Monday, August 15, 2016

FDA Bans Safety Improvements in E-Cigarettes and American Lung Association Supports this Unprecedented Regulatory Blunder

Last Monday, the U.S. Food and Drug Administration (FDA) committed one of the most bone-headed blunders I have ever witnessed in public health. The agency's Center for Tobacco Products (CTP) banned all safety improvements for electronic cigarettes and vaping products.

This means that e-cigarette and e-liquid manufacturers can make no further improvements in the safety of their products, even if they become aware of severe and potentially life-threatening product defects.

NOTE: This is not a parody, and you are not reading The Onion. This is the actual regulation that the FDA put into effect on August 8th.

In order to make a safety improvement, an e-cigarette manufacturer would have to complete a burdensome and extensive pre-market tobacco application (PMTA), a process that is expected to take two years and to cost at least $5 million. This is obviously not an expense that more than 4 or 5 of the companies could afford. And even if they could afford the capital expense, it would still be another 2 years that their known defective product is required to stay on the market.

For example, let's say that a company tests its e-liquid using a more sensitive mass spectrometer and finds that it contains diacetyl, a chemical that has been linked to "popcorn lung," a severe and possibly fatal lung disease. The FDA regulations prohibit the manufacturer from removing the diacetyl from the e-liquid. If the company changes the ingredients of the e-liquid, it would be considered a "new" tobacco product and would therefore require a PMTA. The FDA regulations essentially require the company to continue selling its product with this toxic chemical, rather than to remove it.

Similarly, suppose that a company finds that by switching to a dual coil system, it can lower the unit's heating level and eliminate the formation of formaldehyde, a known carcinogen. The FDA regulations prohibit the manufacturer from making this change. In essence, the FDA is forcing the company to continue selling its product with the carcinogen, rather than to take this simple design measure to eliminate the carcinogen.

You may be wondering: How can this possibly pass Constitutional muster? How can the FDA possibly justify a regulation that - on its face - harms the public health by preventing safety improvements in a consumer product?

The answer is that it cannot justify the regulation. There are only costs - and no benefits - of the prohibition on safety improvements. The FDA has clearly violated the Administrative Procedure Act  by failing to provide a cost-benefit analysis, and the regulation is arbitrary and capricious and serves no legitimate government purpose. But the legal challenges to this regulation will take months (if not years), and in the meantime, the regulation's prohibition on safety improvements remains in effect (unless a judge issues an injunction that prevents enforcement of the regulation while it the issue is being litigated). 

The Rest of the Story

To me, the most surprising aspect of this story is not so much that the FDA blundered by enacting a regulation that immediately and irreparably harms the public's health. The most surprising part of the story is that this move was supported by virtually every national, anti-tobacco organization, including the American Lung Association, which actually praised the ban on safety improvements in e-cigarettes.

How could a ban on safety improvements possibly be a good thing for public health?

The only thing that the American Lung Association is protecting is smoking and continued tobacco use. They lobbied for a policy that actually inhibits the transition away from tobacco products and helps to preserve cigarette sales and cigarette company profits.

Jacob Sullum succinctly summarized the problem in a column last week at  

"The Food and Drug Administration’s e-cigarette regulations, which took effect this week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use. The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety. All of this is unambiguously bad for consumers and bad for public health." 

The rest of the story is that e-cigarettes pose such a threat to the paradigm of tobacco control advocacy that national organizations like the American Lung Association have completely lost their judgment. The sheer fear of a non-tobacco-containing product that could provide satisfaction to smokers without killing them is too much to bear. Ironically, it is the efficacy and health advantages of e-cigarettes that represent the greatest perceived threat to the survival of the mantra of groups like the American Lung Association. And they are fighting to protect that mantra, even at the expense of abandoning the fight against tobacco-related disease and death.

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