Prenatal vitamins are kind of a hot mess. Does anyone care?

In related news… I’m pregnant! A closer look at prenatal vitamins: Why they’ve been in the news, and why there’s so little oversight.


Assorted vitamins in many colors laying flat on a light pink background.s

Happy Friday and welcome to Food Fix! Today’s topic is a little different – supplements, not food – but this one is particularly relevant for me right now because I’m pregnant! (Due in May with bebe number two!) Even if you aren’t keenly interested in prenatals, I hope you’ll read it anyway. After all, if we can’t get prenatal vitamins right, what can we?

Food Fix on the pods: I recently joined Hillari Lombard on Moderate Party, a podcast for moderates, centrists and independents, to talk about my time reporting on FDA and food policy generally. We dig into how I started covering these issues, why I think it’s a shame the mainstream media doesn’t cover food as a serious beat, and more. Listen here.

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Alright, let’s get to it –

Helena

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Prenatal vitamins are kind of a hot mess. Does anyone care?

Prenatal vitamins have been in the headlines the past couple of weeks after a Government Accountability Office study found that many of them are inaccurately labeled or, rather, don’t contain the levels of vitamins and minerals they say they do. 

This is kind of a big deal. It’s standard practice for U.S. health care providers to recommend prenatal vitamins – anyone trying to become pregnant is definitely supposed to be taking them – because folic acid supplementation has been shown to substantially reduce the chance of serious birth defects. It’s one of the few instances where the medical establishment fully embraces supplements, even though they are not subject to regulation or pre-market approval like drugs and other medical products. 

What GAO found: The GAO, an independent agency that helps Congress with government oversight, worked with a lab to test 12 prenatal supplements considered “best-sellers” by major retailers. Eleven of the 12 had at least one tested nutrient – folic acid, iodine, iron, or vitamin A, C, or E – that “on average, contained an amount outside of acceptable deviations from the amount stated on the label.”

The report doesn’t specify which brands were tested, but GAO says it picked a “nongeneralizable sample selected from a list of ‘best-selling’ or ‘top-rated’ prenatal supplements from the websites of major retailers and compared to ‘best of’ lists found online.”

One thing that stood out to me: The study found that gummy prenatal vitamins routinely contained far more folic acid than is listed on the labels. It’s actually acceptable industry practice for gummies – which are increasingly popular – to contain up to 255 percent of what’s listed for folic acid. That’s because nutrients tend to degrade in gummies, so overshooting ensures the products don’t dip below what’s on the label before the product expires. These higher levels could easily push an individual over the upper limit of what’s recommended per day – though it’s unclear whether there’s any actual health impact of ingesting this much folic acid. Regardless, I still found it shocking that a product can contain a nutrient at two or even three times what is listed on the label and a consumer would have no idea.

On the flipside, some of the softgels tested by GAO contained less folic acid than was listed on the label. Tablet prenatals were the closest to what was labeled. Vitamin E was the nutrient that GAO found was most inconsistent, ranging from 28 to 332 percent of what was stated on the label. Vitamin A was also found to be frequently outside of the acceptable deviation.

Good news: The good news here is that GAO’s findings don’t flag anything dangerous, and certainly nothing that would suggest pregnant patients should stop taking prenatals. The agency also tested for heavy metals and found trace amounts of lead or cadmium in half of the products tested, but “not in amounts likely to cause a health concern” based on FDA metrics.

All of that said, this study didn’t sit well with me. I have taken prenatal vitamins for the better part of the last five years – I have a four-year-old and I’m currently 26 weeks pregnant with my second. If these supplements aren’t even accurately labeled, how much should I really trust them?

Hands-off FDA: Even though I’ve covered food policy for nearly 15 years, I’ve largely avoided covering supplements, which are really their own universe with an entirely different set of issues. Congress has directed the FDA to take a mostly hands-off approach when it comes to dietary supplements. There’s almost no pre-market approval, minimal regulation, and the industry is largely expected to police itself.  

As GAO notes: “FDA has limited information about the dietary supplements on the market – including prenatal supplements – to inform its post-market inspections and oversight.” (FDA does conduct a limited number of inspections of supplement manufacturers each year to check that they’re following good manufacturing practices, but these inspections are infrequent and do not typically involve independent testing, instead relying on the company’s own records.)

In the report, GAO recommends that Congress give FDA “sufficient authority to carry out its oversight of dietary supplements.” FDA agreed with the recommendation. I asked the agency if it had a comment on the report. “In general, the FDA does not comment on published reports of product testing but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” an agency spokesperson said.

The supplement industry’s take: The Council for Responsible Nutrition, a major dietary supplement trade group, pushed back on the GAO report, calling it “unnecessarily alarmist.” 

“The worst possible outcome would be for women to read this report and decide not to take prenatal supplements, when research shows the critical benefits these nutrients provide in the form of supplementation,” said Andrea Wong, senior vice president of scientific and regulatory affairs at CRN, in a statement.

Wong later told me that CRN is concerned that the GAO study may not be very accurate. It was a small sample size (just 12 products tested, 36 samples in total), and the trade group has questions about how exactly GAO measured the nutrients in each product. 

This may be a valid objection – I’m certainly no expert in supplement testing methodology – but to my knowledge, there hasn’t been any other independent assessment of whether prenatal vitamins are accurately labeled. That means this GAO report is kind of all we have.

Looking into this, I found myself consistently astonished by how little attention has been paid to these products, which are universally recommended by doctors and often seen by expecting parents as a kind of nutritional insurance policy. I started to get a bit pissed off. Do we really care so little about ensuring the quality of these vital supplements that we haven’t even bothered to look into it?

