Inspections, Compliance, Enforcement, and Criminal Investigations
PuraVida Health Inc. 12-Jan-06
Department of Health and Human Services
Public Health Service
January 12, 2006
Ref. No. DEN- 06-08
RETURNED RECEIPT REQUESTED
PuraVida Health Inc.
166 Turner Dr
Durango, CO 81303
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.puravidahealth com and has concluded that claims in your labeling cause your product FLUVICET to be a drug as defined in section 201 (g)(1)(13) 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)]. Your web site claims that your product is useful in the prevention and treatment of influenza. In addition, the use of "flu" as a component of your product name further suggests that FLUVICET is intended to prevent or treat influenza.
The Internet labeling of your product bears the following claims:
Can you protect your family from the ravages of pandemic flu? Fluvicet is an all natural herbal formula designed to support your body's response to this type of virus."
You should ONLY consider using this product at the first signs of sickness during a pandemic."
Key Factors in Fighting Certain Viral Infections:
Decreasing the risk of initial injection
Decreasing the potential virulence of the infection
Protecting against the after-effects of hemorrhage Inhibition of secondary infections
To accomplish these biological responses to a viral pandemic, FLUVICET contains the following ingredients . . . ."
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.
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