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

Public Health Service
Food and Drug Administration
  19701 Fairchild
Irvine, CA 92612-2506

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 21, 2008

SeniorLife Health, Inc
24591 Del Prado #201
Dana Point, CA 92629

WARNING LETTER
W/L 21-08

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.seniorlifehealth.com and has determined that the products "Green Tea Extract," "Healthy Heart Essentials," "Men's Multi 45 Plus Daily Essentials," "Omega 3-6-9 Complete," "Prostate Health Essentials," and "Women's Multi 45 Plus Daily Essentials" 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:

Green Tea Extract

Healthy Heart Essentials

Men's Multi 45 Plus Daily Essentials

Omega 3-6-9 Complete

Prostate Health Essentials

Under listing of ingredients:

Examples of claims in the form of testimonials include:

Women's Multi 45 Plus Daily Essentials

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 "Green Tea Extract," "Healthy Heart Essentials," "Men's Multi 45 Plus Daily Essentials," "Omega 3-6-9 Complete," "Prostate Health Essentials" and "Women's Multi 45 Plus Daily Essentials" 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 website, 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. 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 ensure 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 written reply should be addressed to:

Pamela B. Schweikert
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions regarding any issue in this letter, please contact MaryLynn Datoc, Compliance Officer at 949-608-4428.

Sincerely,

/S/

Alonza E. Cruse
Director
Los Angeles District

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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