Inspections, Compliance, Enforcement, and Criminal Investigations
Johnson, Steve 09-Jun-03
Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
VIA OVERNIGHT DELIVERY
38731 Arcola Drive
Sterling Heights, MI 49312
Dear Mr. Johnson:
The Food and Drug Administration (FDA) has reviewed your web site at the following address: www.coral-calcium-one.com, www.robert-barefoot-coral-calcium.com, www.purecoralcalcium com, and www.barefoots-coral-calcium-supremecom. This review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products Coral Calcium 1 and Coral Calcium "Supreme." 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 numerous serious diseases . The labeling of your products bears the following claims:
•"If you suffer from any of these life threatening diseases there may be help! Cancer ... Lupus, Hypertension, Diabetes, Heart Disease. . . Fibromyalgia . . . Chronic Fatigue Syndrome . . . Arthritis . . . Alzheimer's Disease, High Cholesterol"
•"Thousands of people around the world are finding relief from over 200 different diseases link [sic] to Calcium Deficiency. People who had these horrible conditions are now living pain free happy lives."
•"...helping to prevent the risk of degenerative diseases."
•"Helps... high or low blood pressure, 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)(1) 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 drugs and the products met the definition of a dietary supplement, they would violate other provisions of the Act. Under the Act, labeling for a dietary supplement may include claims about 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 lack substantiation cause a product to be misbranded under sections 403(a)(1) and 403(r)(6) of the Act.
The labeling of your products bears structure/function claims that include the following:
•"May help cleanse the Kidneys, Intestines and Liver while breaking down heavy metals and drug residues in the body ...
• "Achieve an Alkaline Balance . . . ."
We have reviewed these claims and have concluded that they are not supported by reliable scientific evidence. Because these claims lack substantiation, they cause your product to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6)(B) of the Act.
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.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition