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FDA’s Mommy’s Bliss Nipple Cream Warning Disappears Without Explanation

May 25, 2008

On Friday, the FDA issued a warning about Mommy’s Bliss Nipple Cream (as Christine at OBOS noted), “because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.” The FDA warned consumers not to use the product (intended for nursing mothers), explaining:

Potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

At last check, more than 1,000 blog posts have appeared warning about the FDA’s advisory and cautioning mothers not to use the cream, and the story has been broadly spread through outlets such as CNN.

Strangely, though, the FDA’s warning has vanished from their website. Following the original link turns up a message with a Mommy’s Bliss headline and the explanation, “This document has been removed from the web site. Please update your bookmarks.” A cached version is available here. The original has also been removed from the FDA’s list of news items, although both this and the warning still turn up in a search of the FDA’s website.

What cannot be found in a search of the FDA site is information about the document’s removal. The Mommy’s Bliss people had responded by suspending sales of the product, but also noting that, “Apparently the FDA had conducted an assessment of the product in early October but only contacted the company about two weeks ago. This is extremely troubling since it has taken the FDA over 6 months to inform us of the results of this assessment.” They, and the FDA, also point out that no consumer complaints had been received about the product.

At present, consumers are left wondering whether the FDA erred in issuing the warning, if the product is or is not safe to continue using, and whether Mommy’s Bliss’s statement about the FDA’s process created pressure to remove the warning (whether or not it was correct). The FDA has not issued an updated or corrected statement, but simply removed the original document. Because a corrective statement has not been issued, it is impossible for the average consumer to know whether there are legitimate concerns about the product.

Update: The warning and link to the warning from the news page have now reappeared, although no explanation as to the previous disappearance has been added. In this case, I think it would be appropriate for the agency to point out whether the previous removal was a simple technical or web administrator error, given the wide attention this type of warning was sure to get and uncertainty about the product – the FDA’s own warning states, “the FDA has not received any reports of injury to infants.”

5 Comments leave one →
  1. Labor Nurse permalink
    May 25, 2008 8:25 pm

    You what’s interesting? I am currently at the ACNM meeting in Boston and this company had an exhibitors booth. They were a busy booth, but I never bothered to stop and ask them about this FDA warning; it was salespeople that were manning the booth so I would only get a line of crap about it. Interesting that the warning has disappeared.

  2. May 25, 2008 8:35 pm

    Labor Nurse, I know they sell other products too, but if you get a chance to see what they’re saying about it, that would be very interesting.

  3. Noel permalink
    May 26, 2008 9:57 am

    So did the FDA originally approve this. It would speak volumes of how corrupt the FDA is

  4. May 26, 2008 11:21 am

    Noel, as far as I can tell, this would have fallen into the cosmetics category and so not required FDA approval before being sold.

  5. Geraldine permalink
    February 2, 2010 5:36 am

    This is ridiculous – both phenoxyethanol and chlorphrenesin are preservatives used in tiny amounts in many cosmetics and are approved in the EU which has, in general, much stricter standards than the US.

    ANY nipple cream – indeed any cream at all, that contains water (aqua) in the listed ingredients MUST have a preservative to prevent contamination by bacteria – potentially MUCH more dangerous to baby than any preservative.

    If you want to avoid this, it is best to use a balm (waterless salve) or possibly straight shea butter (unless you have a latex allergy). And obviously wash off any of these products before feeding!

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