[kelly]

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream

[dalbrough]

Wow - that is so scary - although I am way past breast feeding I sure hope all the Moms here see this post.

Deb

[GardenOfDarwin]

Geez, Louise! You'd think there'd be some research done first....frightening!

Susan

[kisaacs]

Wow, scary. Though my angel is bottle fed, thanks for posting. I hope all the babies are okay! That would be terrible to be using something to try to make yourself feel better so you can feed your little one, just to make them sick. Ugh!

Kristen

[Emmie9999]

Oh my goodness, how scary!!! According to the article, the stuff not only can harm infants, but it can worsen the condition it is supposed to help.

So it doesn't work, and in fact has the potential to make things worse for the mother, and to top it all off could potentially harm the child. How the heck did it ever get to market?

[DesignDiva]

Because unless it is a drug, the FDA doesn't "approve" anything that anyone manufactures. They leave it to the consumer and the company to comply with regulations and self-report, and if they get complaints, then they investigate. As long as there is the disclaimer "not FDA approved" even things like herbal concoctions can get out to the market.

Of course, should you put something out there that harms someone and get sued, penalties up to and including criminal negligence can be sought. The prevailing wisdom is that the threat of a lawsuit should be enough to keep manufacturers responsible.

We all know that works soooooooo well, right?

edited to add: Seems they misbranded the product...their website say that they used GRAS (generally recognized as safe) ingredients and listed only

• Shea Butter
• Borage Oil
• Evening Primrose Seed Oil
• Calendula Extract

No Parabens, No Propylene-Glycol, No Sodium Lauryl Sulfate
Fragrance Free



I used to make creams and lotions so I know a bit about the FDA requirements. Phenoxyethanol (ethylene glycol) is a fairly common preservative and should not be of a sufficient quantity to cause any sort of response...of course, a miscalculation could cause a big problem since it is generally added at .1%. Chlorphenesin is also used as a preservative, not in this country so much but there are several (mostly UK-based) companies that do use it. But the really big problem is that neither of these ingredients is listed. The FDA frowns upon that sort of thing. So it is quite likely that if the cream was made following proper percentages neither of these ingredients are in a sufficient quantity to cause any harm at all.



Strangely enough, these two preservatives are generally used in "natural" products that people want to purchase to avoid the mass-market type ingredients and preservatives they think may be harmful. I bet they used Microkill COS.

[kelly]

Wow, Eva, once again, I am impressed by the depth and bredth of your knowledge base!! Thanks for that!

Emmie, I had the same thought- how futile! What a fiasco.

Well, in addition to posting here, I was also busily emailing every online retailer I could find who advertised it for sale. Only one responded, and I'd like to post this wonderful response, and ask that anyone in the market for stuff sold by DownTheLane.com to consider a purchase from them for being so wonderful...
_____________________________________
Hi Kelly,

Thank you for bringing this to our attention. We have unfortunately not been informed so far by the manufacturer or the FDA about this problem, but the warning was only issued yesterday.

We have immediately removed the product from sale, and I have ensured that there are no outstanding orders for this product.

We would never knowingly sell anything that was not regarded as safe by the FDA or the medical community in general.

I can assure you that we care very much about our customers and their babies, and we will be contacting all of our customers who purchased the product asking them to stop using it and we will refund them.

Thanks again for bringing this to our attention.

Kind regards,

Steve Barnes
Earth's Magic Inc. - DownTheLane.com
_______________________________________

How awesome is that? Check out DownTheLane.com!!!!!!!!

[jgsearls]

This is quite possibly THE last subject of a post that I ever thought I'd see on IkeaFans!

[GardenOfDarwin]

I know...I thought it was spam until I saw it was posted by kelly!


Susan

[kelly]

I know, I know, that's why the crazy midnight emailer always posts the link to the FDA site!