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Date: April 8, 2004
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
HBees.com
Administrative Division
1229 Tall Grass Circle
Stow, Ohio 44224
Ref. No. CL-03-HFS-810-83
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.hbees.com and has
determined that the products “Relacore,” and “Opti Stolic” 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 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:
Relacore (Carter-Reed Company)
“Helps Prevent Stress-Related Abdominal Obesity”
“Reduces sub-clinical depression.”
Opti Stolic (NX Nutraceuticals)
“This dilation in turn can lower the pressure within the arteries
and vessels.”
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)).
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
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.
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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