Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy
June 23, 2003
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
4927 W Sunset Park Cir
West Jordan, UT 84088
Ref. No. CL-03-HFS-810-55
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: http://www.heallix.com and has determined that the products "HEALlix"and "Cardio Care" being offered are promoted for conditions that cause these 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 web site establish that these 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 web site include:
"Staphylococcus Aureus: [Pneumonia, eye infections, skin infections such as (boils, impetigo, cellulitis and post operative wound infections), toxic shock syndrome, meningitis, food poisoning, osteomyelitis..."
"Shigella Flexneri: [Severe gastroenteritis (bacillary dysentery)]"
"Salmonella Typhimurium M: [Food poisoning and enteric fever]"
"Bacillus Cereus Group: [Food Poisoning]"
"Candida Albicans: [Yeast Infections]"
"Streptococcus Mutans Group: [Dental plaque and tooth decay]"
Escherichia Coli: [Food poisoning, urinary tract infections,...respiratory tract infections, and wound infections]"
"Haemophilus Influenzae: [Ear infection, pneumonia, meningitis, throat and sinus infections, including epiglottis in children and sinusitis and suppurative arthritis in children]"
"Enterobactor Aerogenes:[Wound infections, urinary tract infections bacteremia, and meningitis]"
"Klebsiella Pneumoniae: [Lower respiratory tract infections, urinary tract and wound infections...]"
Streptococcus Pneumoniae: [Pneumonia, meningitis, sinusitis, otitis media (ear infection)]"
Streptococcus Pyogenes Group A Beth Hemolytic: [Skin infections, upper respiratory infection (i.e. strep throat), impetigo,... scarlet fever and more]
Arthritis, bronchitis, cancer, candida, cold, cuts, flu, hepatitis, pneumonia, sinus, strept [sic] throat, yeast infection.
"…effective in reducing cholesterol…"
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)).
This letter is not intended to be an all-inclusive review of your web site 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 web site, 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.
Susan J. 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 July 31, 2005.