Department of Health and Human Services
Public Health Service
Denver District Office
January 12, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
166 Turner Dr
Durango, CO 81303
Ref. No. KAN 2006-06
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your website at the Internet address 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)(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 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 products bears the following implied claims:
- "Can you protect your family from the ravages of pandemic flu? Fluvicet is an all natural herbal formula designed to support your bodyÕs 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 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 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 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 reply should be addressed to Compliance Officer Shelly L. Maifarth at the above address.
B. Belinda Collins
This page was revised on February 18, 2008.