Department of Health and Human Services
Public Health Service
Office of Nutritional Products, Labeling and Dietary Supplements
July 18, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Harry C. Dougherty, CEO
73-4460 Queen Kaahumanu Hwy #110
Kailua-Kona, HI 96740
Ref. No. CL-06-HFS-810-223
Dear Mr Dougherty:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.astafactor.com and has determined that the products "AstaFactor® SalmonEssentials" and "AstaFactor® Sports Formula" 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:
- AstaFactor® SalmonEssentials
- "SalmonEssentials will help you to:…
- Reduce inflammation…
- Help fight depression
- Relieve symptoms of arthritis"
- AstaFactor® Sports Formula
- "Fight inflammation, the principal cause of … joint pain!
- Alleviated arthritis pain and stiffness"
Under the heading "Testimonials," your website includes a summary of survey results from users of your astaxanthin products, such as AstaFactor® SalmonEssentials and AstaFactor® Sports Formula. The summary includes information about the use of your astaxanthin products for various diseases:
"The survey results also include data on user feedback regarding dosage and:
- Back Pain
- Enlarged prostate"
This summary suggests that your astaxanthin products, including AstaFactor® SalmonEssentials and AstaFactor® Sports Formula, are useful in mitigating and treating disorders and injuries of the back, arthritis, hypercholesterolemia, asthma, and benign prostatic hypertrophy.
Your website also contains disease claims in the form of personal testimonials from users of astaxanthin products, including:
"'[B]lood tests revealed lower LDL cholesterol.'" "'My cholesterol decreased significantly'" "'My cholesterol reduced.'" "Observed 'a slight drop in cholesterol'"
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 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 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 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 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.
Robert J. Moore, PhD
This page was posted on February 12, 2008.