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

Public Health Service
Food and Drug Administration
New England District Office

 

1 Montvale Ave
Stoneham, MA 02180
Telephone: 781-279-1675
FAX: 781-279-1742

April 21, 1999
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Michael Cloud, President
Empowering Technologies, Inc
400 W Cummings Park #1725
Woburn, MA 01801

Ref. No. NWE-19-99W

Dear Mr Cloud:

This letter is written in reference to your firm's marketing of the product, Pro-Symbio PLUS. Labeling that accompanies this product, including the pamphlet entitled "Pro-Symbio PLUS An All Natural HGH-Releaser/Stimulator," the pamphlet entitled "Age Reversing Miracle," the audio tape entitled "AGE REVERSING MIRACLE" and the video tape entitled "BRIDGING THE GAP Age Reversal … Do Or Die?" include claims for treating and preventing various diseases and conditions.

Claims made for the treatment of disease cause the product, Pro-Symbio PLUS, to be a drug (Section 201(g)(1)(B) of the Federal Food Drug and Cosmetic Act [the Act].) These claims include but are not necessarily limited to:

Pamphlet: "Pro-Symbio PLUS An All Natural HGH-Releaser/Stimulator"
reversing increased cholesterol and blood pressure, impaired neurological functions such as Parkinson's and Multiple Sclerosis, heart attack and stroke risk factors are diminished, emphysema patients find their oxygen intake improved, osteoporosis is prevented, presbyopic eyes focus properly, antiobesity agent, regrow burned skin and close ulcerated wounds, promise for Alzheimer's patients.

Further, Pro-Symbio PLUS is represented as an alternative to injectable HGH, an approved drug:

Pamphlet: "Age Reversing Miracle"
In addition to the same claims found in the above mentioned pamphlet, this pamphlet includes statements for fighting viruses such as Herpes, healing of burns and wounds and fighting cancer.
Audio tape: "Age Reversing Miracle"
Statements made on this tape suggest that Pro-Symbio PLUS is useful for treating diabetes, cancer, prostate cancer, arteriosclerosis, and can increase resistance to infection by bacteria and viruses.
Video tape: "BRIDGING THE GAP Age Reversal … Do Or Die?"
Statements made on this tape suggest that Pro-Symbio PLUS is useful for reducing the susceptibility to cancer, bacteria and viruses.

Pro-Symbio PLUS is also a "new drug" (Section 201 (p) of the Act) because it is not generally recognized as safe and effective for treating the various conditions and diseases stated in its labeling.

The drug is also misbranded since the labeling is false and misleading as it suggests that the product is safe and effective for its intended uses when in fact this has not been established (Section 502(a) of the Act) and because the labeling fails to bear adequate directions for the use (Section 502(f)(1) of the Act.)

This letter is not intended to be an all inclusive review of all of your firm's products and labeling.

It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

We request that you take prompt measures to correct these violations. Failure to make prompt corrections may result in enforcement action being initiated by the Food and Drug Administration. This could include seizure of illegal products and injunction against the manufacturer and/or distributor of illegal products.

Please notify this ofhce in writing, within fifteen (15) working days of receipt of this letter, describing the specific steps you have taken to correct the violations and to prevent their recurrence. if corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to the Food and Drug Administration, New England District Office, 1 Montvale Ave, Stoneham, MA, 02180, Attention: E. Frank Gesing, Compliance Officer.

Sincerely,
/s/
John R. Marzilli
District Director

cc:
The Art of Better Living, Inc.
7891 E McClain St #103
Scottsdale, AZ 85260

This page was posted on August 20, 2006.

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