Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy
July 31, 2002
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Founder & President,
Optimal Health Concepts
355 N. Lantana St #730br> Camarillo, CA 93010-6038
Ref. No. CL-02-HFS-810-28
Dear Mr Jones:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.intohealth.com and has determined that the products "Herp-Eeze™," "Red Marine Algae Complex," "MSM," and "FlexMax Glucosamine Sulfate" being offered 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 continued marketing of these products with these claims violates the Act and may subject you or the products to regulatory action without further notice.
Examples of some of the claims observed on your website include:
Herp-Eeze™ claims located under product index "help for herpes" link: "A potent and stable concentrate from the leaf resin of the Creosote bush (Chaparral) which has broad spectrum anti-viral … anti-inflammatory, … anti-microbial, anti-tumerogenic properties. Useful as a natural alternative for Chronic Fatigue Syndrome, Herpes Simplex 1 & 2, Atherosclerosis, Chicken Pox and Shingles, Roseolovirus, Kaposi's Sarcoma, AIDS, HIV 1 & 2, Human Leukemia Virus 1 & 2, and Hepatitis B Virus. Also useful for all inflammatory conditions…"
Red Marine Algae Complex claim located under product index "help for herpes" link: "…is an antiviral food used to help suppress the Herpes Virus, especially in the initial stages of an attack."
MSM claim located under MSM, testimonials, asthma link: "I suffer from asthma and sinus allergies. More recently I have had trouble with an aching knee joint and stiffness in my finger joints. I also, of late, have had bouts of insomnia. … Greg Jones upon hearing this suggested I try MSM … I have had to resort to my asthma inhaler only about half the number of times that I have had to in the recent past. And the pain in my fingers and knee are barely noticable [sic]."
Flexmax Glucosamine Sulfate claims located under product index "arthritis assistance" link: "… very beneficial for those suffering from Arthritis… Helps promote tissue repair, elasticity and cushioning … highly effective."
Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be "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 or as cosmetics if therapeutic claims 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 (DSHEA), 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/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 into 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 may market. It is your responsibility to ensure that all products marketed by your firm are in compliance 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 reach FDA electronically (e-mail) at APope@CFSAN.FDA.GOV, or you may respond in writing to Angela F. Pope, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms Pope at 301-436-2375.
John B. Foret
Division of Compliance and Enforcement
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was posted on May 4, 2006.