Legislative Changes and Administrative Improvements Should Be Considered for FDA To Better Protect the Public From Adulterated Food Products
HRD-84-61
Published: Sep 26, 1984. Publicly Released: Oct 09, 1984.
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Highlights
Pursuant to a congressional request, GAO evaluated the Food and Drug Administration's (FDA) efforts to remove adulterated food products from the market and attempted to determine whether FDA needs additional authority to carry out its mission. GAO reviewed food recalls, food seizures, and prosecution actions carried out by FDA from 1980 to 1982.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| Congress should consider whether FDA needs specific authority to detain adulterated foods while the agency processes seizure requests internally and through the Department of Justice. |
Closed – Not Implemented
|
No consideration was given to this matter during the 100th Congress. This recommendation is over 4 years old. |
| Congress should consider amending the Food, Drug, and Cosmetic Act to give FDA authority to review production and shipping records after it has found that a firm is producing adulterated food products. |
Closed – Not Implemented
|
No consideration was given to this matter during the 100th Congress. This recommendation is over 4 years old. |
| Congress should consider amending section 303(a) of the Food, Drug, and Cosmetic Act to increase the amount of the fine authorized for criminal prosecutions. |
Closed – Implemented
|
The Federal Crimes Enforcement Act, effective January 1, 1985, increased the maximum fine levels for all federal criminal offenses from $100,000 to $500,000 depending upon certain enumerated circumstances. FDA advised GAO that it is the position of Justice that the act applies to all federal offenses, including provisions that FDA enforces. The act now authorizes the higher fines. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | The Secretary of Health and Human Services should direct the Commissioner, FDA, to initiate steps to improve the timeliness of seizure actions by identifying more routine seizure cases involving filth and economic adulteration that could be referred by district directors to U.S. attorneys after concurrence by the FDA Office of the General Counsel (OGC). |
Closed – Implemented
FDA stated that it will periodically revise its policy guidance manual to incorporate this recommendation. In this regard, FDA district offices were instructed to refer cases involving improperly pasturized dairy products and tomatoes contaminated with mold directly to FDA OGC for regulatory action.
|
| Department of Health and Human Services | The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop guidelines specifying required verification procedures to ensure that the destruction and reconditioning of recalled foods is adequately verified directly by FDA or through some alternative means, such as appropriate state or local officials. |
Closed – Implemented
In May 1985, FDA developed guidelines for its district offices to follow in verifying the destruction and reconditioning of recalled products. In July 1986, these guidelines became a part of the FDA inspection manual.
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Topics
Contaminated foodsFood inspectionProduct recallsProduct safetyRegulatory agenciesSearch and seizureGrain and grain productsFood contaminationFood safetyNutrition