FDA commissioner takes the more aggressive stance toward potentially unsafe homeopathic drugs:
Drugs FDA: Scott Gottlieb (FDA commissioner), Food and Drug Administration Commissioner, testified during a House hearing about the opiate epidemic in October. On Monday, Gottlieb (FDA commissioner) proposed a new, more rigorous approach to the regulation of homeopathic medicines.
The Food and Drug Administration on Monday proposed a stricter application of homeopathic remedies, looking at products with the highest security risks, including those that contain potentially dangerous ingredients or that are marketed for serious illnesses without proven benefits.
Drugs FDA: Homeopathy is based on an idea of the eighteenth century that the substances that cause the symptoms of the disease can, in very small doses, cure the same symptoms. Modern medicine, supported by many studies, has refuted the central principles of homeopathy and has shown that products are at best useless and harmful at worst.
Drugs FDA: In accordance with US law. UU. Homeopathic medicines should follow the same rules of approval as other drugs. But, according to a policy adopted in 1988, the agency used “execution criteria” to allow items to be manufactured and distributed without FDA approval.
Drugs FDA: On Monday, the agency said it would intensify the use of high-risk products, including those given by injection, for children or the elderly, or marketed for diseases such as cancer or heart disease or opioids and addictions. beverage
Drugs FDA: The approach proposed by the agency, described in a new preliminary guide, occurs more than a year after homeopathic tablets and belladonna-containing gelatine were attached to 400 wounded and the death of 10 children. A laboratory analysis by the FDA later confirmed that some of the products “contained high and inconsistent levels of belladonna,” a toxic substance, the agency said.
Drugs FDA: Homeopathy has become a $ 3 billion industry that offers treatments for everything from cold cancer to cancer, FDA commissioner Scott Gottlieb (FDA commissioner) said in a statement. “In many cases, people can put their trust and money into therapies that may offer little or no benefit to fighting serious illnesses or, worse, can cause significant and even irreparable harm” due to poor manufacturing quality or hazardous ingredients, he said. he. Gottlieb said the agency realized that
“Some people want to use alternative treatments, but the FDA has a responsibility to protect the public.”
Drugs FDA: The agency said it does not plan to force all homeopathic products to follow the standard drug approval process, which is considered unworkable. As part of its new approach, many products will not be in high-risk categories and will remain available to consumers.
Drugs FDA: The National Center for Homeopathy, which promotes homeopathy and is based in Mount Laurel, New Jersey, states on its website that “homeopathy is a natural, safe and gentle healing system that works with your body to relieve the symptoms of homeopathy. symptoms, recover and improve your overall health. ”
Drugs FDA: Steven Salzburg, a biomedical engineer at Johns Hopkins University, criticized the FDA for its lack of action against homeopathy, saying the country was “just stupid from a scientific point of view, more like a religious belief than a scientist.” He added, “There’s a lot of evidence that these products do not work, which would violate so many principles of biology and chemistry. ”
Drugs FDA: In the month of July, The British national health system announced its intention to prevent doctors from assigning homeopathic medicines. The Simon Stevens executive director described homeopathy as “at best, a placebo and abusive NHS funds.” The measure was one year after the House of Commons asked the government’s health service to stop paying for homeopathic receptions. In order to maintain trust, choice and patient safety, the government should not accept the treatment of placebo, including homeopathy. ”
Drugs FDA: In April 2015 FDA has held public hearings on homeopathic product regulation in order to obtain public information on its enforcement policy. The agency announced on Monday that after a meeting and 9,000 comments published by the public, the FDA decided to propose a new “global approach to the market for pharmaceuticals and risks labeled as homeopathic, sold without FDA approval.”
Drugs FDA: In recent years, the FDA has published advice on other homeopathic pharmacological products, including intranasal products containing zinc, and may cause odor loss; some homeopathic asthma drugs that were not effective in the treatment of asthma and other products containing stringing, the poison used to kill rodents.
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