Prenatal Supplements Strike Out Again

Is It Three Strikes And You Are Out?

Author: Dr. Stephen Chaney

Pregnant CoupleIf you are pregnant, you want the best for your unborn baby. Your doctor has recommended a prenatal supplement, but do the prenatal supplements on the market meet your needs? A few months ago, I shared two studies that concluded that most prenatal supplements on the market are woefully inadequate.

In fact, the authors said, “[Our] analysis found that prenatal supplements vary widely in content, often only contain a subset of essential vitamins, and the levels were often below…recommendations.”

In other words, their study found that most prenatal vitamins on the market may not be adequate to support your needs and the needs of your child through pregnancy and breastfeeding.

Now, a third study on the topic has been published (KA Saunders et al, American Journal of Clinical Nutrition, 117: 823-829, 2023. It differs from the previous studies in that:

1) The previous two studies took a comprehensive approach, while this study focused on 6 key nutrients.

  • The previous studies included all nutrients important for a healthy pregnancy including choline, iodine, and vitamin K, which have only recently been shown to be important for a healthy pregnancy.
  • This study focused on 6 nutrients, vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids, which have long been recognized as essential for a healthy pregnancy.

2) The previous two studies focused on prenatal supplements, while this study focused on all supplements that might be taken by pregnant women.

3) The previous two studies asked whether supplements provided recommended amounts of all nutrients needed for a healthy pregnancy. This study took a “Goldilocks approach” and asked whether levels of these 6 essential nutrients were appropriate (“just right”). The study:

  • Started by determining the intake of these 6 key nutrients by American women. The authors of the study then added the amount of each nutrient provided by the supplements in their study to the amount of that nutrient in the diet of American women and:
    • Calculated the minimum amount of each nutrient that would be needed to assure that 90% of American women taking a particular supplement would meet the recommended intake for pregnant and lactating women.
    • Calculated the maximum amount of each nutrient provided by supplements in their study to assure that that 90% of American women taking that supplement would not get potentially toxic amounts of that nutrient.
  • In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high. They called this the “appropriate dose range” for each nutrient. Goldilocks would have called it “just right”.

I’m sure you are anxiously waiting to learn what their study found. But before we go there, I will describe how the study was done.

How Was The Study Done?

clinical studyFor the dietary intake portion of the study, the authors used dietary intake data previously collected from the Environmental Influences on Child Health Outcomes (ECHO) study.

The ECHO study is a consortium of 69 medical centers across multiple states. It is an observational study of mothers and their offspring designed to understand the effects of early life exposures on child health and development.

The current study analyzed dietary intake data for 2450 participants from 6 medical centers across 5 states in the ECHO study. The women in this study were diverse with respect to ethnicity, education, and weight.

All pregnant women in the current study completed at least one 24-hour dietary recall between 6-week gestation until delivery (24% completed one dietary recall. 76% completed two or more dietary recalls). Dietary intake was generally assessed with an expert interviewer and included all foods and beverages consumed in the previous 24 hours.

For the supplement portion of the study, the authors used the NIH Dietary Supplement Label Database because it is the most complete listing of supplements in the US. The authors selected 20,547 supplements that contained at least one of the 6 essential nutrients from this database.

To determine which of the 20,547 supplements contained appropriate levels of the 6 nutrients (vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids) selected for this study, the authors used the process described in the introduction above. Briefly:

  • The authors added the amount of each nutrient provided by the supplements in their study to the amount of that nutrient in the diet of American women and:
  • Calculated the minimum amount of each nutrient that would be needed to assure that 90% of American women taking a particular supplement would meet the recommended intake for pregnant and lactating women.
  • Calculated the maximum amount of each nutrient provided by supplements in their study to assure that that 90% of American women taking that supplement would not get potentially toxic amounts of that nutrient.

In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high. They called this the “appropriate dose range” for each nutrient.

Why Are The 6 Nutrients Included In This Study Important?

Dietary Intake Is Often Inadequate

The diet analysis of pregnant American women in this study found:

  • 42% were at risk of inadequate vitamin A intake.
  • 96% were at risk of inadequate vitamin D intake.
  • 45% were at risk of inadequate folic acid intake.
  • 55% were at risk of inadequate calcium intake.
  • 93% were at risk of inadequate iron intake.
  • 67% were at risk of inadequate omega-3 intake.

The percentage of women at risk for inadequate intake of these nutrients varied with age, ethnicity, and income levels. But the overall message is clear. Most American women are not getting enough of these essential nutrients from their diet alone.

