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The FDA’s main policy plans for 2018

Last week, the FDA Commissioner Scott Gottlieb, wrote on the FDA’s website to list the major policy goals that the organization has in store for the coming year.

Diane Caruana

December 18, 2017

The Commissioner started by pointing out that besides regulating products to ensure safety, the agency’s responsibility includes “efficiently advancing innovations and therapies that improve patient care, enhance choice and provide competition; by aggressively taking action against serious threats to public health, such as opioid addiction and addiction to the nicotine in cigarettes.”

Tackling the Nicotine Addiction Crisis

The Commissioner went on to list a number of issues that the FDA aims to address and at the top of the list was, “the nicotine addiction crisis”. Last July, the agency announced a new comprehensive plan for tobacco and nicotine regulation, which included lowering the amount of nicotine in cigarettes in order to minimize addiction.

VLNCs (very low nicotine cigarettes), will contain nicotine at levels that do not produce physiological effects. However, opinions on their effectivity remain mixed as several public health experts have expressed concerns that these cigarettes will be delivering the same amount of harmful chemicals without the benefits perceived by the smoker, hence could possibly lead them to smoke more.

“We also serve the public health by efficiently advancing innovations and therapies that improve patient care, enhance choice and provide competition; by aggressively taking action against serious threats to public health, such as opioid addiction and addiction to the nicotine in cigarettes.”Scott Gottlieb M.D., FDA Commissioner

The Commissioner also mentioned once again the fact that the agency aims to “facilitate innovation in products that can deliver satisfying levels of nicotine to adults”, so that smokers are able to switch to safer alternatives that could potentially save their life.

Advanced Notice of Proposed Rule-making

Gottlieb said that the FDA’s efforts to minimize nicotine addiction “will include an Advance Notice of Proposed Rulemaking asking critical questions related to our pursuit of regulation that would result in a targeted reduction of the nicotine levels in combustible cigarettes to eliminate or dramatically reduce their addictive value.”

“FDA is taking new steps to facilitate innovation in products that can deliver satisfying levels of nicotine to adults who want or need such access without the same health risks associated with combustible tobacco.”Scott Gottlieb M.D., FDA Commissioner

The Advanced Notice of Proposed Rulemaking will also be looking at e-liquid flavours, how to best regulate them in order to limit their appeal to adolescents, whilst considering the role that they are having in helping adult smokers take the leap from smoking to vaping.

Read Further: FDA