Hi Anon.
I have not seen any specific decision from FDA regarding the use of salicylic acid during pregnancy for topical products. Remember, all cosmetics must, by definition, be topically applied. So the real question starts with safety of the ingredient in the formulation. For example, if the salicylic acid is potentially absorbed through the skin (say because of the presence of so-called "penetration enhancers") then you need to understand how much is absorbed, how quickly this occurs, what the potential sytemic exposure levels might look like and then what those exposure levels might cause to the fetus. If it is not absorbed through the skin, then the situation is somewhat simpler because you now know that the fetus is unlikely to be exposed. But that final determination should be reached based on facts and data and should be documented by a person who is authorized by the company and qualified by experience, education and/or training to make such a determination.
Remember - the law requires that you as the company selling the product to ensure that your product is safe for its intended use and any reasonably foreseeable misuse. So if the product is either specifically labeled for use during pregnancy or if the product is not labeled as contraindicated for use during pregnancy then you need to ensure that the product is in fact safe for use during pregnancy.
And just a quick reminder here - FDA traditionally has considered pregnancy and lactation to be part of the same cohort so be careful to ensure that there is an assessment of the use by women who might be breastfeeding while using your product. I remember a major issue years ago with a breast cream that actually got pretty bad because the product contained honey and caused serious adverse reactions not for the women using the product but for the babies who were breastfeeding.
Hope this helps think through the process.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 07-Dec-2020 17:32
From: Anonymous Member
Subject: FDA Position on Salicylic Acid and Pregnancy
This message was posted by a user wishing to remain anonymous
Hi,
Is anyone familiar with the FDA's position when it comes to claiming that a cosmetic product containing Salicylic acid is safe for pregnant and nursing women? I can't seem to find any guidance specific to this claim and wanted to see if anyone may have more information.