"Pregnancy Safe" Skincare - Does that Mean Anything?

First Posted on July 6, 2023 in:insights & debunksscience deep dive

Since one of the chemists is now preggers, we can no longer avoid this can of worms. It’s time to tackle the topic of pregnancy-safe skincare and what that even means! We admit that the main reason for avoiding this topic for as long as we have is because, 1. This discussion is still best decided with your doctor. And 2. The data behind any sort of pregnancy-safe claims is sparse at best.

Knowing this, let’s try to go through some of the data and why pregnancy-safe skincare may or may not matter to you during this 9-month period.

First! Let’s Manage Expectations

If you start googling “pregnancy safe” skincare, feelings of overwhelming confusion creeping into your soul is normal! Just know that the medical world feels the same way. In fact, here are two incredibly different perspectives on pregnancy in skincare within research realm:

  1. The Not Too Worried View Point:With the exception of hydroquinone, which has a relatively high systemic absorption rate, and tretinoin, for which the evidence is controversial, these products act locally and therefore produce minimal systemic levels. Consequently, in most cases women can deal with these cosmetically unappealing skin conditions without compromising the safety of their unborn children.” - Canadian Family Physician Journal
  2. The Incredibly Cautious View Point: Cosmetic products contain various chemical substances that may be potential carcinogen and endocrine disruptors. Women’s changes in cosmetics use during pregnancy and their risk perception of these products have not been extensively investigated…Pregnant women are particularly vulnerable to the potential risks of the endocrine disruptors contained in cosmetics. First, cosmetics use is far more common among women than men. Second, pregnancy is a vulnerable time for the development of the embryo and fetus because of their immature metabolism…” - International Journal of Environmental Research and Public Health

This really highlights two ends of the spectrum in perspective, and the wide gap in view point is mainly because there just won’t be enough data to draw significant conclusions from and the reality is that no one is willing to test on pregnant women to be certain.

Why do we know so little about drugs and pregnancy?

There's a stat floating around that > 98% of medications have no or insufficient safety and/or pharmacokinetic data to guide dosing during pregnancy and lactation. Reasons for this being mainly because of the safety of testing on actual pregnant women but also the lack of financial incentive, absent of mandate, and ethical challenges. 

Additionally, the drug pathways complicate this research as well. Systemic absorption (through blood) is only one piece. They also want to look at how these compounds diffuse through the placenta and ultimately effect (or don't effect) the development of the baby.

For skincare, we also need to add one additional factor which is topical application. When these products are applied on skin, the pathway of absorption is different and concentrations are not on the same scale as oral drugs.

How drugs were classified for pregnancy and what that means for skincare ingredients

A few years back, the FDA was using 5 drug classes (A, B, C, D, and X) for pregnancy. Although the FDA has since moved away from this classification system, this is probably the easiest way to think about how to segment skincare ingredients. It is important to remind ourselves that in terms of skincare, most of the data simply doesn’t exist. The one category of ingredients where we have more insights on is acne. Since acne topicals are regulated by the FDA, we have a lot more insights there.

*Why did they move away from this classification system? Because it didn’t give enough clarity on risks or include scenarios such as breast feeding…aka. pretty much the overarching theme of this blog post.

Nonetheless, this does give us some framework on how to breakdown ingredients for pregnancy. These are the classes:

FDA Pregnancy Categories

Category A: 404 Not Found!

To start, we have category A. This is where we can say with pretty solid conviction that the drugs is safe to use during pregnancy. To qualify for category A, the drug must pass a human clinical that showed no harm to the fetus and no risk to the fetus in the third trimester.

There are only 10 drugs that fall into category A with one of them being folic acid. Needless to say, there are no skincare ingredients that fall in this category. Strong start!

Category B: Animal Testing Results Don’t Make Us Too Worried

The next best thing is testing in animal model. This is where they look at a couple of generations of rodent breeding to understand if there’s any risk to the mother or fetus. Since animals are very different than humans, this only provides a tiny snapshot, but it’s a snapshot nonetheless.

The good news is that topical antibiotics (erythromycin and clindamycin) as well as azelaic acid are in this category! We recommend using azelaic acid both day and night to get the most efficacy out of your product.

Category C: Animal Testing Shows Some Risk or There is No Animal Data Found

This category is probably the wild wild west of the five drug classes and really needs some further explanation. Technically this category means that the drug has not shown to be harmful to the fetus, but there is still some reason for concern compared to Category B. What that definition doesn’t say is that it also includes drugs that don’t have any real data indicating it’s safe or not safe! That’s really open-ended and feels like that junk closet where you stash uncategorizable items. In fact, here are three examples to depict the spectrum of skincare ingredients that are included in this category:

  • Benzoyl Peroxide: Systemic absorption is minimal, and benzoyl peroxide is metabolized into benzoic acid in the skin. Doesn't sound super risky...
  • Hydroquinone: Although human studies have shown low risk and no adverse side effects, they found much higher systemic absorption of hydroquinone compared to other ingredients. Very open ended...
  • Tretinoin: This is the real can of worms because the concern around any retinoid use during pregnancy actually comes from oral isotretinoin (accutane), but topical tretinoin is a slightly different molecule and a much different pathway. A 2015 meta-analysis did look at first-trimester exposure to these medications and didn’t find a significant impact on birth defects. However, there isn’t enough data to say there’s no effect at all and unfortunately the end conclusion is that women who are exposed to these medications are 20 percent more likely to have a baby with a significant birth defect vs. those that aren’t exposed. That’s not insignificant! We should also note, many papers have cited this and adapalene as not recommended for pregnancy despite being a category C.

