FDA notice on Mommy’s Bliss Nipple Cream

Don’t know how many of you use this, but if you do, or know someone who does, please let them know:

From an FDA e-mail notice (boldface mine):

FDA informed consumers NOT to use or purchase Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of a decrease in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant’s strength of grip and a change in skin color.

From the FDA’s May 23 news release:

Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.

Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.

Consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency’s voluntary reporting program, by e-mail at http://www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

This is the company’s response:

On the evening of May 23, the FDA issued a warning that consumers stop using the Nipple Cream.

The FDA had initiated discussions with us regarding the Nipple Cream on May 1st, 2008. Apparently the FDA had conducted an assessment of the product in early October but only now contacted the company. The FDA took over 6 months to inform us of this assessment which suggests that the FDA did not consider the product to pose a serious health hazard.

The product has been on the market for over a year and there have been no consumer complaints. On the contrary, the feedback on the product has been very positive.

The FDA is concerned primarily about infant ingestion of Chlorphenesin and Phenoxyethanol, two ingredients in this product which are used extensively as preservatives in many other cosmetic products. There is the potential of exposure of these two preservatives to nursing infants when using the Nipple Cream, but we have no evidence that this potential exposure at such a minute level is harmful.

However, even though we believe the product to be safe, we have stopped selling the product. We have notified all retail stores and distributors who have carried this product about the FDA warning and have asked them to remove the product from the shelf and return all unsold units to us. All individual consumers who purchased the Nipple Cream directly from us are being contacted and offered a full refund.

If you have the Mommy’s Bliss Nipple Cream and would like to return it for a full refund, please call us toll free at 877-457-4955.

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