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Health Claim Notification for the Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced Risk of Heart Disease

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Under section 403(r)(3)(C) (21 U.S.C. § 343(r)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a manufacturer may submit to FDA a notification of a health claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. Prior to the Food and Drug Administration Modernization Act of 1997 (FDAMA), companies could not use a health claim or nutrient content claim in food labeling unless FDA published a regulation authorizing such a claim. Two provisions of FDAMA (specifically sections 303 and 304 which amend, respectively, sections 403(r)(3) and 403(r)(2) (21 U.S.C. §§ 343(r)(3) and (2)) of the FD&C Act) now permit distributors and manufacturers to use claims if such claims are based on current, published, authoritative statements from certain federal scientific bodies, as well as from the NAS. The notification must be submitted to FDA at least 120 days before the food is introduced into interstate commerce. The claim may be made after 120 days from the date of submission of the notification until such time as 1) FDA issues a regulation prohibiting or modifying the claim or finding that the requirements for making the claim have not been met, or 2) a district court in an enforcement proceeding has determined that the requirements for making the claim have not been met.

On January 24, 2007, the FDA received a notification from Frito-Lay, Inc. (Frito-Lay) submitted pursuant to Section 403(r)(3)(C) of the FD&C Act (21 U.S.C. § 343(r)(3)(C)) and regarding a health claim for the relationship between dietary substitution of saturated fat with unsaturated fatty acids (UFAs) and reduced risk of heart disease (the January 24 notification). The 120-day period from the date of submission of the Frito-Lay notification is May 24, 2007. Therefore, after this date, manufacturers may use the claim specified in the notification, as modified by the notifier in a letter to FDA dated May 11, 2007 (The May 11 letter), on the label and in labeling of any food product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit the claim.

The following statements from the 1989 NAS report titled Diet and Health: Implications for Reducing Chronic Disease Risk listed in the January 24 notification are considered authoritative statements.

"Clinical and animal studies provide firm evidence that omega-6 polyunsaturated fatty acids when substituted for saturated fatty acids result in a lowering of serum total cholesterol and LDL cholesterol and usually also some lowering of HDL cholesterol levels."
"Clinical studies indicate that substitution of monounsaturated for saturated fatty acids results in a reduction of serum total cholesterol and LDL cholesterol without a reduction in HDL cholesterol."

The claim language proposed by Frito-Lay was modified in the May 11 letter to read as follows:

"Replacing saturated fat with similar amounts of unsaturated fats may reduce the risk of heart disease. To achieve this benefit, total daily calories should not increase."

According to the January 24 notification, Frito-Lay intends to apply the claim to vegetable oils, spreads, and shortenings that have a total unsaturated fat content of 80% or more of total fat. The notification also proposes to apply the claim to oil-containing foods in the following categories: crackers, salad dressings, salads, sauces and dips, and grain, vegetable and fruit-based snacks. It bears noting, however, that the claim is available for use on any food that satisfies the requirements for the claim under Section 403(r)(3)(C) of the FD&C Act (21 U.S.C. § 343(r)(3)(C)), and is not limited to those listed in the notification.

Under FDAMA, an otherwise authorized claim may be made if "the claim and the food for which the claim is made are in compliance with [section 403(r)(3)(A)(ii)] and are otherwise in compliance with [section 403(a)] and section 201(n)" of the FD&C Act (21 U.S.C. § 343(r)(3)(C)(iii), referring to 21 U.S.C. §§ 343(r)(3)(A)(ii), 343(a) and 321(n) respectively). The regulations through which the agency implements sections 403(a) and 201(n) of the FD&C Act with respect to health claims are contained in 21 CFR 101.14 (general requirements for health claims) and the requirements for specific health claims in Subpart E (21 CFR 101.70 through 101.83). These regulations ensure that health claims that are made on the labels or in the labeling of foods are not false or misleading. Health claims that do not meet these regulations may be considered misleading. Food labeling that is false or misleading in any particular is deemed to be misbranded under section 403(a) of the FD&C Act.

The general health claim requirements in 21 CFR 101.14 and the requirements set forth in regulations for specific health claims relating to coronary heart disease (CHD) include a number of nutrient level requirements. For example, under the general health claim requirements, a conventional food may not bear a health claim unless it contains, prior to any nutrient addition, at least 10% of the Daily Value for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed (RACC) (21 CFR 101.14(e)(6)). Also, under 21 CFR 101.14(e)(3), a food may not bear a health claim if that food exceeds any of the disqualifying nutrient levels for total fat, saturated fat, cholesterol, or sodium set out in 21 CFR 101.14(a)(4). In regulations authorizing CHD-related health claims, FDA has further required, with limited exceptions,(1) that foods bearing the claims meet the "low fat" criterion defined by 21 CFR 101.62(b)(2), "low saturated fat" criterion defined by 21 CFR 101.62(c)(2), and the "low cholesterol" criterion defined by 21 CFR 101.62(d)(2) (see authorized claims in 21 CFR §§ 101.75, 101.77, 101.81, 101.82, and 101.83). Distributors and manufacturers wishing to use health claims on their food labeling are responsible for making sure their products are in compliance with the applicable laws and regulations. The FD&C Act and its implementing regulations, as well as FDA guidance on health claims, are available through links at www.fda.gov.

The notification and materials regarding the claim have been assigned Docket No. 2007Q-0192 and are publicly available from the FDA Division of Dockets Management. Persons interested in these documents may view them at the Division of Dockets Management from 9am to 4pm, Monday through Friday at 5630 Fishers Lane, room 1061, Rockville, MD 20852. The Division of Dockets Management may be contacted at 301-827-6860. FDA has also made the documents available on the Dockets web site.

(1) Under the FD&C Act, FDA may, by regulation, allow a claim that does not otherwise meet specific requirements based on a finding that such a claim would assist consumers in maintaining healthy dietary practices and based on a requirement that the label contain an appropriate disclosure. See 21 U.S.C. § 343(r)(3)(A)(ii). See also 21 CFR 101.14(e)(3).

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