Q: What guidance does the FDA have for Slack Fill?


A: The Food and Drug Administration's (FDA) law ("Federal Food, Drug, and Cosmetic Act" abbreviated "FD&C Act") at Section 403(d) defines a food as being "misbranded" if its container is so made, formed, or filled as to be misleading. Further, the FD&C Act at Section 301(a)-(c) forbids interstate commerce in misbranded food.

The laws of the Food and Drug Administration (including the Federal Food, Drug, and Cosmetic Act) are available by Internet through FDA's homepage at address http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm.

A printed copy may be purchased for $21.00 (the name is "Compilation of Laws Enforced by the United States Food and Drug Administration and Related Statutes, Volume 1") using your major credit card from the U.S. Government Bookstore at telephone number 202-512-1800. The stock number is 017-012-00378-8.

REGULATIONS

FDA's regulation concerning the label statement "below standard in fill" are in the book "Title 21, Code of Federal Regulations, Parts 100 to 169" (21 CFR 100-169) at 21 CFR 130.14(b). The text of 21 CFR 130.14b is available from the Government Printing Office web site at: http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=130&SECTION=14&TYPE=TEXT

PURCHASING THE BOOK OF REGULATIONS

The book "Title 21, Code of Federal Regulations, Parts 100 to 169" (21 CFR 100-169) may be purchased with your major credit card by telephoning the main office of the U.S. Government Bookstore in Washington DC (telephone number 202-512-1800) or a regional bookstore that may be near you. The telephone numbers and addresses of the regional bookstores are listed at http://bookstore.gpo.gov/locations/index.html.

 

Source: Industry Activities Staff, May 2000
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