Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy
March 14, 2005
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Circle of Health, Inc
2852 Willamette St, PMB 399
Eugene, OR 97405
Ref. No. CL-04-HFS-810-120-R
Dear Mr Kruger:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.ayurveda-herbs.com and has determined that the products "Pushkaramula Rasayana #3 Asthma Ease," "Shilajit Rasayana #17 Diabetes Ease," and "Skullcap Rasayana #16 Epilepsy Ease" are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your web site establish that the 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 violates the Act.
Examples of some of the claims observed on your web site include:
Pushkaramula Rasayana #3 Asthma Ease
"A Natural Herbal Dietary Supplement for ASTHMA"
Shilajit Rasayana #17 Diabetes Ease
"A NATURAL HERBAL ALTERNATIVE REMEDY FOR DIABETES"
"Indications which this product can be used for …
- diabetes control …
- dissolves tumors"
"It [Shilajit, an ingredient in the product] is widely used for diabetes, impotency, chronic fatigue, genito-urinary diseases …."
Skullcap Rasayana #16 Epilepsy Ease
"A NATURAL HERBAL ALTERNATIVE FOR EPILEPSY"
"Indications for which this product can be used …
- epilepsy treatment, medication …
- insomnia cure …
- nervous system disorders …
- anxiety disorder …"
"It [Skullcap, an ingredient in the product] is also used for … neuralgia, neurosis … hypertension, arthritis, drug addiction …."
In addition, the names of these products, which include the name of a disease followed by the verb "ease," promote the products for mitigation or treatment of the named diseases.
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 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.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements if claims about diagnosis, cure, mitigation, treatment, or prevention of disease are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain requirements are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 CFR 101.93(g)).
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.
This letter is not intended to be an all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may respond in writing to Linda J. Webb, Compliance Officer, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning this letter, please contact Ms Webb at 301-436-2375.
Susan J. Walker, MD
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was revised on October 5, 2005.