Pure Encapsulations Updates to the Supplement Facts Panel: What, Why and When Andrew Halpner, PhD Vice President, Science & Technical Services
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Brief Overview of Food Labeling Prior to the early 1970s, few regulations for labeling of nutrients in foods
Brief Overview of Food Labeling 1973 Modification to the Food Drug and Cosmetic Act of 1938 Specified that when nutrition labeling was present, it must include: o Calories, protein, carbohydrate and fat AND % of the US RDA of vitamins A, C, B1, B2, B3 and calcium and iron US RDAs were based on Recommended Dietary Allowance (RDA) set forth by the National Academy of Sciences in 1968 Since a single value was needed for labeling, it typically represented the highest value for a given nutrient in the RDA table for adult males and non-pregnant women Very few changes to labeling were made for the next 10-15 years
Brief Overview of Food Labeling By 1990, FDA published rules for mandatory labeling of almost all packaged foods
Brief Overview of Food Labeling Sought to replace US RDA with Reference Daily Intakes (RDIs) RDIs were essentially based on the most recent RDA (1989) AND proposed a new term Daily Reference Value (DRV) o DRV = components important to health but did NOT have an RDA - Fat, saturated fat, cholesterol, etc
Brief Overview of Food Labeling Sought to replace US RDA with Reference Daily Intakes (RDIs) RDIs were essentially based on the most recent RDA (1989) AND proposed a new term Daily Reference Value (DRV) o DRV = components important to health but did NOT have an RDA - Fat, saturated fat, cholesterol, etc RDI DRV Daily Value (DV)
Supplement Facts and Nutrition Facts Updates: What s Changing and Why FDA is amending labeling regulations for conventional foods and dietary supplements Provides updated nutrition information to assist consumers in maintaining healthy dietary practices Reflects current thinking on nutritional requirements and consumer behavior Numerous aesthetic changes to Nutrition Facts panels New RDIs and DRVs (new Daily Values) for almost every nutrient! New units of measure for vitamins A, E and folate
Supplement Facts and Nutrition Facts Updates: What s Changing and Why FDA is amending labeling regulations for conventional foods and dietary supplements Provides updated nutrition information to assist consumers in maintaining healthy dietary practices Reflects current thinking on nutritional requirements and consumer behavior Numerous aesthetic changes to Nutrition Facts panels New RDIs and DRVs (new Daily Values) for almost every nutrient! New units of measure for vitamins A, E and folate IU
Current Coming Soon
Current Coming Soon
Current Coming Soon
Current Coming Soon
Structure Function Claim
Structure Function Claim Gluten Free
Quality Information by QR Codes Structure Function Claim Gluten Free
Major Supplement Facts Updates Nutrient Current DV New DV Vitamin A 5,000 IU 900 mcg RAE (3,000 IU) Vitamin D 400 IU (10 mcg) 20 mcg (800IU) Vitamin E 30 IU (20mg) 15 mg (22.4 IU) Folic acid/folate 400 mcg 400 mcg DFE unit of measure updated Choline N/A 550 mg Added Sugar N/A 50 g Vitamin K2 will no longer contribute to the Daily Value for vitamin K
Vitamin A Changing from International Units (IU) to Micrograms Retinol Activity Equivalents (RAEs) mcg RAE more representative of the weight of material, but still accounts for different forms of vitamin A functioning differently in the body Retinol and beta-carotene have different metabolism and activity in the body and therefore have different RAEs o For example: 1 mcg retinol = 1 mcg RAE 2 mcg beta-carotene = 1 mcg RAE o Must convert from IUs to mcg RAE The RDI is ALSO changing o Current RDI = 5,000 IU (which equates to 1,500 mcg RAE) o New RDI = 900 mcg RAE (which equates to 3,000 IU)
Vitamin A Example In IUs Vitamin A Activity/Serving = 15,000 IU Vitamin A Activity from Vitamin A 5,000 IU Vitamin A Activity from Betacarotene 10,000 IU Current RDI = 5,000 IU Current %DV = 300%
Vitamin A Example In mcg RAE Vitamin A Serving = 4,500 mcg RAE Vitamin A Activity from Vitamin A 1,500 mcg Vitamin A Activity from Betacarotene 3,000 mcg New RDI = 900 mcg RAE New %DV = 500 %
Vitamin A Current Label Claim 15,000 IU Current RDI = 5,000 IU %DV = 300% Coming Soon Label Claim 4,500 mcg NEW RDI = 900 mcg RAE (3,000 IU) %DV = 500% Vitamin A (33% as Vitamin A Palmitate [5,000 IU]/67% [10,000 IU] as natural beta-carotene). 15,000 IU Vitamin A (67% (3,000 mcg) as beta-carotene). 4,500 mcg Vitamin A Activity from Vitamin A 5,000 IU Vitamin A Activity from Betacarotene Vitamin A Activity from Vitamin A 1,500 Vitamin A Activity from Betacarotene 10,000 IU 3,000 mcg
Folic Acid New regulations change the folic acid listing from simply the weight of the material, to a unit that accounts for the absorption of the nutrient.
