|Subject:||Labeling/Promotional Claims False & Misleading/New Drug|
|Issuer:||Denver District Office|
|Issued:||Jan. 26, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Denver District Office
January 26, 2006
6107 Chelsea Manor Ct.
Boulder, CO 80301
Dear Mr. Sichel:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://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 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)(B)]. Your web site claims that your product is useful in the prevention and treatment of influenza.
The Internet labeling of your product bears the following claims:
"*Del-Immune VT™ 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 U.S.C. 321(g)(1)(B)]. 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 [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 the labeling is false and misleading in that it suggests that this drug is effective for the prevention and treatment of influenza when, in fact, these claims are not supported by competent and reliable scientific evidence.
Even if your product Del-Immune VT™ 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 web site ( http://www.delimmune.com/default.asp?utm_medium=cpc&utm_campaign=Avian&utm_source=google ) contains the following statements about this product:
"The product is now produced in the U.S. 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 web site 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 web site 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 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 reply should be addressed to Compliance Officer Shelly L. Maifarth at the above address.
B. Belinda Collins