Despite the fact that homeopathic preparations are supposed to be diluted to the point where none of the original ingredient remains, the FDA says it has received increasing reports of products containing distinctly unhomeopathic quantities of things like belladonna being associated with serious adverse events.
The FDA has also had to issue warnings about homeopathic zinc-containing intranasal products which may cause a loss of the sense of smell and other homeopathic remedies which contain potentially toxic ingredients, such as nux vomica, which contains strychnine.
However, it is not just products with safety concerns that the new proposals are designed to address. Following in the footsteps of the NHS, the Australian National Health and Medical Research Council, The House of Commons Science and Technology Committee and more recently, the Royal College of Veterinary Surgeons and the European Academies Science Advisory Council (EASAC), the new FDA proposals highlight the risk from homeopathic remedies being marketed for serious diseases or conditions when they have not been shown to offer clinical benefits.
The proposals also highlight the risk to vulnerable populations that: "may also be at greater risk of harm as a result of foregoing the use of medical treatments that have been found safe and effective."
FDA Commissioner Scott Gottlieb, M.D. said: "In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer.
"In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients.
"Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
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Photo: Multicolored homeopathy tubes isolated on a white background. Lush. Shutterstock.
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