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The FDA's New Overreaching Regulations on Vaping Products Harm Public Health and Destroy Innovative Small Businesses

On August 8, the Food and Drug Administration’s (FDA) new rules on vaping products go into effect. Federal law gives the FDA the power to regulate “tobacco products,” and the new rules cover a long list of products that the FDA is now deeming tobacco products. In a leap of logic that only a regulator could understand, the FDA will apply its “tobacco” regulations to products that do not contain tobacco, such as e-cigarettes and other vaping products. How can this be possible? Well in the mind of a regulator in Washington, the idea that a product or activity might not be subject to regulation is a foreign concept.

The Tobacco Control Act of 2009 gave the FDA regulatory authority over tobacco products, specifically listing obvious candidates like cigarette tobacco and smokeless tobacco. For additional tobacco products, the law gave the FDA the power to “deem” other types of tobacco as subject to tobacco product regulations. In May 2016, the FDA announced the list of products they now will be deeming tobacco products, including a number of e-cigarette and vaping products which do not contain tobacco.

The logic the FDA used for this blatantly illegal power grab is thus: some e-liquids contain nicotine derived from tobacco, therefore, they must be subject to FDA “tobacco” regulation. But the FDA was not content with just that step. Since many e-liquids contain synthetic nicotine, nicotine derived from other plants, or contain no nicotine at all, there would be a whole host of products that were outside FDA jurisdiction. For a regulator this is unconscionable. So the FDA decided that all components of vaping equipment that could be used with e-liquids containing tobacco-derived nicotine are subject to FDA tobacco regulation, and therefore any e-liquid that could be used with such vaping equipment is also subject to tobacco regulation.

So Congress gives the FDA the authority to regulate tobacco products, and the FDA uses that authority to regulate tobacco-free and even nicotine-free products. If that doesn’t make sense to you, perhaps that’s why you are not a regulator.

These new regulations are not penny-ante either. The regulations will require that vaping product companies come to the FDA begging for permission from the feds sell each product they manufacture, with each product requiring a separate application. Given that these applications could cost $1 million or more each, and there are hundreds of unique products available, these rules will effectively put all but the largest vaping manufacturers out of business. The regulations also include severe restrictions on sales of vaping products.

These crushing regulations will eliminate innovation, limit access and reduce sales. This in an industry that before these rules was projected to be potentially worth $50 billion a year by 2025. Not only will these regulations stifle an emerging industry, it could also perversely harm American health. E-cigarettes are widely used to help people quit smoking real cigarettes. Given that vaping e-liquid is at least 95% safer than smoking tobacco, these FDA rules reducing public access to vaping products are actually a step backward in protecting public health.

With this overreach, federal regulators show yet again that they cannot be trusted to act with restraint. These regulations were not made with logic or the public interest in mind; they were created to achieve the maximum extent of federal regulatory power. In today's out of control regulatory state that attitude is sadly not unique.