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B-179195 1 (1974-03-21)

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WASHINGTON, D.C. 20548
     RELEASED


B-179195


MAR,


The Honorable Frank E. Moss
Chairman, Subcommittee for Consumers
Committee on Commerce
United States Senate


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Dear Mr. Chairman:

     Your letter of July 12, 1973, requested that we review activities
which led to the issuance by the Food and Drug Administration (FDA) of
Compliance Policy Guide No. 7210.2, dated July 8, 1969, which changed
     olcy and permitted the use of the term Potat9chips for prod-
ucts made from dried or dehydrated potatoes. You also requested that
we evaluate whether FDA made this change in accordance with the Federal
Food, Drug, and Cosmetic Act (FD&C Act) and the customary procedures
of FDA.

     We have concluded that FDA issued Compliance Policy Guide (CPG)
No. 7210.2 in accordance with its customary procedures. However, with
regard to whether FDA made the change in accordance with the FD&C Act,
the statutory authority to render a decision on actions by FDA under
the FD&C Act has been placed in the Federal courts and there have been
no suits against FDA to provide a test of its action in issuing CPG
No. 7210.2.

     From FDA's inception, companies have sought its opinion, before
marketing products, on whether products or labeling would trigger
regulatory c   ,jpi by FDA. To preclude any loss of competitive advan-
Pa age    in its deliberations on these requests, has made a practice
of meeting only with the company requesting its advice. However, after
opinions were delivered and when they were of general interest, FDA
published them as Trade Correspondence. Also, FDA advised its field
offices of these opinions to guide them and to promote consistency in
their compliance activities.

     FDA began issuing CPG's on June 20, 1969, to guide its personnel
in arriving at compliance decisions regarding the provisions of the
FD&C Act and other acts on which FDA has established an enforcement
osition. The CPG's contained the advisory opinions formerly pub-
lished as Trade Correspondence, and compliance policies derived
from other sources.


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