Government Operations:

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 9, 1984.

Additional Materials:

Contact:

Janet L. Shikles
(202) 512-7119
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

GAO found that, while FDA is authorized to seize adulterated foods, it is not authorized to detain such products while seizure actions are being processed by FDA and the Justice Department. FDA frequently requests states to detain adulterated foods or requests firms to voluntarily hold food products. However, GAO found several instances where products were unavailable for seizure by the time seizure actions were processed. GAO believes that: (1) if FDA had detention authority over adulterated foods, similar to its authority over medical devices, it could prevent greater amounts of adulterated foods from reaching the market; and (2) FDA could more easily remove adulterated foods from the market if it had the authority to review food manufacturers' production and distribution records. GAO also found that: (1) FDA could hasten the seizure process by eliminating several levels of review within FDA; (2) FDA has not adequately monitored recalled foods to ensure that recalled products are reconditioned; and (3) fines assessed for violations of federal laws pertaining to adulterated foods are relatively small.

Matters for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: No consideration was given to this matter during the 100th Congress. This recommendation is over 4 years old.

    Matter: 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.

  2. Status: Closed - Not Implemented

    Comments: No consideration was given to this matter during the 100th Congress. This recommendation is over 4 years old.

    Matter: 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.

  3. Status: Closed - Implemented

    Comments: 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.

    Matter: 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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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).

    Agency Affected: Department of Health and Human Services

 

Explore the full database of GAO's Open Recommendations »

Oct 24, 2014

Oct 20, 2014

Oct 9, 2014

Oct 8, 2014

Oct 2, 2014

Sep 30, 2014

Sep 26, 2014

Sep 25, 2014

Sep 19, 2014

Looking for more? Browse all our products here