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Over the Counter Prenatal Vitamins: Are They Safe?

The dietary supplement industry made headline news last February, and it wasn’t good news. Unfortunately, the story was part of a much larger problem. Let me explain.

The State of Dietary Supplements

Dietary supplements sold within the United States are not evaluated by the FDA before sale. Examples of products that fall under the dietary supplement umbrella include: capsules of a powdered botanical, multivitamin gummies, bottles of fish oil, over-the-counter weight loss pills, and more. If you’re wondering if a product is classified as a dietary supplement or not, check the label. Dietary supplements are required to use the “Supplemental Facts” label (not “Nutritional Facts”).

A dietary supplement is, for the most part, defined by two qualities. The first quality is rather straight-forward: “A dietary supplement is a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.”1 The second quality has to do with what counts as a “dietary ingredient.” Dietary ingredients are things like vitamins, minerals, amino acids or enzymes, and they can’t be “new” compounds.2

The FDA can (and has) made rules regarding dietary supplements. Dietary supplements aren’t allowed to make certain kinds of claims, are required to list their ingredients, must follow certain manufacturing guidelines, and so on.

However, due to the Dietary Supplement Health and Education Act (DSHEA), it is very difficult for the FDA to actually control the sale of dietary supplements. A product marketing itself as a dietary supplement may be blatantly illegal, but it doesn’t need approval to reach the shelves of stores across the United States. Companies selling these products are simply trusted to follow the rules. If the FDA discovers a product that is unsafe and/or doesn’t follow regulations, the burden of proof rests with the FDA. It is not easy for the FDA to pull a product from the market.3

Maybe this situation doesn’t sound all that problematic. There are certainly lawmakers and lobbyists who say that the FDA oversight of dietary supplements is just fine as it is. They say that, even while contaminated dietary supplements take lives, as study after study shows that dietary supplement labels are typically inaccurate, and as the FDA fights a losing battle against dietary supplements with unlisted, illegal, addictive and/or dangerous ingredients.

That’s right. Dangerous and illegal substances — steroids, analogs of Viagra, antidepressants, amphetamines or amphetamine-like substances, etc. — are being sold in stores across the United States, marketed as diet pills or sexual enhancement supplements. The FDA is trying to stay on top of this practice, but they can’t do anything about it until the product has already hit the shelves.4,5

The same law that restricts the FDA’s ability to keep controlled substances off the shelves similarly restricts the FDA’s control of the multivitamins and herbal supplement market.

It’s common knowledge that weight loss pills are dangerous. But people trust their multivitamins. Of course, you’re not likely to get an amphetamine analogue in your store-brand multivitamin — that doesn’t mean that our vitamins are without problems of their own.

Way back in 2005, the IOM expressed concern regarding the product reliability of dietary supplements. Their concerns have proven to be accurate. Various studies have shown contaminants or vastly inaccurate supplemental facts labels in herbal and vitamin products.6 With services like ConsumerLab.com and LabDoor, it’s become much more evident that our most trusted vitamin products aren’t what they claim to be. For example, labdoor.com found that otc prenatal vitamins range most in their amount of folic acid, with lab tests showing that the products had anything from ~ 6% to ~ 300% the amount of folic acid claimed on the label.7

February: The New York Attorney General

All of this sets the stage for what happened in February. Attorney General Eric Schneiderman had herbal supplements from a handful of major retailers tested. The tests failed to detect the listed ingredients in a majority of the supplements tested — name-brand supplements from GNC, Walgreens, Walmart and Target. Mislabeling is illegal and the attorney general sent cease and desist letters to these retailers, requesting the sale of these apparently illegal supplements be stopped immediately. The media reported the results of the attorney general’s test with fervor.

The media also reported that the tests revealed contamination of many of these products. Ingredients that were not listed on the labels were found by the tests.

Then the backlash began. The media realized that there was a major flaw to the tests in question — the tests were for DNA in the products, while a properly processed herbal supplement may have none of the DNA of its plant source. It isn’t the DNA of, for example, echinacea, that people consume for potential health benefits. Rather, benefits are attributed to other chemicals from the plant. A perfect echinacea extract would have no DNA at all.

Of course, the tests did still turn up important information; products were contaminated with DNA from sources that were not listed on the labels. For example, one ginkgo biloba product that advertised itself as “gluten free” was found to contain wheat DNA.8 Contamination uncovered by these tests raises concerns especially for consumers with allergies.

How this situation in New York plays out remains to be seen. Legal actions are ongoing and more tests are underway. GNC has already reached a settlement with the New York Attorney General and will be implementing stricter testing and transparency standards.

The Upshot

Over-the-counter dietary supplements are largely unregulated. A savvy consumer without extra health concerns may feel comfortable using a resource like LabDoor to ensure they know what they’re paying for. But what about people with allergies? What about mothers who don’t want to risk not getting the nutrients they need during pregnancy?

For these people especially, we recommend choosing a prescription vitamin.

Prescription vitamins may, additionally, be able to provide formulations that you can’t get over the counter. For example, prescription prenatal vitamins can contain more folic acid than OTC prenatal vitamins.

Going with a prescription vitamin also ensures that you talk with your doctor before beginning a vitamin regimen that could potentially cause health issues. For example, higher doses of vitamin E are especially dangerous for pregnant women.

Either way, though, we always recommend talking with your doctor before beginning (or stopping) any supplement regimen.


References

1 Q&A on Dietary Supplements

2 Dietary Supplement Health and Education Act of 1994

3 Dangerous Dietary Supplements Return to Store Shelves

4 American Roulette — Contaminated Dietary Supplements

5 Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

6 Many “Natural” Supplements Are Contaminated

7 Top 10 Prenatal Vitamins

8 New York Attorney General Targets Supplements at Major Retailers