Department of Health and Human Services' logo Department of Health and Human Services

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

May 20, 2008

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Vitapurity
Vitapurity Corporation
Vitapurity Nutraceuticals
5246 Dobrot Way
PO Box 5462
Central Point, Oregon 97502-0060

WARNING LETTER
SEA 08-18

Dear Sir or Madam

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.vitapurity.com and has determined that the products "Citral," "Ellagic Ultra," "Lycopene 25," "Pacific Ocean Shark Cartilage," "Miracle Mushroom Blend," and "Buffered Vitamin C Crystals" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your web site include:

Citral

Ellagic Ultra

Examples of some of the claims on your website in the form of testimonials include:

Lycopene 25™

Pacific Ocean Shark Cartilage

Miracle Mushroom Blend

Buffered Vitamin C Crystals

Further, your website cites a number of publications about your products or their ingredients. Many of these publications concern the use of the products or their ingredients for treatment or prevention of cancer. When scientific publications are used commercially by the seller of a product to promote the product to consumers; such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.

The following are examples of reference citations used to market your products for disease treatment and prevention on your website:

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products "Citral," "Ellagic Ultra," "Lycopene 25TM"," "Pacific Ocean Shark Cartilage," "Miracle Mushroom Blend," and "Buffered Vitamin C Crystals" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your web site, we noticed that you were promoting the products listed above for the treatment and/or prevention of diseases other than cancer and that you were also promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, 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 assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. 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 directed to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021.

Sincerely,

/S/

Charles M. Breen
District Director

CC:
Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580

This page was posted on July 19, 2010.

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