How the new FDA e-Cig regulations Will Limit Consumer Choice

The New e-Cig & Vape Law

The United States Federal Drug Administration (FDA) has, as of August 2016, begun regulating all e-Cigarettes and vaping related products under the same 2008 US law which previously only regulated cigarette sales.

These new rules are predicted to have a particularly dramatic impact on eCig and vape manufacturers, because they mandate that every eCig related product must be approved by the FDA before it can be legally sold in the US.

Each flavor, nicotine content level, or other variation of a product are each treated as a separate product, requiring individual approval. With the cost of obtaining an FDA approval estimated at $1,000,000 USD per product, it’s widely acknowledged that the number and variety of products available to be sold to US consumers will drop precipitously over the next three years as this law takes full effect.

What does this mean for US vaping?

What impact does this FDA e-Cig regulation have on e-Cig consumers? After all, the trend towards additional regulation of e-Cigs globally seems to be going in the opposite direction in the UK and in other countries, as evidenced by a Royal College of Physicians recommendation of the benefits of eCigs as outweighing the harms?

Unfortunately, the answer is likely that these US regulations will have a very significant impact on the US eCig market by limiting the range of products available.

The reason one law can do so much, is that the roughly $5 billion dollar global vaping market is driven in large part by US consumer demand, which totals nearly $2.4 billion, versus, for example, UK consumption of £459m. If expectations about the impact of these regulations on the US market prove correct, that the size of the US vaping market will dramatically decrease, and moreover the scope and variety of products available on the US market due to dramatically increased regulatory costs will shrink significantly, one can reasonably expect that most global e-Cig product manufacturers will not continue to invest in creating new products which cannot be sold in the U.S. market, which represents nearly 50% of global demand.

As such, one might reasonably project that in approximately two to three years, as this law takes full effect, the variety of products available globally, and to US consumers specifically, will be dramatically fewer than the range and variety of products available today.

Conclusion

The extension of the US FDA’s oversight and regulation from cigarettes to all e-Cigs and vape related products is currently being challenged in US courts for constitutionality. If those legal challenges are successful, there may yet be changes made to the FDA’s regulations which will lessen the hurdles imposed on manufacturers ability to sell their products in the US market. That would in turn be expected to ensure a greater variety of products available on the global market. But without the success of those cases, US eCig consumers should expect that the quantity and variety of e-Cig and vape products manufactured will shrink significantly over the next two to three years.

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