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Dear Group
I have a small query regarding the use of a phytocompound “quercitin”.
I like to know that if this phytocompound is used in its purified form in a functional food, food or
a dietary supplement whether it will affect the regulatory status of the final product. In another
way whether a product prepared by using quercitin Is still covered under regulations for functional
food, food or a dietary supplement. I look forward for your expert comments on this.
Regards
Nishant Paliwal
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Nishant:
A company could make a case that quercitin is "grandfathered" as an ingredient in dietary
supplements (I assume we are talking about the F.D.A. because other countries have very different
requirments).. The regulatory requirements for a functional food is much more strict than for a
dietary supplement. The real issue for inclusion of quercitin in a food or dietary supplement is the
claims made in advertising...they are very limited. You can not say they "cure" or "treat" any
disease.
Sincerely,
Carol Collins
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Dear Nishant,
Please check for "Risorine" a novel formulations (DCGI approval 2009). This formulation containing
200 mg of rifampicin, 300 mg of isoniazid and 10 mg of Piperine (herbal bioenhancer like Quercitin)
has been launched in India by Cadila Pharma in November 2009.
Regards,
Sudipto Basu
Principal Scientist
Sai Life Sciences Ltd, Pune
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