FDA out of control

Recently, this paper reported on vaping culture in Nevada. Then on May 5, the Food and Drug Administration (FDA) issued new regulations that could drive a stake into the heart of the vaping industry.

The FDA announced it was extending its regulatory powers over “tobacco products” to include not only cigarettes, but cigars, hookah and pipe tobacco, and “electronic nicotine delivery products,” which means e-cigarettes and vape pens. They called this a “milestone in consumer protection”—which means it is a death knell for thousands of cigarette smokers who will find it more difficult to switch to vaping.

The FDA did not ban e-cigarettes. They just put regulatory pillows over the heads of the vaping and cigar industry manufacturers and will hold them there until they stop thrashing. Every new “tobacco product” has to submit to a long, arduous, expensive regulatory review before they can bring the product to market. The opening gambit is a million-dollar new product application fee. This will put small vaping companies and startups out of business.

The hand that's pushing down on the regulatory pillow is the FDA’s decision to decide the merits of an application based on the population as a whole test, instead of on the impact to current tobacco users. No one disputes that heavy cigarette smoking is dangerous. At least 30 percent of heavy cigarette smokers—two packs a day or more—can expect to have severe health consequences, such as lung cancer.

The other forms of nicotine ingestion, such as smokeless tobacco, cigars and pipe tobacco, are far less dangerous, reducing serious health risks down to around 5 percent. E-cigarettes are even safer, because the combustion temperature is very low and the user does not inhale heated smoke and chemical byproducts with the nicotine. The prestigious British medical journal Lancet just published a major study confirming the much better health outcomes of vaping compared to cigarette smoking.

By using the population as a whole standard, the FDA is saying that new users of alternative tobacco products may enjoy nicotine ingestion so much they will later switch to cigarette use.

There is no evidence that this “gateway drug” theory is actually occurring in real life, but the New Deal-era FDA believes it has the statutory authority from Congress to limit the liberty of the people and do a preemptive strike at the industry, you know, just in case.

It saddens me to see the young Bernie supporters who believe the answer to every problem is more government regulation. The progressive ideal of administrative agencies that combine the constitutional powers of legislation, administration and judicial determination based on overly broad Congressional statutes, subject only to later judicial review by a not-so-independent judiciary, is a double-edged sword. Yes, these progressive agencies get headlines, and the public sees the approval process, and assumes the government is on the job. But what is unseen are the effects that the regulations have on entrepreneurial innovation and free choice by consumers. They have no measurement to comprehend how many opportunities are lost for those who desperately need an alternative solution but never get to see it because the regulatory burdens keep the solution from the market.

The FDA is waging a war on pleasure, making nicotine ingestion itself the target. Nicotine by itself has no serious adverse health effects, and if the delivery system is safe, or at least much safer than cigarette smoking, the agency is making a moral, rather than a health and safety, determination.

The FDA is outmoded and should be abolished because it does more harm than good.