By Jeanne Yacoubou, MS
In July 2016 The Food and Drug Administration (FDA) ruled that vitamin D2 could be added as a nutrient supplement to plant-based beverages intended for use as milk alternatives as well as to non-dairy yogurt alternatives. https://www.federalregister.gov/documents/2016/07/18/2016-16738/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d2
[VRG Note: Vitamin D2 (ergocalciferol) is derived from fungal or plant sources. Vitamin D3 (cholecalciferol) is most often derived from sheep’s wool (lanolin) although a vegan vitamin D3 form is available http://vitashine-d3.com/. Vitamin D3 is frequently added to cow’s milk and orange juice.]
The VRG wondered if vitamin D2 was permitted by the FDA to be added to orange juice since nothing in the recent ruling specifically addressed this issue.
We searched Title 21 of the Code of Federal Regulations (CFR) and located the status of both forms of vitamin D as a food additive.
Here it states that vitamin D3 may be added to juice; Vitamin D2 is not mentioned.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.380
By contrast, vitamin D2 may be added to certain foods:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=172.379
On this page it states that “Vitamin D2 may be used safely in foods as a nutrient supplement defined under 170.3(o)(20) of this chapter…” but there is no mention of juice. Under that section, the CFR states the definition: “Nutrient supplements: Substances which are necessary for the body’s nutritional and metabolic processes.”
Here’s where the CFR states that it’s admissible in certain foods/beverages to use either form of vitamin D as “vitamin D.” Again, orange juice is not specifically identified in relation to vitamin D2 supplementation.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=184.1950
Searching for more information about FDA’s position on vitamin D2 in orange juice, we contacted a few government scientists who conduct nutrition research.
Dr. Bess Dawson-Hughes, MD at the USDA Human Nutrition Research Center on Aging at Tufts University sent us a link to a pertinent article on vitamin D titled Vitamin D fortification in the United States and Canada: current status and data needs http://ajcn.nutrition.org/content/80/6/1710S.full.pdf+html
A footnote in Table 1 Lawful addition of vitamin D to foods in the United States of this article specifies that vitamin D3 is permitted in juices. It appears that Table 1’s “vitamin D” for the other foods/beverages can be either vitamin D2 or vitamin D3.
We asked Dr. Dawson-Hughes: Do you know if FDA’s position is that since D2 is defined as a dietary supplement and it is NOT expressly prohibited from being added to juice, then companies may add it to juice?
She replied:
Since milk can be fortified with D2 or D3 (see statement below from the Calvo article), I would think that D2 can be used to fortify other foods.
This is the statement from the article linked above on which Dr. Dawson-Hughes based her conclusion:
…Vitamin D, which includes crystalline vitamin D2 and
D3 and vitamin D2 and D3 resin formed from the irradiation of ergocalciferol and cholecalciferol, can be added as the sole source of added vitamin in the food categories shown in Table 1 and must not exceed the specified limitations …
The VRG also contacted FDA by email and phone for confirmation. Here is our question posed in January 2017 to FDA’s Food and Cosmetics Information Center and Technical Assistance Network (FCIC/TAN) followed by their reply:
Q: … [In the CFR] D2 is permitted in plant-based milks but I see only D3 as allowable in fruit juice.
Are companies in the US permitted to add vitamin D2 to orange juice?
A: Thanks for your inquiry! Yes, vitamin D (2 & 3) can be added to orange juice.
Thank you for contacting FDA’s FCIC/TAN.
The VRG followed up with a phone call to FCIC to inquire about the specific reference in CFR’s Title 21 on which FCIC based its answer.
We began the phone call by asking whether a juice company could add vitamin D2 to orange juice. The immediate response was “If a company has approval.” Wondering which CFR regulation supports this reply, we continued by asking for the CFR reference. We received this answer after being put on hold for a few minutes: “If vitamin D2 is not expressly written as prohibited [in the CFR] it may be used [as a dietary supplement defined in 21CFR170.3] in orange juice.” The call was disconnected while we repeated our request for the CFR reference for this statement.
Related Information:
• http://ajcn.nutrition.org/content/77/6/1478.abstract?ijkey=d73961b7bcd1c655998db2664e6d31f2bf51d074&keytype2=tf_ipsecsha
• https://www.ars.usda.gov/ARSUserFiles/80400525/Articles/AJCN87_1092S-1096s.pdf
• http://www.nutraingredients-usa.com/Suppliers2/Lichen-based-vegan-vitamin-D3-gains-momentum-as-Nordic-Naturals-introduces-new-product
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