Latest news with #andCosmeticAct
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Miami Herald
09-05-2025
- Health
- Miami Herald
Doctor's illegal butt enhancements in FL left patients feeling burning, feds say
A doctor promised that silicone injections he used for butt enhancements were 'safe' — but many of his patients had bad reactions, including some who went to other doctors to have the silicone removed, according to federal court filings. Now, Nhan Pham, 54, of Orlando, is facing up to three years in prison, according to a May 8 news release from the U.S. Attorney's Office for the Middle District of Florida. Pham misled patients when he assured the silicone oil he ordered online and injected into their bodies during gluteal and butt enhancement procedures was ''natural,' and would dissolve over time,' federal prosecutors said. Some patients felt 'severe pain' as well as burning, discoloration, itchiness, soreness and hardness at their injection sites after receiving injections from Pham at his office in Kissimmee and his Orlando home between 2015 and 2019, according to prosecutors. Silicone injections for body enhancements are not only dangerous, but they're illegal, according to the U.S. Food and Drug Administration. Pham, who's accused of violating the Federal Food, Drug, and Cosmetic Act, has pleaded guilty to a federal charge: receipt in interstate commerce and proffered delivery of an adulterated device, the U.S. Attorney's Office said. His defense attorney, Fritz J. Scheller, told McClatchy News on May 8 that while Pham 'has accepted responsibility for his actions, they should not be the sole measure of the man.' Pham served in the U.S. military and 'has provided exemplary service to this country' and 'to a countless number of his patients,' Scheller said. He added that several patients have expressed support for Pham. For butt enhancement procedures, Pham had patients pay him in cash, according to court documents. He was paid $20,400 in total by six people who received silicone oil injections, prosecutors said. Injections offered to undercover agent The gallons of unapproved silicone Pham ordered online was linked to a U.S. subsidiary of a company located in Japan, according to prosecutors, who said the oil wasn't 'medical grade.' Pham got the silicone oil from an online shop, which 'sourced' the oil from another company, which sourced the silicone from the Japan-based company, prosecutors wrote in filings. Pham was implicated in the criminal case after prosecutors said he offered injections to an undercover agent in September 2019. His sentencing hearing is scheduled for Aug. 14, according to the U.S. Attorney's Office. In the four years that Pham performed the illegal butt enhancement procedures, according to prosecutors, the FDA warned the public about injectable silicone. In a 2017 alert, the agency said unregulated silicone products used for butt, breast and other body enhancements could result in 'serious injuries and disfigurement.' In the U.S., silicone injections are only allowed to be used during eye surgeries, specifically retinal detachment procedures, according to ScienceDirect.
Yahoo
08-05-2025
- Health
- Yahoo
Orlando physician pleads guilty to using illegal silicone in cosmetic surgeries
A doctor in Orlando has pleaded guilty to federal charges over using illegal materials for cosmetic procedures. The Justice Department says Nhan Pham,54, pleaded guilty to receipt in interstate commerce and proffered delivery of an adulterated device. This violates the Federal Food, Drug, and Cosmetic Act. A sentencing hearing is set for Aug. 14. Pham faces a maximum penalty of three years in federal prison. Pham is a physician who performed various cosmetic surgical and nonsurgical procedures. According to the plea agreement, between 2015 and 2019, he ordered silicone oil online and injected that silicone into his patients for gluteal and buttock enhancement procedures at his office and home. The Justice Department states that the 'U.S. Food and Drug Administration has not approved the use of injectable silicone for body contouring or enhancement and has issued warnings to the public advising them of the illegality of and health risks associated with silicone injections.' Prosecutors say Pham inaccurately represented the substance he was injecting into patient's bodies was 'safe,' 'natural' and would dissolve over time. After receiving the silicone oil injections, prosecutors say patients experienced complications that included sharp and severe pain, discomfort, discoloration, itchiness, burning, inflammation, soreness and hardness in the injection areas. On Sept. 24, 2019, Pham offered to perform silicone oil injections on an undercover law enforcement agent. Click here to download our free news, weather and smart TV apps. And click here to stream Channel 9 Eyewitness News live.
Epoch Times
25-04-2025
- Health
- Epoch Times
What to Know About the Two Banned Food Dyes
It's unlikely that you'd ingest either of the two synthetic food dyes—Citrus Red No. 2 and Orange B—that the U.S. Food and Drug Administration announced on April 22 it will ban in the coming months. You'd only be at risk of the two dyes if you were to eat the peel of Florida oranges, which are often injected with Citrus Red No. 2 to make them more visually appealing to consumers, or if Orange B were currently produced—which it hasn't been for decades. 'Because it was no longer produced, there was no need to actively ban it,' Bryan Quoc Le, a food scientist and food industry consultant, told The Epoch Times in an email. 'The banning of these two dyes is fairly inconsequential.' The FDA announced it would initiate the process of revoking authorization of Citrus Red No. 2 and Orange B as part of its plan to eliminate all remaining synthetic dyes from the food supply by the end of 2026. The agency intends to work with the food industry to get all food dyes out of circulation. Orange B The FDA approved Orange B in 1966, with a limitation that it not exceed 150 parts per million in finished food. It was a colorant limited to hot dog and sausage casings and wasn't permitted in cosmetics or medications. Studies showed Orange B, an azo dye, was damaging to the spleens, livers, and kidneys in rats. The Center for Science in the Public Interest (CSPI) asked the FDA to officially ban it in its 2010 food dye Related Stories 4/22/2025 4/23/2025 'In 1978 the FDA proposed banning Orange B (Fed Reg. October 3, 1978), but, because companies stopped using it, the FDA never bothered to finalize the ban; it should do so now,' wrote authors Sarah Kobylewski and Michael F. Jacobson. Rupa Health notes that exposure to Orange B could include mild effects like skin reactions, hyperactivity, irritability, headaches, difficulty breathing, and gastrointestinal discomfort, such as nausea, vomiting, and diarrhea. Citrus Red No. 2 Citrus Red No. 2 is also an azo dye, only approved at a level of no more than two parts per million for adding color to the skins of unprocessed Florida oranges. About 1,500 pounds—enough dye to color two billion oranges—are certified annually by the FDA. 'Citrus Red No. 2 is classified as 'possibly carcinogenic to humans,' which is why it is only allowed for orange peels that will not be eaten, and not for oranges that will be processed, which would release the dye into the edible portions, such as juice. Animal studies found that it can cause bladder tumors,' Quoc Le said. A Other studies have raised concerns about cancer, according to the CSPI report. Because the federal Food, Drug, and Cosmetic Act that governs toxicology levels for human health forbids any link to cancer in human or animal studies, the CSPI has long argued that Citrus Red No. 2 shouldn't be used in food. Some recipes call for cooking with grated orange peels, and the CSPI report noted experts' concern about eating peels this way. The CSPI report quoted an internal FDA memo written by FDA veterinarian Kent J. Davis saying, 'Citrus Red 2 then becomes an intolerable human health hazard if only from the amounts consumed from fingers after peeling oranges treated with this dye. (Some additional dye may be ingested with peel or orange.)' Plans for Bans As early as the 1930s, azo-derived dyes were All food colorants—including natural ones, like those derived from beets, carrots, and turmeric—must be approved by the FDA. The nine synthetic dyes—Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, Citrus Red 2, Orange B, and Red No. 3—currently used must also be certified when a new batch is made, a process that ensures accurate measurements. The FDA banned Red No. 3 in early 2025 with a grace period that expires Jan. 15, 2027, for food and Jan. 18, 2028, for medication. As part of the April 22 announcement, the FDA is asking companies to voluntarily remove Red No. 3 prior to the deadlines. Future plans will include a timeline for phasing out synthetic dyes, the FDA said. It also But there are questions about how exactly RFK Jr.'s ban on food dyes will play out. Susan Mayne, former head of FDA's Center for Food Safety and Applied Nutrition during the Obama, Trump, and first two years of the Biden administration, says the ban is not really a ban. It cannot be enforced because it did not follow standard procedure. She said this week's FDA announcement amounts to a call for voluntary action on the part of food makers. 'People were left very unclear in terms of what they are going to be doing,' she said. 'At the same time, there are state actions that are moving to ban products from coming into the state food supply or into school lunch programs.' Mayne said it is unclear how this federal approach will relate to the policies already being enacted at the state level. Why Dye? Florida resorted to dying their naturally pale oranges in the 1930s. By the 1950s, Florida opted to sell a large part of their harvested oranges to food manufacturers for use in concentrate—and those oranges cannot be tainted with dye. That's why the FDA regulation on Citrus Red No. 2 is specific about its use for unprocessed oranges. As a percentage of the total pounds of synthetic food dyes that the FDA certifies in batch tests every year, neither Orange B nor Citrus Red No. 2 register as a fraction of a percent. Quoc Le said banning them is a sensible way to phase out all synthetic dyes. 'With few uses for these dyes, it's much easier to remove them from the food system, as only a handful of applications exist and substitutions can be done quickly. These dyes are fairly low-hanging fruit.'
