Department of Health and Human Services
Public Health Service
200 C St SW
May 6, 2002
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
1908 Jasmine St
Denton, TX 76205
Ref. No. CL-02-HFS-810-23
Dear Mr Currell:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses: http://www.arthritispainrelief.com and http://www.srhealth.com and has determined that the products "JointRenew™" and "JointRenew2™" 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 websites 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 websites include:
"JointRenew™: A Dietary Supplement Shown Effective for Reversing Cartilage Damage and Relieving Pain for People Who Suffer from Arthritis"
"Discover Arthritis Pain Relief with JointRenew2 — the Safe, 100% Natural Solution for Reducing or Eliminating the Aches and pains of Arthritis"
"The conditions that show the greatest response are rheumatoid arthritis and osteoarthritis. If you experience the symptoms of either of these conditions, JointRenew2 will help. If you lack mobility in your hands, hips, knees, or other joints — or if you experience joint pain or inflammation — you're likely to benefit from JointRenew2's incredible ability to ease your symptoms and heal your body."
"It is important to note that the combination of glucosamine sulfate and chondroitin sulfate with collagen will not only protect the cartilage, but also provide the building blocks required to rebuild lost cartilage to restore the joint to a normal state."
"Glucosamine helps to reduce pain and improve joint function in those afflicted with osteoarthritis. It has also been shown to inhibit at least two of the enzymes that degrade cartilage and has certain anti-reactive properties. This means that glucosamine actually blunts the damaging effects of certain chemicals on the cartilage in joints."
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 websites 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 APaeng@CFSAN.FDA.GOV, or you may respond in writing to Andrew H. Paeng, 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 Mr Paeng at 301-436-2375 for Food Safety and Applied Nutrition.
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.