FDA Proposes Rule to Exempt Certain Whole Oat Products from "Low Fat" Requirement for Soluble Fiber Health Claims
The Food and Drug Administration (FDA) has issued a proposed rule that would amend 21 CFR 101.81(c)(2)(iii) to exempt certain whole oat products from the "low fat" nutrient content requirement for soluble fiber from certain foods and coronary heart disease health claims (soluble fiber health claims).
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FDA notes that the amendment would expand the use of this health claim to some whole oat products that are currently ineligible because they do not meet the "low fat" requirements.
Written or electronic comments on the proposed rule are due by April 23, 2007.
Proposed Rule is in Response to Petition to Exempt Soluble Fiber from "Low Fat" Requirement
According to FDA, this proposed rule is in response to a petition submitted by the Quaker Oats Company. The petition requested that FDA amend the soluble fiber health claim so that foods that exceed the nutrient content requirement in 21 CFR 101.62 for "low fat" due to fat content derived from whole oat sources (i.e., oat bran, rolled oats, whole oat flour, and oatrim) listed in 21 CFR 101.81(c)(2)(ii)(A) would be eligible to bear the soluble fiber health claim.
FDA Proposes Regulatory "Low Fat" Exemption for Whole Oat Sources
FDA states that in light of its tentative decision to accept the petitioner's request, FDA is proposing to amend 21 CFR 101.81(c)(2)(iii)(C) by removing the phrase "low fat" food and creating a new 21 CFR 101.81(c)(2)(iii)(D) to specify that the food making a soluble fiber health claim shall meet the "low fat" food requirement, unless the food exceeds this requirement due to fat content derived from whole oat sources listed in 21 CFR 101.81(c)(2)(ii)(A).
- written or electronic comments are due by April 23, 2007
FDA contact - Vincent de Jesus (301) 436-1450
FDA proposed rule (D/N 2006P-0069, FR Pub 02/06/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-1849.pdf