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

Public Health Service
Food and Drug Administration
Southwest Region Denver District Office

 

Bldg 20, Denver Federal Ctr
PO Box 25087
6th Ave & Kipling St
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

January 6, 1998
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Richard Bizzaro, President
Weider Nutrition International
2002 S 5070 W
Salt Lake City, UT 84663

Ref. No. DEN-98-05

Dear Mr Bizzaro:

This letter is written in reference to your firm's marketing and distribution of "PHENCAL" and "PHENCAL 106". Your products are offered as alternatives to the drug, Phentermine, which is a prescription drug intended to treat obesity. Labeling your products as alternatives to Phentermine represents claims that your products are intended for the same use as Phentermine. Thus, you are representing PHENCAL and PHENCAL 106 as treatments for obesity.

Additionally, brochures(labeling) titled "PHENCAL 106, The Natural Weight Loss Alternative" and "PHENCAL, Get in Control and Stop the Yo-Yo Diet" contain statements indicating that these products are also intended to treat imbalances of neurotransmitters in tie brain. These statements are disease claims and not structure/fhnction claims. Therefore these products, PHENCAL and PHENCAL 106, are drugs as defined in Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) and "new drugs" [Section 201(p)] based on:

Also, PHENCAL and PHENCAL 106 are misbranded because their labeling fails to bear adequate directions for use (Section 502(f)(1) of the Act) and their labeling is false and misleading since it suggests that the products are recognized as safe and effective for their intended use (Section 502(a) of the Act) and this is not the case. Labeling is not limited to the immediate product containers but includes all promotional literature which you distribute in comection with the products.

This letter is not intended to be an all inclusive review of all labeling and products your firm markets. 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 action to correct these violations. Failure to promptly correct these violations may result in etiorcement action being initiated by the Food and Drug Administration without fhrther 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 as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. 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 implemented.

Your reply should be directed to the Food and Drug Administration, Denver District Office, Attention: Shelly L. Maifarth, Compliance Officer.

Sincerely yours,
/s/
Gary C. Dean
District Director

This page was posted on August 20, 2006.

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