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

Public Health Service
Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

VIA UPS NEXT DAY

October 12, 2010

W/L 05-11

Van Cleve, Alexandra Webmaster
Longevity Plus
600 N Beeline Hwy
Payson, Arizona 85541

Dear Mr. Cleve:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.longevityplus.com in July 2010 and has determined that the products "Beyond Chelation Improved," "EndoKinase," "Viral Defense" and "Wobenzym-N 200ct" are promoted for conditions that cause the product 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 websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Beyond Chelation Improved

EndoKinase

Viral Defense

Wobenzym-N 200 ct

Your website links directly to www.gordonresearch.com which is operated by Garry F. Gordon, MD. On a webpage titled "Biography," Dr. Gordon states that he is "full-time consultant for Longevity Plus" and is "responsible for the design of the majority of their supplements, which are widely used in alternative health practitioners [sic] around the world."

Dr. Gordon's website contains numerous articles, as well as video and audio materials that include disease claims for your products.

Examples of some of the claims for your products found on www.gordonresearch.com include:

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.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were 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 film 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 sent to:

Blake Bevill, Director,
Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions regarding any issues in this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer at (949) 608-4477

Sincerely,

/S/
Alonza Cruse
District Director

This page was posted on October 15, 2010.

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