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June 23, 2003
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Heallix
4927 W Sunset Park Circle
West Jordan, Utah 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:
HEALlix
"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: [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]
Uses
Arthritis, bronchitis, cancer, candida, cold, cuts, flu,
hepatitis, pneumonia, sinus, strept [sic] throat, yeast infection.
Cardio Care
"…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 U.S. 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 C.F.R. 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 Parkway, College Park, Maryland
20740-3835. If you have any questions concerning any issue in this
letter, please contact Ms. Pope at (301) 436-2375.
Sincerely yours,
/s/
Susan J. Walker, M.D.
Acting Director
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
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