By Gilbert Ross, M.D.
If the FDA's proposed regulations go into force, the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.
At last, after months of anticipation, the FDA finally unleashed the proposed regulatory plan — the “deeming regulations” — that the drug agency will apply to electronic cigarettes (ecigs). If these regulations go into force — and that may take years — the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.
The devil in the 241-page long proposed regulations is the requirement for new tobacco products to get what amounts to pre-market approval via a “new tobacco product application” (NTPA). The FDA estimates that such NTPAs will require thousands of man-hours of data collection and hundreds of thousands of dollars or more, a burden few current ecig companies will be able to survive.
The irony is that older, less reliable ecig products are grandfathered in. The Family Smoking Prevention and Tobacco Control Act (FSPTCA), the 2009 law which devolved tobacco oversight to the FDA, specifies February 15, 2007 as the cut-off date for grandfathered products: any ecigs on the market as of that date are automatically approved. Newer products can get approval by piggy-backing on those older products, if a company can show to the FDA’s satisfaction that a newer product is essentially equivalent to a grandfathered product, but perhaps only 1 percent of all ecigs and vapor products will qualify. For both the older, grandfathered products as well as new products, it’s unclear what type or level of change will trigger the NTPA requirement: it may be a modification as minor as a new flavor or an improved battery.
Some ecig marketers will likely have the wherewithal to play the FDA’s regulation game and come out the other side: those sold by the Big Tobacco companies, all of whom are either in the reduced-harm ecig market, or soon will be. Big Tobacco companies, and perhaps a few of the bigger ecig companies, have the financial resources and the regulatory expertise to get their products approved to remain on the market.
While the proposed regulations are not as catastrophic as they might have been — if the agency had deemed the devices as medicines, requiring years of clinical trials, the whole market would have shut down for years — the slow-motion strangling of this vibrant and innovative technology may have been written in the federal code.
The truly tragic aspect of these regulations is that the heavy hand of government is coming down on the neck of a product with huge potential to be a groundbreaking technology in the long, bitter fight against cigarette smoking. While the FDA trumpets its “success,” thanks to the FSPTCA and the “public health” nonprofits warning smokers to stay the course and stick with ineffective FDA-approved cessation aids, the war on smoking has nearly ground to a halt: The CDC’s own datasheets show that the smoking rate has fallen 3 percentage points over seven years (from 21 percent in 2005 to 18 percent in 2012).
The real problem facing responsible public health authorities remains today as it has been for decades: how to reduce the toll of preventable deaths from smoking. Half of smokers try to quit each year, yet less than one in ten succeed. Forty-two million smokers remain addicted, among whom almost half a million succumb to smoking-related illnesses each year (and another 8 million or so suffer from smoking-related illnesses). The FDA-approved cessation aids “succeed” only slightly more often than cold-turkey quitting, so eventually half of all smokers will succumb to their habit. Yet, despite these inconvenient facts, the CDC and the FDA stick to the same line: “Keep on using only the FDA-approved products, do not even try ecigs.” This amounts to a “quit or die” fundamentalist philosophy: smokers should not only quit, but according to the authorities, they must quit “in the right way,” abstinence only.
Over its five-year existence, the FSPTCA has accomplished little other than erecting barriers to the entry of truly effective new cessation products, such as ecigs. When a promising alternative product such as the ecigarette comes along, the FDA expends vast amounts of energy trying to contain this technology and impede truthful discussion of it, instead of figuring out how to make it more accessible to desperate smokers. Ecigs or “vapor products” have shown promise in helping addicted smokers finally quit. They provide smokers’ craved drug — nicotine — along with many of the comforting rituals of smoking, but without the toxins and carcinogens in the deadly, addictive products of tobacco combustion: the smoke. Last century, the tobacco control movement, including the FDA and the CDC, fought Big Tobacco’s duplicitous manipulation of science. Big Tobacco sought to distract the public from the obvious fact: cigarettes are deadly. Today, it is the tobacco control movement whose messages are laden with misinformation and distortions of their own data, aiming to scare smokers away from ecigs.
On a more positive note, the FDA did manage to ignore the hysterics from some politicians about nicotine poisoning and child-friendly flavors ostensibly seducing young people into a lifetime of nicotine addiction and smoking. Nor did the FDA address advertising or Internet sales: both hot-button issues would have clearly approached or transgressed constitutional dicta and spurred litigation, delaying implementation for years.
One possible upside of the long-delayed publication of the FDA regulations is that they might form the basis for more forceful resistance to the plague of restrictions and bans being contemplated in various cities and states against ecigs — lately including New York state. One rationale given by local and state health officials advocating banning ecigs or sending vapors outdoors is the perceived “regulatory vacuum” at the federal level. Now that vacuum is on the way towards being filled (for example, the tobacco center wisely ruled that minors should not be allowed to purchase ecigs; several cities and states have come to the same conclusion).
Given these new proposed regulations, what will the ecig and vapor landscape look like several years hence? Desperate, addicted smokers who might have been released from cigarette bondage via these devices may find the cupboard bare. And who will be left standing at the end of this bureaucratic nightmare? A few of the biggest ecig companies, most likely — and almost definitely, the relatively new players in the ecig business: Big Tobacco. So the new regulations will harm smokers and deliver most of the ecig market into the waiting arms of Big Tobacco. One wonders if this is the result those who crafted the FSPTCA wanted to see.
How did we come to this state, where the most benign, effective product for nicotine delivery became the prime target of over-zealous, destructive regulation? The urge to regulate first and evaluate the scientific data later must be resisted.
If these regulations go into force, the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly. It is not too late for the FDA to issue a course correction after reviewing the thousands of public comments it is sure to receive between now and the July 9 deadline. If enough public health experts and ex-smoking vapers write in, maybe the agency will see the error of its ways and use its vast powers to exempt more vapor products from these oppressive requirements.
Dr. Gilbert Ross is the executive and medical director of the American Council on Science and Health, a public-health nonprofit.