Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Denver District Office

 

Bldg 20, Denver Federal Center
PO Box 25087
6th Ave & Kipling St
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

August 2, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Christopher D. Edwards
American Nutrition
735 N Park St #E
Castle Rock, CO 80104

Ref. No. DEN-06-22-UTL

Dear Mr Edwards:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.americannutrition.com and has determined that the products "American Nutrition® Odorless Garlic," "American Nutrition® Echinacea Extract," and "American Nutrition® L-5-HTP" 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 website 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 website include:

American Nutrition® Odorless Garlic
"Researchers have found odorless garlic to:
  • Helps fight viral, fungal and bacterial infections
  • Odorless Garlic may help to destroy certain viruses such as fever blisters, genital herpes, and a certain type of influenza"
American Nutrition® Echinacea Extract
"Echinacea was used by Native American Indians for wounds, infections, …"

"Echinacea has been used … to help speed wound healing, to reduce inflammations, and to treat colds, flu's [sic], and infections. Many of the active components of echinacea have antibacterial, antiviral, and antifungal properties. Echinacea has also been used externally to … heal wounds, eczema, burns, psoriasis, herpes, vaginitis, canker sores, abscesses. … Recent research has indicated that echinacea has potent anti-tumor activity[.] Our Standardized Echinacea Angustifolia Extract is produced by a European phyto-pharmaceutical company. … Like all European herbal extracts, the extraction of our Echinacea Angustifolia Extract is regulated to the same high standard as Over-The-Counter drugs."

American Nutrition® L-5-HTP
"[S]cientists have discovered that L-5-HTP helps with depression,…"

"Other symptoms that L-5-HTP may help with include: … migraines, obsessive-compulsive behaviors, … Our American Nutrition Brand 5-HTP is manufactured by European Swiss Pharmaceutical company Nuova. In Switzerland where L-5-HTP is a prescription drug."

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 do not comply 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 requirements are met. However, claims that dieta:ry 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/--lyd/fr000106.htm1 (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 website 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 website, please contact FDA. You may respond in writing to Ms Regina A. Barrell, Compliance Officer, at the above address.

Sincerely yours,
/s/
B. Belinda Collins
District Director

This page was posted on February 12, 2008.

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