Pressure still mounting on FDA over child safety requirements

Written by || 24 July, 2014 || Regulatory news analysis |

U.S. Capitol 300x180An influential member of the U.S. Congress has urged the Food and Drug Administration (FDA) to mandate child-proofing for e-liquid containers, as the wrangling over whether e-cigarettes pose a threat to young people rumbles on.

Rosa DeLauro, a Connecticut Democrat in the House of Representatives known for her liberal views, interest in health policy and criticism of the FDA, has written to the agency’s commissioner Margaret Hamburg raising the issue of nicotine poisoning from e-liquid.

The letter from DeLauro, who sits on a number of relevant committees including the appropriations subcommittee that covers the FDA, follows an earlier communication from her to Hamburg which highlighted widely-held concerns over flavours and advertising appealing to children.

In the latest communication, DeLauro said nicotine poisoning is “on the rise” and argued: “Parents demand common sense rules from FDA which ensure that any container for nicotine liquids is only available on the market in a child-proof design. I ask that you move immediately to address this issue, and require that all nicotine refill cartridges for electronic delivery devices be child proof.”

Similar pleas were addressed to the FDA last month by the American Medical Association and ten public health organisations. The federal agency is currently in the comments phase of its proposed regulations for e-cigarettes.

Meanwhile, the American Journal of Preventive Medicine has published an FDA-funded special supplement focusing on the 2012 National Youth Tobacco Survey, which included the much-cited data that half of middle and school high school students were aware of e-cigarettes, 6.8 percent had used them, and 2.1 percent had used them in the previous 30 days.

What This Means: The protection-of-minors case in the U.S. is hardly even being argued on the merits any longer; by many it is taken as a given on relatively little evidence that e-liquid poisoning is a significant threat, that children are attracted by flippant flavourings, and that advertising is aimed at kids (even though the basis for alarmism over advertising is particularly thin).

The 2012 data is one of the pillars of those arguments, apparently carrying much weight within the FDA, too. And few in positions of power will speak out against them, given the political unacceptability of seeming reckless over children’s safety.

This means the pressure on the FDA to act continues to build. It will not be a surprise to see restrictions on child-proofing and flavours, at least, in the final version of the agency’s deeming regulations.

– Barnaby Page ECigIntelligence staff

Photo: Eric Weaver