US FDA is taking strict enforcement policy towards Homeopathic Drugs

US FDA is taking strict enforcement policy towards Homeopathic Drugs

Washington: On Monday the US Food and Drug Administration (FDA) proposed a stricter enforcement policy towards homeopathic drugs.

It said that it would target the products which pose greater safety risk including those containing potentially harmful ingredients or being marketed for cancer, heart disease and opioid and alcohol addictions.

The decision FDA comes more than a year after homeopathic teething tablets and gels containing belladonna were linked to 400 injuries and the deaths of 10 children.

The agency said that some of the products “contained elevated and inconsistent levels of belladonna”, a toxic substance.

FDA Commissioner Scott Gottlieb said that homeopathy has grown into to a US$3 billion industry that peddles treatments for everything from cancer to colds.
He further added that “In many cases, people may be placing their trust and money in therapies that may bring little or no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm” because of poor manufacturing quality or unsafe ingredients.

The National Center for Homeopathy, which advocates for homeopathy and is based in Mount Laurel, NJ, says on its website that “homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health.”

The homeopathic drugs are required to meet the same approval rules as other drugs under US law. But under a policy adopted in 1988, the agency has used “enforcement discretion” to allow the items to be manufactured and distributed without FDA approval.

Based on the 9000 comments submitted by the public, the FDA had decided to propose a new “comprehensive, risk-based enforcement approach to drug products labelled as homeopathic and marketed without FDA approval.”

The FDA has issued several warnings over the past years about other homeopathic drug products, including zinc-containing intranasal products that may cause a loss of sense of smell;
The agency also said that certain homeopathic asthma products have not been effective in treating asthma, and other products contain strychnine, a poison used to kill rodents.