Inspections, Compliance, Enforcement, and Criminal Investigations
Natures Hand 09-Dec-03
Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
VIA OVERNIGHT DELIVERY
781 S. Midlothian Rd.
Mundelein, IL 60060
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your web site at the following address: www.natureshand.com. This review shows serious violations of the Federal Food,Drug, and Cosmetic Act (the Act) in the labeling of your product 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 product is useful in the prevention, treatment, or mitigation of numerous serious diseases. The labeling of your product bears the following claims:
" ... Cancer; Diabetes; Arthritis; Heart Disease ... Fibromyalgia; High Cholesterol. ..Alzheimer's Disease; Chronic Fatigue Syndrome; Lupus . . .Hypertension . . .. Barefoot's Coral Calcium addresses all of these!"
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act. Because the product is not generally recognized as safe and effective when used as labeled, it is also a new drug 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). This drug is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use.
Even if the labeling for this product did not contain language that caused it to be a drug and the product met the definition of a dietary supplement, it 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 product bears structure/function claims that include the following:
"Neutralize harmful acids."
We have reviewed this claim and have concluded that it is not supported by reliable scientific evidence. Because this claim lacks substantiation, it causes 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