Borchardt Consulting

It’s About Time

Posted on: October 18, 2011

Some months ago, I was contacted by the Food and Drug Administration (FDA) to discuss infant products.  They had heard through their partnership with the Consumer Product Safety Commission (CPSC)  that I had been advocating for professionals to contact baby product companies when they made claims that a product would protect a baby from SIDS.   Shortly thereafter, they issued a joint press release with the CPSC that they were going to start cracking down on false claims.  I believe that has been going on in the background.  Finally, the FDA issued a warning to consumers. Claiming to prevent SIDS is a medical claim.

FDA Product Enforcement

FDA Goes after Unproven Claims

The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.

Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include:

  • baby monitors,
  • mattresses,
  • crib tents,
  • pillows,
  • crib bedding, including bumpers and blankets, and
  • infant positioners.
Recently, the FDA has improved on our idea.  They have developed a way for consumers and professionals to report a product.  See their instructions listed below.

How to Report a Complaint or Problem

Report a Complaint

If you have questions or complaints about a baby product with medical claims, you can call FDA at 1-888-INFO-FDA (1-888-463-6332) or your local FDA district office. They will be able to tell you if the FDA has cleared or approved the medical device in question.

Report a Problem

If you experience an injury or malfunction when using a baby device, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Please include the following information in your reports:

  • Manufacturer’s Name
  • Device Name (Brand Name)
  • Date Device was Manufactured
  • Distributor’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if required)

I am thrilled at this new move!  Thank you FDA!

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