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Public Health Service |
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One Montvale Ave |
Department of Health and Human Services
January 30, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Nina E. Anderson
The Long Life Catalog Co
561 Shunpike Rd
Sheffield, MA 01257-9758
Ref. No. NWE-06-06W
Dear Ms Anderson:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address www.longlifecatalogs.com and has concluded that claims in your labeling cause your product ISD-10 Immune System Defense to be a drug as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)(B)]. You can find the Act and FDA's regulations through links on FDAÕs Internet homepage: 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 USC 321(g)(1)(B)]. Your website claims that your product is useful in the prevention and treatment of avian flu and other forms of influenza.
The Internet labeling of your product bears the following claims:
- "Flu … prevention with humic/fulvic acid"
- "Benefits:
reduces inflammation
anticancer
antitumor
antiviral" - "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 USC 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 USC 321(p)]. Under section 505 of the Act [21 USC 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 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 notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 USC 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 haven 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, US Food and Drug Administration, New England District Office, 1 Montvale Ave, 4th Fl, Stoneham, MA 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.
Sincerely,
/s/
Gail T. Costello
District Director
This page was revised on February 18, 2008.