Inspections, Compliance, Enforcement, and Criminal Investigations
Iceland Health, Inc 30-Nov-05
Department of Health and Human Services
Public Health Service
Kansas City District
November 30, 2005
RETURNED RECEIPT REQUESTED
Ref. KAN 2006-05
Iceland Health, Inc.
2615 Harney Street
Omaha, NE 68131
The Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.icelandhealth.com and has concluded that claims in the labeling for your product Immunity Plus 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 homepage: 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)(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 products bear the following claims :
"Immunity Plus Boost your body's immune system to ward off . . . flu"
"Be Prepared for the flu season and especially the threat of avian (bird) flu by keeping your immune system strong. Protect yourself and your loved ones with Immunity Plus."
"[O]ur Immunity Plus formula provides you with the highest level of alkylglycerois (G-E lipids) found in nature . . . Alkylglycerols have been used for years as an effective choice against . . . flu."
"We're so sure that the potent natural alkylglycerols in Immunity Plus will keep you healthy that we make this guarantee. If you get . . . flu, . . . while taking our Immunity Plus every day for 30 days, we'll give you your money back. "
"The Journal of Alternative and Complementary Medicine states Alkyglycerols are able to stimulate the helper T-cells which destroy bacteria in the body. Viral infections, such as influenza . . . , can be prevented or reduced significantly."
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 drug is also misbranded within the meaning of section 502(a) of the Act [21 U.S.C. 352(a)] because their labeling is false and misleading in that it suggests that this drug is effective for the prevention and treatment of avian flu and other forms of influenza when, in fact, these claims are not supported by competent and reliable scientific evidence.
This letter an all-inclusive review of your website and the products that your form 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 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 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 reply should be addressed to Compliance Officer Joseph G. Kramer at the above address.
John W. Thorsky
Kansas City District