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How the FDA Deals with Unapproved Foreign Traditional Medicines in the US?
(Thursday, August 22, 2024) India is the source of many traditional, alternative, and herbal medicines including Ayurveda, Unani, and Homoeopathy. Although these medicines are mostly sold in India, a significant amount is exported to the US; almost 25% of all traditional medicines exported from India are destined to the US. FDA is aware that while none of these medicines are approved, they still make it to US consumers. Traditional medicines play an important role in medical care in many countries. Although many countries have some version of traditional medicines, those from India and China are the most recognized worldwide. Both countries have well-developed regulatory processes for traditional medicines sold locally. Traditional medicines are known to contain heavy metals, uncharacterized plant extracts, animal-sourced materials, and other unknown ingredients. These ingredients are considered risky, unsafe, or even poisonous under US laws. None of them are approved by the FDA. So, when they are exported to the US, they are primarily labeled as dietary supplements, ethnic food, or cosmetics. Under US laws it is considered import and sale of unapproved and adulterated illegal drugs. The FDA is aware of such products in the US market but has kept a mostly hands-off approach to enforcement, focusing primarily on reports of adverse events or other complaints. Traditional medicine is based on medical and physiological principles very different from Western medicine. The US laws for regulating drugs were primarily designed for conventional chemical and biological drugs. Those principles cannot be applied easily to traditional medicine. That is why, most countries in the World, including European, Australian, and Canadian regulators have distinct regulatory pathways for traditional medicines. Unlike the US, the traditional medicine regulatory pathways allow the European and Canadian regulators to register traditional medicines and conduct proper pharmacovigilance to track their use and associated adverse events. The US FDA, on the other hand, is primarily focused on convincing the manufacturers of these medicines to pursue the conventional drug approval routes with no success. Traditional medicines hold significant promise. One out of three people on the planet uses traditional medicines to manage their health while being fully aware that these treatments are not approved by their regulators. The FDA’s hands are tied due to the lack of regulatory processes for such products outside of the conventional pathways. So, it is left to the manufacturers to pursue FDA approval for business and financial reasons. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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