Tag: Food and Drug Administration
Battle of the feds: FTC tells FDA to do its job regulating homeopathy
Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under...
The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients...
Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation
The Society for Science-Based Medicine has commented on the FDA's reconsideration of how to regulate homeopathic products.
GcMAF and the life and death of an autism quack
[Editor’s note: This is an extra bonus post that has appeared elsewhere. This week’s post will appear in several hours.] A mysterious apparent suicide and conspiracy theories Three weeks ago, those of us who combat the antivaccine movement noted the then-very recent death of an autism quack and antivaccinationist (but I repeat myself) who’s been big in the “autism biomed” movement for...
FDA & CDC find raw pet food unpalatable
The FDA recently announced it would send field staff out to collect samples of commercially-manufactured raw dog and cat food. The samples will be analyzed for Salmonella, Listeria monocytogenes and E. coli, all of which have been found in raw pet food, in the animals who eat it, in their feces, on their bodies after eating it, in the areas they inhabit,...
Supplements are the Wild West of health. One Attorney General is out to change that.
Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient,...
FDA and Homeopathy: Part Two.
Friends, FDA, countrymen, lend me your ears; I come to bury Homeopathy, not to praise it. The evil that homeopaths do lives after them; The good is oft interred with their bones; So let it be with Homeopathy. The noble Ullman Hath told you homeopathy was effective: If it were so, it was a grievous fault, And grievously hath Homeopathy answer’d it....
Should the FDA crack down on homeopathic “remedies”?
In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a...
Stem cell clinics and unapproved, for-profit human experimentation
Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the...
New FDA regulatory role threatens bogus diagnostic tests
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...