FDA

Mr Beast, Logan Paul, & KSI’s Lunchly Subjected To FDA Investigation Following Allegations Of Moldy Meals

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MrBeast, Logan Paul, and KSI created a holy trifecta of superstar content creators to launch their packaged meal brand, Lunchly. But their combined Internet clout isn’t getting past the United States’ Food and Drug Administration easily. Moreover, allegations emerged on social media that the Lunchables competitor’s products were moldy, such as the cheese on their pizza alternative. According to TMZ Sports, the FDA announced on Friday (October 25) that it received over ten complaints from consumers, including one that claims that the meal caused an illness. The federal agency also indicated that it will review these complaints and update the public if a public health advisory is necessary.

Furthermore, the FDA also made note of Lunchly’s responsibility to adhere to Good Manufacturing Practices regulations to ensure the safety of their products. In addition, they warned of strict applicable action if they find that the brand does not – or did not – comply with these rules. Many individuals online complained about this alleged mold issue, such as a viral video from influencer Rosanna Pansino. If you don’t know what Lunchly is, it’s a pre-packaged meal similar to Lunchables that includes (and promotes) Logan Paul and KSI’s PRIME energy drink and MrBeast’s Feastables food products.

Read More: Logan Paul Sues Coffeezilla Over Alleged CryptoZoo Lies

KSI, MrBeast & Logan Paul Promoting Lunchly

“All Lunchly products go through a stringent review process to ensure the quality and safety of its products,” a representative for the company reportedly stated to TMZ Sports to address the issue. “That process consists of multiple inspections and approvals, including that of the USDA, before any product can even leave the manufacturing facility.” KSI and Logan Paul even addressed the controversy on the latter’s podcast earlier this week. Like the backlash to the former’s “Thick Of It” collab with Trippie Redd, they chalked it up to haters just farming engagement with clickbait fodder.

We’ll see whether this FDA investigation results in any significant action or findings. Elsewhere, MrBeast is still dealing with the fallout of the massive controversy involving colleague Ava Kris Tyson. As for Logan Paul and KSI, we’ll see if this new federal statement has them change their previously dismissive tune. Surely everyone on both sides of these complaints will come through with more public statements addressing these allegations.

Read More: MrBeast Breaks Silence On Ava Kris Tyson Allegations And Takes Swift Action

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FDA Faces Scrutiny Over Mifepristone Decision: A Threat to Women’s Health

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The U.S. Food and Drug Administration (FDA), in charge of safeguarding the safety of our food and drugs, finds itself embroiled in a legal battle as the U.S. Supreme Court prepares to hear arguments in a lawsuit against the agency. At the heart of this legal dispute lies the FDA’s decision regarding mifepristone, a high-risk drug used in medication abortion procedures. This decision, made despite acknowledged inadequacies in the supporting data and studies, has raised serious concerns about the welfare of hundreds of thousands of Americans impacted by its ramifications.

Mifepristone’s FDA-approved label warns of its potential dangers, with approximately one in 25 women facing the prospect of ending up in the emergency room after taking the drug. Recognizing these risks, the FDA initially instituted stringent safety measures, including mandatory in-person medical care with a licensed physician before and after taking the drug. These precautions aimed to detect life-threatening conditions like ectopic pregnancy and monitor for complications such as severe bleeding and infections.

However, in both 2016 and 2021, the FDA controversially eliminated these requirements, allowing for the distribution of mifepristone without ongoing in-person medical supervision. This decision came despite the drug’s Black Box warning highlighting the potential for “serious and sometimes fatal infections and bleeding.” What’s alarming is that the FDA based its decision on data and studies it openly admitted were unreliable and inadequate.

The FDA’s reliance on its Adverse Event Reporting System (FAERS) database to justify the removal of in-person requirements raises serious questions. The agency itself acknowledges that FAERS data alone are insufficient to determine a drug’s safety profile. Additionally, the FDA’s failure to address the absence of reporting requirements for non-fatal serious adverse events leaves a critical gap in monitoring and responding to potential risks associated with mifepristone use.

