Exporting Countries must document their pre-1994 herbal exports
As per the recent FDA ruling it is no longer possible to use listings such as the Herbs of Commerce compiled by the American Herbal Products Association (AHPA) in 1995 of “grandfathered” or old herbal ingredients (ODIs) to prove the pre- Oct 15, 1994 status of an ingredient in the US. The FDA now requires independently verifiable records in the forms of trade brochures and other communications to accept the ODI status of an ingredient.
According to me, now countries such as India and China who have had substantial herbal exports to the US pre-1994 must organize quickly a database of their exports through customs and other private records so that such information can be shared with the FDA and the existing business of Indian herbal ingredients in the US is not disrupted. Sharing of private records from pre-1994 must be made mandatory by a central information authority and confidential portions may be viewed only by National Regulators like FDA and MHRA to confirm the history of safe use of traditional herbs in their own countries and the countries of origin. The Ayurvedic Drug Manufacturer’s Association (ADMA) has already requested its members to furnish such data for the general benefit of the community but industry response is not yet clear.
In fact, such a program may help in expanding the existing list of ODIs from India and China as more data emerges from Customs and private records. Currently there are 350 ODI herbs from India according to ADMA. Indian dietary supplement companies doing business with the US are still wary of notifying a New Dietary Ingredient to the FDA as past success rates for such notifications have been very low.
Going forward, I think, a robust database of contemporary data on the safety and efficacy of herbal medicines can be generated out of a well-organized program of Pharmaco-epidemiology for herbal medicines. Such a private-public program of Herbal epidemiology powered with modern day IT tools, will go far to document the history of safe and effective use for policy-makers and regulators to take informed decisions on such products in the future.
- Jayesh Chaudhary (jayesh@ayuherbal.com)
