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FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

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Amazon among companies cited for offering products that are not FDA-approved

Today, the U.S. Food and Drug Administration announced it issued three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags. 

“It is the FDA’s duty to protect public health from harmful products not approved for the U.S. marketplace” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law.”   

Moles should be evaluated by a health care practitioner. Self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and treatment, and even cancer progression. The FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring. The sale of these products risks public health and may jeopardize consumers’ health when used without consulting a health care professional.  

The FDA issued the warning letters to:

The mole and skin tag removal products sold by these firms have not been evaluated by the FDA for safety, effectiveness or quality and require FDA approval. The introduction or delivery for introduction of these products into interstate commerce without an approved application is an additional violation of the FD&C Act.

Today’s warning letters alert the companies that failure to adequately address the violations cited by the FDA may result in legal action including seizure and/or injunction. The companies have 15 days from receipt of the warning letter to respond to the agency with actions they have taken to address any violations. The FDA will continue to use all tools available to protect public health and remove fraudulent or unproven drug products from the U.S. marketplace. Warning letters are not meant to be final agency action. 

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The FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. The FDA works to protect consumers by informing about the risks and how to buy online safely.

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Rod is a blogger, writer, filmmaker, photographer, daydreamer who likes to cook. Rod produces and directs the web series, CUPIC: Diary of an Investigator. He is also the editor, producer and administrator of TNC Network.

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Health

Investigators capture a “molecular snapshot” to illuminate the origins of pulmonary arterial hypertension

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Newswise — Pulmonary arterial hypertension (PAH) is a rare and incurable disease of the lung arteries that causes early death. In PAH, excess scar tissue and thickening of lung blood vessels occur as the result of increased cell “biomass.” These changes obstruct blood flow and are detrimental to the heart, but until now the basic features of biomass in PAH were not known. A team led by investigators at Brigham and Women’s Hospital (BWH), a founding member of the Mass General Brigham healthcare system, in collaboration with Matthew Steinhauser, MD, a metabolism and cell imaging expert at the University of Pittsburg, and investigators at the University of Vienna, set out to better understand the origins of arterial biomass in PAH. Using an animal model of PAH, the team applied network medicine and advanced molecular imaging tools to identify chemical building blocks that are taken up by arterial cells and ultimately contribute to blood vessel obstruction. Using multi-isotope imaging mass spectrometry (MIMS) under the guidance of Steinhauser and Christelle Guillermier, PhD, at BWH, the researchers could pinpoint the location and abundance of key contributors to biomass, including the amino acid proline and the sugar molecule glucose. Using MIMS, the team visualized proline and glucose tracers injected into the bloodstream of an animal model of PAH. They saw that the molecules were used by arterial cells of the lung to build excess scar tissue (including the protein collagen), which contributed to blood vessel obstruction. 

“Our study describes the world’s first use of multi-isotope imaging mass spectrometry (MIMS) in the study of lung disease,” said Bradley Wertheim, MD, of the Brigham’s Division of Pulmonary and Critical Medicine. “MIMS is a powerful microscopy tool that produces a ‘molecular snapshot’ that can provide information down to the resolution of a single cell.” 

“These findings suggest that the uptake and metabolism of protein precursors may be fundamental to PAH biology.  Closer investigation of proline and glucose in human PAH may uncover opportunities to inhibit biomass formation, prevent obstruction of lung arteries, and decrease the chance of heart failure for PAH patients,” said co-senior author Bradley Maron, MD, of the Brigham’s Division of Cardiovascular Medicine.

Read more in JCI Insight.

Source: Brigham and Women’s Hospital

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fitness

Renaissance ClubSport Launches ‘Live Life Better’ Campaign

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The upscale Orange County fitness resort rings in the new year with a commitment to fitness, wellness, mental health and a free $350 new member package offered for a limited time with signup.

ALISO VIEJO, Calif. /PRNewswire/ — Renaissance ClubSport, Aliso Viejo’s premier fitness resort, has officially rolled out their new ‘Live Life Better’ campaign for 2023. The all-inclusive club offers opportunities to level up both your mental and physical health for a life well experienced. ‘Live Life Better’ kicks off with an exciting free ($350 value) new member package that is only available for a limited time. The incentive includes 2 personal training sessions, a sports lesson, free smoothie and more. The extensive property at ClubSport has a robust array of services that offer something for the entire family, including 3 hours of child care daily for family memberships.

Renaissance ClubSport Website

Feel better, be better, and live life better

“Living better is about empowering our guests, elevating their fitness potential and giving a renewed sense of purpose for the new year.” says Heather Stanek, Vice President/General Manager at ClubSport. “This is not about the usual new year new me commitment, but rather being comfortable with who you are and making small, smart choices to level up throughout the year. We are confident that our top tier classes and facilities will bring not only positive change, but a lot of fun during your “glow up” process.”

Throughout 2022 ClubSport underwent a massive renovation, which includes a 5,000 sq/ft performance training space (The Edge), new Pickleball courts and an upgraded Formula3 studio for boutique fitness classes, within their 100,000 square feet of fitness offerings. ClubSport recently added Jiu Jitsu classes for kids on top of the multiple other daily classes available for members including yoga, HIIT, and so much more.

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Reach new physical goals with ClubSport led fitness classes, personal trainers, swim in the lap pool and even warm up with a nice game of basketball or racquetball. Improve mental health with a visit to the R Spa, mind/body classes, indoor sauna, steam room and hot tubs. Plus enjoy social activities including wine tasting, sound baths, live music or one of their new monthly Life Hack Series workshops designed to eliminate life’s frustrations in simple and uncomplicated ways to live life better. Many guests enjoy reconnecting with friends over lunch at their on-site restaurant.

