Tuesday, May 10, 2016

FDA Regulations Present an Imminent Threat to the Safety of the Public: Urgent Changes are Needed

While I have already argued that the FDA deeming regulations pose a long-term threat to the public's health because they will result in the removal of most vaping products from the market (so cigarette sales will continue uncontested), today I explain why these regulations pose a substantial immediate threat to the public's health.

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 substantial equivalence (SE) determination (which is unlikely because few, if any products are similar to a predicate product on the market in 2007), an SE exemption (which is unlikely because the company cannot show that the product is essentially the same as a predicate product on the market in 2007), or a new product application (which will be prohibitively expensive for most companies). Moreover, these regulations will discourage companies from undertaking any revisions to their products. Several companies have already decided to freeze their inventory and discontinue their innovation research and development.

To be clear, even small changes in products will not be allowed. For example, changes to the battery will not be allowed. If a company wanted to change to a new type of battery in a rechargeable model they produce, this will not be allowed because it would represent the introduction of a new tobacco product into the market for interstate commerce. Similarly, if a company wanted to change their propylene glycol supplier and use a different grade of propylene glycol, this would not be allowed.

The Rest of the Story

The FDA deeming regulations present an imminent threat to public safety. Why? Because after August 8, companies will not be able to make changes to their products to improve product safety.

Suppose company X finds out on August 7 that one its e-cigarettes exploded. The company does an investigation and finds that the batteries they are using do not contain the proper safety features to prevent explosion. The company wants to change batteries in their products to protect the public from an immediate and severe safety hazard. In the absence of the deeming regulations, the company could replace the batteries the next day. But the deeming regulations actually prevent the company from making such a change to its product. You can easily see how these regulations impose an imminent threat to public safety.

Suppose that a company finds a way to prevent potential safety hazards by introducing a new battery overcharge protection system. After August 8, the company cannot do that.

Suppose a company wants to change from a low-grade propylene glycol to a much purer, USP propylene glycol. That would not be allowed because it would represent the introduction of a new tobacco product into the marketplace.

Suppose the company determined that the voltage setting on its battery was too high and resulted in the formation of formaldehyde. Is that company allowed to lower the voltage setting to avoid this problem? Once again, the answer is no because it would represent the unlawful introduction of a new tobacco product into the marketplace.

The regulations will have a chilling effect on product innovation, including safety improvements. This is obviously not in the interests of protecting the public's health. And to the contrary, it actually introduces safety concerns that would not otherwise have been present if companies were permitted to make improvements in their products without pre-authorization.

I can't see how these regulations are going to hold up in court because there needs to be a public health rationale behind them. There is no public health rationale behind the prohibition of product safety improvements.

Remember that in banning the introduction of new products, the FDA is not only preventing the potential introduction of new products that could represent an increased threat to public safety, but it is also preventing the introduction of much safer products.

The rest of the story is that the FDA is essentially freezing any defective products that are on the market as of August 8th, producing a substantial safety hazard.

If defective batteries are on the market as of August 8th, those batteries will continue to explode and cause damage, even if the manufacturers recognize the danger and want to eliminate the hazard.

It should have been clear to the FDA that the requirement for pre-market approval of new cigarettes does not fit the regulation of vaping products. The only reason for the prohibition of new cigarette products in the 2009 Tobacco Act is that there was a history of tobacco industry product changes that resulted in harm to the public's health. For example, companies added ammonia to their products to make them more addictive, introduced light cigarettes to deceive consumers into thinking these products were safer, etc. That is the reason for the pre-market approval for cigarettes.

But it makes no sense to apply that framework to electronic cigarettes because there is no evidence and no reason to believe that companies are manipulating their products in a ways that make them more hazardous to consumers. In fact, it is quite the opposite. For the most part, the innovations that have taken place are improving the safety profile of vaping products. For example, it appears that the diethylene glycol problem has essentially been resolved, we now have many brands on the market which have been shown not to produce detectable levels of any hazardous volatile organic compounds, and the prevalence of unsoldered joints and other manufacturing defects appears to be decreasing.

Since the FDA seems determined to continue to try to force a round peg into a square hole, it is now incumbent upon Congress to intervene and create a new statutory regulatory framework for vaping products. That framework should eliminate any requirements for pre-market approval of vaping products and instead, should require the FDA to simply promulgate a set of uniform safety standards, including batteries that do not explode.

1 comment:

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