Natural Options Corp 12/21/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	555 Winderley Pl., Ste. 200 Maitland, FL 32751

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-11-11

December 21, 2010
 

Claudia Muharram, President/Director
Natural Option USA Corporation
4957 SW 74th Court
Miami, FL 33155

Dear Ms. Muharram:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at
the Internet address http://www.natural-option.com/ in December 2010 and has determined
that the product OsteOrganicCAL (a sea algae calcium compound packaged with Vitamin D3)
is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic
claims on your website establish that the product is a drug because it is intended for use in the
cure, mitigation, treatment, or prevention of disease. The marketing of this product with these
claims violates the Act.

Examples of some of the claims observed on your web site include:

Claims in the form of personal testimonials on the OsteOrganiCAL webpage:

• "My clinical results in reversing osteopenia and osteoporosis have been better than
those obtained using Fosamax."

• "[M]y bone density test showed considerable improvement. My first bone density test
indicated I was at risk for traumatic fracture. After I began the OsteOrganiCAL
program, my follow-up test showed considerable improvement."

• "April of 1995, I had a bone scan. The result: I was diagnosed with severe
osteoporosis. In May I found out about a product called OsteOrganiCAL, I took
OsteOrganiCAL for three months, went and had another bone scan. My overall bone
density was increased 3.9%. I have never felt better."

• "[I] had a hard fall, my hip was black and purple. My chiropractor said she had never
seen any bruise that bad, without a broken hip. I am sure it was the Natural Option
product [OsteOrganiCAL] that saved me from a break. Thank you so much for
stronger bones."

• "[S]even months my wife has been on OsteOrganiCAL. During this time she has not
fractured any bones."

Claims made under the heading "OsteOrganiCAL® CASE STUDY ANALYSIS":

• "The fall of 2003 the Osteoporosis Education Project completed a yearlong pilot study
with the sea algae calcium and vitamin D product known as "OsteOrganiCAL®". The
study included eleven postmenopausal women, six of whom experienced impressive
gains in bone mineral density from use of the product."

• "[A]nalysis of these cases documents the potential of this novel Calcium and Vitamin
D product [OsteOrganiCAL] to halt and reverse the osteoporosis process in
postmenopausal women."

• "Using OsteOrganiCAL however, the few women in the sample with only moderate
bone loss (osteopenia) also benefited significantly from this therapy."

Your product is not generally recognized as safe and effective for the above referenced uses
and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C.
§ 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 U.S.C. § 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. Furthermore, your product OsteOrganiCAL is misbranded within the
meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because the labeling for this
drug fails to bear adequate directions for use.

This letter is not intended to be an all-inclusive review of your website and the products your
firm markets. It is your responsibility to ensure that all products marketed by your firm
comply with the Act and its implementing regulations. We advise you to review your
website, product labels, and other labeling and promotional materials for your products to
ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their
future recurrence. Failure to do so may result in enforcement action without further notice.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and
distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days from your receipt of this
letter as to the specific steps you have taken to correct the violations noted above and to
ensure that similar violations do not recur. Your response should include any documentation
necessary to show that correction has been achieved. If you cannot complete all corrections
before you respond, please explain the reason for the delay and the date by which the
corrections will be completed.

Your response should be directed to Winston Alejo, U.S. Food and Drug Administration,
Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have
any questions about this letter, please contact Mr. Alejo at (407) 475-4731.
 

Sincerely,
/S/
Emma R. Singleton
Director, Florida District

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