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: Calories, protein, carbohydrate and fat o 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) DRV = components important to o 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) DRV = components important to o 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! IU • New units of measure for vitamins A, E and folate Current Coming Soon Current Coming Soon Current Coming Soon Current Coming Soon

Structure Function Claim Structure Function Claim

Gluten Free Quality Information Structure Function Claim by QR Codes

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) unit of measure Folic acid/Folate 400 mcg 400 mcg DFE 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 For example: o • 1 mcg retinol = 1 mcg RAE • 2 mcg beta-carotene = 1 mcg RAE Must convert from IUs to mcg RAE o • The RDI is ALSO changing Current RDI = 5,000 IU (which equates to 1,500 mcg RAE) o New RDI = 900 mcg RAE (which equates to 3,000 IU) o Vitamin A Example In IUs

Vitamin A Activity/Serving = 15,000 IU

Vitamin A Activity from Vitamin A Current RDI = 5,000 IU 5,000 IU Vitamin A Activity Current %DV = 300% from Beta- carotene 10,000 IU Vitamin A Example In mcg RAE

Vitamin A Serving = 4,500 mcg RAE

Vitamin A Activity from Vitamin A New RDI = 900 mcg RAE 1,500 mcg New %DV = 500 % Vitamin A Activity from Beta- carotene 3,000 mcg Vitamin A Current Coming Soon Label Claim 15,000 IU Label Claim 4,500 mcg Current RDI = 5,000 IU NEW RDI = 900 mcg RAE (3,000 IU) %DV = 300% %DV = 500%

Vitamin A (33% as Vitamin A Palmitate Vitamin A (67% (3,000 mcg) as [5,000 IU]/67% [10,000 IU] as natural beta-carotene).…4,500 mcg beta-carotene).…15,000 IU

Vitamin A Vitamin A Activity Activity from from Vitamin A Vitamin A Vitamin A Vitamin A Activity Activity 5,000 IU 1,500 from Beta- from Beta- carotene carotene 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

CH3 HO

CH3 HO H3C O

CH3 * * * H C O R R R 3 CH Alpha-Tocopherol 3 Alpha-Tocotrienol

CH3 HO CH3 HO O

O CH3 CH Beta-Tocotrienol 3 Beta-Tocopherol

HO HO

H3C O H3C O CH3 CH3 Gamma-Tocotrienol Gamma-Tocopherol

HO HO O O CH3 CH Delta-Tocotrienol 3 Delta-Tocopherol Vitamin E

CH3 HO

CH3 HO H3C O

CH3 * * * H C O R R R 3 CH Alpha-Tocopherol 3 Alpha-Tocotrienol

CH3 HO CH3 HO O

O CH3 CH Beta-Tocotrienol 3 Beta-Tocopherol

HO HO

H3C O H3C O CH3 CH3 Gamma-Tocotrienol Gamma-Tocopherol

HO HO O O CH3 CH Delta-Tocotrienol 3 Delta-Tocopherol 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 Sugars (free, mono- and disaccharides) o Sugars from syrup and honey o Sugars from concentrated fruit or vegetable juices o DV = 50 grams o 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 New products will incorporate the new format o Updated format will be phased into existing o 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

Learn more at PureEncapsulations.com/webinars Thank You Mention code W-SUPFACTS1117 for a $25 credit and free shippingǂ on your next Pure Encapsulations order. Credit is for direct orders by health practitioners only. Valid in the U.S. only.

ǂCoupon code valid on one order only through 12/31/2017. Credit is for direct orders placed by health professionals in the U.S. only. Offer cannot be combined with other promotions or previous orders. Free standard shipping will become available at checkout.

Q & A with Andrew Halpner, PhD