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B-179195 1 (1974-03-21)

handle is hein.gao/gaobabkwl0001 and id is 1 raw text is: .. JCTED _ Not to be released ovzside the 6enra, 7 I? - yCeO'Iie Office except on the basis of spec:,C a l17.:,? lbyte (f~f;C Of Con~gressional Relat~o,. 3, a Irecaid al w3 Ih2- 07)4 is kept by t piDtributjon SeC OA COMPTROLLER GENERAL OF 'OAS WASHINGTON, D.C. 20546 B-1 79195 RELEASED VAR 2 1 174 The Honorable Frank E. Moss Chairman, Subcommittee for Consumers Y Committee on Commerce United States Senate Dear Mr. Chairman: Your letter of July 12, 1973, requested that we review activities I 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 FDA policy and permitted the use of the term potato chips 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 action by FDA. To preclude any loss of competitive advan- tage, FDA 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 Sosition. The CPG's contained the advisory opinions formerly pub- ished as Trade Correspondence, and compliance policies derived from other sources. 60300 3

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