Unlike other baby products, including bassinets and cribs, the cardboard boxes aren’t regulated by the Consumer Product Safety Commission and haven’t been tested to meet the mandatory safety standards required of all other infant sleep products on the market. ASTM International, which develops manufacturing and safety standards for a variety of products, has formed a task force to propose safety rules for baby boxes. The standards ultimately could be adopted by the federal safety commission, but the process is likely to take at least a year to complete.
“If you look at nursery products in general, they’re highly regulated,” said Ann Marie Buerkle, acting chairwoman of the safety commission. “So there is an abundance of caution until we can make a determination.”
Ms. Buerkle said there are a number of unknowns about the boxes. “What is the box made of? How durable is it? If you use it through three different children does it deteriorate?” she said. “But those are things they’ll determine in the standards committee.”
The Baby Box Company, which is making the majority of the boxes that are distributed in the United States, said it has voluntarily tested its product for safety with independent laboratories and claims the boxes meet safety standards similar to those for bassinets.
Jennifer Clary, chief executive and co-founder of the Baby Box Company, said parents participating in one of the free programs must complete an online education course on safe sleep, baby care and nutrition, among other topics. But parents can also purchase the boxes directly online without the education requirement for $69.99 or up to $225 for a box filled with baby products.
But Dr. Moon said safety standards need to be decided by unbiased experts, not the companies that make a product. She said she has many unanswered questions about the boxes herself, including: What are the age and weight limits for baby boxes made in the United States? Is it safe to pick up the box with the baby in it? What is the airflow quality inside the box? Is it safe to place the box with baby inside on the floor or on another surface?
The enthusiasm for the boxes is largely because they are popular in Finland, where the infant mortality rate — 1.7 deaths per 1,000 live births — is less than one-third that of the United States. In Finland, the baby box is free to all new mothers if they obtain prenatal care by the fourth month of pregnancy.
But the box is just one aspect of the health care provided to new mothers in that country. Anita Haataja, a senior researcher at Kela, which oversees the development and delivery of the maternity packages in Finland, said there is no research proving that the boxes themselves help prevent infant deaths.
Most parents in Finland don’t even use the boxes as a baby bed. A recent survey found that just 37 percent of families there used the baby boxes as a sleeping place, Dr. Haataja said. “The box as a sleeping box is a marginal issue; the baby’s health is associated with the maternal health care system,” she said. “Our low infant mortality rate is due to free of charge high quality maternal and child health care services and child care guidance.”
Dr. James Greenberg, director of neonatology and co-director of the Perinatal Institute at Cincinnati Children’s Hospital Medical Center, said low rates of preterm birth in Finland are the primary reason infant mortality is low compared to the United States. “The idea that the baby box can reduce infant mortality doesn’t really make a lot of sense,” said Dr. Greenberg. “It’s not plausible that the box is going to address the biggest driver of infant mortality in the U.S., which is preterm birth.”
On Monday, Temple University released data showing that box programs may influence the sleep practices of new parents. When new mothers in the Temple program received a baby box and face-to-face sleep education from a nurse before leaving the hospital, their reported rate of bed-sharing with their infant within the first eight days of life was 25 percent lower than the reported bed-sharing rate of mothers given nursing instructions and no baby box. Bed-sharing is a risk factor for suffocation and other sleep-related deaths. The A.A.P. recommends that infants sleep alone, on their backs, without any loose, soft bedding.
Dr. Megan Heere, medical director of the Well Baby Nursery at Temple University Hospital and lead author of the study, said she was optimistic about the baby boxes and their potential role in promoting safe sleep. “At this point we have no reason to believe they’re dangerous,” Dr. Heere said. “We’re of the thought process that it can only help.”
But the size of the box giveaways in the United States already dwarfs the 35,000 boxes given away annually in Finland, so some experts say we can’t assume the program will have the same outcome across hundreds of thousands of American infants. Dr. Moon of the A.A.P. noted that far more study is needed before parents can be certain the boxes are safe. “If it were my child, I would get something that meets C.P.S.C. standards,” she said.
An earlier version of this article included an outdated name for a product standards organization. It is ASTM International, not the American Society for Testing and Materials.