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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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US Health Supplements 09-Jun-03

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

5100 Paint Branch Parkway
College Park, MD 20740



JUNE 9, 2003

WARNING LETTER

VIA OVERNIGHT DELIVERY

John Butera
US Health Supplements
4617 Holt
Bellaire, TX 77401

Dear Mr. Butera:

The Food and Drug Administration (FDA) has reviewed your web site at the following address: net. This review shows serious violations of the www.coral-calcium-supplement.net Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products Barefoot Coral Calcium Plus, Coral Calcium Daily, Halstead Stony Coral Minerals Coral Calcium, Herbalab Fossilized Coral Calcium, Nature's Benefits Coral Calcium Powder, Natures Benefit Marine Coral Minerals. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act]. Your web site claims that your products are useful in the prevention, treatment, or mitigation of cancer. The labeling of your product bears the following claims:

•"Coral Calcium also is credited with many properties know [sic] to ward off cancer growth."

•"Barefoot Coral Calcium Formula has not only the anti-cancer protection from the calcium, but also the cancer protecting qualities of the Vitamin D that is part of the formula."

These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act. Because the products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These drugs are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be addressed to Compliance Officer Jennifer Thomas at the above address.

Sincerely,

/S/

Joseph R. Baca
Director
Office of Compliance
Center for Food Safety and Applied Nutrition