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

Public Health Service
Food and Drug Administration
Central Region
Baltimore District Office

 

900 Madison Ave
Baltimore, MD 21201-2199
Telephone: 410-962-3396
FAX: 410-962-2307

May 22, 2000
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Niles S. Price, President
Price's Power International, Inc.
13014 Green Grove Ln
Newport News, VA 23608

Ref. No. FEI 3002930145

Dear Mr Price:

This letter is in reference to your firm's marketing and distribution of Predator Chromium Picolinate and Power Plus Natural Phen-Fen. Labeling for these products contains therapeutic claims that represent and suggest that the products are intended to be used in the cure, mitigation, treatment or prevention of disease, or intended to affect the structure or fimction of the body. Such claims cause the products to be drugs within the meaning of Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

Labeling is not limited to the immediate product containers. The promotional literature distributed in connection with your products is also considered as labeling.

Objectionable claims include the following:

PREDATOR Chromium
Lowered serum cholesterol levels, heart disease, high piccolinate blood pressure.
POWER PLUS NATURAL
Obesity.
PHEN-FEN—

Predator Chromium Picolinate and Natural Phen-Fen are new drugs within the meaning of Section 201(p) of the Act and, therefore, may not be legally marketed in this country without approved New Drug Applications filed pursuant to Section 505(a) of the Act. These drugs are also misbranded within the meaning of Section 502(f)(1) and 502(a) in that their labeling ftils to bear adequate directions for the uses for which they are being offered and their labeling is false and misleading because it suggests that these products are safe and effective for their intended uses, when in fact, this has not been established, respectively.

This letter is not intended to be an all-inclusive list of deficiencies regarding the labeling and the products marketed by your firm. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

Furthermore, therapeutic claims for additior al products are included in your firm's product labeling. Such claims may also cause these products to be new drugs m-d misbranded drugs. Products and claims include:

St. John's Wart
depression, alternative to prescribed antidepressants, (compared to) Prozac.
Liquid Lunch-Stacker 2 Fat
lower cholesterol level, prevent cancer, Burner osteoporosis, dental caries and plaque.
Glucmamine Chondroitin 750
repair damaged joints, reverse damage in joint Arthritic Support Formula cartilage, arthritis, osteoarthritis, (compare to) nonsteroidal anti-inflammatory drugs (NSAIDS), relieve pain, exert a beneficial effkct of the disease process itsel~ musculoskeletal conditions.
Chondroiton Sulfate/Glucosamine HCL Vilagro
decreased potential for injury, arthritis, anyone who has joint problems or is at high risk for them, inflammation, more effbctive than ibuprofen in treating degenerative arthritis.

All reference to Viagra male impotence, menstrual irregularities, chronic fatigue syndrome, tuberculosis, menstrual disorders, stomach cancer, sterility, reproductive and sexual disorders.

Power Plus Melatonin
prevention of cancer.
Thermbuterol
decrease blood cholesterol
Chromium Picolinate
with Lowered serum cholesterol
Herbs
blood pressure.
And Extra Strength Chromium Picolinate Tablets
and triglyceride levels. levels, heart disease, high

We acknowledge receipt of a letter dated March 7, 2000 from your attorney, Arthur J. Kamp, David, Kamp & Frank, LLC, Newport News, VA (enclosed). In response to Mr. Kamp's letter we offer the following comments:

Although Section 704(a)(1)(B) of the Act excludes access to "financial data", it does not exclude access to "shipment data" including invoices. Our investigator requested copies of your invoices and shipping documents during the FDA inspection on February 8, 2000, to document the introduction of your drug products into interstate commerce. Our purpose was not to collect financial data. As your attorney stated in the March 7, 2000, letter, the redaction of the cost of the products listed on the requested invoices is acceptable.

We request that you take prompt action to correct the violations cited above. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without fi.uther notice. The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office, in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence, including the tirnefiame within which such corrections will be completed. If corrective action cannot be completed within 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, Richmond Resident Post, 10710 Midlothian Tpk #424, Richmond, VA 23235, to the attention of Scott J. MacIntire, Compliance Officer. Mr MacIntire can be reached at 804-378-162, extension 14.

Sincerely,
/s/
Lee Bowers
District Director

Enclosure

This page was posted on August 20, 2006.

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