FDA pledges to crack down on homeopathy treatments

pharmafile | December 19, 2017 | News story | Manufacturing and Production, Sales and Marketing FDA homeopathy, US, pharma 

Following in the steps of authorities in the European Union, Australia and the United Kingdom, the FDA has pledged to crack down on homeopathic treatments with a new “risk-based enforcement approach”, the US regulator has revealed in a draft guidance.

Homeopathic medicine has been allowed to be distributed without the regular approval needed by traditional drugs since the FDA passed a special policy in 1988. However, since then the small movement has grown into a $3 billion industry, the regulator has deemed a new approach necessary.

“In recent years, we’ve seen a large uptick in products labelled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” commented FDA Commissioner Scott Gottlieb. “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.”

The new plans won’t require homeopathic products to get approval, with the FDA saying that would be impractical. Instead, the regulator will be ramping up scrutiny of products in this class that could present potential health risks. The decision is thought to be driven by an incident at the end of 2016 where homeopathic teething tablets and gels containing belladonna – a toxic substance – led to 400 injuries and 10 deaths of children.

The practice of homeopathy is based in the 18th century, on the belief that substances that cause disease symptoms can cure those same symptoms when administered in small doses.

Steven Salzberg, a biomedical engineer at Johns Hopkins University in Maryland, is one of many professionals in the scientific community outspoken against the movement, calling homeopathy “just silly from a scientific point of view, more like a religious belief than a scientific belief”, which claims to “cure all sorts of conditions – pain, colds, asthma, indigestion, arthritis, you name it – and yet there’s not a whit of evidence”

Salzberg calls the FDA’s decision “terrific”, but warns that manufacturers of homeopathy products will now be likely to “hit back hard with lots of spurious claims in an effort to confuse consumers and to protect their profits.”

In July this year, NHS Chief Executive Simon Stevens called homeopathy “at best a placebo and a misuse of scarce NHS funds”, alongside the reveal of plans to stop doctors prescribing the products.

 Matt Fellows

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