The Organic & Natural Health Association (O&N), with research support from Grassroots Health, submitted a health claim petition to FDA regarding vitamin D’s role in reducing preterm births. According to Karen Howard, CEO and executive director of O&N, this petition was denied because FDA said the studies didn’t account for the vitamin D participants received through sunlight exposure.

Rather than walk away defeated, Howard and her Association made lemonade out of lemons, by supporting the substantiation of a structure/function claim, which currently appears on Simply GOODHEALTH’s Vitamin D3 label.

In this podcast with Sandy Almendarez, content director, Informa Markets, Howard tells the tale of the structure/function claim development and what lessons the rest of the industry can learn. They cover:

Learn more on this top from Howard on the SupplySide Education webinar, “The making of a supplement claim,” on Tuesday, July 7, at 2 p.m. Eastern. Register for free here.

Podcast Transcript:

Sandy Almendarez, content director, Informa Markets: Hi. Welcome to a Healthy Insider Podcast. I am Sandy, and on the phone, I have Karen Howard, who is the CEO and executive director of the Organic & Natural Health Association. Hi, Karen.

Karen Howard, CEO and executive director of the Organic & Natural Health Association: Hello.

Almendarez: Thank you so much for joining me today. We are going to talk about the making of a supplement claim, which Karen has a lot of experience in, recent experience as well. Karen has spent more than 30 years working with Congress, state legislators and health care organizations to help develop innovative health care policy and programs. She’s held a variety of executive positions including serving as professional staff for a Congressional Committee and as policy expertise in the diverse areas of integrative and complementary medicine managed care, health care technology and mental health. Prior to joining O&N, she served as president of the National Animal Supplement Council, served as an executive director for both the American Association of Naturopathic Physicians and the Association of Accredited Naturopathic Medical Schools.

The Organic & Natural Health Association worked with research partner Grassroots Health on research regarding vitamin D, and they took this research and they submitted a petition to FDA to allow supplements that contain vitamin D to make claims about the association between vitamin D and a decreased risk of preterm births, and the story just gets more interesting from there. So Karen, I'm going to let you take it away. Can you tell us about this petition and the submission process to FDA, and how it came about?

Howard: Absolutely. There are a couple of things that drive action at Organic & Natural Health. One of them is basically focusing on research, consumer education and advocacy. One of the things that had plagued us as an industry, frankly, and has certainly been an issue for Organic & Natural is claims submission process. Not the submission necessarily, although that has its issues too, but how we use health claims and what these structure/function claims are, how it’s confusing for the public, and essentially an exercise in futility to get a message out to practitioners and consumers.

When we looked at the body of evidence of vitamin D, we realize that our strength was essentially not just in the projects that have been completed by Grassroots Health that demonstrated a 60% reduction in preterm births with higher levels of vitamin D, but the whole body of evidence that existed was about three feet tall. Our objective was to demonstrate that it was serum level that was making a difference for preterm births, not necessarily the amount of vitamin D that you take. Because the failure of our research being plastered across the hinterlands is usually, “this product does not work. There were no demonstrated results.” Inherently, all of those random clinically controlled trials are measurement of how much people take, never measurements of the actual level of the nutrient in your body, so this is where we were sort of marshaled our forces around these issues to submit this three-foot tall stack of paper to the FDA saying serum levels matter, and this is the dramatic impact of serum levels on vitamin D. Also, pregnant women should do this in consultation with their physicians.

Almendarez: As I understand, FDA denied this petition. Can you talk about why they said they did this, and more on that?

Howard: I’ve worked in DC since 1983, engaged in conversations with the agencies from the first day that I started as a very young person, and I don't think I've seen a more contentious set of meetings ever. Submissions go as submissions go, and then there were two meetings. A large contingency of FDA representation and our contingency was significant as well. As most people know Todd Harrison is president of the board, and head of the FDA practice at Venable. We brought Carole [Baggerly, Director, and Founder] in from GrassrootsHealth, so we had a significant knowledge base there, and it became clear during the conversation that the orientation of FDA was not going to accept our premise. As we pushed and pushed as to why they couldn't evaluate the difference between the dosage of vitamin D versus the level of vitamin D in your blood, the only fallacy that they could point to in those portions of the studies that we were referencing around that related to not controlling for people going into the sun. So, essentially what we're doing dealing with is a hospital in South Carolina, where women on Medicare plans primarily subsidized health care, who may have more than one child may have two or three, may have two or three jobs have engaged and decided to go into this study, and participate, increase their vitamin D levels, and the fallacy that they kept pointing that to was “You haven't controlled for them going outside and getting sunlight,” which seemed rather preposterous.

One of the conclusions that was stated at the table as we tried to get a logical sense of how to proceed was stated—and I wrote it down, so I have it is—“Science doesn't allow you to apply common sense.”

Almendarez: Oh, my Goodness.

Howard: Yes, it was rather startling, that's why I wrote it down. It became clear that systemically, while we were being hammered on the outside for not being able to demonstrate changes in health status related to consumption of nutrients that aren't food based, well, our actual food versus dietary supplements, that structurally the FDA has put itself in a in a situation over time, and with the benefit I'm sure of interpretation of regulation, that this is just not a possibility when it comes to health claim.

