Prior to 1976, the FDA did not regulate medical implants, and so shoddy and even deadly devices proliferated, inserted into Americans' body. Read the rest
Medtronic (previously) is a notoriously insecure medical implant manufacturer whose devices have been repeatedly shown to be grossly insecure -- their pacemakers can be hacked before leaving the factory! Read the rest
Ben Goldacre (previously) led a team that created the FDAAA Trials Tracker, "A live informatics tool to monitor compliance with FDA requirements to report clinical trial results." Read the rest
The FDA is finally putting a stop to food companies trying to tempt customers who can’t distinguish baking ingredients from symbolic forms of affection. Officials from the US Food and Drug Administration sent a letter to the owners of Nashoba Brook Bakery warning them the company was violating label regulations by listing “love” as an ingredient in its granola, according to Bloomberg News.
"Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient,” the FDA wrote in the letter.
John Gates, CEO of Nashoba Brook Bakery, said the FDA’s warning about the granola “ingredient” was “silly.”
“I really like that we list ‘love’ in the granola,” Gates said in a telephone interview with Bloomberg News Tuesday. “People ask us what makes it so good. It’s kind of nice that this artisan bakery can say there’s love in it and it puts a smile on people’s face. Situations like that where the government is telling you you can’t list ‘love’ as an ingredient, because it might be deceptive, just feels so silly.”
The letter also warned food products were “prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”
“Some of FDA’s observations, particularly on some of the sanitation issues, were helpful,” Gates said.
Image: pxhere Read the rest
The FDA's Sept 6 warning letter to Epipen manufacturer Meridian (a division of Pfizer) condemns the company for knowingly shipping out defective products that led to the death of the customers who paid hyper-inflated prices for the devices, which Meridian manufactured for notorious pharma profiteers Mylan. Read the rest
Looking for an appetite suppressant? The U.S. Food & Drug Administration can help. Just stop by FDA's Defect Levels Handbook to learn how many insect legs and rodent hairs are acceptable in various foods sold to the American public. Read the rest
When Purdue Pharma's patent on the MS Contin was close to expiry, the Sackler family who owned the company spent millions trying to find a product that could replace the profits they'd lose from generic competition on MS Contin: the result was Oxycontin, a drug that went on to kill Americans at epidemic scale. Read the rest
The Electronic Frontier Foundation just filed comments with the FDA in its embedded device cybersecurity docket, warning the agency that manufacturers have abused the Digital Millennium Copyright Act, threatening security researchers with lawsuits if they came forward with embarrassing news about defects in the manufacturers' products. Read the rest
Both the UK and Australian governments have issued reports describing homeopathy as bunk, and now the US Food and Drug Administration and Federal Trade Commission are holding hearings on the regulation of high-priced sugar-pills. Read the rest
Back in September, the Centers for Disease Control and Prevention issued a report connecting the use of antibiotics in livestock to antibiotic resistance in humans. It was an important step in turning science into action. Although human use and misuse of antibiotics and the spread of antibiotic-resistant bacteria in hospitals are important parts of the puzzle of antibiotic resistance, the massive use of antibiotics by the agricultural industry also plays a key role. In fact, the vast majority of antibiotics used in the United States are used by animals. (Reasonable estimates range as high as 80%.)
What's more, the vast majority of that antibiotic use has nothing to do with the health of the animals. The antibiotics have the side effect of promoting weight gain. Important drugs like penicillin and tetracycline are regularly doled out to cows and pigs and chickens as part of their daily feed in order to make them fatter — a practice which has been shown to directly reduce those drugs' effectiveness at treating actual illness in humans. Today, the FDA announced that it plans to change this ... but there are problems. Read the rest
At what point does interesting-but-potentially-incorrect-or-misleading information become a potential threat to health? How do you regulate a product that current regulations were never set up to handle? The University of Michigan's Risk Science Center put together this quick cartoon that neatly summarizes the problems and questions at the heart of the FDA's crackdown on 23andMe, which Xeni wrote about on Monday.
A couple of other smart takes on this that have come out in the past couple of days: • Genomics expert Michael Eisen delves deeper into the question of how we should regulate personal genetic testing. • Journalist David Dobbs rounded up some diverse opinions. You should pay attention to his blog. He's been doing a lot of great reporting on genetics and culture and is planning on publishing a longer piece on the 23andMe stuff later this week. Read the rest
Short version: There is LOTS the FDA doesn't want to tell you about livestock antibiotic use. And that matters. As I reminded you yesterday, the antibiotics we use to keep ourselves alive and healthy are rapidly losing their effectiveness against a whole host of diseases. Antibiotic resistance to disease is driven by overuse of antibiotics — both in humans and in animals. And there are lots of antibiotics being used on animals. The trouble is, public health researcher know very little about that use. Because the FDA refuses to release more than the bare minimum of data. For added fun, last year, they stopped even trying to regulate antibiotic use on livestock — opting instead for voluntary self-control systems. Read the rest
