FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry

ConclusionsI just can't go on any longer. And we haven't even come to the safety testing requirements. All we've done up to this point is found out what's in the aerosol of each product under various conditions. Now, we have to study the toxicity of each component of the aerosol. For each, we have to now conduct toxicology studies and possibly clinical studies as well. We also have to consider using "computational modeling using surrogate chemical structures" if we aren't able to complete toxicological testing of each constituent.And we still haven't come to the required assessment of the acute and chronic health effects, user typography, consumer perception of product risk, packaging, and labeling, consumer comprehension of product labeling and instructions, and a study of unintended uses of the product, including abuse liability. Plus, for each constituent in the aerosol, we need to provide data on health effects, including "changes in physiological measurements, such as heart rate and blood pressure, changes in lung, cardiac, and metabolic function; adverse experiences, such as throat irritation and cough; and changes in laboratory values, such as mediators of inflammation and complete blood count indices."The rest of the story is that these regulations are absolutely insane. The FDA has no idea what it is doing. And what it is doing is completely losing its perspective. The agency is prepared to divert nearly all of its resources to implement and process the PMTA applicat...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs