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

Public Health Service
Food and Drug Administration
Mid-Atlantic Region
New Jersey District Office

 

Waterview Corporate Ctr
10 Waterview Blvd, 3rd Fl
Telephone: 973-526-6008
Parsippany, NJ 07054

July 30, 1997
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Clyde V. Rockoff, Director
Universal Protein Supplement Corp.
3 Terminal Rd
New Brunswick, NJ 08901

Ref. No. 97NWJ42

Dear Mr Rockoff:

The Food and Drug Administration (FDA) collected surveillance samples of [redacted] products manufactured by your firm for [redacted].

Analysis by FDA of these-samples" revealed that" the products contain significantly lower nutrient levels than declared on their labels. Dietary supplements that contain added nutrients at levels significantly below the declared amounts are adulterated under Section 402(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that a valuable constituent has been omitted in whole or in part. Such products would also be misbranded under Section 403(a)(1) of the Act in that the label is false and misleading regarding nutrient levels declared on the labels.

A lot of [redacted] boxes of [redacted] was collected as FDA Sample No. 97-770-081. FDA analysls of a composite from 6 boxes showed that the packets contained 66.5 mg (66.5 mg check analysis) or 66.5% (66.5% check analysis) of the 100 mg of niacin declared on the label.

A lot of [redacted] cases of [redacted] boxes plus [redacted] loose boxes of [redacted] was sampled under FDA Sample .No 97786-136. Two boxes were collected at random from each of 12 shipping cases. FDA analysis of a composite from 12 boxes showed that the packets contained: 0.0 mcg at screening level (0.0 mcg check analysis) or 0.0% check analysis) of the 150 mcg of vitamin B12 declared on the label; 27.8 mg, 30.4 mg (32.5 mg check analysis) or 55.6%, 60.8% (65.0% check analyses) of the 50 mg of niacinamide declared on the label; 25.8 mg (28.8 mg, check analysis) or 51.7% (57.6% check anaiysis) of the 50 mg of pantothenic acid declared on the label; 0.0 mcg at screening level (0.0 mcg check analysis) or 0.0% check anaiysis) of the 400 mcg of folic acid declared on the label.

FDA Sampie No. 97-786-137 was collected from a lot of 11 cases of 12 boxes and 20 loose boxes of [redacted]. One box was collected at random from each [redacted] shipping cases and two boxes were collected from [redacted] case.

FDA analysis of a composite from [redacted] boxes showed that the packets contained: 344 mg (362 mg check analysis) or 23.0% (24.1% check analysis) of the 1500 mg (150% USRDA) of calcium declared on the label; 10.1 mg (10.7 mg check analysis) or 2.53% (2.67% check analysis) of the 510 mg of magnesium declared on the label; 0.088 mg (0.041 mg check analysis) or 0.18% (0.08% check analysis) of the 75 mg of zinc declared on the label; and 0.013 mg (0.010 mg check analysis) or 2.58% (1.98% check analysis) of the 25 mcg (420% USRDA) of chromium declared on the label.

FDA Sample No. 97-786-138 was collected from a lot of [redacted] cases of [redacted] boxes of [redacted]. One box was collected at random from each of [redacted] shipping cases and [redacted] boxes were collected from one case. FDA analysis of a composite from [redacted] boxes showed that the packets contained: 0.0 mcg at screening level (0.0 mcg check analysis) or 0.0% (0.0% check analysis) of the 50 mcg of vitamin B12 declared on the label; 0.0 mg at screening level (7.2 mg check analysis) or 0.0% (14.4% check analysis) of the 50 mg of pantothenic acid declared on the label; and 0.0 mg at screening level (0.0 mg check analysis) or 0.0% (0.0% check analysis) of the 200 mcg of folic acid declared on the label.

A lot of [redacted] cases of [redacted] boxes of [redacted] was sampled under FDA Sample No. 97-786-139. Two boxes were collected at random from each of [redacted] shipping cases. FDA analysis of a composite from boxes showed that the packets contained 0.0 mcg at screening level (0.0 mcg check analysis) or 0.0% (0.0% check analysis) of the 150 mcg of vitamin B12 declared on the label; and 0.0 mcg at screening level (0.0 mcg check analysls) or 0.0% check analysis) of the 400 mcg of folic acid declared on the label.

A lot of [redacted] boxes of [redacted] was sampled under FDA Sample No. 97-786-140. [redacted] boxes were collected at random. FDA analysis of a composite from [redacted] boxes showed that the packets contained: 0.0 mcg at screening level (0.0 mcg check analysis) or 0.0% (0.0% check analysis) of the 500 mcg of vitamin B12 declared on the label; and 74.2 mg (72.7 mg check analysis) or 74.2% (72.7% check analyses) of the 100 mg of niacinamide declared on the label.

The findings for these samples indicate that your firm does not have adequate procedures to ensure that products are formulated to contain nutrients at the levels represented on the label. we request you notify this office in writing within 15 working days of receipt of this letter, of the steps you have taken to ensure the other products you have manufactured do not contain nutrient levels below the amount declared on the label and to ensure that new production is formulated to contain the declared nutrient levels. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which the corrections will be completed. Failure to produce a product with the declared nutrient content may result in regulatory action such as seizure or injunction without further notice.

Your reply should be directed to the attention of Richard T. Trainor, Compliance Officer, Food and Drug Administration, 10 Waterview Blvd, 3rd Fl, Parsippany, NJ 07054.

Sincerely yours,
/s/
Douglas I. Ellsworth
District Director

This page was posted on August 20, 2006.

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