Mumbai: The US drug regulator, the Food and Drug Administration (FDA), has issued a warning to California-based Bazaar of India Inc., an online distributor of Indian Ayurvedic products, saying it was flouting US laws on safety and promotional ethics.
FDA’s move, targeting at least 11 Ayurvedic drugs marketed by the firm, follows a controversy that erupted in the US last year after a paper in the Journal of American Medical Association (Jama) claimed that one-fifth of the Ayurvedic products made locally and in India and sold in the US online contained lead, mercury or arsenic in excess of acceptable limits.
The paper was lead-authored by Robert Saper of the department of family medicine at the Boston University School of Medicine and Boston Medical Center.
Bazaar of India is among a few online distributors of Ayurveda products in the US whose products were tested in a study by Jama for the report.
In a 7 July letter to Kush Khanna, president and chief executive of Bazaar of India, FDA said the products marketed by the firm were drugs under US law as they are intended to cure or prevent disease, and there was no evidence that they were generally recognized as safe and effective.
The FDA letter, posted on its website, warned the firm that it could be charged with misbranding because these products were offered for conditions that were not amenable to self-diagnosis or treatment by individuals who were not medical practitioners.
Bazaar of India, according to the FDA letter, had been promoting brands such as Acnenil, Cold Aid, Sugar Fight, Heart Plus, Hingwastika, Bakuchi, Guggulu, Brahmi, Tagar, Licorice and Triphala, with label information that they they were meant to treat conditions such as acne, cold, diabetes and heart diseases, among others.
Khanna could not be contacted for comment. However, a disclaimer on the company’s website says, “The statements on this website have not been evaluated by the Food and Drug Administration. Products and information provided on this site are not intended to diagnose, treat, cure or prevent any disease. If you have a medical condition, consult your physician. All information is provided for educational purposes only.”
Although FDA said in its letter that US law authorizes the seizure of illegal products and injunctions against the manufacturers of such products, it gave the company 15 days to notify the regulator of steps taken to correct the violations.
“It is unfortunate that Ayurveda as an authentic medicinal system that has been in practice for centuries here is yet to be fully understood and recognized in the US,” said Ranjit Puranik, chief executive of Mumbai-based Ayurvedic drug maker Shree Dhootapapeshwar Ltd, who is also general secretary of the Ayurvedic Drug Manufacturers Association of India.
He added, however, that distributors of Ayurveda products often did not understand that promoting drugs without required approvals and without following marketing rules would invite regulatory action.