All over the map: It’s not just that we lack independent oversight of whether prenatal supplements contain what they say they do, but there are also no standards or even voluntary guidelines on what should be in them. 

There’s strong clinical evidence that folic acid substantially reduces neural tube defects. The American College of Obstetricians and Gynecologists (known as ACOG) is clear on recommending that patients take a daily prenatal vitamin with 400 micrograms of folic acid – in addition to consuming foods that are fortified or naturally contain folate, like dark leafy green vegetables.

Once you go beyond folic acid, however, the supplement advice starts to get confusing and inconsistent. Iron is often recommended as the next most essential supplement, but ACOG doesn’t specifically recommend it. The group does recommend that vegetarians take B12. (Otherwise, ACOG recommends getting key nutrients from foods.)

Emily Oster, a popular author, economist and parenting expert, last week wrote about prenatal vitamins and suggested you really only need four nutrients in them: folic acid, iron, vitamin C and DHA. But even these four are not typically included in many prenatal supplements (and this advice is not in line with ACOG). Plenty of prenatal vitamins don’t contain iron (the gummies almost never do – apparently iron tastes terrible), and many prenatals don’t contain DHA, either.

Calls for more oversight: ACOG did tell me that they saw the GAO report as confirmation that there needs to be more FDA oversight of prenatal vitamins – something Congress would likely have to take action on. 

“Unfortunately, due to the way that vitamins and other dietary supplements are regulated by the FDA, it’s difficult to know what levels are in each of the nutrients in various brands of prenatal vitamins,” said Christopher Zahn, ACOG’s interim CEO and chief of Clinical Practice and Health Equity and Quality. “The GAO report is a powerful example of why ACOG supports increased FDA oversight and the standardization and regulation that’s needed to make sure prenatal vitamins and supplements are safe and accurately labeled. It’s critical that patients feel secure knowing that what they are consuming is not harmful to them or their pregnancy.”

As far as I know, there’s been no discussion of ramping up oversight of prenatals on Capitol Hill. Sen. Jon Ossoff (D-Ga.) requested the GAO report, but he’s made no statements about it and his office declined to answer questions about what sparked the inquiry.

Advice to consumers? After diving into this issue, I’d hoped to be able to come up with some helpful tips about how to pick a prenatal. Unfortunately, I didn’t land on much sound advice. Everyone I talked to recommended something a little different. One option is to stick to well-known brands or look for third-party certifications, like USP or NSF (though GAO didn’t find third-party certified products performed better). Clean Label Project does third-party testing for heavy metals in supplements. There are also external groups like Labdoor and ConsumerLab that conduct limited testing of supplements on the market and report their findings. 

But really, I think it’s unfair to expect parents to do so much research about this, on top of all the other decisions we have to make about everything from car seats to cribs and, in many cases, infant formula – which all happen to be regulated. For now, I’m just crossing my fingers and hoping that my prenatal vitamins contain what they should.

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What I’m reading

Sen. Sanders urges FDA to impose ‘strong warning labels’ to combat diabetes and obesity (Senate). “As discussions on a new proposed front-of-package label rule that would better inform consumers about the health impacts of their food are underway at the Food and Drug Administration (FDA), Sen. Bernie Sanders (I-Vt.), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, sent a letter to FDA Commissioner Robert Califf, M.D. urging the FDA to require corporations in the food and beverage industry to put strong, evidence-based warning labels on their products to protect the health of the American people,” per Sanders’ office. “‘I am encouraged that the FDA has begun the process of issuing a proposed front-of-package label rule that would better inform consumers about the health impacts of their products high in added sugars, sodium, and saturated fats,’ wrote Sanders. ‘However, from what I have seen thus far, these efforts do not go nearly far enough.’”

Kraft Mac and Cheese sales take a hit after cuts to food stamps (Bloomberg). “It’s been just about a year since the US government slashed additional pandemic-related food-stamp benefits, and some of the companies that make and sell food are seeing that hit their sales,” reports Deena Shanker. “Food companies have been reporting volume declines for more than a year now, making up for lost sales with price hikes… On Wednesday, packaged-food giant Kraft Heinz Co. cited the reduction in benefits as a major headwind that the company and the industry faced in 2023. ‘We saw some challenges in our mac-and-cheese business,’ Chief Executive Officer Carlos Abrams-Rivera said on an earnings call. ‘Frankly, it’s a business that is driven disproportionately by our SNAP exposure.’”

The leading lab-grown-meat company just paused a major expansion (WIRED). “In September 2023, Upside Foods announced its plans to open a large cultivated-meat plant in Glenview, Illinois. The 187,000-square-foot plant was slated to have an initial capacity of millions of pounds of bioreactor-brewed meat per year, which would make it one of the largest planned factories in the nascent cultivated-meat industry. The company nicknamed the facility Rubicon, signifying ‘a point of no return’ for cultivated-meat production,” reports Matt Reynolds. “WIRED can reveal that Upside’s plans to build Rubicon have been put on hold, and the company will instead focus on doubling its investment in its established facility in Emeryville, California, before it continues work in Glenview.”

Should you be using ChatGPT for nutrition advice? New study says not (Eating Well). “If you’ve jumped on the ChatGPT bandwagon, you might use it to write your social media posts, poems for your sweetie or legal documents. But should you be using it for medical information? Specifically, should you use ChatGPT for nutrition advice? A new study suggests probably not,” writes Carrie Myers.

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