The Risk of Inadequate and Excessive Intake Of These Nutrients

These 6 nutrients were chosen in part because reviews by the Cochrane Collaboration have concluded that inadequate intake of these nutrients are associated with complications during pregnancy and delivery. They can also adversely affect the health and normal development of the baby.

This is important because the Cochrane Collaboration is considered the Gold Standard of clinical studies. You can find a more detailed description of Cochrane Collaboration studies and why they are the Gold standard here.

[Note: The Cochrane Collaboration has not yet evaluated choline, iodine, and vitamin K for pregnant women, but their inclusion in prenatal supplements is supported by multiple clinical studies.]

In addition, excess intake of all these nutrients except omega-3s can harm both the fetus and the mother. The is why the Food and Nutrition Board has set ULs (Upper Limits – the level above which toxicity can occur) for 5 of the 6 nutrients. This is important because previous studies have suggested that up to 25% of women may be getting toxic levels of one or more of these nutrients when you consider both their dietary intake and their prenatal supplement.

Summary

In other words, both too little and too much of these nutrients can harm the mom and her baby. It is critical that prenatal supplements get the dosing right.

It is for that reason that the authors of this study have set an “appropriate dose range” (high enough that 90% of women have enough of each nutrient to prevent deficiency and low enough that 90% of women do not exceed the UL for each nutrient) as the standard for evaluating the adequacy and safety of supplements for pregnant women.

Prenatal Supplements Strike Out Again

Of the 20,547 supplements (421 labeled as prenatal supplements) available on the US market as of December 31, 2022, the investigators reported that:

  • Only 69 (0.3%) supplements contained all 6 nutrients considered essential for a healthy pregnancy.
  • Only 1 supplement contained all 6 nutrients at the appropriate doses, and it wasn’t even labeled as a prenatal supplement.

In addition:

  • One supplement containing all 6 nutrients put 100% of the women in their study at risk for excessive intake of folic acid.
  • Another supplement containing all 6 nutrients put 46% of the women in their study at risk of inadequate calcium intake.

The authors concluded, “Almost no US dietary supplements provide key nutrients in the doses needed for pregnant women. Affordable and convenient products that fill the gap between food-based intake and estimated requirements of pregnancy without inducing excess intake are needed to support pregnant women and their offspring.”

In short, the conclusion of this study can be summed up as, “Prenatal Supplements Strike Out Again”.

[Note: It sometime takes a while for supplement labels to be posted in the NIH Dietary Supplement Label Database. The authors acknowledged that this study may not include supplements introduced or reformulated in the last quarter of 2022.]

Is It Three Strikes And You Are Out? 

pregnant women taking vitaminsIf you are pregnant or thinking of becoming pregnant, this should be a wake-up call.

70% of pregnant women in this country take prenatal supplements, usually based on recommendations by their health care provider. They assume the prenatal supplements meet their needs and the needs of their unborn baby.

Yet three studies evaluating the adequacy of prenatal supplements have been published in the past few months. They took very different approaches in evaluating the supplements. But all three studies concluded that the vast majority of prenatal supplements on the market are woefully inadequate.

You may be wondering, “Is it three strikes, and you are out?” Are there no decent prenatal supplements on the market?  The answer to those questions is, “No. There are good prenatal supplements on the market.”

You may be wondering how I can say that in the face of such overwhelming negative data. That’s because while all 3 studies were very good studies, they each had “blind spots”:

1) Each of the studies used very stringent criteria for identifying adequate prenatal supplements. In some cases, their criteria were stricter than the RDA recommendations and the recommendations of the American College of Obstetrics and Gynecology for pregnant and lactating women. It could be argued that their criteria were too stringent.

2) In the case of the current study, it could also be argued that evaluating only 6 nutrients is not a good criterion for evaluating the adequacy of prenatal supplements. For example, I looked up the one supplement rated as adequate in this study. It does provide appropriate doses of the 6 nutrients this study focused on. It also provides appropriate doses of vitamin K and iodine. But it does not provide choline. It is a very good supplement for women, but it is not the perfect prenatal supplement.

So, what can you do? How can you find the best prenatal supplement for you? Unfortunately, you cannot rely on advice from your friends or your health professional. You cannot rely on advertisements. That is a good place to start, but you have to do your own sleuthing.

