By The Washington Post | PUBLISHED: April 4, 2019 at 10:43 pm | UPDATED: April 4, 2019 at 10:43 pm By William Wan and Laurie McGinley | The Washington Post Federal and state authorities announced steps this week to rein in for-profit stem cell clinics from New York to Florida, ramping up efforts to rein in a booming industry that critics say are offering unapproved and expensive treatments that have harmed a growing number of patients. New York state’s attorney general filed a lawsuit Thursday against a Manhattan clinic called Park Avenue Stem Cell — accusing it of “fraudulent and illegal advertising regarding its stem cell procedures.” A day earlier, the Food and Drug Administration sent 20 letters to stem cell companies, telling them to stop selling unapproved products in violation of federal laws. The FDA also sent a more formal letter of warning to an Altamonte Springs, Florida, company, called Cord for Life, that has sold umbilical cord blood products … [Read more...] about FDA, New York attorney general take steps to police stem cell industry
By The Washington Post | PUBLISHED: December 21, 2018 at 4:48 pm | UPDATED: December 21, 2018 at 4:48 pm By Laurie McGinley | Washington Post A dozen patients in three states were hospitalized with serious bacterial infections after receiving injections of umbilical cord blood that purportedly contained stem cells, according to federal and state health officials. The Food and Drug Administration said Thursday that it had issued a warning to San Diego-based Genetech Inc., the company that manufactured the treatment that contained E. coli and other dangerous bacteria. The patients in Florida, Texas and Arizona became seriously ill after receiving injections and IV infusions of the product at orthopedic clinics, according to a report by researchers from the Centers for Disease Control and Prevention, the FDA and the Florida Department of Health. The patients were seeking relief from degenerative joint disease, back pain and a rotator-cuff tear, the account said. Three were … [Read more...] about FDA issues warning after stem cell treatment sickens
Sesame allergies are becoming increasingly common in the United States. Allergic reactions to sesame can be severe: A recent study found that one-third of sesame-allergic children reported one or more ER visits related to a food allergy in the past year. The Food and Drug Administration requires food manufacturers to include the top eight allergens on food labels, but not sesame, which is No. 9. Based on the growing number of people with sesame allergies and the danger of such reactions, the FDA should add sesame to its allergen labelling requirements. Last month, my 8-month-old son had his first bite of hummus off the tip of a baby spoon. Within two minutes, his body went into anaphylaxis. He vomited. He broke out in hives. He had trouble breathing. We were fortunate to have an EpiPen on hand – the emergency room doctor later told us that the quick administration of epinephrine saved his life. My son is one of at least 300,000 people in the US with an allergy to sesame. … [Read more...] about One of the most common and dangerous allergens doesn’t appear on food labels in the US. The FDA should move fast to change that.
Breaking News Emails Get breaking news alerts and special reports. The news and stories that matter, delivered weekday mornings. SUBSCRIBE Dec. 20, 2018 / 8:49 PM GMT By Maggie Fox One of the biggest names in tobacco — Altria — is taking a large stake in Juul, the biggest name in vaping. Altria announced on Thursday that it was taking a 35 percent stake in Juul and planned to aggressively help promote the e-cigarette brand. Both companies said their aim was to create a giant to help smokers move to safer products. But anti-tobacco activists say they do not trust the deal, and at least one antitrust expert with experience fighting tobacco companies said the arrangement smelled funny to him. “Big Tobacco just got bigger, and products like Juul have addicted a new generation putting nicotine in every classroom across America,” said Robin Koval, CEO & President of the Truth Initiative, set up to counter decades of tobacco industry marketing. Altria is … [Read more...] about Juul now has ‘800-pound gorilla’ to fight FDA, experts warn
The Food and Drug Administration is looking for "pathways" to legalize the sale of CBD oil and other cannabis-based compounds in food and beverages in a move that could remove one of the last remaining legal hurdles for companies hoping to sell such products across state lines. FDA Commissioner Scott Gottlieb outlined steps the agency is considering in regulating cannabis products after President Donald Trump signed the farm bill into law on Thursday. The legislation — an $867 billion, five-year spending bill that funds agricultural, nutrition and other federal programs — also loosened some federal restrictions on cannabis. It legalized hemp by removing it from the Controlled Substances Act while preserving the FDA's authority to regulate the products. "I think it's really a game-changer," said Joshua Horn, a cannabis industry lawyer and partner at Fox Rothschild. "The significance is now you have some aspect of the cannabis world legalized on a federal basis." The changes … [Read more...] about FDA Weighs Legalizing Interstate Sales of Cannabis-Based CBD in Food, Drinks