Reasonable "regulations" proposed in the New York Times

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On Sunday, an article by Sally Satel, a resident scholar at the American Enterprise Institute, was published in The Opinion Pages of the New York Times. In the article Satel points out that not enough smokers are switching to e-cigs despite their relative safety and that the initial public enthusiasm over e-cigarettes is waning. She mentions a few reasons for this: Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse. The point is that there are some bad apples in the e-cig industry and we currently don't have a good way of knowing which ones are good, and perfectly safe and which ones are not. So it is no wonder smokers are sceptical. But how can we turn this trend around? You really don't have to be a rocket scientist to see that the proposed FDA regulations would effectively put most of the independent e-cigarette industry out of business, leaving Big Tobacco comfortably in total control of the market. Satal explains why in her article: Consider the complexity. The proposal has some useful provisions, such as a ban on sale to minors and a requirement to disclose ingredients. But the proposal would also push e-cigarettes into the hugely burdensome regulatory framework that Congress set up for any new tobacco product. Although the deeming rule does have some traces of reason in it, it will do more harm than good. Satel, however, has some really good suggestions on how the FDA could use their resources to actually help smokers quit instead. You see you don't really need strict, expensive regulations to make vaping safe. The majority of products on the market today are perfectly safe, so all you need to do is point the users in the right direction.  Instead of waiting years to develop burdensome regulations, the F.D.A. should act now by setting interim safety guidelines. These guidelines would not carry the force of law, but they could go far to bolster smokers’ confidence that a safer way to inhale nicotine exists. The agency should start by focusing on a few basic steps. It should outline basic good-manufacturing practices for the devices and liquids, including limits on the amount of chemicals, like formaldehyde, and metals, like nickel, that can be present in the aerosols. It should disallow outright some contaminants in the nicotine solution and flavorings. It should require manufacturers to ensure that all batches of chemicals are traceable and that all sources of hardware are known. The guidelines should also require makers to verify that e-cigarette batteries can be charged safely and that they will operate safely in the course of normal use. Interim guidelines should require manufacturers to use childproof packaging that carries a warning: “This product contains nicotine, which is addictive and is intended for adult smokers only.” Also, a mechanism for reporting adverse effects is needed. Satel says that these should be only guidelines not laws. In my opinion some of her proposed guidelines could also carry the force of law (limits on chemicals for example), but enforcing them should not be done the way the FDA suggests with a pre-market approval scheme that would put all the innovative forces in the industry out of business. The independent companies are also the ones that are focusing their innovations towards user safety (take Evolv for example). Big Tobacco on the other hand (which would be left in total control under such regulations), has never been, and never will be, very concerned with user safety. Instead of pre-market approval, a system where the authorities can check that the manufacturers are following the rules and their products are safe could be established. If controls show that a manufacturer is not playing by the rules they can be forced to start doing so or eventually be shut down by the authorities. In addition to this the industry organizations could establish a system where manufacturers voluntarily apply for approval, documenting that they follow the organizations guidelines, and then be allowed to use this approval in their marketing. Such systems would let customers choose the safe alternatives, making it hard for the unreliable players to earn money, and eventually vaping will be even safer than it is today. Last, but not least, Satel suggests the FDA lets the industry tell the truth about e-cigarettes. Although I'm not sure about the wording on her label, it would be a big step forward: Finally, the F.D.A. should allow companies to tell smokers about the benefits of switching to vaping products. Labels could read: “While more research is needed, it is likely that e-cigarettes meeting F.D.A. interim safety guidelines are much safer than smoking.” photo credit: tbecreview via photopin cc

On Sunday, an article by Sally Satel, a resident scholar at the American Enterprise Institute, was published in The Opinion Pages of the New York Times. In the article Satel points out that not enough smokers are switching to e-cigs despite their relative safety and that the initial public enthusiasm over e-cigarettes is waning. She mentions a few reasons for this:

Smokers are barraged with news about inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse.

The point is that there are some bad apples in the e-cig industry and we currently don't have a good way of knowing which ones are good, and perfectly safe and which ones are not. So it is no wonder smokers are sceptical. But how can we turn this trend around?

You really don't have to be a rocket scientist to see that the proposed FDA regulations would effectively put most of the independent e-cigarette industry out of business, leaving Big Tobacco comfortably in total control of the market. Satal explains why in her article:

Consider the complexity. The proposal has some useful provisions, such as a ban on sale to minors and a requirement to disclose ingredients. But the proposal would also push e-cigarettes into the hugely burdensome regulatory framework that Congress set up for any new tobacco product.

Although the deeming rule does have some traces of reason in it, it will do more harm than good. Satel, however, has some really good suggestions on how the FDA could use their resources to actually help smokers quit instead. You see you don't really need strict, expensive regulations to make vaping safe. The majority of products on the market today are perfectly safe, so all you need to do is point the users in the right direction. 

Instead of waiting years to develop burdensome regulations, the F.D.A. should act now by setting interim safety guidelines. These guidelines would not carry the force of law, but they could go far to bolster smokers’ confidence that a safer way to inhale nicotine exists.

The agency should start by focusing on a few basic steps. It should outline basic good-manufacturing practices for the devices and liquids, including limits on the amount of chemicals, like formaldehyde, and metals, like nickel, that can be present in the aerosols. It should disallow outright some contaminants in the nicotine solution and flavorings.

It should require manufacturers to ensure that all batches of chemicals are traceable and that all sources of hardware are known. The guidelines should also require makers to verify that e-cigarette batteries can be charged safely and that they will operate safely in the course of normal use. Interim guidelines should require manufacturers to use childproof packaging that carries a warning: “This product contains nicotine, which is addictive and is intended for adult smokers only.” Also, a mechanism for reporting adverse effects is needed.

Satel says that these should be only guidelines not laws. In my opinion some of her proposed guidelines could also carry the force of law (limits on chemicals for example), but enforcing them should not be done the way the FDA suggests with a pre-market approval scheme that would put all the innovative forces in the industry out of business. The independent companies are also the ones that are focusing their innovations towards user safety (take Evolv for example). Big Tobacco on the other hand (which would be left in total control under such regulations), has never been, and never will be, very concerned with user safety. Instead of pre-market approval, a system where the authorities can check that the manufacturers are following the rules and their products are safe could be established. If controls show that a manufacturer is not playing by the rules they can be forced to start doing so or eventually be shut down by the authorities. In addition to this the industry organizations could establish a system where manufacturers voluntarily apply for approval, documenting that they follow the organizations guidelines, and then be allowed to use this approval in their marketing. Such systems would let customers choose the safe alternatives, making it hard for the unreliable players to earn money, and eventually vaping will be even safer than it is today.

Last, but not least, Satel suggests the FDA lets the industry tell the truth about e-cigarettes. Although I'm not sure about the wording on her label, it would be a big step forward:

Finally, the F.D.A. should allow companies to tell smokers about the benefits of switching to vaping products. Labels could read: “While more research is needed, it is likely that e-cigarettes meeting F.D.A. interim safety guidelines are much safer than smoking.”

photo credit: tbecreview via photopin cc