Council for Responsible Nutrition
1300 19th Street, N.W., Suite 310
Washington, D.Q 20036-1609
(202) 872-1488
Telefax (202)872-9594

December 17, 1996

Dockets Management Branch (HVA-30-305)
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, Maryland 20857

RE: OVER-THE-COUNTER DRUG PRODUCTS CONTAINING COLLOIDAL SILVER INGREDIENTS OR SILVER SALTS.
Docket No. 96N-0144

The Council for Responsible Nutrition (CRN), a trade association of the dietary supplements and dietary ingredients industry, hereby submits its comments on FDA's October 15, 1996, proposed regulations on the above referenced topics.

SCOPE OF APPLICATION

The title of this proposed regulation and the section of the Code of Federal Regulations that is proposed (21 CFR 310.548) clearly indicate that the proposed regulation would apply only to drug products with the specified ingredients. The discussion in the Supplementary Information provided, however, seems ambiguous about whether the Food and Drug Administration intends for its conclusions to apply to non-colloidal forms of silver and to dietary supplement products that contain silver.

COMMENT

We request clarification of this issue. In any further publication or communication on this topic, FDA should explicitly state that this rulemaking does not apply to dietary supplements.

Respectfully submitted,

/s/ John N. Hatheock

John N. Hatheock, Ph.D.
Director of Nutritional and Regulatory Science

cc: Dr. Fred Shank, Dr. Edward Scarbrough, Dr. Elizabeth Yetley