Department of Health and Human Services
Public Health Service
College Park, Maryland 20740
Al Czap, President
Thorne Research, Inc.
25820 HWY 2
Dover, Idaho 83825
September 29, 2004
Ref. No. CL-04-HFS-810-l03
Dear Mr. Czap:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.thome.com and has determined that the products Perfusia-SRTM, Lycopene, Coleus Forskohlii, Bacopa, MSM-750, Calcium D-Glucarate, DHA (omega-3 from algae), Herbal Bulk, Medibulk, Mediclear, Mediclear Packets, Glycgel, and Olive Leaf Extract are promoted for conditions that cause these products to be drugs under section 20l(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 D.S.C. 9321(g)(1)]. The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of diseases. The marketing of these products with these claims violates the Act. Examples of some of the claims observed on your web site include:
"Perfusia-SR, a ... sustained-release L-arginineL-arginine is converted directly to nitric oxide. ... Inadequate nitric oxide production and the resultant endothelial dysfunction appears to be at the center of the atherosclerotic processInadequate nitric oxide production and endothelial dysfunction is present in many clinical conditions, including: Coronary heart disease, Hypertension, Erectile dysfunction, Diabetes, Peripheral vascular disease, Alzheimer [sic] and vascular dementiasSupplementation with Perfusia¬ SR improves endothelial function."
"Lycopene has also been positively associated with reduced risk of prostate, breast, and lung cancers, and might be protective of gastrointestinal and cervical cancers as well."
"[L Jowers blood pressure."
"Bacopa monniera has been found to provide benefit in anxiety disorders."
"The sulfur in MSM (Methyl Sulfonyl Methane) can be utilized by the formation of... cysteine. Arthritic joints have been found to be low in both sulfur and cysteine. "
"[D]etoxification of potent environmental toxins responsible for tumorogenesis and growth."
DHA (omega-3 from algae)
"Inability to desaturate EF As to DHA has been implicated in attention deficit disorder. "
Herbal Bulk and Medibulk
"[H]elps lower cholesterol."
Mediclear and Mediclear Packets
"[D]esigned to be used...for...allergies"
"[A ]ntiviral... activity"
Olive Leaf Extract
"Olive leaf extract exhibits important antiviral, antibacterial,.. .hypoglycemic, and vasodilatory effect."
Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, these products may also be "new drugs" under section 201(p) of the Act [21 U.S.C. 9 32 1 (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. 9 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective. Perfusia-SRTM,
Lycopene, Coleus Forskohlii, Bacopa, MSM-750, Calcium D-Glucarate, DHA (omega-3 from algae), Herbal Bulk, Medibulk, Mediclear, Mediclear Packets, Glycgel, and Olive Leaf Extract are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fail to bear adequate directions for use [21 U.S.C. 9352(f)(1)].
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 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 conditions 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/frOOOl06.html> (codified at 21 C.F.R. 9 101.93(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 trans dermal 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 C.F.R.) 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 reach FDA electronically (e-mail) at Kenneth.Taylor@CFSAN.FDA.GOV, or you may respond in writing to Kenneth M. P. Taylor, Ph.D., Chemist, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
If you have any questions concerning this letter, please contact Dr. Taylor at (301) 436-1439.
Susan 1. Walker, M.D.
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling
and Dietary Supplements
Center for Food Safety
And Applied Nutrition
This page was posted on November 27, 2004.