With that in mind, I have listed 7 simple rules for selecting the best possible prenatal supplement in  my article about the first two studies. Use these rules for evaluating every prenatal supplement you come across. Happy sleuthing.

The Bottom Line 

A recent study evaluated all 20,547 supplements on the US market to see if they met the needs of pregnant women in this country.

  • They focused on 6 nutrients (vitamin A, vitamin D, folic acid, calcium, iron, and omega-3s) known to be essential for a healthy pregnancy.
  • They determined the dietary intake for all 6 nutrients in a cross section of pregnant women in the US.
  • They added the amount of the 6 nutrients in each of the 20,547 supplements to the dietary intake of those nutrients by pregnant women.
  • They then asked which supplements provided the “appropriate dose” of all 6 nutrients. They defined “appropriate dose” as the dose range that was.
    • High enough to prevent deficiency of that nutrient in 90% of pregnant women taking the supplement…and…
    • Low enough to prevent toxicity from that nutrient in 90% of pregnant women taking the supplement.
  • In other words, for each of the 6 nutrients they calculated a supplemental dose range that was neither too low nor too high.

Of the 20,547 supplements (421 labeled as prenatal supplements) available on the US market:

  • Only 69 (0.3%) supplements contained all 6 nutrients they considered essential for a healthy pregnancy.
  • Only 1 supplement contained all 6 nutrients at the appropriate doses, and it wasn’t even labeled as a prenatal supplement.

The authors concluded, “Almost no US dietary supplements provide key nutrients in the doses needed for pregnant women. Affordable and convenient products that fill the gap between food-based intake and estimated requirements of pregnancy without inducing excess intake are needed to support pregnant women and their offspring.”

[Note: It sometime takes a while for supplement labels to be posted in the NIH Dietary Supplement Label Database. The authors acknowledged that this study may not include supplements introduced or reformulated in the last quarter of 2022 or early 2023.]

If you are pregnant or thinking of becoming pregnant, this should be a wake-up call.

70% of pregnant women in this country take prenatal supplements, usually based on recommendations by their health care provider. They assume the prenatal supplements meet their needs and the needs of their unborn baby.

Yet three studies evaluating the adequacy of prenatal supplements have been published in the past few months. And all three studies concluded that the vast majority of prenatal supplements on the market are woefully inadequate.

You may be wondering, “Is it three strikes, and you are out?” Are there no decent prenatal supplements on the market?  The answer to those questions is, “No. There are good prenatal supplements on the market.”

You may be wondering how I can say that in the face of such overwhelming negative data. That’s because while all 3 studies were very good studies, they each had “blind spots”:

For more details on this study and 7 tips on finding the best prenatal supplement for you, read the article above.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease. 

____________________________________________________________________________

My posts and “Health Tips From the Professor” articles carefully avoid claims about any brand of supplement or manufacturer of supplements. However, I am often asked by representatives of supplement companies if they can share them with their customers.

My answer is, “Yes, as long as you share only the article without any additions or alterations. In particular, you should avoid adding any mention of your company or your company’s products. If you were to do that, you could be making what the FTC and FDA consider a “misleading health claim” that could result in legal action against you and the company you represent.

For more detail about FTC regulations for health claims, see this link.

https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

 

 

Will Non-GMO Foods Be Less Nutritious?

The Unintended Consequences of the Proposed Non-GMO Labeling Laws

Author: Dr. Stephen Chaney

CerealPost Foods recently announced that their Grape Nuts cereal will be completely non-GMO. General Foods followed suit by announcing that their Original Cheerios will also be non-GMO. That’s good news, right?

Maybe, but it turns out that the new non-GMO Grape Nuts will no longer contain vitamins A, D, B12 or riboflavin, and the amount of riboflavin in a serving of Cheerios decreased from 25% of the daily recommended value (DV) to 2% of the DV.

The cereal manufacturers claim that their new cereals are more wholesome, but one nutrition expert said “The new products are arguably less healthy given their lower vitamin content.”

I’ve never been one to claim that throwing a few vitamins into a serving of cereal turns it into a nutrition powerhouse, but the decreased vitamin content of the new non-GMO cereals does raise a few questions.

  • Why were the vitamins removed?
  • Did it have anything to do with the cereals being non-GMO?
  • Does this mean that the non-GMO processed foods of the future will be less nutritious than the foods they replace?

The cereal manufacturers were mum when asked these questions, so we will need to rely on some scientific sleuthing and a bit of intuition to get the answers.