Folic Acid Synthetic folic acid has a greater bioavailability compared with natural food folates.
Folic Acid mcg mcg DFE Dietary Folate Equivalents
Folic Acid mcg mcg DFE Dietary Folate Equivalents 1 mcg folic acid = 1.67 mcg DFE
Folic Acid mcg mcg DFE Dietary Folate Equivalents 1 mcg folic acid = 1.67 mcg DFE Current RDI = 400 mcg New RDI = 400 mcg DFE
Folic Acid Currently 400 mcg folic acid = 100% DV Coming Soon 400 mcg = 667 mcg DFE = 167% DV
Folic Acid Currently 400 mcg folic acid = 100% DV Coming Soon 400 mcg = 667 mcg DFE = 167% DV
Folic Acid Currently 400 mcg folic acid = 100% DV Coming Soon 400 mcg = 667 mcg DFE = 167% DV Label will read: %DV Folate 667 mcg DFE 167% (400 mcg folic acid)
Vitamin E Vitamin E is a family of compounds consisting of alpha, beta, gamma, and delta tocopherols and tocotrienols. HOWEVER, for labeling purposes, only alpha-tocopherol counts this is NOT new.
Vitamin E HO CH 3 CH 3 H 3 C O CH 3 * * * R R R Alpha-Tocopherol HO C H 3 CH 3 O Alpha-Tocotrienol CH 3 CH 3 HO HO O CH 3 O Beta-Tocopherol CH 3 Beta-Tocotrienol HO HO C H 3 CH 3 O Gamma-Tocopherol C H 3 CH 3 O Gamma-Tocotrienol HO HO CH 3 O Delta-Tocopherol CH 3 O Delta-Tocotrienol
Vitamin E HO CH 3 CH 3 H 3 C O CH 3 * * * R R R Alpha-Tocopherol HO C H 3 CH 3 O Alpha-Tocotrienol CH 3 CH 3 HO HO O CH 3 O Beta-Tocopherol CH 3 Beta-Tocotrienol HO HO C H 3 CH 3 O Gamma-Tocopherol C H 3 CH 3 O Gamma-Tocotrienol HO HO CH 3 O Delta-Tocopherol CH 3 O Delta-Tocotrienol
Vitamin E What s new? Moving from IU mg alpha-tocopherol Current RDI = 30 IU (20mg) New RDI = 15 mg (22.4 IU) AND 2 mg of synthetic alpha-tocopherol = 1 mg of natural-source alpha-tocopherol
Vitamin E Current 400 IU (from d-alpha) = 1,333% DV 268 mg New Label 268 mg = 1,787% DV
Vitamin D Vitamin D units changing from IU mcg HOWEVER IUs can remain on the label in addition to mcg RDI INCREASED Current RDI = 400 IU (10 mcg) New RDI = 20 mcg (800 IU) Label will read: Vitamin D (as cholecalciferol) 20 mcg (800 IU) 100%
Fiber Fiber definition changing Only 7 approved sources of isolated/synthetic fiber (> 3 DP) Beta-glucan Psyllium Husk Cellulose Guar Gum Pectin Locust Bean Gun HPMC Non-digestible carbohydrates (> 3 DP) and lignin that are intrinsic in plants Reference Value changing from 25 g to 28 g
Added Sugars New addition to the facts panel Sugars that are added during the processing of foods o Sugars (free, mono- and disaccharides) o Sugars from syrup and honey o Sugars from concentrated fruit or vegetable juices o DV = 50 grams Previous listing of Sugars is now Total Sugars Added Sugars indented under Total Sugars
Updated Supplement Facts Example
Updated Supplement Facts Example
Updated Supplement Facts Example
Updated Supplement Facts Example
Updated Supplement Facts Example
Updated Supplement Facts Example
Updated Supplement Facts Example
When Can You Expect To See Changes? FDA has recently announced that the implementation deadline has been extended by 12 18 months (exact extension period has not yet been finalized) Pure Encapsulations is moving forward with label updates o New products will incorporate the new format o Updated format will be phased into existing products over the next few months Literature to assist both healthcare professionals as well as patients will be provided Rule stated that large companies need to reformat by July, 2018
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Q & A with Andrew Halpner, PhD