This is to advise you that in June 2009 the Food and Drug Administration (FDA) reviewed your website at the Internet address www.banyanbotanicals.com and has determined that your brand of Banyan Ayurvedic Herbs products ("Shilajit," "Mahasudarshan," and "Kanchanar Guggulu") are promoted for conditions that cause them to be drugs under section 201 (g)(l)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violate the Act.
"Traditional Uses: ... impotence, lung disorders ... enlarged prostate, urinary tract disorders"
"supports the body's natural defenses against bacteria and viruses"
"Herbal Actions: ... anti-inflammatory... antipyretic, antiviral, decongestant ..."
"Traditional Uses: colds, flus, liver and spleen disorders .. .inflammations"
"Traditionally used for fever and disorder of the liver and lymph .. ,"
"assisting the immune system in times of infection"
"Herbal Actions: anti.:.inflammatory ... expectorant"
"Traditional Uses: tumors ... goiters, hemorrhoids"
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, they are "new drugs" under section 201(P) of the Act [21 U.S.C. §J21(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your "Shilajit," "Mahasudarshan," and "Kanchanar Guggulu" products are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and its labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your product do not cause them to violate the Act.
You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Your response should be directed to the Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-008, Attention: Nancy G. Schmidt, Compliance Officer. If you have any further questions, please feel free to contact Ms. Schmidt at (303) 236-3046.