572x2048.jpg 1572w, https://dw-wp-production.imgix.net/2025/08/Vape-Flyers_7.jpg 1612w" sizes=" (max-width: 442px) 100vw, 442px" />Safa Goods, a U.S. company that distributes Chinese vape products, was a sponsor of the Alternative Products Expo in Nashville.</div>
Safa also sold dozens of flavors aside from menthol and tobacco in additional brands.
The company is the subject of a New York lawsuit <a href="https://ag.ny.gov/press-release/2025/attorney-general-james-sues-nations-largest-vape-distributors-fueling-youth">suing</a> multiple vape distributors “for illegally distributing, marketing, and selling flavored disposable vapes.”
A primary concern with these vapes, with flavors more fit for a candy store than a tobacco shop, is that they appeal to children. Illegal e-cigarettes often attract children and teens through bright colors and fruit- and candy-based flavors, according to Makary.
The FDA spokesman said the agency works with “federal partners to combat these attempted illegal imports and enhance enforcement activities,” especially against vape products “that may be appealing to youth.”
An FDA seizure in 2023 included the illegal brand Lost Mary. Expo wholesaler Strictly E-Cig’s 2025 product catalog advertised 30 flavors of Lost Mary vapes, with names such as Dragon Drink, Rocket Popsicle, and Scary Berry. The Lost Mary products are available for purchase online.
Another wholesaler, Sol Trading, leaned into pastel colors and “cutie, fruity flavors” to market its UT Bar vape, which one employee pitched as both a vape and a fidget toy.
The UT Bar combines two flavors into one vape. The flavor combinations included B-Pop and Watermelon, Citrus Ice and Sour Fab, Cool Mint and Icy Mint, and Raspberry and White Peach.
Multiple sellers advertised flavor combinations at the Expo. Chinese-based company Ziip Lab sold its Z-Land vape, which allows the user to stack up to three vape pods for more than 125,000 flavor combinations, according to a handout from the booth.
The flyer advertised stacking flavors such as Berry Mix and Guava, as well as Blueberry, Green Apple, and Orange. Z-Land comes in a total of 51 flavors, including Milk, Rainbow Rain, and Skittle Ice Fruits.
Another wholesaler, Unishow, sold GeakNexx vapes at the Expo. Unishow <a href="https://www.fda.gov/media/128992/download?attachment">received</a> an FDA warning letter in 2019 for selling illegal products. The GeakNexx vapes came in about a dozen illicit flavors, including Blue Oat Donut, Frozen Fcuking Fab, and Strawberry Banana.
The Alternative Products Expo, Kangvape, Safa Goods, Strictly E-Cig, Unishow, and Ziip Lab did not respond to requests for comment.
The illegal vapes didn’t stop with the wholesalers. The Alternative Products Expo itself advertised a giveaway of $50,000 worth of illegal vape products, including the disposable Geek Bar Pulse and the Raz DC25000, and the Raz TN9000. The <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/denverelectroniccigarettescom-708988-05162025">Geek Bar Pulse</a>, Raz DC25000, and <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nepa-wholesale-inc-710957-06262025">Raz TN9000</a> have been cited in FDA warning letters.
The Expo promoted the illegal vapes giveaway with a large sign and a locked case of vapes just inside the entrance to the convention center. It also marketed the giveaway online and in the official show book.
The advertised flavors included Blue Razz Ice, Fire and Ice, and Miami Mint. An additional flavor, Strawberry Burst, did not contain nicotine.
The Expo was not only for vapes, but also “the full spectrum of alternative products,” including CBD-based products, mushrooms, and Kratom, another drug that’s become dangerously popular with America’s teenagers.
Many of these vapes are smuggled into the United States. A previous Daily Wire investigation <a href="https://www.dailywire.com/news/china-is-flooding-america-with-illegal-vapes-and-more-than-90-fly-under-the-radar">found</a> that over 90% of imported Chinese vape products in 2024 were not included in U.S. import data. The companies often disguise their products by labeling them as battery chargers and flashlights.
“[What] we have been doing is laughable,” Makary said. “We’re going to start confiscating and seizing. We’re going to take this seriously.”

