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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sacred Mountain Management Inc 28-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Denver District Office
Bldg 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone : 303-236-3000
FAX: 303-236-3100



Warning Letter


November 28, 2005

CERTIFIED MAIL
RETURNED RECEIPT

Sally Robertson
Sacred Mountain Management Inc.
23709 Emerald Trail
Deer Trail, CO 80105

Dear Ms. Robertson:

The Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.absolutehealth.org and has concluded that claims in the labeling for your product Nature's Biotics™ cause the product 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 Intemet labeling of your product bears the following claims:

  • "Avian Flu Prevention" [heading of the page that discusses the use of Nature's Biotics® to prevent flu and has links to price and order information for the product] "

  • "Personally, I believe that Nature's Biotics® will keep me protected from getting the Avian Flu if it cortmes my way."

  • "[T]he soil-based organisms (SBO's) in Nature's Biotics® are able to stimulate the immune system in such a way as to help ward off attacks from mutated forms of the influenza virus (such as the Avian flu). . . ."

  • "I am 68 years old now and my doctors want me to take a flu shot every year since my age puts me at risk for dying from the flu. However, I have not had a shot nor a case of the flu since I~started taking Nature's Biotics® in 1997."

  • "The best defense against the Avian flu is to stimulate your immune system to produce vast pools of uncoded antibodies ready to fight a new virus."

  • "I personally want to take Nature's Biotics® way before the Avian flu hits to make sure my immune system has a vast reservoir of uncoded antibodies ready to be properly coded when needed ."

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 Shelly L. Maifarth at the above address.


Sincerely,

/s/

Howard Manresa for B. Belinda Collins
District Director