​By Scott Douglas Jacobsen

According to the CSP Magazine’s Angel Abcede, the FDA is considering new enforcement policy, which would include harm reduction policy. One aspect of the policy is geared around nicotine addiction as one core strategy. The research will focus on electronic cigarettes as an alternative to combustible cigarettes

Many have been curious as to the new US FDA position and strategy with President Trump’s new administration. Gottlieb’s document provided some insight.

The new Commissioner of the FDA, Dr. Scott Gottlieb, issued a document on nicotine addiction and breaking it:

“Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products. To be successful, all of these steps must be done in concert and not in isolation.”

He argued for more research and public discussion with combustible and electronic cigarettes (as an alternative to combustible cigarettes, for example). The other option to combustible cigarettes was to argue for an engineering of the low-nicotine options of cigarettes, not simply e-cigarettes. This is to reduce the probability of youths becoming involved in addictions to cigarettes.

In response to this need, the FDA has, in the past, extended deadlines for new-product applications – for several years, apparently. There is a pronounced crisis in addiction that threatens American families.

As noted by Gottlieb, “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less-harmful sources, needs to be the cornerstone of our efforts.

This is of concern to the FDA generally. The focus on nicotine levels was found to be among the most unexpected announcements. In accordance with this, there will be the issuance of an Advance Notice of Proposed Rulemaking (ANPRM) for input on pluses and minuses for the introductive of lower-level cigarettes.

There will be public-commentary on lower-nicotine cigarettes as well as public-commentary on the dangers around various alternatives such as e-cigarette batteries, e-liquids for youths, and the potential for traditional cigarettes to be more harmful than easy e-cigarettes.

“A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes,” Gottlieb said.

Groups with traditional anti-tobacco stances, such as Campaign for Tobacco-free Kids in Washington, D.C., agreed with as well as having healthy scepticism against comments made by Gottlieb. These conversations incorporate harm reduction philosophy in a high-level organization with potential for positive impacts on the lives of North Americans.

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