TABLE 4-1 Comparison of Safety Standards Included in Federal Regulations

Article

Safety Standard

Safety Decision

Foods or Food Additives (Federal Food, Drug and Cosmetic Act)

Reasonable certainty of no harm

Food Additive Petition—Food and Drug Administration (FDA) must approve that the material is safe

Generally Recognized as Safe—Notifier makes safety determination; FDA reviews notification

Drugs (Federal Food, Drug and Cosmetic Act)

Risk-benefit

FDA must prove the material is safe and efficacious

Dietary Supplements (Dietary Supplement Health and Education Act)

Reasonable assurance that ingredient does not present a significant or unreasonable risk of illness or injury

FDA must prove the material is not safe

ill. Their purchase and consumption are unsupervised, unlike drugs for which access is carefully controlled and use is supervised by a physician. However because of the special role of infant formulas in the diet of infants, FDA requires that these products meet certain standards developed under the Infant Formula Act.

Quality Factors and Safety Aspects of Infant Formula

Section 412 of the FD&C Act and associated regulations issued by FDA deal with good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formulas. It is important to understand the concept of “quality factors” when considering the safety of ingredients, even though they are not considered as an integral part of the safety assessment of new substances under Section 409.

Quality factors are discussed in the report of the House Committee on Interstate and Foreign Commerce that accompanied the 1980 Infant Formula Act. An ingredient can only be used commercially (incorporated into infant formulas for sale) after the requirements of Section 412 (e.g., nutrient requirements and quality factors) are satisfied. This means that the new ingredient must be incorporated into the formula and the formula must then be tested for each required nutrient (i.e., protein, fat, essential fatty acids, vitamins, and minerals) under 21 U.S.C. 350a, Section 412(i). However the FD&C Act also mandates that the Secretary of the U.S. Department of Health of Human Services establish requirements for quality factors consistent with the scientific knowledge and states that the nutrient and nutrient level required by the Act may be revised. Under current regulations, the concept of quality factors has not been developed; the requirements focus on meeting the level of specific nutrients.

FDA has proposed to revise several aspects of its infant formula regulations, including requirements for quality factors and Good Manufacturing Practices (GMPs). FDA has proposed to revise “Quality Factors for Infant Formulas” (FDA, 1996), the subpart that defines the minimum quality factors for infant formulas. In these proposed regulations, FDA identifies two factors for which there is scientific basis to define them as quality factors, namely that the formula is “capable of supporting normal physical growth of infants” and “protein is of sufficient biological quality to meet the protein requirements of infants.” FDA, in proposed rule Section 106.3(o), has defined quality factors in a manner that encompasses



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