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

October 1, 1999
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Robert E. Yates, President
Vancol Industries, Inc.
1700 E 68th Ave
Denver, CO 80229

Ref. No. DEN-99-23

Dear Mr Yates:

This letter is in reference to the products "Immunity Green Tea", "Vitality Orange Pineapple", "High Energy Citrus Punch", "Potency Fruit Punch", and "Focus Watermelon Kiwi" promoted, marketed, and distributed by your firm. Product labels for these products make the following disease claims:

Based on the claims made for these products and their intended uses, these products are drugs under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). They are also new drugs under Section 201(p) of the Act and may not be legally marketed in the United States without approved New Drug Applications (Section 505 of the Act). These drugs are also misbranded within the meaning of Section 502(f)(1) of the Act because the labeling fails to bear adequate directions for use. They are further misbranded within the meaning of Section 502(a) of the Act because the labeling is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established.

This letter is not intended to be an all-inclusive review of all labeling and products your firm markets. It is your responsibility to assure 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 violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug and Cosmetic Act provides for seizure of iilegal products (Section 304) and for injunction (Section 302) against the manufacturer and/or distributor of illegal products.

Your response should include —

  1. each step that has been or will be taken to completely correct the current violations and to prevent the recurrence of similar violations;
  2. the time within which correction will be completed; and
  3. any documentation necessary to show that correction has been achieved.

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. You should also include 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 with in 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 attention of Ms Shelly L. Maifarth, Compliance Officer, at the above letterhead address.

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

This page was posted on August 20, 2006.

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