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U.S. Department of Health and Human Services

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Enforcement Actions

SeniorLife Health Inc.

   

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

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

WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


August 21, 2008

 

W/L 21-08


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


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


• "At Last an Affordable and Convenient Way to Gain the Many Health Benefits ... of Green Tea Extract ... High Antioxidant Value Reduces Cancer Risk"
• "[B]enefits of our Green Tea Extract™: ... 2004 Study Shows It Aids in the Fight Against Ovarian Cancer"
• "A 2004 Swedish study of 61,000 women showed ... a 46% lower risk of ovarian cancer in women who drank two or more cups of tea per day, compared with non-drinkers and each additional cup of tea per day was associated with an 18% lower risk of ovarian cancer,' researchers reported."
• "[T]he Journal of the National Cancer Institute published the results of a study indicating that green tea reduced the risk of esophageal cancer by nearly sixty percent. University of Purdue researchers recently concluded that a compound in green tea inhibits the growth of cancer cells."


Healthy Heart Essentials


• "Vitamin E ... helps fight against some cancers."
• "Some other benefits of taking Health Heart Essentials™ are: ... Assists in the Protection Against Prostate Cancer"
• "Vitamin E is a Powerful Weapon ... It has certain anti-cancer benefits and may inhibit the growth of cancer cells at the local level."
• "[P]eople with cancer often have lower levels of Vitamin E. Plus, population-based trials suggest that diets rich in antioxidants, including Vitamin E, may be connected to a reduced risk of certain types of cancer, such as colon cancer. Laboratory studies have generally shown that Vitamin E inhibits the growth of some cancers in test tubes and animals, particularly hormone responsive cancers such as breast and prostate. There is reason to believe, therefore, that, for these types of cancer at least, supplementation may prove beneficial for both prevention and treatment."


Men's Multi 45 Plus Daily Essentials


• "[B]enefits of our Men's Multi 45 Plus Daily Essentials™: ... Grapeseed Extract Helps Fight Cancer Cells"
• "Rich Anti-oxidants to Fight Cancer ... "


Omega 3-6-9 Complete


• "Omega-3 fatty acids are made from Alpha Linolenic Acid .... [A]nother study looking at ALA and its relation to breast cancer found that women with high levels of Alpha-Linolenic Acid have a 60% lower risk of breast cancer than women with low levels of the nutrient."
• "Omega-9 fatty acid, or Oleic acid ... may protect against some cancers."


Prostate Health Essentials


• "Lower PSA & Defend against Prostate Cancer"
• "Avoid Prostate Cancer Risk"
• "Prostate Health Essentials™ can help you fight against possible prostate cancer."·
• "Prostate Health Essentials™ is The Natural Choice for Solving Your Persistent Prostate Symptoms While also Reducing Your Risk of Prostate Cancer. Backed Up with 100% Guaranteed [sic] of Results! Shown to Shrink Enlarged Prostate."
• "Order Prostate Health Essentials™ and reduce an enlarged prostate, improve night time urinary flow, lower PSA scores ... all without the cost and negative side effects of prescription drugs."


Under listing of ingredients:


• "Selenium: A Journal of the National Cancer Institute study revealed that men with high blood levels of selenium were about half as likely to develop advanced prostate cancer. Selenium can potentially cut your risk of prostate cancer."
• "Studies show that daily Selenium supplements cut your risk of prostate cancer by 50% of more. Quite a few promising studies published in 2004 showed the potential benefits of selenium in the prevention of prostate cancer."

• "Lycopene: Reduces the chances of prostate cancer. ... Several research studies have suggested that the chances of prostate cancer may be decreased by taking Lycopene as a supplement."
• "Vitamin E: Daily doses of Vitamin E can reduce prostate cancer risk by a third and the disease's death rate by up to 41 percent, a recent study of thousands [sic] men in Finland. "This study for the first time really gives us that ray of hope that ... a vitamin E supplement ... can actually hope to prevent prostate cancer,' said study co-author Dr. Demetrius Albanes."
• "Green Tea: New research suggests that phytochemicals in green tea may help prevent the spread of prostate cancer. Research found that the phytochemicals in green tea increase the number of enzymes that convert carcinogens that locate themselves in the
prostate into harmless inactive chemicals."
• "Graviola: Some studies have show [sic] graviola to have anti-viral, anti-parasitic and potent anti-cancer properties."
• "Red Raspberry: Research at the Hollings Cancer Center shows that one cup of raspberries per week will stop prostate cancer growth for a period of up to one week."
• "Quercetin: Blocks the androgen (hormone) activity in androgen-responsive human prostate cancer cell lines. By blocking the androgen activity, the growth of prostate cancer cells can be prevented or stopped."


Examples of claims in the form of testimonials include:


• "I am very impressed with the effectiveness of your prostate remedy.... [T]wo weeks ago 1 found out that my PSA has actually gone down. My doctor is impressed. I'll continue with your prostate formula."
• "I was having problems with a borderline PSA of 5.2. After taking your Prostate Essentials for 4 months my PSA level has dropped to 4.0."


Women's Multi 45 Plus Daily Essentials


• "[B]enefits of Women's Multi 45 Plus Daily Essentials™: ... Grapeseed Extract Fights Cancer Cells"
• "Clinical studies have proven that the risk of cancer ... is increased when low levels of vitamins and minerals are present."


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