Pure Encapsulations®

Updates to the Supplement Facts Panel: What, Why and When

Andrew Halpner, PhD

Vice President, Science & Technical Services

Webinar Disclosure

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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:

• 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