Yahoo
19-03-2025
- Business
- Yahoo
Hims & Hers stock tumbles as the FDA issues a warning about 'unapproved' weight loss drugs
Hims & Hers (HIMS), the millennial-skewed telehealth company, saw its stock tumble nearly 9% on Tuesday, as the company braces for big regulatory shifts in the weight-loss drug industry. Hims stock took a hit just a day after the U.S. Food and Drug Administration (FDA) updated a page on its website outlining its concerns with the use of what it calls 'unapproved GLP-1 drugs.' GLP-1 drugs are a class of drugs, made popular by Novo Nordisk's (NVO) Ozempic, which mimic hormones that regulate blood sugar and suppress appetite. The FDA warned Monday that the use of unapproved versions of these drugs including compounded versions can 'be risky for patients, as unapproved versions do not undergo FDA's review for safety, effectiveness and quality before they are marketed.' Back in May, Hims & Hers started selling compounded semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — for just $199 a month. That's a big difference compared to Ozempic's $1,000 list price and Wegovy's $1,349 price tag. Compounding means a pharmacy or physician customizes an approved drug to fit an individual patient's needs. The company's total sales grew 69% last year to $1.5 billion. Hims & Hers was able to sell this off-brand version because of recent shortages of GLP-1 drugs. Normally, the Food, Drug, and Cosmetic Act prohibits making drugs that are just copies of commercially available ones. However, when drugs are in shortage, the U.S. Food and Drug Administration (FDA) doesn't consider them commercially available. Now that the Ozempic shortage is over, Hims & Hers will have to stop selling 'essential copies' of compounded semaglutide this year. The FDA said it will start citing companies and healthcare providers that continue to offer 'essential copies' of compounded semaglutide starting May 22 or after a judge rules on a lawsuit from the industry group Outsourcing Facilities Association — whichever comes later. 'We will have to start notifying customers in the coming month or two that they will need to start looking for alternative options on the commercial dosing,' Hims & Hers CEO Andrew Dudum told investors during a call in February. Still, Hims & Hers has other avenues to explore. The company could continue to offer more personalized semaglutide formulations and shift its focus to older generic weight-loss drugs. Additionally, on Tuesday Bank of America Securities (BAC) analyst Allen Lutz adjusted the firm's price target for Hims & Hers by $1 to $22 — notably $12 below the stock's opening price that day. Lutz maintained an 'underperform' (sell) rating. Lutz noted that while overall sales grew 124% year over year in February, GLP-1 medications now make up about 45% of the company's online revenue. Meanwhile, growth outside of GLP-1s has slowed, with core sales increasing just 30% in February — down from 40% in the fourth quarter and 47-50% in the third. 'Slowing core growth is an important barometer as semaglutide could exit the model at any time and now represents close to 50% of sales,' Lutz wrote. For the latest news, Facebook, Twitter and Instagram. Sign in to access your portfolio
Associated Press
17-03-2025
- Business
- Associated Press
Cellphire Therapeutics CLPH-511 Fast Track Designation Granted
ROCKVILLE, Md., March 17, 2025 (GLOBE NEWSWIRE) -- Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply. Fast Track designation, granted under section 506(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), is designed to expedite the development and review of drugs that address serious conditions and have the potential to fill an unmet medical need. The designation allows Cellphire Therapeutics to engage in more frequent communication with the FDA, facilitating a more efficient path toward regulatory approval. Additionally, Fast Track status enables the company to take advantage of rolling review for its Biologics License Application (BLA), which allows submission and review of a portion of the BLA prior to the application being complete. Products with Fast Track Designation could also be eligible for Priority Review at the time of BLA submission, if clinical data demonstrates a significant improvement in safety or efficacy. 'This Fast Track designation recognizes CLPH-511's potential to address the unmet need of acute hemorrhage and Cellphire looks forward to continued collaboration with FDA to get this product to patients that need it as soon as possible', said Damien Bates, CMO of Cellphire Therapeutics. Acute hemorrhage remains a leading cause of morbidity and mortality in trauma, surgery, and critical care settings. Platelet transfusions are essential in managing severe bleeding, but logistical challenges, including short shelf life and limited availability, often hinder timely access. CLPH-511, a frozen and activated platelet product, is designed to overcome these limitations by providing a readily available, long-lasting alternative that can be deployed in both civilian and military settings. The use of CLPH-511 in acute hemorrhage is currently being investigated in a Phase 2/3 adaptive design study, titled 'Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery' (CRYPTICS - NCT04709705). Cellphire Therapeutics will continue to advance the clinical development of CLPH-511, leveraging the benefits of this Fast Track designation to bring this innovative therapy to patients as quickly and efficiently as possible. For more information on the CRYPTICS study, visit About Cellphire Therapeutics Cellphire Therapeutics, Inc.'s vision: No one should die from controllable hemorrhage. A private, clinical stage biotechnology company developing next-generation, allogeneic, platelet-derived therapies, Cellphire has a portfolio of platelet-derived biologics including two assets in clinical development: its late-stage biologic CLPH-511, a cryopreserved platelet (CPP) therapy with extended shelf life, and CLPH-211, part of the FPH® family of freeze-dried, platelet-derived hemostatic agents. Once approved, Cellphire's differentiated technologies will address significant unmet health system and medical needs across various clinical settings including acute bleeding associated with surgery, trauma and traumatic brain injury. For more information, visit This CPP Project is supported by the US Army Medical Research and Development Command under Contract No. W81XWH20C0030. The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. Contact: Robert Woods
