| Public Health Service |
5100 Paint Branch Parkway |
Departmentof Health and Human ServicesJUN 10 2003
WARNING LETTER
VIA OVERNIGHT DELIVERY
I Coral Calcium/Thin America
44290 Delco Blvd
Sterling Heights, MI 48310
33184 Ryan Road
Sterling Heights, MI 48310
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your web site at the following address: www. l-coral-calcium.com. This review shows serious violations of the Federal Food, Drug, and Cosmetio.Act (the Act) in the labeling of your Coral Calcium products. 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 orprevention 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 numerous serious diseases. The labeling of your products bears the following claims:
• "Defy arthritis. . .
•"Combat arthritic conditions and heart disease"
•". . .helping to prevent the risk of degenerative diseases . . . "
•"Helps . . . high cholesterol . . . rheumatoid arthritis, ulcers, psoriasis, ulcerative colitis,gastroenteritis . . . "
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)(l) of the Act, in that the labeling for these drugs fails to bear adequate directions for use.
Even if the labeling for these products did not contain language that caused them to be drugsand the products met the definition of a dietary supplement, they would violate otherprovisions of the Act. Under the Act, labeling for a dietary supplement may include claimsabout the product's effect on the structure or function of the human body. However, these"structure/function" claims must be truthful and not misleading. Claims that lacksubstantiation cause a product to be misbranded under sections 403(a)(1) and 403(r)(6) of theAct.
The labeling of your products bears structure/function claims that include the following :
•"Cleanse the kidneys, intestines, and liver"
• "Achieve a healthy alkaline level"
•"Breakdown heavy metals and drug residues in your body"
•"Coral Calcium . . .keeps the pH level of our body fluids in sync . . . "
•"Coral Calcium raises the alkalinity of the extra cellular fluid that surrounds your cells."
We have reviewed these claims and have concluded that they are not supported by reliablescientific evidence. Because these claims lack substantiation, they cause your products to bemisbranded within the meaning of sections 403(a)(l) and 403(r)(6)(B) of the Act,
The above violations are not meant to be an all-inclusive list of deficiencies in your productsand their labeling. It is your responsibility to ensure that products marketed by your firmcomply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers anddistributors of those products. You should take prompt action to correct these, deviations andprevent their future recurrence. Failure to do so may result in enforcement action withoutfurther 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 toassure that similar violations do not occur. If corrective actions cannot be completed withinfifteen working days, state the reason for the delay and the time within which the correctionswill 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
