Trends In Labeling

Donnell ScottFood Labeling Services AIB International

Current marketing claims

“0g trans fat”

“No Cholesterol”

“Whole Wheat”

“Low Carb”

“Fat Free”

“Gluten Free”

“Heart Healthy”

Omega 3‐Fatty Acids

Current Marketing Claim: “0g Trans Fat”

Suggested: “0g trans fat per serving”

Is an amount claim

If food exceeds disclosure levels, must have disclosure statement adjacent to the claim.

Current Marketing Claim: “0g Trans Fat” Disclosure levels for amount claims:

13g fat 4g saturated fat 60mg cholesterol 480mg sodium

Per RACC and labeled serving size Also, per 50g for products with RACC’s

30g or less

Current Marketing Claim“0g Trans Fat”

Example: “0g Trans Fat per Serving

See Nutrition Information for Sodium content”

(“See nutrition”…statement needed only if exceed a disclosure level)

urrent Marketing Claim:Fat Free”

Defined Nutrient Content Claim 21CFR101.62(b)Food contains less than 0.5g fat per RACC and labeled servingContains no added ingredient that is a fat or understood by consumers to contain fat.

urrent Marketing Claim:at Claims21CFR101.62(b)“Low Fat” 3g or less of fat per RACC Also, per 50g if RACC 30g or less

“Reduced Fat” Comparative claim 25% less fat per RACC than an appropriate

reference food

urrent Marketing Claim:No Cholesterol”

Defined Nutrient Content Claim (21CFR101.62(d))13g fat or less per RACC and labeled serving; also per 50g for products with a RACC 30g or less Less than 2mg cholesterol per RACC 2g or less saturated fat per RACC If exceed 13g fat per RACC and serving

size, total fat amount must be declared next to cholesterol claim.

urrent Marketing Claimsholesterol Claims21CFR101.62(d)

“Low Cholesterol” 20mg or less cholesterol per RACC Also, per 50g if RACC 30g or less

“Reduced Cholesterol” At least 25% less cholesterol per RACC

compared to appropriate reference food.

urrent Marketing ClaimGluten Free’

Proposed regulationContains no ingredient from wheat,rye or barley (prohibited grains)Contains no ingredient derived from a prohibited grainContains less than 20ppm of gluten

urrent Marketing ClaimWhole Wheat’

Flour source should be all Whole Wheat FlourStandards of Identity for “Whole Wheat Bread, Rolls & Buns” (21CFR136.180)Guidance for Industry for Whole Grain Labeling statements

urrent Marketing ClaimHeart Healthy’

Use of the terms ‘health’ or ‘healthy’implies a nutrient content claim.

Use of the term ‘Heart Healthy’ implies heart disease health claim

urrent Marketing ClaimHealthy’

Requirements for ‘Healthy’ - product meets the following:Low Fat per RACCLow Saturated Fat per RACCLess than 60mg Cholesterol per RACCLess than or equal to 480mg sodium per RACC and labeled servingContains at least 10% of DV/RACC for Vitamin A, C, Calcium, Iron, Protein orFiber.

urrent Marketing ClaimsHeart Healthy’

Implies a Heart Disease Health Claim

Must be authorized by FDA Defined in regulations Notification submitted through FDA

Modernization Act (FDAMA) Qualified Health Claims

urrent Marketing ClaimsHeart Healthy’

Must not exceed disqualifier levels

Must meet “Jelly Bean Rule” At least 10% of the DV of Vit A, Vit C,

Calcium, Iron, Fiber or Protein per RACC without fortification to qualify

Must meet requirements for specific authorized claims.

urrent Marketing Claimsmega-3 Fatty Acids

Can make factual statements, as long as truthful and not misleadingExample: “x grams of Omega-3 fatty acids”

urrent Marketing Claimsmega-3 Fatty Acid

Only nutrient content claims not in danger of being rescinded are the ones for ALA in the Martek Notification Good Source High More

urrent Marketing ClaimsLow Carb”

Not a defined claim

Would be considered misbranding

urrent Marketing Claimsntioxidants21CFR101.54(g)Nutrient content claim that describes a level of an antioxidantNutrient must have a DRV / RDI and have recognized antioxidant activityMust meet the nutrient content claimNutrient must be listed in the claim

urrent Marketing Claimsntioxidants

Example:“High in Antioxidant Vitamin C” To meet the claim above product must

contain 20% or more of the RDI for Vitamin C.

Future Forecast

uture Forecast

“Low Sodium” “Reduced Sodium” “Gluten Free” “High Fiber” “Low Fat” “Whole Grains”

uture Forecastodium Claims21CFR101.61Low sodium 140mg or less sodium per RACC Also per 50g for products with 30g or less

RACCReduced Sodium At least 25% less sodium per RACC than an

appropriate reference food Quantitative information must be on label

uture Forecastodium ClaimsSodium Free Less than 5mg sodium per RACC and

labeled serving

Very Low Sodium 35mg or less sodium per RACC Also per 50g for products with 30g or less

RACC

uture Forecastiber21CFR101.54“Good Source” or “Contains” or“Provides” 10-19% of DV per RACC“High” or “Rich In” or “Excellent Source” 20% or more of DV per RACCFor Fiber claims, if product is not ‘Low Fat’, then must disclose fat content per labeled serving close to claim.

uture ForecastWhole Grain

Guidance for Industry and FDA Staff Whole Grain Label Statements

FDA’s current thinking on: What is considered a whole grain What type of whole grain statements may be

allowed

uture Forecast

‘Gluten Free’ Proposed regulation

‘Low Fat’ 21CFR101.62(b)(2)

abel Claims

Truthful and not misleading

Follow specific requirements for: Nutrient content claims Authorized health claims Guidance documents Proposed regulations

esources

www.fda.gov/Food/LabelingNutrition/Guidance & Regulatory Information Label Claims

Donnell Scottdscott@aibonline.org