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Public Health Service |
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300 Pearl St #100 |
Department of Health and Human Services
February 2, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
John Sichel
Del-Immune V
2316 Delaware Ave #266
Buffalo, NY 14216-2687
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address www.delimmune.com and has concluded that claims in your labeling cause your product Del-Immune V™ 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, mitigUSC f 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:
- "Del-Immune V™ offers immediate immune system support to help your body fight the flu.…"
- "To help with immune system support for flu, … use two capsules at least twice a day for three to four days."
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 drug is also misbranded within the meaning of section 502(a) of the Act [21 USC 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.
Even if your product Del-Immune V™ did not contain disease claims in its labeling that cause it to be a drug, it would be misbranded as a dietary supplement because your website (www.delimmune.com/default.asp?utm_medium=cpc&utm_campaign=Avian) contains the following statements about this product:
"The product is now produced in the US with the consent to market from the Food and Drug Administration (FDA). The FDA has determined that the product conforms to the guidelines for consumer safety under Natural Supplement Regulations."
These statements are false and misleading. FDA does not approve or grant a "consent to market" for dietary supplements sold in the United States. Further, FDA has not issued any "Natural Supplement Regulations" or guidelines for consumer safety under such regulations. The statements from your website quoted above suggest that FDA has approved or otherwise sanctioned the marketing of your product, and has determined that your product meets FDA safety guidelines. In fact, your product is not approved by FDA, nor has FDA reviewed its formulation or the representations made for it. Moreover, FDA has not determined that your product conforms to any statutory requirement in the Act or to any FDA regulation or guidance issued under the authority of the Act. Therefore the statements from your website quoted above, which you are using in the promotion of your product, are false and misleading. These false and misleading representations misbrand your product under section 403(a)(1) of the Act.
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 response should be addressed to Patricia A. Clark, Compliance Officer, US Food and Drug Administration, 300 Pearl St #100, Buffalo, NY 14202.
Sincerely,
/s/
Edward W. Thomas
Acting District Director
This page was posted on February 12, 2008.