Title: We Tested Prenatal Supplements to See What's in Them--Here's What
We Found

Description: Many pregnant people take prenatal vitamins or supplements
to promote healthy pregnancies and babies. But these widely-used
supplements are not subject to the same scrutiny for safety and labeling
as prescription drugs. For a new report, we looked at whether some
prenatal supplements contain harmful substances, such as heavy metals,
and whether their product labels were accurate. GAO's Karen Howard tells
us more. 

Related GAO Work: GAO-24-106689, Prenatal Supplements: Amounts of Some
Key Nutrients Differed from Product Labels

Released: December 2023

[MUSIC]

[Karen Howard:] Supplements, including prenatal supplements, are very
much a buyer beware marketplace.

[Holly Hobbs:] Hi and welcome to GAO's Watchdog Report. Your source for
fact-based, nonpartisan news and information from the U.S. Government
Accountability Office. I'm your host, Holly Hobbs. Many pregnant people
take prenatal vitamins or supplements to promote healthy pregnancies and
babies. But these widely used supplements are not subject to the same
scrutiny for safety and labeling as prescription drugs. For a new
report, we were asked to look at whether some prenatal supplements
contain harmful substances, such as heavy metals, and whether their
product labels were accurate. Joining us to talk about our new report is
GAO's Karen Howard, who led this work and is an expert in chemistry.
Thanks for joining us. 

[Karen Howard:] Thanks for having me, Holly. 

[Holly Hobbs:] So, Karen, what could happen if someone took a prenatal
supplement that had a dangerous level of a substance? What could happen
to them, and what could happen to their baby?

[Karen Howard:] That's a great question. So, we bought 12 different
brands of prenatal supplements. And we tested them for two categories of
substances. First, we tested for six nutrients that are important for
the health of the parent and the baby. And second, we tested for heavy
metal contaminants that aren't supposed to be there, but might be
present. So, in terms of the heavy metals, that's an easy question. If
there are levels of heavy metals that are too high, that can be harmful
to the developing baby, particularly its brain, cognitive development,
and also growth. So obviously heavy metals are bad. But even the
nutrients, the vitamins and minerals, which are of course why somebody
takes a prenatal supplement--they can be a problem if the person gets
too
much or too little. So, if the levels are too low, that can actually
create problems for the developing baby. For example, it might not get
enough folic acid, which is very important for the development of the
nervous system, the brain and the spinal cord, for example. But levels
that are too high can also be a problem. And one example is vitamin A.
In the early stages of pregnancy in the first couple of months of fetal
development, too much vitamin A can actually lead to miscarriage or to
birth defects. So we're concerned in the vitamins and minerals category
about both too little and too much. 

[Holly Hobbs:] So you mentioned we looked at some supplements. We
actually looked at some best-selling, top-rated supplements. Were any of
them dangerous? 

[Karen Howard:] In terms of the heavy metals, the good news is that none
of our 12 supplements had levels of heavy metals that would be
considered dangerous. Six of the 12 or half of those brands that we
tested, did have detectable amounts of lead or cadmium. And we tested
also for mercury and arsenic, and didn't detect any of those in the 12
supplements. But of the six that had detectable levels of lead or
cadmium, those levels were far below levels that the FDA would consider
dangerous. So, we can conclude that the levels are low enough to be
safe.

[Holly Hobbs:] What about the nutrients? 

[Karen Howard:] That question is actually impossible to answer because
there are no standards for what should be in a prenatal supplement or
how much should be there. Manufacturers can actually add whatever
amounts of those nutrients they want. One supplement might contain a
very different amount of nutrients than another supplement contains. We
think that might be a surprise to a lot of consumers because, I think,
they would assume that they're pretty consistent from one brand to
another, and it doesn't really matter which one they choose. So because
there are no standards here, we did look at some guidelines. These are
just voluntary suggestions from some outside parties. We use those as
kind of a guide of what might be safe or what might be of concern. We
did find that four of our 12 products had folic acid at levels that was
below what the label claimed. So that might mean that the pregnant
individual and their baby aren't getting a sufficient amount of folic
acid. In the same way iodine, in two of our 12 products, we found iodine
at levels below what the label said the supplement contained. And FDA
actually considers a supplement to be misbranded - So something that
they could take action against the manufacturer for, if the levels of
nutrients are below what the label says they should be. None of our
nutrients were present at levels higher than recommended guidelines for
any of our supplements. So that's good news. 

[Holly Hobbs:] So the Food and Drug Administration, the FDA, that's
normally the agency you think of when you think of drugs and drug
safety, right? How is the FDA overseeing these supplements? 

[Karen Howard:] We think the average consumer would be surprised to know
that FDA does not have the legal authority to regulate prenatal
supplements with the same rigor that it uses to regulate medicines--even
though doctors often recommend these supplements to their patients and
even prescribe them to their patients, which gives consumers a sense of
comfort that these are medicines, that they're well controlled, that
they can be comfortable, that they're safe to take. In fact, FDA
regulates supplements not as medicines, but as a category of food, which
has much looser requirements. They don't have to be tested before they
go on the market to make sure they're safe. They don't even have to be
reported to FDA before they go on the market. FDA can only take action
if they find a problem, which means maybe something has already gone
wrong.

{Music break}

[Holly Hobbs:] So Karen just told us that while prenatal vitamins are
prescribed by doctors and are important for promoting a healthy
pregnancy, consumers may be surprised to know how limited oversight of
these supplements are. Karen, we've said a lot of scary things. What is
a pregnant person supposed to do with this information?

[Karen Howard:] Based on the supplements we tested--which again, only 12
brands, there are a lot more brands on the market. We don't know what's
in those. We didn't include them in our testing--But the supplements we
tested did not exhibit any levels that were dramatically above the
recommended guidelines. The levels of heavy metals were at low levels
that would be considered safe by FDA. So overall, the guidance that a
vitamin should be taken is probably wise. But we do believe there are
some steps that should be taken to increase FDA's authority in this
area.

[Holly Hobbs:] So, we found this problem with FDA's authority. What do
we think needs to be done about it? 

[Karen Howard:] In our report, we included a recommendation for Congress
to provide FDA with additional authority to provide stronger oversight
of the prenatal supplement market. We think that's especially important
in this market in particular because the population is so vulnerable--
pregnant individuals, and they're developing babies. So, we strongly
encourage Congress to consider increasing FDA's legal authority to
regulate in this area. 

[Holly Hobbs:] And last question, what's the bottom line of this report? 

[Karen Howard:] The bottom line is that supplements, including prenatal
supplements, are very much a buyer beware marketplace. There are no
standards for what goes into prenatal supplements. FDA has limited
authority to regulate them. Oversight usually occurs only after they're
on the market and action can only be taken after a problem is
identified, which might be too late. 

[Holly Hobbs:] That was Karen Howard talking about GAO's new report on
prenatal supplements. Thanks for your time, Karen. 

[Karen Howard:] Thank you. 

[Holly Hobbs:] And thank you for listening to the Watchdog Report. To
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