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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Healthy Origins 1/14/09

   

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


WARNING LETTER
09-PHI-05

CERTIFIED MAIL
RETURN RECEIPT REQUESTED 

January 14, 2009

Mr. Barrett Eby
Healthy Origins
P.O. Box 12615
Pittsburgh, PA 15241-0615

Eby Sales International Inc
206 Westbridge Dr.
Morgan, PA 15064

Dear Mr. Eby:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.healthyorigins.com and has determined that the products "Healthy Origins CoQ10Gels," "Healthy Origins E-400," "Healthy Origins Inositol Powder," "Healthy Origins Lyc-O-Mato," "Healthy Origins LycopenePlus," and "Healthy Origins Seleno Excell Selenium" 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 website include:

Healthy Origins CoQ10 Gels

  • "CoQ10 supplementation has also been shown to be an effective adjunct treatment to conjunctive heart failure, angina pectoris, high blood pressure, arteriosclerosis, mitral valve prolapse and periodontal disease, as well as helpful in the treatment of muscular dystrophy, chronic fatigue, diabetes, allergies ... AIDS ...."
  • Online brochure associated with "FREE CoQ10 Info" link:
o "CoQ10 has been proven to be of significant value in alleviating the effects of the following: heart disease, high blood pressure, cancer ... muscular dystrophy, multiple sclerosis, Parkinson's disease and periodontal disease."
o "A new approach to Parkinson's disease was reported at the 2002 annual meeting of the American Neurological Association ... and simultaneously published in the journal Annual [sic] of Neurology, Dr. Clifford Shultz and colleagues at the University of California, San Diego, showed that oral coenzyme Q10 can actually slow the progression of Parkinson's disease."

Healthy Origins E-400 

  • "Two major studies revealed that both men and women who supplement with at least 100 IU of Vitamin E per day for at least 2 years have a 37-41% drop in the risk of heart disease [New England Journal of Medicine]."

Healthy Origins Inositol Powder 

  • "It [inositol] is primarily used in the treatment of liver problems, depression[,] panic attacks and diabetes."
    "[H]elps in the reduction of blood cholesterol levels ...."

Healthy Orieins Lyc-O-Mato (also referred to on your website as "Healthy Origins Lyc-O-Mato 15 mg Olive Oil") 

  • "The message was clear: 15mg capsules of tomato lycopene helped reduce the size and severity of prostate tumors in men who took the capsules twice daily. As Omer Kucuk, M.D., delivered the message before the American Association of Cancer Research."

Healthy Origins Lycopene Plus (also referred to on your website as "Healthy Origins Lyc-O-Mato with Seleno Excell" or "Healthy Origins Lyc-O-Mato Lvcopene Plus") 

  • "This powerful anti-oxidant combination acts as ... protection against certain types of cancer and decrease in the incidence of blood clotting and balancing the good and bad cholesterol."

Healthy Origins Seleno Excell Selenium 

  • "[T]hought to play a role in prostate cancer prevention and other cancers. Selenium is a trace mineral that has now gained prominence as a potential powerful weapon against cancer."
  • "A five year US study conducted at Cornell University and the University of Arizona showed that taking 200 mcg of selenium daily resulted in 63% fewer prostate tumours [sic] and 46% fewer lung malignancies. In addition, the selenium can protect the heart by decreasing the risk of blood clotting and increasing the ratio of HDL(good) cholesterol to LDL (bad) cholesterol."

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 riot 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 "Healthy Origins CoQ10 Gels," "Healthy Origins Inositol Powder," "Healthy Origins Lyc-O-Mato," "Healthy Origins Lycopene Plus" and "Healthy Origins Seleno Excell Selenium" 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 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 these deviations 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 Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, Room 900 U.S. Customhouse, 2nd Chestnut Street, Philadelphia, PA 19106.

Sincerely,

/S/

Even L. Carter
Acting Director
Philadelphia District

cc: Pennsylvania Department of Agriculture
Bureau of Foods & Chemistry
2301 North Cameron Street
Harrisburg, PA 17120-9408
Attn: Sheri Morris