June 23, 2003
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
The Power Store
1011 North Galena Avenue
Dixon, Illinois 61021
Ref. No. CL-03-HFS-810-52
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.thepowerstore.com
and has determined that the products "Omega Twin Flax Borage -
Barleans," "High Lignan Flax Oil - Barleans,"
"Yeast Fighters - Twinlab," "E Super Complex 1,
0000 Iu- Twinlab," "Omega 3 Fish Oil - Twinlab,"
"C 1000 Caps - Twinlab," "C+ Citrus Bioflavonoid
- Twinlab," "Potassium 99 mg - Twinlab,"
"Magnesium 400 mg - Twinlab," and "Emergen C
Tangerine - Alacer" 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 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 web
site include:
Omega Twin Flax Borage - Barleans
".reduce blood pressure, decrease arthritis
pain, lower cholesterol and reduce the risk of blood clot
formation."
High Lignan Flax Oil - Barleans
".reduce blood pressure, decrease arthritis
pain, lower cholesterol and reduce the risk of blood clot
formation."
Yeast Fighters - Twinlab
".lower 'bad' cholesterol."
E Super Complex 1,000 Iu - Twinlab
"Antioxidant important in the prevention of
cancer & Cardiovascular Disease."."reduces blood
pressure, aids in preventing cataracts.."Omega 3 Fish Oil
- Twinlab
".reduce blood pressure, decrease arthritis
pain, lower cholesterol and reduce the risk of blood clot
formation."
C 1000 Caps - Twinlab
".may help protect against certain cancers,
cataracts and heart disease."
C+citrus Bioflavonoid - Twinlab
".may help protect against certain cancers,
cataracts and heart disease."
Potassium 99 mg - Twinlab
".helps prevent stroke,."
Magnesiumm 400 mg - Twinlab
".prevent depression,."
Emergen C Tangerine - Alacer
"Promotes.wound healing, and resistance to
infections." ".protect against certain cancers,
cataracts and heart disease."
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.
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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