Moreover, the FDA’s reliance on studies evaluating mail-order dispensing of abortion drugs, despite their limitations and red flags, further undermines the credibility of its decision-making process. These studies revealed alarming rates of hospitalization and unplanned clinical encounters associated with mail-order dispensing, directly contradicting the FDA’s rationale for removing in-person requirements.

In light of these deficiencies, the FDA’s decision to authorize self-administration of mifepristone poses a grave risk to women’s health, exposing them to serious and life-threatening complications without adequate medical oversight. The agency’s failure to engage in reasoned decision-making, as required by the Administrative Procedure Act, highlights a troubling disregard for public safety.

The lawsuit challenging the FDA’s actions, supported by Alliance Defending Freedom attorneys and a coalition of doctors and medical associations, underscores the urgency of holding the agency accountable. These healthcare professionals, who witness firsthand the harms inflicted by the FDA’s recklessness, are advocating for the restoration of common-sense health and safety standards.

As the case heads to the Supreme Court, the American people deserve a federal government committed to evidence-based decision-making and prioritizing public health above all else. The FDA must not be allowed to jeopardize women’s health with insufficiently supported conclusions and inadequate rationales. It’s time to ensure that no agency is above the law, and that the FDA fulfills its duty to protect and promote the well-being of all Americans.

Watch below. Thoughts?

The post FDA Faces Scrutiny Over Mifepristone Decision: A Threat to Women’s Health first appeared on The Source.

The post FDA Faces Scrutiny Over Mifepristone Decision: A Threat to Women’s Health appeared first on The Source.

FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline

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On Friday, the Food and Drug Administration approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The drug, Lecanemab, will be sold under the name Leqembi and is a monoclonal antibody infusion administered every two weeks for patients with mild cognitive impairment.

Alzheimer’s is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. Most drugs approved by the FDA for Alzheimer’s target helping symptoms, not actually slowing the progression of the disease.

In late September the companies that developed the drug, Eisai and Biogen, reported a phase 3 clinical trial of 1,795 patients. Results found that Leqembi slowed the cognitive decline of those who received by 27% after 18 months. The FDA expects to review the phase 3 data “soon.”

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In 2021, the FDA approved another Alzheimer’s drug developed by Biogen, called Aduhelm. For a second time, the administration did not seek the advice of its advisory committee. The approval of Leqembi offers hope to patients after continuous failures to find effective treatments. A mid-stage trial was conducted including 856 patients with Alzheimer’s disease.

Side effects of the newly approved drug have been reported according to experts. Due to approval by an accelerated pathway, the early adoption offers a new medication that “fills an unmet medical need.” However, companies are still required to conduct additional clinical trials to confirm the benefits of their drugs and mitigate risk factors that would require removal from the market. 

Safety concerns have been raised regarding use of the drug. Data shows a minimum of three deaths can be linked to the medication after the patients experienced brain swelling or brain bleeding. Phase 3 trial data reflects that nearly 12.6 % of patients who received the medication experienced brain swelling, compared with just 1.7% of those in the placebo group. About 17% of patients who received the drug experienced brain bleeding, compared with 9% in the placebo group. Still, the company is confident the benefits offered by the drug are worth facing possible risks. 

In a scathing congressional report, detailing the approval of Aduhelm, investigators express that the agency failed to adhere to its own standards and that its approval of Aduhelm was “rife with irregularities.” Public Citizen, an advocacy group, has urged the FDA to postpone its decision on whether to approve Leqembi while the companies finish the additional clinical trials needed for full approval. 

The emotional toll placed on patients and family members of those with Alzheimer’s disease is nothing short of heartbreaking. Though Leqembi is not a cure; it aims to slow the progression of the disease by removing clumps of beta-amyloid — long believed by scientists to be one of the main causes of the disease — from the brain.

The biweekly medication is expected to cost around $25,000 annually for a single patient, Ivan Cheung, the U.S. chairman and CEO of Eisai, reported. The Centers for Medicare & Medicaid Services currently limits coverage of drugs that target amyloid in the brain, so uptake of the new medication is likely to be limited at first, Cheung added.

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