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Friday
Aug082014

NCPPR's Comments to the FDA Regarding E-Cigarette Regulations

E cigarettes DPC

Today the National Center for Public Policy Research submitted comments to the Food and Drug Administration regarding e-cigarette regulations known as "Deeming Regulations."

When the proposed rule was first published, I told the Associated Press that "the devil will be in the details."

One of those details is the fact that the FDA has stated that it does not believe congress gave the agency authority to set a unique "grandfather date" for E-cigarettes to allow them to come to market without undue regulatory burdens.

I suspect the FDA is receiving thousands of comments, many from smokers who say they've quit smoking cigarettes by using e-cigarettes instead.

The FDA acknowledges that harm reduction benefit of e-cigs. But it says, in the proposed deeming regulations that, the grandfather date it sets in the proposed rule is a problem, at least for industry and the former smokers that rely on that industry. The FDA's grandfather date creates huge regulatory burdens, but it says its hands are tied by Congress.

In my comments, I argue otherwise. I explain why the FDA should use its statutorily granted discretion in setting a grandfather date for e-cigarettes to the effective date of the proposed rule, or, at earliest, as the date the proposed rule was published.

There's a lot of legal terminology here. The bottom line is that if the FDA imposes the rule it drafted, just about all of the e-cigarettes on the market today would eventually have to come off the market because of the huge regulatory burden, and almost all innovation would be stifled. If this happens, smokers who quit smoking using these products have said that they would either buy unregulated products on the market, or simply go back to smoking cigarettes as a result of the FDA's decision.

In the comments submitted today, NCPPR explains that the proposed rule is fundamentally flawed because it misinterprets the statute in concluding that the agency does not have the statutory authority to protect public health by setting the grandfather date for substantial equivalence to a more current date than February 15, 2007.

Here is the full text of the comments:

To: FDA Center for Tobacco Products

RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

From: Jeff Stier, Senior Fellow, National Center for Public Policy Research, Director, Risk Analysis Division

Date: August 8, 2014

I am writing on behalf of the Risk Analysis Division of the National Center for Public Policy Research, a conservative think tank.

The FDA has solicited comments on what FDA actions or regulatory approaches, if any, should be taken for proposed deemed tobacco products that are "new tobacco products" under section 910(a)(1) of the FD Act. The act, passed by congress as the Family Smoking Prevention and Tobacco Control Act, became law on June 22, 2009. The law granted the FDA regulatory authority over tobacco products.

In this submission, I will explain why the FDA should use its statutorily granted discretion in setting a grandfather date for e-cigarettes to the effective date of the proposed rule, or, at earliest, as the date the proposed rule was published.

The U.S. District court in Washington, DC has ruled that because the nicotine in e-cigarettes is derived from tobacco, the FDA has the authority to regulate them as tobacco products, even though there is no actual tobacco in them. (Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010))

However the statute did not require the FDA to regulate e-cigarettes. Instead, the Tobacco Control Act provided the FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products. In addition, the statute separately gave the agency the authority to deem other tobacco products as tobacco products under the statute.

Congress required that the agency's implementation of the statute must, "provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products." [Citation]

The FDA would be failing in its statutorily-based mission to protect public health by setting the grandfather date for all newly deemed products to February 15, 2007. Specifically, there's no rational basis for applying the statute's grandfather date for products other than those for which the statute gave the agency immediate regulatory authority. The February 15, 2007 grandfather date applies to products that congress gave FDA direct regulatory authority over. It should be self-evident that the grandfather date in the statute did not apply to products that were not yet deemed as tobacco products. This is true especially regarding a class of products that had no substantially equivalent product on the market and which also have the potential to improve public health. Instead, the statute explicitly provides for flexibility in this regard, with direct language describing the bill's purpose to "to impose appropriate regulatory controls on the tobacco industry." [Citation]

The agency's attempt to incorrectly set the grandfather date for newly deemed e-cigarettes to February 15, 2007 is a failure to exercise its statutorily granted flexible enforcement authority, as well as a failure to implement the statute's call for appropriate regulatory controls. As a result of the agency's misapplication of the statute, the FDA's proposed rule would have the unintended consequence of harming public health by failing to provide effective oversight of industry's effort to develop, introduce, and promote less harmful tobacco products. Ironically, in claiming to implement the statute by adhering to the wrong grandfather date, the agency would be failing to enforce the statute and would harm public health in the process.

The statute sets forth two pathways, or on-ramps, to legally market new tobacco products. The first pathway, substantial equivalence, is the pathway where the grandfather dates comes into effect. In order to be eligible for this on-ramp, the new product must be "substantially equivalent" to a product on the market as of a specific grandfather date. For products already on the market as of the grandfather date, this on-ramp presents the lowest regulatory hurdle to bringing a product to market.

