Need for More Effective Regulation of Direct Additives to Food

HRD-80-90: Published: Aug 14, 1980. Publicly Released: Aug 14, 1980.

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The Food, Drug and Cosmetic Act requires that the safety of direct food additives be based on scientific evidence and that the evidence be reviewed and approved by the Food and Drug Administration (FDA). However, the act exempts from review and approval substances generally recognized as safe (GRAS) by experts or approved for use before 1958, and allows the safety determination for some of those substances to be based on experience drawn from common use in food. The safety of several of these exempted substances has been questioned. A review was undertaken to determine whether current legislative authority and FDA regulatory practices adequately protect the public against hazards from substances directly added to food. GAO examined provisions of the act which exempt about 1,450 substances from food additive regulation by FDA; reviewed several exempted substances the assumed safety of which was later questioned, and the removal from use of which has been proposed or completed; and evaluated the potential impact these exemptions could have on the level of evidence supporting the safety of the substances.

The FDA administrative regulations do not clearly define the scientific evidence needed to support the safety of a food additive or explain how it conducts safety assessments. The regulations do not distinguish among the different kinds of evidence which support each substance's safety affirmation. Experience from common use in food has questionable value in assuring that an additive is safe, because individuals are exposed to numerous substances, including environmental contaminants, over a long period. Adverse effects from exposure to harmful substances may not occur for many years. Since FDA is not required to review and approve GRAS substances, there is no assurance that consistent criteria are applied in determining the safety of all such substances. Of the 39 petitions received in 1979 for GRAS designations of substances used after 1958, review of 18 has been completed. Four of the 18 contained sufficient scientific evidence to support a GRAS affirmation. During 1978, FDA received 14 petitions requesting that food additives be approved. As of October 1979, regulations had not been approved or published for any of these substances. In seven petitions reviewed, FDA had determined that the scientific evidence supporting the substance's safety was inadequate and had requested addition evidence. In five cases, data not specifically identified in the regulations were requested. Developmental efforts are currently underway to publish definitive scientific testing guidelines and review criteria for determining the safety of food additives.

Matter for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: This report is 6 years old and no action has been taken on this recommendation. Additional work to update the findings is needed to determine if this recommendation is still valid.

    Matter: Congress should amend the Federal Food, Drug and Cosmetic Act to eliminate exemptions for GRAS and prior sanction substances. Changes to the law should provide for sufficient flexibility to encourage the use of information already available and to recognize that different types of scientific evidence may be appropriate to support the safety of food additives. The amendment should also provide a date on which the safety of all GRAS and prior sanction substances must be subject to Federal review and approval.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to publish regulations establishing review criteria for assessing the safety of food additives and issue guidance defining the methods and controls to be used in conducting scientific safety tests.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: HHS disagreed with this recommendation stating that generalized statements about the levels of evidence that support GRAS affirmation would not provide a clear picture of the basis for particular decisions. Although FDA issued guidelines (August 1983) for chemistry and technological data requirements of GRAS petitions, it did not address the levels of incidence needed to support GRAS affirmation.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to revise regulations which list substances that FDA has affirmed as GRAS to indicate the kinds of evidence that support their safety.

    Agency Affected: Department of Health and Human Services


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