FDA Allowed Cardiovascular Health Claims
Assembled for Prepared Foods’ Cardiovascular Health Virtual Trade Show -- December 16, 2010


Heart Health Claims (SSA)
FDA’s Guidance for Industry a Food Labeling Guide

* Sodium and Hypertension (21 CFR 101.74)

* Dietary Saturated Fat & Cholesterol and CHD Risk
    (21 CFR 101.75) http://tinyurl.com/23lec2b

* Fruits, Vegetables & Grain Products that contain Fiber, particularly Soluble Fiber & CHD Risk
(21 CFR 101.77) http://tinyurl.com/277h69h

* Soy Protein & CHD Risk
    (21 CFR 101.82) http://tinyurl.com/2726pnw    (Final: http://tinyurl.com/24wdble)

* Plant Sterol / Stanol Esters & CHD Risk    (21 CFR 101.83) http://tinyurl.com/28roudp    (Letter on Interim Health Claim Rule  http://tinyurl.com/258lrgz)

* Soluble Fiber* from Certain Foods & CHD Risk
    * Eligible sources of (beta-glucan) soluble fiber from the following whole oat and barley sources: Oat bran, Rolled Oats, Whole Oat Flour, Oatrim, Whole Grain Barley and Dry Milled Barley, Soluble fiber from psyllium husk with purity of no less than 95%

    (21 CFR 101.81) http://tinyurl.com/35kndgh
    Final Rule: http://tinyurl.com/38r8aoh

    Final Rule (Amended) on Whole Oats: http://tinyurl.com/3abzokb
    Final rule (correction) Psyllium husk: http://tinyurl.com/3562rca
    Final Rule on Oatrim: http://tinyurl.com/343ok92
    Final Rule on Barley: http://tinyurl.com/343ok92
    Final Rule on Barley Betafiber: http://tinyurl.com/32yw5yl



(FDAMA (FDA Modernization Act) Health Claims)

* Potassium & Risk of HBP and Stroke: http://tinyurl.com/32k5n2a

* Whole Grain Foods & Heart Disease Risk:

* Saturated Fat, Cholesterol & Trans Fat, and Reduced Risk of Heart Disease: http://tinyurl.com/27zfw6h

* Substitution of Saturated Fat w/ Unsaturated Fatty Acids & Heart Disease Risk: http://tinyurl.com/2etnt4s



Qualified Heart Health Claims
Summary Chart: http://tinyurl.com/ycplc3k

* B Vitamins & Vascular Disease: http://tinyurl.com/2btgafe

* Nuts & Heart Disease: http://tinyurl.com/29vgnmq

* Walnuts & Heart Disease: http://tinyurl.com/28dx2v9

* Omega-3 Fatty Acids & CHD: Letter #1 - http://tinyurl.com/23n38qw; Letter #2 - http://tinyurl.com/2bv3cas

* Monounsaturated Fatty Acids From Olive Oil & CHD: http://tinyurl.com/2a5nhhn

* Calcium & Hypertension (DS): http://tinyurl.com/2bq9hpv

* Unsaturated Fatty Acids from Canola Oil & CHD Reduced Risk: http://tinyurl.com/28ug38u

* Corn Oil & Corn Oil-Containing Products & HD Reduced Risk: http://tinyurl.com/2ashmsm



FDA Structure / Function Heart Health Claims

* Structure/function claims different for DS vs. foods
See: http://tinyurl.com/27tezyq

 * Subtle differences between structure/function & disease claim
"maintains healthy cholesterol levels"
    Not permitted: "lowers cholesterol"
    Source: FDA -- http://tinyurl.com/ yebd9em

* Justin Prochnow Overview: http://tinyurl.com/2efpx2b

Compiled by Claudia Dziuk O’Donnell, Prepared Foods, Chief Editor, 11/1/2010
Filed on www.NutraSolutions.com -- Search for "PF Virtual Tradeshow Heart Heath Claims" or PFVTHC