Inspections, Compliance, Enforcement, and Criminal Investigations
The Long Life Catalog Company 30-Jan-06
Department of Health and Human Services
Public Health Service
New England District
January 30, 2006
RETURNED RECEIPT REQUESTED
Nina E. Anderson
The Long Life Catalog Company
561 Shunpike Road
Sheffield, MA 01257-9758
Dear Ms. Anderson:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://longlifecatalogs.com and has concluded that claims in your labeling cause your product Zap-V to be a drug as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. You can find the Act and FDA's regulations through links on FDA's Internet home page: http://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, 21 U.S.C. 321 (g)(1)(13)]. The labeling for your product on your web site bears the following claims under the title "Zap-V":
"Flu . . . prevention with humic/fulvic acid"
"Humic acid . . . dilates a healthy cell and causes permeability so it can enter. Fulvic acid acts as a carrier to the cell. The two together become a formidable antiviral."
"Viral loads were reduced considerably in studies performed on HIV patients in Africa in 2003. The National Institute of Health in 2002 concluded that humic acids exhibit effects both as a preven-tive (sic) and a curative for a broad range of viruses."
"In Moscow, doctors analyzed the use of humic acid . . . . They studied its relationship to hepatitis and concluded that . . . [it] made sense to study it further as to its potential influence on hepatitis.
1 Bottle contains 30 tablets of 250mg humic and fulvic acids."
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because your 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 [21 U.S C. 321(p)]. Under section 505 of the Act [21 U.S .C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). This letter is not an all-inclusive review of your website and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 U.S.C. 332 and 334]. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
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 ensure 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 written response should be sent to Seth A. Mailhot, Compliance Officer, U.S. Food and Drug Administration, New England District Office, 1 Montvale Avenue, 4th floor, Stoneham, Massachusetts 02180-3500.
If you have any questions about this letter, please contact Mr. Mailhot by telephone at (781) 596-7769 or by fax at (781) 596-7896.
Gail T. Costello
New England District Office