IMG_6982

From Banana Taffy To Dragon Drink: The Illegal Chinese Vapes Flooding The U.S. Market

Drugs

Investigation

Nashville

News

Vape

A week ago, President Donald Trump <a href="http://www.forbes.com/sites/dariosabaghi/2025/08/11/trump-says-marijuana-rescheduling-will-be-decided-within-weeks/">said</a> that he would soon decide whether to move cannabis from Schedule I to III for purposes of the Controlled Substances Act of 1970 (CSA), which would take marijuana out of the category of drugs that cannot be used for any purpose. Doing so would be a huge mistake. Huge.
Congress placed cannabis in Schedule I — the category for drugs that have no legitimate medical use, that are potentially addictive, and have no safe use even under a physician’s supervision — when it passed the CSA 55 years ago. While Congress empowered the U.S. Attorney General, after consultation with the Secretary of Health and Human Services, to reschedule cannabis, in the ensuing half-century, no Republican or Democratic attorney general has done so, and no court has ruled that they must do so.
In 2023, however, cannabis advocates finally found a friend. Admiral Rachel L. Levine, HHS Assistant Secretary for Health under President Biden, <a href="http://www.jamanetwork.com/journals/jamapsychiatry/article-abstract/2834954">recommended</a> that Attorney General Merrick Garland transfer cannabis into Schedule III. To justify that conclusion, Levine invented a newfangled test that relied heavily on the fact that multiple states have adopted medical cannabis programs. As a matter of law, that rationale is wrong for multiple reasons.
First, Congress could not have been clearer that it is the exclusive responsibility of the U.S. Food and Drug Administration (FDA), not the states, to decide whether a drug is safe, effective, and uniform. Levine’s rationale effectively and unlawfully transfers decision-making authority from the FDA to the states.
Second, the FDA has never approved the botanical form of cannabis as a safe, effective, and uniformly made drug. The FDA has approved the synthesis of compounds found in the plant by legitimate pharmaceutical companies, but has not approved the interstate distribution of the cannabis plant enjoyed by Cheech and Chong and Harold and Kumar fans.
Third, the FDA could not find that the cannabis plant is safe, effective, and uniformly made.
Start with its safety. The cannabis sold today is <a href="https://www.congress.gov/116/meeting/house/110381/witnesses/HHRG-116-IF14-Wstate-VolkowN-20200115.pdf">far more powerful</a> than the version smoked at Woodstock. At that time, the tetrahydrocannabinol (THC) content — the psychoactive ingredient in cannabis — was 3-6%. Now, some concentrated cannabis products can have a 90% THC content. That difference is like comparing near beer to grain alcohol.
Growing evidence also links cannabis use to a host of <a href="https://www.congress.gov/116/meeting/house/110381/witnesses/HHRG-116-IF14-Wstate-VolkowN-20200115.pdf">adverse physical outcomes</a>, such as oral, head, and neck cancers; cardiovascular disorders; pulmonary disease; and numerous adverse psychological effects, such earlier onset of psychosis; reduced IQ; childhood poisonings; amotivational syndrome; increased school absenteeism; and a reduced likelihood of graduating high school, enrolling in a university, or completing higher degree requirements. Heavy cannabis users and people who begin its use as minors and continue into adulthood are particularly <a href="https://www.congress.gov/116/meeting/house/110381/witnesses/HHRG-116-IF14-Wstate-VolkowN-20200115.pdf">susceptible</a> to these harms.
Plus, botanical cannabis can be adulterated with a host of dangerous, unhealthy, or downright disgusting contaminants. Dr. Nora Volkow, Director of the National Institute on Drug Abuse, told Congress in 2020 that “individuals across the country are using cannabis strains and extracts that have not undergone the rigorous clinical trials required to show that they are safe and effective for medical use, and are not regulated for consistency or quality.”
As I explained in an <a href="https://www.heritage.org/sites/default/files/2023-08/SR275.pdf">earlier article</a>, among the “hodgepodge” of dangerous contaminants found in the cannabis sold today are E. coli, fungi, mold, toxins, hazardous chemical solvents such as butane and propane, pesticides, heavy metals (such as arsenic, lead, and mercury), and other harmful and disgusting substances such as formaldehyde and insects. The FDA would never allow such contaminants to be present in any drug sold to the public.
