Thursday, November 10, 2016

Is There a Silver Lining in a Dark Cloud?

From a public health perspective, there are many reasons to be concerned about the outcome of Tuesday’s election. However, there is one reason to potentially be encouraged. With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.

The Rest of the Story

Although the issue was not directly addressed during the campaign, I would expect President-elect Trump to be supportive of vaping products and especially of the thousands of small businesses that are likely going to be forced out of business under the FDA’s current nicotine regulatory policy. In addition, we know that there are several Republican senators (whose party will now control the Senate) who are sympathetic to the public health damage being done by current policy. Moreover, several senators have specifically considered holding hearings on the issue and are amenable to the introduction of legislation to chart a different course than the FDA is currently taking.

I believe that this is actually a historic opportunity, due to a strange but true alignment of the stars. We must take advantage of this opportunity to undo the damage that the FDA’s vaping products policy has done and is slated to do moving forward.

However, it is important that we not settle for a quick-fix. We can do better than that. I don’t think we need to settle for a Cole-Bishop type amendment that merely changes the grandfather date for vaping products. Instead, I think there is an opportunity to put on the table a proposal for a new, comprehensive regulatory strategy for vaping products that treats these products completely differently from tobacco cigarettes and tobacco products. I believe that we need to create a separate and distinct regulatory framework specifically for vaping products, one that is not based on the Family Smoking Prevention and Tobacco Control Act.

Such a policy must take into consideration the relative risk profile of e-cigarettes compared to real cigarettes and must regulate these products accordingly. While Mitch Zeller has publicly stated the need to do this, the agency’s actual deeming regulations do just the opposite: they throw e-cigarettes into the exact same box as cigarettes and in fact give preference to tobacco-full, rather than tobacco-free cigarettes.

I don’t even think that the FDA is necessarily the appropriate agency to regulate vaping products. Perhaps it would be more appropriate to give regulatory jurisdiction to the Consumer Products Safety Council or a similar agency with experience regulating the safety of consumer products, rather than an agency whose sole experience is with regulating drugs and devices, where the regulatory standard is “safety” and “effectiveness.” Vaping products are not designed to be either safe or effective. They are designed as an alternative to deadly cigarettes. And they need to be regulated as such.

The basis of a regulatory policy for vaping products should be the promulgation of a set of safety standards that will maximize the benefits of these products, while minimizing their potential harm. Regulation of battery safety, heating temperature (and therefore, levels of adverse chemicals such as formaldehyde), flavoring ingredients, quality control, and marketing should be a priority. The pre-market approval process should be completely abandoned. The modified risk provisions should not be applied to vaping products. And finally, the statute should clearly state that smoking cessation claims will not be considered to be drug claims and that therefore, vaping products will not be regulated as drugs unless they specifically make claims about treatment of nicotine dependence or withdrawal. Claims related to smoking cessation should be explicitly allowed, subject of course to accuracy and validity of the claims.

The Senate has been understandably hesitant to tackle this issue during the election season. However, with a new administration the time will be ripe to take this issue on.

One might argue that it is unlikely that an administration would completely repeal an agency regulation that is already in force. However, President-elect Trump does not seem timid about threatening to completely repeal other health statutes and regulations so I don’t see any reason why he would be reluctant to do that with the FDA’s ill-advised e-cigarette regulations.

1 comment:

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