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."
Cost per 5,000 IU: 50 cents vs Bio-Tech and many other vendors 2 cents
- US Law Forbids the Medicinal Use of Natural Substances – Sept 2019
- FDA now allows specific Omega-3 health claims (Vitamin D claims are feasible) July 2019 - has the following
+It seems feasible to make similar claims for Vitamin D – there is a lot of “credible evidence”
+Would be nice to have a Vitamin D group which would benefit from FDA approving “credible claims”
Would probably need >$30,000 to petition the FDA
Unfortunately, unaware of a group that would benefit
- Off Topic: FDA does change after lots of money and decades of pressure (amalgum in this case) - Oct 2020
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