May 27, 2008

FDA’s Mommy’s Bliss Nipple Cream Warning Disappears (and Reappears) Without Explanation

On Friday, the FDA issued a warning about Mommy’s Bliss Nipple Cream (as Christine 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 vanished from their website. Following the original link for much of the day on Sunday turned 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.” The original had also been removed from the FDA’s list of news items, although both this and the warning still turned up in a search of the FDA’s website (leading to blank pages).

What could not 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.

Thus, for the entire time the warning was missing, consumers were 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 had not issued an updated or corrected statement, but simply removed the original document. Because a corrective statement has not been issued, it was impossible for the average consumer to know whether there are legitimate concerns about the product.

The warning and link to the warning from the news page reappeared later on Sunday, 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.”


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