USFDA To Prioritise Regulation On Homeopathic Drugs Marketed In US
On Wednesday USFDA issued a final guidance on Homeopathic Drug Products, describing the agency’s approach to prioritising enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval, USFDA said in a statement.
The top US regulator said that it has developed a risk-based approach under which the agency intends to prioritise specific categories of homoeopathic drug products that potentially pose a higher risk to public health.
USFDA stated that the drugs which are intended for populations at greater risk for adverse reactions, including those with weakened immune systems, infants and children, the elderly, and pregnant women, as well as ophthalmic and injectable products as the routes of administration for these products bypass some of the body’s natural defences.
The agency anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritise for enforcement and regulatory action. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality.
Previously, the FDA warned the public about certain homeopathic products, including those containing a toxic substance and ones recalled due to contamination.
