|Company:||Coral Calcium Factor|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Seattle District Office|
|Issued:||May 20, 2008||Closed:||
Department of Health and Human Services
Public Health Service
May 20, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-17
Coral Calcium Factor
89989 Green Hill Road
Eugene, Oregon 97402
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet www.coralcalciumfactor.com and has determined that the product "Coral Calcium Daily" is promoted for conditions that causes the product to be a drug under section 201(g)(1)(13) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(13)]. 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:
• "CORAL CALCIUMA[sic]™ may make the DIFFERENCE for YOU if You Suffer from any of these life-threatening diseases . . ."
• "Thus, the more calcium, the more oxygen, and therefore, the less cancer and other degenerative disease."
• "By the 1980s Dr. Reich had cured thousands, but lost his license for explaining that the consumption of mineral nutrients, such as calcium, could prevent cancer and a host of other diseases."
• "[B]y the late 1990s, other medical men of wisdom were also discovering that calcium supplements, could indeed reverse cancer."
• "In the October 13, 1998 issue of the New York Times wrote an article appeared [sic] entitled A[sic] Calcium Takes Its Place As a Superstar of NutrientsA" [sic] in which it reports that a study published in the Journal of the American Medical Association reported that A[sic] increasing calcium. . . might also prevent, cancer in such organs as the breast, prostate and pancreasA [sic]."
• "The January 14, 1999 issue of the Phoenix Republic wrote in an article entitled'A [sic] Calcium Reduces TumorsA' [sic] that the New England Journal of Medicine reported A [sic] 'adding calcium to the diet can keep you from getting tumors in your large intestineA [sic]."
• "Then the February, 1999 issue of the Readers Digest wrote in an article entitledA[sic] '[The A'SuperstarA'[sic] NutrientA' [sic] that the Journal of the American Medical published A [sic] 'when the participants consumption reached 1500 milligrams of calcium a day, cell growth in the colon improved toward normal (this means that the cancer was reversed)A[sic].'"
Your website also contains disease claims in the form of personal testimonials, including:
• "A[sic] 'In October 1996 I was diagnosed with prostate cancer . . . In October of that year I started following Robert BarefootA[sic]'s calcium regime. In July 1997 I had another prostate biopsy in which no evidence of malignancy was found. The regime outlined in the books The Calcium Factor and Death By Diet improves the immune system to where the body can heal itself, without intrusive measures like surgery, chemotherapy or radiation,A[sic]' S. Ross Johnson, Retired President of Prudential Insurance Company of America."
• "'Mr. Barefoot has been highly influential in my survival of prostate cancer...[h]e has aided me in not only arresting the progression of my disease, cancer, through diet and nutrition, but also reversing it.' Philip Sharples, President Sharples Industries Inc."
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. Your product "Coral Calcium Daily" is also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
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. We advise you to review your website, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your product do not cause it 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 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be complete within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
CC: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580