Time goes on, and we have a second call. And the second call opens with we're not going to approve a qualified health claim. To which, 15 minutes into the call, I said, “I need to step back because we didn't submit a qualified health claim. So, you are telling us we submitted a health claim, so you telling us that you're not going to approve, even if we resubmit so that we can get it posted for comment?” Really, we knew that we had a cadre of people and stakeholders out there that wanted to get this message out. They basically said no, “We won’t approve that either.”

And then we waited for the letter to come. And that's when they actually denied it. And that's when we saw an open door.

Almendarez: And I want to talk about that open door because this sounds such a sad situation, but I love that you and O&N took this and saw the silver lining. How does this denial from FDA help actually support health claims for vitamin D?

Howard: Well, it won’t support a health claim, but it will support a structure/function. Claims, so that's how we turned it on its head. Because one of the things that we were arguing about was being able to get this information into practitioners’ hands. We understand that people are going to have limits in their ability and availability to be able to learn all of this. Just because we live in that world all day long doesn't mean the rest of the world does, and they kept pushing that we needed to go take this information to the OBGYN Association ourselves, when we kept saying consumers want to read this on the bottle.

We said, “Well, if the vitamin D serum level, as it as it stated in the letter, is not a food or a substance, then there's nothing wrong with saying increased serum levels create healthier pregnancies. So, we noodled around with that for quite a while because if nutrients serum levels don't count, do we then have the ability to say there's a structure/function claim that increased serum levels are helpful in reducing preterm birth rates, and then we haven't violated the law? So that's eventually what we created. A structure/function claim that says—this is in the letter to FDA—“Pregnant women who have higher serum vitamin D levels have a  decreased risk of preterm birth. Adding a vitamin D supplement to a healthy diet can help increase serum vitamin D levels. Your health care practitioner can measure serum vitamin D levels and determine appropriate dosage of Vitamin D3 for you.”

Almendarez: This is coming to market, right?

Howard: It's coming to market. The process basically says you submit that, and if you don't hear anything, you're good to go.

Almendarez: And I presume you followed that, and now you've got a partnership with Simply GOODFATS regarding this structure/function claim for vitamin D? Can you talk about that?

Howard: Well, then you know, it's funny. I mean, this seems so clear so easy and so risk free, so it took us some time to find one of our members who was positioned well to be able to submit the claim on that company letterhead, and that's when we found Simply GOODFATS, and Naomi Whittel [founder, Simply GOODFATS] is a new member of our board of directors, and of course, being a mom, an being Naomi, she was incredibly supportive of our effort to do this. She has a bottle with a modified version of this that we know is on the market, and we are now utilizing in our consumer education campaign to begin to push this specific message out

It's actually on a bottle, and one of the main reasons that we did that was not that we thought somebody was going sell an enormous amount of this product on their shelves. But just show the industry that there's another way to skin this cat, that just because the FDA says that serum levels don't matter, we know from our research work and our partnership with Grassroots Health that it absolutely is the secret to being able to demonstrate to consumers that your product is effective. What I've heard, Mostly from Grassroots Health who works with a lot of vitamin D suppliers, is that people are very anxious about utilizing this language for fear that they will get in trouble with the FDA, which is one of the reasons I'm excited about being able to do this with you guys and being able to share the story and explain the level of the low level of risk associated with this.

Almendarez: What do you what lessons do you think that other supplement brands can take from the story, even if they don't market vitamin D?

Howard: It took five years for this most recent omega-3 health claim related to heart, to get an approved qualified health plan, so our position on this is as we continue to grow the body of data associated with nutrient levels around omega-3, and our next process will engage magnesium, what we're trying to do now is show people that there's a better way to look at data. It doesn't mean you have to exclude clinical trials, but clinical trials were designed for pharmaceuticals, and therefore, they measure the impact of a foreign agent in your body, specifically to see if it's effective, or it will kill you. Nutrients, as we know, are very different. You already have these nutrients in you. The question is, “What your body doing with them and how do they interact?” So, for most people, they take dietary supplements kind of with the prayer and a song; it's not a not an antibiotic. You don't feel better in 3 days. Now, that said, you can take magnesium and sleep better day one. But the reality is if we're going to be transparent with our consumers and do the best we can to help them, they need to know that to achieve a certain levels, they need to take a different amount. Each person is going to be very different, so that individualized personal health care we all talk about is great as long as it's empowering people to understand what it is they need to take, why and how much of it.

For me, it's a bit of a research re-education effort to say, “Look what we've done with vitamin D. This is significant.” A reduction in preterm birth of 60% changes not only the finances of our health care system, but the personal lives and the future of our children. We can't afford to not look at some of our nutrient bases and say, if 80 to 90% of us are deficient in omega-3, we have to do something about that. The study just came out in Finland, saying that women have low vitamin D levels, and that didn't measure any post level [J Am Acad Child Adolesc Psychiatry. 2019 Dec 18;S0890-8567(19)32232-4. DOI: 10.1016/j.jaac.2019.11.021]. They didn't give him anything, but they are evaluating that and they found that the rates of ADHD are higher. So, we're short siding ourselves by not taking the time to do this work, and putting our faith In what's actually happening in our bodies and relying instead on sort of this quote “gold standard,” that doesn't really fit.

Almendarez: I wholeheartedly agree. Thank you so much Karen for joining me on this podcast and for going over some of this stuff.

Howard: My pleasure.