Like we said, it’s the wild wild west. It’s a pretty broad range of ingredients with a broad range of conclusions and toxicology profiles. In this category, you’ll find ingredients: hydroquinone, salicylic acid, benzoyl peroxide, tretinoin, adapalene and also oral zinc!

Category D: Possible Risk to the Fetus But May Be A Necessary Evil/Need for the Pregnant Mom

This group is really only entertained if there’s no other option available as this category has positive evidence of human fetal risk. There are a few oral antibiotics for acne found in this class: tetracycline, minocycline, and doxycycline.

Category X: All Data Points to Don’t!

In this category, there are animal or human studies that have proven fetal abnormalities. These ingredients include tazarotene and isotretinoin (accutane).

So What About the Highly Touted Pregnancy Safe Alternative…Bakuchiol?

Despite all the marketing around it, bakuchiol has never been tested nor has any data on being safe for pregnancy. We have no idea why this ingredient gets touted as pregnancy safe in comparison to the rest. It appears to us that the only metric bakuchiol has is “not retinol”. If anything, this shows how unregulated this term is in the skincare industry and ultimately the “pregnancy safe” guidelines can vary brand to brand.

What About Endocrine Disruptors (ED)

There is a very conservative camp of individuals and researchers looking at the overall sum of endocrine disruptors and their effects on pregnancy and fetus development. The reasoning behind their focus on pregnancy is that it happens to be a particularly vulnerable and influential time period where the pregnant mom’s hormones correlate quite closely with the development of the fetus. Because of this concern, there are some individuals that are paying closer attention to the summation of endocrine disruptors in their lives. It’s important to note that this isn’t just a focus on cosmetics. You’ll need to consider EDs in food packaging, water sources, clothing, etc. Calculating all the potential EDs sources can be an incredibly difficult task, just know that both the EU and the WHO have been looking into this for quite some time. We’ve included their reports in our references section for those wanting to learn more.

For the Curious: Victoria’s Personal Anecdote and Decision-Making For This Period of Time

At the end of the day, you are the master of your body and the mother of your soon-to-be child. It should be up to you and your medical provider to decide the best course of action during the next 40 weeks and no one else! Not even us!

For me, I’ve felt that skincare during this time period becomes such a small, insignificant part in my life because there are way too many things to think about during this time period - what to eat, how much weight to gain, how to exercise, how to sleep, what drugs to take, oh and don't stress! (why does everyone keep telling me this?) but also mainly HOW IS THE BABY DEVELOPING? There’s enough to think about, that I don’t feel the need to force myself to use (or don’t use) skincare which means my skincare routine is pretty simple. My morning routine is so fast now it’s essentially just wash - Aquafix - sunscreen - done!

Currently, the kid is making me break out like a teenager again, and I’ve resigned to letting that be my skin for the next 9 months. This means I basically don’t use anything from Category C and down (no benzoyl peroxide, no salicylic acid, no retinol or retinol derivatives). Instead, consider a 10% azelaic acid morning and night. Also, I still use chemical sunscreens and still stick to my ascorbic acid serum. 

Hopefully you find comfort in knowing that it's ok to skincare your way during this time period and if you somehow realize you've been using a product with retinol...it's nothing to really sweat about too too much. 

Takeaways

  • “Pregnancy Safe” Skincare is an unregulated claim because there is very little data and evidence on most skincare ingredients. No one wants to test skincare ingredients on pregnant women.
  • The FDA has previously categorized drugs for pregnancy into 5 classes. Class C has the biggest grey area of safety and contains ingredients such as hydroquinone, benzoyl peroxide, and tretinoin.
  • Bakuchiol has not been validated as a pregnancy-safe retinoid alternative.

References

  1. Marie, C.; Cabut, S.; Vendittelli, F.; Sauvant-Rochat, M.-P. Changes in Cosmetics Use during Pregnancy and Risk Perception by Women. Int. J. Environ. Res. Public Health 2016, 13, 383. https://doi.org/10.3390/ijerph13040383
  2. Chien AL, Qi J, Rainer B, Sachs DL, Helfrich YR. Treatment of Acne in Pregnancy. J Am Board Fam Med. 2016 Mar-Apr;29(2):254-62. doi: 10.3122/jabfm.2016.02.150165. PMID: 26957383.
  3. Putra IB, Jusuf NK, Dewi NK. Skin Changes and Safety Profile of Topical Products During Pregnancy. J Clin Aesthet Dermatol. 2022 Feb;15(2):49-57. PMID: 35309882; PMCID: PMC8884185.
  4. Sheffield JS, Siegel D, Mirochnick M, Heine RP, Nguyen C, Bergman KL, Savic RM, Long J, Dooley KE, Nesin M. Designing drug trials: considerations for pregnant women. Clin Infect Dis. 2014 Dec 15;59 Suppl 7(Suppl 7):S437-44. doi: 10.1093/cid/ciu709. PMID: 25425722; PMCID: PMC4303056.
  5. Oster, Emily. Expecting Better: Why the Conventional Pregnancy Wisdom Is Wrong--and What You Really Need to Know. Penguin Books, 2021.
  6. WHO: State of the Science of Endocrine Disrupting Chemicals 2012, ISBN: 978 92 4 150503 1
  7. European Parliament: Endocrine Disruptors - From Scientific Evidence to Human Health Protection (Petition) 

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