POV: New FDA Regulations on Vaping Products a Failure
From: BU Today | Opinion (Boston University)
They do not protect public’s health, do impose a public safety hazard
Michael Siegel, a School of Public Health professor of community health sciences, can be reached at mbsiegel@bu.edu.
On May 5, the US Food and Drug Administration (FDA) released its long-awaited regulations on electronic cigarettes and vaping products. These rules, which require every one of the more than 10,000 vaping products on the market to submit a pre–market approval application simply to stay on the market, were widely applauded by antismoking and health groups. What may not have been apparent at the time, but what I have discovered through a detailed analysis of the 499-page regulations, is that these regulations not only fail to protect the public’s health, but they impose a public safety hazard.
One key hallmark of the FDA regulations is that as of August 8, 2016, no new vaping products will be allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially freeze the vaping market as it exists on August 8. From that date forward, not only will companies not be able to introduce new products, but they will also be unable to make changes in their existing products. Such changes would require a new product application, which is prohibitively expensive for most companies. Moreover, these regulations will discourage companies from undertaking any revisions to their products.