Cannabis can also lead to physical dependence in users. Heavy or long-term use can lead a person to develop a tolerance to THC, requiring ever greater quantities of the chemical to experience the same euphoria. As drug policy experts Wayne Hall and Rosalie Pacula have explained, there is a 10% risk of addiction for people who have ever used cannabis, a 20-33% for people who use it more frequently, and a 50% risk — &#8220;<a href="https://www.heritage.org/sites/default/files/2023-08/SR275.pdf">a coin flip</a>” — for people who use it daily. Driving while stoned can, of course, lead to motor vehicle accidents that maim or kill pedestrians or other drivers and their passengers.
Keep in mind that the FDA has <a href="http://www.heritage.org/sites/default/files/2023-08/SR275.pdf">never</a> given approval for a drug to be smoked. Why? There is no uniform depth or length of any one inhalation, and no uniform number of inhalations that users follow. Moreover, the nation concluded over 60 years ago that smoking burnt carbon products damages a smoker’s health, which explains why major medical institutions such as the American Medical Association, the U.S. National Institutes of Health, and the Royal College of Physicians have <a href="http://www.heritage.org/sites/default/files/2023-08/SR275.pdf">not</a> recommended smoking as a legitimate drug delivery system.
The raw cannabis plant also is not “effective” for purposes of the Food, Drug, and Cosmetic Act. Only a handful of controlled studies have examined whether pot can be used as a legitimate treatment for disease or injury; the results are <a href="https://www.law.georgetown.edu/public-policy-journal/wp-content/uploads/sites/23/2019/09/17-2-Larkin-Madras.pdf">inadequate</a> to draw any scientific conclusion.
The most common justification offered is that its psychoactive calming effect makes it a legitimate analgesic alternative for pain. But that argument is medically <a href="https://www.law.georgetown.edu/public-policy-journal/wp-content/uploads/sites/23/2019/09/17-2-Larkin-Madras.pdf">unsound</a>. Cannabis is too weak to substitute for opioids as a treatment for severe pain — indeed, it hinders cessation of opioid use by anyone trying to kick an opioid <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4127123/pdf/nihms609765.pdf">dependency</a> — and scientific proof that THC is a valid treatment for lower levels of pain is also lacking.
To be sure, smoking a joint can get you “high,” but that is not the test for a medicine’s effectiveness. As Dr. Peter Bach, Director of the Center for Health Policy and Outcomes at the Memorial Sloan Kettering Cancer Center, <a href="https://www.wsj.com/articles/if-weed-is-medicine-so-is-budweiser-11547770981?gaa_at=eafs&amp;gaa_n=ASWzDAh7LaDEYv_vcqs-izvRtTLHvE4_TMMU_qu3NyDxy9OXughPlX3zaBL-&amp;gaa_ts=689c8e99&amp;gaa_sig=tzI2Ti78lH5zRhqIjd3w0ZVcT308pAa8r1GA3Re1URauoN8dYXnoBs5EqZYAmoitDwKaFsuYPpeZooGzKZ9AwA%3D%3D">explained</a>, “[E]very intoxicant would pass that sort of test because you don’t experience pain as acutely when you are high. If weed is a pain reliever, so is Budweiser.”
Finally, the cannabis plant is not a <a href="http://www.heritage.org/sites/default/files/2023-08/SR275.pdf">uniformly made product</a>. As Brian Thomas and Mahmoud ElSohly <a href="http://www.heritage.org/sites/default/files/2023-08/SR275.pdf">explained</a> in their book The Analytical Chemistry of Cannabis, “The number of parameters on which cannabis can vary is enormous,” and differs according to “strain, growing conditions, harvesting methods and handling,” to “storage and processing of the raw material to combining them with a wide variety of foods and other excipients in manufacturing, and to “methods of administration (eating, smoking, ‘vaping,’ applying to mucous membranes)” and so forth.
Botanical cannabis also varies according to potency and the presence of cannabinoids (i.e., biochemically active compounds), which tends to <a href="http://www.heritage.org/sites/default/files/2023-08/SR275.pdf">offset or moderate</a> the potential adverse effects of high THC consumption, such as anxiety, cognitive impairment, amotivational syndrome, dependence or addiction, and psychosis.
In sum, the Levine recommendation from 2023 is wrong as a matter of law and medically unsound, indeed dangerous. If the President truly wants to Make America Healthy Again, he should reject that recommendation.
* * *
Paul J. Larkin is the John, Barbara &amp; Victoria Rumpel Senior Legal Research Fellow at The Heritage Foundation.
The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.

Trump Administration Considers Reclassifying Marijuana As A Less Dangerous Drug

Dude, Rescheduling Cannabis Downwards Would Be A Huge Mistake. Huge.

addiction

Congress

Federal Government

Marijuana

The Food and Drug Administration’s top vaccine and gene therapy regulator has reportedly been ousted from his position.
Dr. Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research, recently came under scrutiny for a request to <a href="https://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold">pause</a> shipments of a gene therapy for Duchenne muscular dystrophy (DMD), claiming the genetic treatment is linked to three potential deaths. Earlier this week, the FDA lifted the pause for DMD patients who are still able to walk.
Andrew Nixon, a spokesman for Health and Human Services, confirmed Prasad is no longer with the FDA but did not share details about his departure.
“Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Nixon said in a statement. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”
In a statement issued on July 18, Prasad said the gene therapy &#8212; called Elevidys and made by Sarepta Therapeutics &#8212; needed to be paused for patient safety.
“Protecting patient safety is our highest priority, and the FDA will not allow products whose harms are greater than benefits,&#8221; he said. &#8220;The FDA will halt any clinical trial of an investigational product if clinical trial participants would be exposed to an unreasonable and significant risk of illness or injury,”
FDA Commissioner Marty Makary gave his support to Prasad, seeming to praise the &#8220;swift action.&#8221;
“Today, we’ve shown that this FDA takes swift action when patient safety is at risk,” Makary said. “We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges.”
Some conservatives criticized Prasad for pausing the therapy. A piece published by RealClearHealth said Prasad was standing with &#8220;progressive health policies,&#8221; and not the president.
<blockquote class="twitter-tweet">
More on the man destroying <a href="https://twitter.com/POTUS?ref_src=twsrc%5Etfw">@POTUS</a> legacy for helping patients. FDA’s Vinay Prasad Stands with Progressive Health Policies <a href="https://t.co/4wQ3mRuA6U">https://t.co/4wQ3mRuA6U</a>
— Rick Santorum (@RickSantorum) <a href="https://twitter.com/RickSantorum/status/1948769526776025597?ref_src=twsrc%5Etfw">July 25, 2025</a></blockquote>
&#8220;Prasad’s hostility toward breakthrough therapies is not confined to policy memos. He has dismissed Elevidys as &#8216;disgusting&#8217; because of its $3.2 million price tag, decried its &#8216;unclear benefit,&#8217; and labeled it a &#8216;useless drug,'&#8221; the piece said. &#8220;He lumped it together with Sarepta’s earlier exon-skipping therapy Exondys 51, calling its approval the result of &#8216;shenanigans&#8217; and &#8216;FDA politics&#8217; overriding science.&#8221;
In the past, Prasad expressed publicly his skepticism of President Donald Trump&#8217;s &#8220;right to try&#8221; policy.
However, Emily Kopp, an investigative journalist from The Daily Caller, suggested Big Pharma was playing a role in the controversy. &#8220;Hit pieces on FDA’s Vinay Prasad are being fed to the right by pharma company Sarepta, the maker of an experimental drug that just killed an eight year old boy,&#8221; she wrote.
<blockquote class="twitter-tweet">
Hit pieces on FDA’s Vinay Prasad are being fed to the right by pharma company Sarepta, the maker of an experimental drug that just killed an eight year old boy. <a href="https://t.co/1wCq3ksXWZ">https://t.co/1wCq3ksXWZ</a> <a href="https://t.co/Y8aeRtqBU9">pic.twitter.com/Y8aeRtqBU9</a>
— Emily Kopp (@emilyakopp) <a href="https://twitter.com/emilyakopp/status/1948867147855212627?ref_src=twsrc%5Etfw">July 25, 2025</a></blockquote>
Though Prasad was a critic of COVID vaccine protocols and other pandemic-related approaches, his personal politics have also become <a href="https://loomered.com/2025/07/28/exclusive-trump-fda-official-vinay-prasad-once-said-he-stabbed-a-trump-voodoo-doll-to-curse-him/">a topic</a> for some on the Right. Makary, however, recently defended Prasad from attacks. “There’s not a political bone to his body,” Makary <a href="https://www.politico.com/video/2025/07/26/commissioner-marty-makary-defends-fdas-vinay-prasad-1690337">said</a> of Prasad last weekend. “He’s an impeccable scientist, I think one of the greatest scientific minds of our generation.”

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The Food and Drug Administration (FDA) will crack down on illegal vapes entering the U.S. from China, FDA Commissioner Marty Makary told ABC News.
&#8220;[What] we have been doing is laughable,&#8221; Makary said. &#8220;We&#8217;re going to start confiscating and seizing. We&#8217;re going to take this seriously.&#8221;
The illegal e-cigarettes appeal to children and teens through bright colors and fruit- and candy-based flavors, according to Makary. The vapes are often disguised as handheld video game consoles, highlighters, or smartphone cases, ABC News <a href="https://abcnews.go.com/US/fda-head-warns-illegal-vaping-products-china/story?id=123977131">reported</a>.
&#8220;There is no approved vaping product in the United States that has a video game,&#8221; Makary said. &#8220;There is not an approved vaping product in the United States that has one of these cutie fruity flavors.&#8221;
The only legal e-cigarette flavors are menthol and tobacco, Makary said. There are only 39 authorized e-cigarette products in the U.S.
&#8220;Eighty-five percent of the vaping products sold in the vape stores are illegal according to the FDA&#8217;s list,&#8221; Makary said. &#8220;We don&#8217;t even know what&#8217;s in some of these vaping products.&#8221;
Makary said stopping illegal vapes is a &#8220;top priority&#8221; for the agency.
U.S. Customs and Border Patrol seized about two million illegal vape products last month, ABC News reported. The vapes are worth about $34 million.
&#8220;This is just a small fraction of the seizures we have here,&#8221; CBP official Eric Everson told the outlet.
Over 90% of Chinese vape products imported to the U.S. in 2024 were not reported in American import data, The Daily Wire previously <a href="https://www.dailywire.com/news/china-is-flooding-america-with-illegal-vapes-and-more-than-90-fly-under-the-radar">reported</a>. Experts say Chinese manufacturers intentionally mislabel their products to avoid duties, tariffs, and FDA regulations.
In late 2023, CBP agents <a href="https://apnews.com/article/ecigarettes-elf-bar-fda-teen-vaping-434dc600866cf2a626aa8c7a0063ac43">seized</a> $18 million worth of illegal vapes mislabeled as shoes, toys, and other items.
The influx of illegal vapes led Attorneys General from 27 states to <a href="https://content.govdelivery.com/attachments/IACIO/2025/04/10/file_attachments/3226671/2025.04.09%20-%20Letter%20on%20Chinese%20E-Cigarettes.pdf">write</a> a letter to the Trump administration asking for help &#8220;combating the flood of illegal Chinese products — including illegal Chinese e-cigarettes marketed to minors.&#8221;
&#8220;Illegal, flavored Chinese e-cigarettes are flooding the U.S. market in flagrant disregard of State and federal laws. The products have never been approved by the FDA and target America’s youth,&#8221; the Attorneys General wrote in April. &#8220;They are often brought into the country in mislabeled packaging or shipped in a manner specifically designed to evade detection by the FDA and U.S. Customs and Border Protection.&#8221;

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