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FDA allows the claim that Vitamin D “supports healthy pregnancies and promotes full-term births” – Oct 2019

Organic & Natural Health Association’s Push on Vitamin D and Healthy Pregnancy Makes Label Debut with Simply GOODFATS

The work Organic & Natural Health Association put into action along with research partner, GrassrootsHealth around the promotion of vitamin D for healthy pregnancies is finally making its debut on vitamin D product labels with Naomi Whittel’s company, Simply GOODFATS being the first to market a new structure/function claim on its vitamin D3 product.

In 2018, Organic & Natural Health submitted a petition (  Download 40 page petition from VitaminDWiki ) to the Food and Drug Administration and had two follow-up meetings, requesting that the agency permit dietary supplements containing vitamin D to make a health claim concerning the association between vitamin D and a decreased risk of preterm births. The petition was based on numerous studies showing an association between higher serum vitamin D levels in pregnant women and a reduced risk of preterm births. This year, the petition was rejected based on FDA’s decision that although vitamin D is a food source, serum levels of vitamin D are not considered food or components of food, therefore cannot be characterized as a substance to decrease the risk of preterm births.

“It’s an interesting position they took, that actually opens the door for companies with vitamin D supplements to include language on their labels that supports healthy pregnancies and promotes full-term births,” said Karen Howard, CEO and executive director of Organic & Natural Health. “Given FDA’s conclusion that the proposed health claim can’t be based on nutrient serum levels, only on how much vitamin D people take, we conclude it is appropriate, and essential, to educate consumers on how vitamin D affects the body’s function during pregnancy and reduces the risk of preterm birth.”

Simply GOODFATS Vitamin D3 label will be the first product to include “supports full-term birth” and “supports a healthy pregnancy” along with a structure/function claim:

  • "Pregnant women who have higher serum vitamin D levels have a decreased risk of preterm birth. Adding a vitamin D3 supplement to a healthy diet can help increase serum vitamin D levels. Your healthcare practitioner can measure serum vitamin D levels and determine appropriate dosage of vitamin D3 for you."

 SIMPLYGOODFATS

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Cost per 5,000 IU: 50 cents vs Bio-Tech and many other vendors 2 cents


See also VitaminDWiki


FDA Claims with Vitamin D

Note: As of Oct 2019, the FDA does not appear to allow any other claim about Vitamin D, not even Rickets
FDA does allow a claim for Calcium plus Vitamin D for Osteoporosis
Unfortunately, a large amount of supplemental Calcium is known to cause many problems


Created by admin. Last Modification: Tuesday October 6, 2020 09:56:27 GMT-0000 by admin. (Version 15)

Attached files

ID Name Comment Uploaded Size Downloads
12779 Simply.jpg admin 11 Oct, 2019 16:12 16.87 Kb 263
12778 vitamin-D-claim-submission-3.28.18.pdf PDF 2018 admin 11 Oct, 2019 16:07 713.47 Kb 151
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