PURPOSE

To provide policy on the handling of problems, real or potential, associated with products for infants and toddlers.

BACKGROUND

Two of the most vulnerable groups of consumers we are charged with protecting are infants and toddlers. They are particularly vulnerable because they depend on adults for their sustenance and care. They cannot communicate how they feel or how they are being affected by a particular product or treatment. As a consequence, we must be extremely vigilant concerning reports of problems or potential problems associated with products used by infants and toddlers.

Our experience over the past several years has emphasized that responsibility in this area must be exercised with the above in mind. Therefore, the following policy is provided.

POLICY

All investigations and sample analysis involving products for infants and toddlers are to be considered top priority. Immediate follow-up is imperative in situations involving life-sustaining products such as infant formulas, monitors or incubators for premature infants, and critical drugs targeted for this group. Please see IOM 901.2 for follow-up instructions of infant and toddler foods.

Transmission of essential information should be relayed by the fastest means available.

All information associated with these investigations and sample analyses should be via electronic transmission (EMS, facsimile, telephone) or overnight mail delivery. Accurate summaries of information transmitted by telephone should be maintained in memo form through existing policy and procedures.

Samples are to be delivered by air freight/air express or over-night package delivery.

DEEO should be notified immediately of any reported defects involving infant or toddlers products. DEEO will establish the frequency and means of subsequent reports of progress.

The same top priority considerations are to be applied to all outstanding guidance material (IOMO; RPM; FMD and C/P) when the product is for infants or toddlers.

If traditional investigation authorities provided by the FD and C Act and other acts administered by FDA prove inadequate to conduct the investigation, use of such approaches as administrative warrant, criminal search and seizure, investigative grand jury, etc. should be considered and recommendations for such actions expedited.