ClubSport is the place where you can experience life better with loved ones, your kids, and yourself. Access to The Edge, Pickleball, and all classes are available daily and are included for all members and overnight guests of their 174-room boutique hotel. ClubSport is located at 50 Enterprise, Aliso Viejo, CA 92656 and more on the gym can be found at www.clubsports.com

About Renaissance ClubSport:

ClubSport isn’t just another fitness club – we are a fitness resort. One of the largest health clubs in Orange County, our studio-style classes include HIIT, yoga, group training, and more! Our state-of-the-art equipment, dedicated staff, and outstanding amenities provide a unique environment where members can enjoy fitness, relaxation, and recreation.

First opened 2008, ClubSport is an all-in-one gym experience that is easily accessible from the 73 toll road and is a quick drive from exits off the 5 and 405 freeways. ClubSport is available to those with a membership and to hotel guests during their stay. The club is open Monday-Friday from 5am to 10pm and Saturday-Sunday from 6am to 10pm. To take a peek at ClubSport and for membership information please visit www.clubsports.com

SOURCE Renaissance ClubSport

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https://stmdailynews.com/category/lifestyle/health-and-wellness/fitness/

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Health

Anti-ageing gene shown to rewind heart age by 10 years

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Breakthrough offers a potential target for patients with heart failure

Newswise — An anti-ageing gene discovered in a population of centenarians has been shown to rewind the heart’s biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.

Associated with exceptional longevity, carriers of healthy mutant genes, like those living in blue zones of the planet, often live to 100 years or more and remain in good health. These individuals are also less prone to cardiovascular complications. Scientists funded by the British Heart Foundation believe the gene helps to keep their hearts young by protecting them against diseases linked to ageing, such as heart failure.

In this new study, researchers demonstrate that one of these healthy mutant genes, previously proved particularly frequent in centenarians, can protect cells collected from patients with heart failure requiring cardiac transplantation.

The Bristol team, led by Professor Paolo Madeddu, has found that a single administration of the mutant anti-ageing gene halted the decay of heart function in middle-aged mice. Even more remarkably, when given to elderly mice, whose hearts exhibit the same alterations observed in elderly patients, the gene rewound the heart’s biological clock age by the human equivalent of more than ten years.

Professor Madeddu, Professor of Experimental Cardiovascular Medicine from Bristol Heart Institute at the University of Bristol and one of the study’s authors, explained: “The heart and blood vessel function is put at stake as we age. However, the rate at which these harmful changes occur is different among people. Smoking, alcohol, and sedentary life make the ageing clock faster. Whereas eating well and exercising delay the heart’s ageing clock.

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“In addition, having good genes inherited from parents can help to stay young and healthy. Genes are sequences of letters that encode proteins. By chance, some of these letters can mutate. Most of these mutations are insignificant; in a few cases, however, the mutation can make the gene function worse or better, like for the mutant anti-ageing gene we have studied here on human cells and older mice.”

The three-year study was also performed in test tube human cardiac cells in Italy. Researchers from the MultiMedica Group in Milan led by Professor Annibale Puca, administered the gene in heart cells from elderly patients with severe heart problems, including transplantation, and then compared their function with those of healthy individuals.

Monica Cattaneo, a researcher of the MultiMedica Group in Milan, Italy, and first author of the work said: “The cells of the elderly patients, in particular those that support the construction of new blood vessels, called ‘pericytes’, were found to be less performing and more aged. By adding the longevity gene/protein to the test tube, we observed a process of cardiac rejuvenation: the cardiac cells of elderly heart failure patients have resumed functioning properly, proving to be more efficient in building new blood vessels.”

Centenarians pass their healthy genes to their offspring. The study demonstrates for the first time that a healthy gene found in centenarians could be transferred to unrelated people to protect their hearts. Other mutations might be found in the future with similar or even superior curative potential than the one investigated by this research. Professor Madeddu and Professor Annibale Puca of the MultiMedica Group in Milan believe this study may fuel a new wave of treatments inspired by the genetics of centenarians. 

Professor Madeddu added: “Our findings confirm the healthy mutant gene can reverse the decline of heart performance in older people. We are now interested in determining if giving the protein instead of the gene can also work. Gene therapy is widely used to treat diseases caused by bad genes. However, a treatment based on a protein is safer and more viable than gene therapy.

“We have received funding from the Medical Research Council to test healthy gene therapy in Progeria. This genetic disease, also known as Hutchinson-Gilford syndrome, causes early aging damage to children’s hearts and blood vessels. We have also been funded by the British Heart Foundation and Diabetes UK to test the protein in older and diabetic mice, respectively.”

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Annibale Puca, Head of the laboratory at the IRCCS MultiMedica and Professor at the University of Salerno, added: “Gene therapy with the healthy gene in mouse models of disease has already been shown to prevent the onset of atherosclerosis, vascular ageing, and diabetic complications, and to rejuvenate the immune system.

“We have a new confirmation and enlargement of the therapeutic potential of the gene/protein. We hope to test its effectiveness soon in clinical trials on patients with heart failure.”

Professor James Leiper, Associate Medical Director at the British Heart Foundation, which funded the research, said: “We all want to know the secrets of ageing and how we might slow down age-related disease. Our heart function declines with age but this research has extraordinarily revealed that a variant of a gene that is commonly found in long-lived people can halt and even reverse ageing of the heart in mice.

“This is still early-stage research, but could one day provide a revolutionary way to treat people with heart failure and even stop the debilitating condition from developing in the first place.”

The study is funded by the British Heart Foundation and the Italian Ministry of Health.

Paper

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The longevity-associated BPIFB4 gene supports cardiac function and vascularization in aging cardiomyopathy’ by Annibale Puca et al. in Cardiovascular Research [open access]

Source: University of Bristol

https://stmdailynews.com/category/lifestyle/health-and-wellness/health/

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