Hi Anon.
I would generally be
very careful with such a claim. First, cosmetics are among the most litigated areas of the US FDA product classes and typically these suits result in far more likely class actions in my experience.
Second, such a claim is essentially an "absolute" claim in that you are not going to be able to say something like "Safe from Pregnant or Nursing Moms under the following conditions" because I fully suspect that the marketing team will have heart attacks as soon as you get the word "under" out of your mouth or they read it in your email!
Third, such a claim needs to consider so many different toxicological endpoints that it would be unrealistic (and potentially impossible - think EU Cosmetics Regulation!) to do the testing between the costs, the test design and then whether you can ethically do the test in people or if you need to start in animal models (note my initial point about the EU!).
Fourth, no matter what you do, there is almost always going to be a person out there that has some sort of reaction that will turn that reaction into utter insanity for you, your colleagues and your company.
Overall, I would avoid it entirely. If you are still looking to make the claim I would engage outside counsel and toxicologists to ensure that you do your due diligence and whatever you can to avoid the inherent issues that almost certainly will come up in your way in the future.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 11-Feb-2020 09:17
From: Anonymous Member
Subject: Cosmetic Claims For Pregnant
This message was posted by a user wishing to remain anonymous
Hi,
We currently have a product that on the market that we're interested in claiming is safe for pregnant or nursing people. What criteria must we meet to be able to do so?