- The Washington Times - Friday, May 25, 2018

ANALYSIS/OPINION:

The Food and Drug Administration issued parents some stern warnings about teething medicines for their babies, and simultaneously told manufacturers and retailers that if they didn’t “voluntarily” stop selling the product to the tiny toddler demographic, they would face legal action from the feds.

Voluntary compliance — gotta love the federal definition of that, yes?

But the bigger question with this FDA message to consumers is this: Why now?

And the bigger theme, of course, would be this: Shouldn’t parents, rather than government, be the final deciders of what’s best for their babies?

After all, the FDA has been warning about the use of creams containing benzocaine for those under the age of 2 for years now, saying consumers have complained about deadly, albeit rare, side effects that lead to illness and even death. Key to note: Rare. The kind of rare that strikes at aspirin or Icy Hot users, maybe.



But now, the warnings against Orajel-type products go hand-in-hand with the notification of legal action to come.

“We urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain,” said FDA Commissioner Scott Gottlieb, in a statement.

And those who don’t?

“The FDA said it will take legal action,” Fox News reported, “against … companies that don’t voluntarily comply as soon as possible.”

Church and Dwight Co. Inc. has already pulled its four Orajel teething products targeting the baby market and will no longer make Baby Orajel and Orajel Medicated Teething Swabs. Other companies will soon follow.

But it’s the fine print that tells why the FDA is taking action now, versus back in 2006, 2011 and 2014, when it issued similar warnings about benzocaine-laced products in babies.

Public Citizen, a nonprofit consumer agency, petitioned the FDA more than four years ago to halt the sales of benzocaine teething medicines for babies, and when ignored, went forth with a lawsuit. The FDA was going to have to respond to the petition, by law, within the coming days.

This would’ve put the FDA is an awkward and uncomfortable position of declaring a side — of declaring, in essence and once and for all, whether the product was safe or deadly for babies. Issuing warnings is one thing; taking a strong stand in a court of law is quite another, one that would have pointed the fingers of blame back at the FDA if the parents of a baby suffering adverse effects from Orajel were to seek redress via the legal route.

The FDA already has a long-running reputation as being politicized.

“Court Documents Reveal FDA Politicized Plan B Approval,” ran one Women’s Media Center headline back in 2006, about the morning-after pill.

Another, from 1997, from the Citizens Against Government Waste: “Taxpayer Watchdog Group Blasts FDA For Playing Politics With Premarin.”

Another, from NPR in 2005: “FDA Woes May Lead to Credibility Problems.”

Another, from The Washington Post in 2006: “Senators Prod FDA on Politicization of Agency.”

Yet another, from 2009 from The New York Times: ” Science and Lobbying at the F.D.A.

Yet now, suddenly, the FDA is to be believed and trusted?

Methinks the agency’s new warning to teething medicine manufacturers and sellers is little more than a CYB move — cover your butt, avoid any potential for lawsuit and negative press. And sadly, it’s parents who’ve lost most. It’s parents who’ve been stripped of their rights to decide what’s best for their own children.

• Cheryl Chumley can be reached at [email protected] or on Twitter, @ckchumley.

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