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Pure Encapsulations®
Updates to the Supplement Facts Panel: What, Why and When
Andrew Halpner, PhD
Vice President, Science & Technical Services
Webinar Disclosure
Seminars, teleconferences and webinars such as this are for educational purposes only and are intended for licensed health care practitioners. These therapies are not substitutions for standard medical care. Practitioners are solely responsible for the care and treatment provided to their own patients.
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:
• 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
What’s Changing and Why
Supplement Facts and Nutrition Facts Updates:
• 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
What’s Changing and Why
IU
Coming Soon Current
Current Coming Soon
Current Coming Soon
Current Coming Soon
Structure Function Claim
Structure Function Claim
Gluten Free
Structure Function Claim
Gluten Free
Quality Information by QR Codes
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
Choline N/A 550 mg
Added Sugar N/A 50 g
unit of measure updated
Vitamin K2 will no longer contribute to the Daily Value for vitamin K
Major Supplement Facts Updates
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 Activity from Beta-carotene
10,000 IU
Vitamin A Activity from Vitamin A
5,000 IU Current RDI = 5,000 IU Current %DV = 300%
Vitamin A Activity/Serving = 15,000 IU
Vitamin A Example In IUs
Vitamin A Activity from Beta-carotene
3,000 mcg
Vitamin A Activity from Vitamin A
1,500 mcg New RDI = 900 mcg RAE New %DV = 500 %
Vitamin A Serving = 4,500 mcg RAE
Vitamin A Example In mcg RAE
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 Activity from Beta-carotene
3,000 mcg
Vitamin A Activity from Vitamin A
1,500
Vitamin A Activity from Beta-carotene
10,000 IU
Vitamin A Activity from Vitamin A
5,000 IU
Vitamin A (67% (3,000 mcg) as beta-carotene).…4,500 mcg
Vitamin A (33% as Vitamin A Palmitate [5,000 IU]/67% [10,000 IU] as natural
beta-carotene).…15,000 IU
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
Folate 667 mcg DFE 167% (400 mcg folic acid)
Label will read: %DV
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.
O
OH
CH3
CH3
Beta-Tocopherol
O
OH
CH3
CH3
Gamma-Tocopherol
O
OH
CH3 Delta-Tocopherol
O
OH
CH3
CH3
CH3
Alpha-Tocotrienol
O
OH
CH3
CH3
Beta-Tocotrienol
O
OH
CH3
CH3
Gamma-Tocotrienol
O
OH
CH3 Delta-Tocotrienol
O
OH
CH3
CH3
CH3 * * *
Alpha-Tocopherol R R R
Vitamin E
O
OH
CH3
CH3
Beta-Tocopherol
O
OH
CH3
CH3
Gamma-Tocopherol
O
OH
CH3 Delta-Tocopherol
O
OH
CH3
CH3
CH3
Alpha-Tocotrienol
O
OH
CH3
CH3
Beta-Tocotrienol
O
OH
CH3
CH3
Gamma-Tocotrienol
O
OH
CH3 Delta-Tocotrienol
O
OH
CH3
CH3
CH3 * * *
Alpha-Tocopherol R R R
Vitamin E
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
Current
400 IU (from d-alpha) = 1,333% DV
268 mg
New Label
268 mg = 1,787% DV
Vitamin E
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%
Vitamin D
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
Fiber
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”
Added 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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