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History

Try this experiment. Go to your medicine cabinet and pull out your vitamins. Read the small print. Do they make any health claims? For example, we have reported many times that vitamin D levels over 40 ng/ml are associated with a reduced risk of breast cancer, but why doesn’t it say that on the bottle? Or why doesn’t your calcium bottle say calcium is important to prevent broken bones? We all know it is, and yet that “claim” is not on the bottle. Why?

The Nutrition Labeling and Education Act was signed into law in 1990 but gave food manufacturers and dietary supplement suppliers some time to conform to the law. It started being enforced in 1993. The law requires that all food and dietary supplement labeling be devoid of health claims unless these claims have been certified through the FDA. The FDA created a process for certification which is centered on the item needing “significant scientific agreement” within the medical and scientific community. This FDA web page explains the standard and has links to all approved health claims that have been certified since 1990, and the one that has been denied.

What claims have been certified for dietary supplements?

There are currently only two certified claims for dietary supplements.

The first one was approved in March 1996 and went into effect in April 1996. It associated folate (also known as folic acid) and neural tube defects. This was a big step for the researchers of folate, as the first research showing a correlation between folate and neural tube defects was back in 1965.In the early 1990s, with two separate RCTs clearly demonstrated a reduced risk of neural tube defects in response to folic acid supplementation. It was those RCTs that provided the basis for the FDA claim. After this time, the US government started fortifying grains with folate in 1998. An evaluation by the Centers for Disease Control in 2015 showed a 25% decrease in neural tube defects by 2005, and this level remains constant. This effort is considered a success. The health claim had four model wordings, one of which is

Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.

The second certified health claim for dietary supplements, associating calcium and vitamin D with osteoporosis, was approved in September 2008 and went into effect January 1, 2010. After that time, supplement manufacturers could put a perfectly-worded claim on their bottles of calcium and D (together only).Two model wordings were approved, which is most likely what manufacturers use. Here is one

Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.

And now we are hoping that bottles of vitamin D could have a health claim associated with preterm birth.

What is the process for certifying a claim?

The FDA has 15 days to acknowledge receipt of the petition. After that time they have 45 days to either send it back because the information was not complete or create a docket number. That starts a 60-day clock where the petition is on a public web page and open for comment. After that time is up, the FDA has 270 days to issue a ruling – accepting or denying the claim.

All in all, a laborious process, and around a year-long.

What is the health claim that has been submitted?

Organic & Natural Health Association created and filed the petition and is leading this process. Much of the scientific evidence provided in the claim has come from research at the Medical University of South Carolina, Dr.’s Hollis and Wagner, and the Protect our Children NOW! project.

The proposed claim is

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

Our hope is that after this claim is approved, not only can this claim appear on vitamin D bottles, but as in the case of folic acid this would start a chain of events which would lead to every obstetrician testing vitamin D levels at their patient’s first prenatal visit, explaining the benefit of getting their vitamin D levels above 40 ng/ml (100 nmol/L) and ultimately ending the racial disparity around preterm birth and drastically reducing preterm birth in the US, and hopefully worldwide.

What are the next steps?

The claim was filed on March 27, 2018. So the FDA has 15 days to acknowledge receipt and then another 45 days to create a case and start the process or send it back. You may inform your representatives about this petition by clicking on the flag below.

GrassrootsHealth and Organic & Natural Health Association will be on Capitol Hill April 12 to meet with Congressional staff from across the country and share the story of how vitamin D reduces the risk of preterm birth and the need for FDA to approve this health claim.

What can I do to help?

Right now, continue to work within your communities to spread the word about the benefits of vitamin D. We will inform you when the time for public comment arrives, so you may voice your support. There may also be a time when it is appropriate to write to your Congressional Representative or Senator, and we can provide guidance and materials at that time.

Click here to support the petition

Resources

Research to Support Vitamin D Petition – Vitamin D and Preterm Birth
GrassrootsHealth
Blog describing the research within FDA petition
Read Blog

The 21st Century Revolution in Pregnancy
GrassrootsHealth Press Release
March 29, 2018
Read Press Release

Organic & Natural Health Association Submits Petition to FDA for Vitamin D, Preterm Birth Health Claim
Organic & Natural Health Association
Press Release
March 28, 2018
Read Press Release

FDA Submission Document
Filed with the FDA
March 27, 2018
Read Submission Document

FDA Description of Nutrition Labeling and Education Act
Web page with description and links to approved and denied claims
Simplest source for getting detail on each claim (click on approved claims)
Go to Web Page

Folic Acid Food Fortification—Its History, Effect, Concerns, and Future Directions
Krista S. Crider et al.
Nutrients
March 2011
Read Paper