The Flaw in The Proposed Non-GMO Labeling Laws

I first discussed this topic a few months ago in a “Health Tips From The Professor” article titled “When is GMO Non-GMO?” I received a lot of irate comments from people who take every word on the non-GMO websites and videos as the gospel truth. (The professor has never been one to shy away from controversy when he sees claims that aren’t based on good science.)

However, I think my article was misunderstood by some of my readers, so let me review my conclusions briefly:

  • There are definitely environmental concerns around the widespread use of GM crops – especially those that allow heavy pesticide and herbicide usage.
  • There are potential health concerns related to the consumption of unprocessed GM foods and proteins derived from GM foods – although those heath concerns have been blown way out of proportion in the media.

If the proposed Non-GMO labeling laws stopped there, they would be scientifically justified. But they go one step further by requiring that processed foods labeled as non-GMO cannot contain any ingredient obtained from a GM source. There is no scientific justification for this.

  • Nutrients (sugars, oils & vitamins) derived from GM sources are chemically and biologically indistinguishable from those same nutrients derived from non-GMO sources.

The intentions of the proposed non-GMO labeling laws are good, but whenever you go beyond what good science supports there are often unintended consequences – such as the vitamin-depleted non-GMO cereals that the food manufacturers have just announced.

Will Non-GMO Foods Be Less Nutritious?

Non-GMOTo understand the answer to that question, let’s look at what probably happened to the vitamins in the non-GMO cereals.

In today’s world many vitamins are purified from genetically modified microorganisms – bacteria & yeast that have been modified to overproduce certain vitamins. In evaluating the significance of that statement, here are a few facts to consider:

1)     We have gotten vitamins from these sources for many years.

    • B vitamins have been obtained from yeast for at least a hundred years.
    • A significant portion of the vitamins we absorb on a daily basis are made by bacteria in our gut.

2)     The only difference today is that these microorganisms have been genetically modified to overproduce the vitamins.

3)     These are naturally sourced vitamins.

  • The microorganisms are the same ones that have provided these vitamins for generations.
  • The enzymes used by the microorganisms to make the vitamins are the same.

4)     There is no downside to the use of GM organisms as a source of natural vitamins.

    • There is no environmental risk from the use of these GM microorganisms. They don’t contain any dangerous genes that could wreak havoc if they escaped from the food processing plants.
    • Because the purified vitamins are indistinguishable from those obtained from non-GMO sources, there are also no health risks.

5)     The advantage of using these GM organisms is clear. It substantially lowers the cost of vitamins and allows them to be used in the mass market – for example, in popular breakfast cereals.

6)     Most food manufacturers can’t simply use non-GMO sourced vitamins and raise their prices.

    • A recent poll showed that 53% of Americans prefer non-GMO foods, but only 11% are willing to pay more for those foods

What Does the Future Hold?

Even though they are scientifically flawed, the proposed non-GMO labeling laws will probably become the law in several states in the near future. (Good science has never played much of a role in political decisions.)

Currently, there simply aren’t enough non-GMO vitamins available to supply the mass market – even if price were no concern. So, in the short term, many non-GMO processed foods are likely to be less nutritious than the foods they will replace – as we just saw with Grape Nuts and Cheerios.

However, most people feel that American ingenuity and the law of supply and demand will eventually result in a bigger supply of reasonable priced non-GMO vitamins. When that happens non-GMO processed foods will be just as nutritious as the older GM versions.

However, at this point nobody knows how long that will take.

The Bottom Line:

1)     There is a scientific basis for environmental and potential health concerns regarding genetically modified whole foods and the protein extracted from these foods.

2)     However, proposed non-GMO labeling laws would require that a processed food be labeled as genetically modified if it contains any nutrient purified from a genetically modified organism.

3)     There is no scientific justification for this requirement. Purified vitamins from GM and non-GM microorganisms are chemically and biologically indistinguishable. Furthermore, the GM microorganisms used to produce the vitamins pose no environmental or health risks.

4)     Non-GMO vitamins (vitamins prepared from non-GMO microorganisms) are currently in short supply and are very expensive compared to vitamins prepared from GM microorganisms.

5)     Consequently, the unintended consequence of these proposed non-GMO labeling laws will likely be that many of the new non-GMO processed foods will contain fewer vitamins and, therefore, will be less nutritious than the foods they replace – at least in the short term. The new non-GMO Grape Nuts and Cheerios may be just the tip of the iceberg.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

Health Tips From The Professor