If a product is not substantially equivalent to a product on the market as of the grandfather date, or if it does not meet the other substantial equivalence requirements, the manufacturer must submit a Premarket Tobacco Application. [Citation]

The FDA's Premarket Tobacco Application guidance states that,

"Premarket Tobacco Applications must demonstrate that the new tobacco product is appropriate for the protection of the public health, which will be determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products, and taking into account:

The increased or decreased likelihood that existing users of tobacco products will stop using such products; and

The increased or decreased likelihood that those who do not use tobacco products will start using such products."

Congress intended the substantial equivalence standard to be lower than the premarket tobacco application so that industry would be allowed to make changes to products that did not introduce new health risks. By not developing a rationally grounded grandfather date for e-cigarettes, the deeming regulation runs the risk of stifling innovation of lower risk products that weren't even contemplated by the statute. In the proposed rule, the FDA comes close to acknowledging as much. The proposed rule addresses the concern raised by "industry" (and no doubt, by many e-cigarette consumers who quit smoking cigarettes with the help of these products), that,

"many tobacco products we are proposing to deem that are currently being sold may not be 'grandfathered' tobacco products because many were not commercially marketed or modified until after February 15, 2007. We understand that this may be particularly true in the case of e-cigarettes and similar novel products."

In addition, the FDA directly acknowledges that under the proposed rule's grandfather date, no technology-based products such as e-cigarettes would be permitted to pursue the substantial equivalence pathway available to the more harmful combustible cigarettes.

"Moreover, new products that come on the market in the future would never be grandfathered tobacco products because they would be coming on the market after February 15, 2007." [Citation]

The proposed rule then fails to acknowledge that the statute gave the FDA flexibility to apply the statute in order to protect public health. The rule states,

"We do not believe that we have the authority to alter or amend this grandfathering date, which is set by statute."

Instead, the FDA writes in the proposed rule that,

"Therefore, FDA believes most proposed deemed tobacco products would be considered new tobacco products and would be required to obtain an order from FDA prior to marketing under one of the three pathways listed in section VIII.A.6."

This interpretation is incorrect because the February 15, 2007 grandfather date applies to products that the FDA must regulate under the statute, and not to products that must first be deemed as tobacco products by the agency. To accept the FDA's tortured interpretation of the statute, one would have to believe that congress intended to set a grandfather date in the statute for products that weren't under the FDA's regulatory authority when the statute went into effect.

There is no specific language in the statute which sets a grandfather date for products not yet deemed tobacco products. In fact, the law came into effect in 2009, prior to the 2010 Sottera decision that laid the legal basis for the FDA to attempt to deem e-cigarettes as tobacco products under the statute.

In reality, the statute wisely authorized the FDA to come up with different regulations for newly deemed products. With an eye towards new products not specifically contemplated in the statute, congress granted the FDA "flexibility" to promulgate rules that protect public health. Congress also stated that the purpose of the statute is "to impose appropriate regulatory controls on the tobacco industry," as well as "to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases."

The agency's failure to exercise this discretion would have the exact opposite effect of the statute's overall goal of protecting public health by unnecessarily forcing e-cigarette manufacturers to pursue the burdensome Premarket Tobacco Application route to the market. This route is the most expensive and time consuming legal pathway to the market. If the FDA does not exercise its discretion with regard to the grandfather date, it would pervert the public health intent of the statute by allowing the substantial equivalence route for cigarettes, the most harmful form of tobacco use, while, by the agency's own admission, forcing less harmful non-combustible products to climb a much steeper on-ramp.

It should be noted that is possible that there were some vapor products on the market as of February 15, 2007, but those products did not appeal to a large number of smokers and continue to evolve significantly so as to present less harm and to be of greater appeal to smokers looking for an alternative to cigarettes. Those products bear no substantial equivalence to the products that are today helping a significant portion of smokers quit smoking.

In his interview with the Robert Wood Johnson Foundation's NewPublicHealth, the director of the FDA's Center for Tobacco Products, Mitch Zeller addresses the need for the flexible application of the authority congress granted the agency, with regard to lower risk, noncombustible products like e-cigarettes.

"The other example is if at the end of the day people are smoking for the nicotine, but dying from the tar, then there's an opportunity for FDA to come up with what I've been calling a comprehensive nicotine regulatory policy that is agency-wide and that is keyed to something that we call the continuum of risk: that there are different nicotine containing and nicotine delivering products that pose different levels of risk to the individual.

Right now the overwhelming majority of people seeking nicotine are getting it from the deadliest and most toxic delivery system, and that's the conventional cigarette. But if there is a continuum of risk and there are less harmful ways to get nicotine, and FDA is in the business of regulating virtually all of those products, then I think there's an extraordinary public health opportunity for the agency to embrace some of these principles and to figure out how to incorporate it into regulatory policies." [Citation]

One meaningful and concrete way the FDA could incorporate these principles of a continuum of risk is to use the discretion granted in the statute by setting a more current grandfather date which would include the products on the market today which are achieving the public-health results Mr. Zeller has pointed to in his numerous discussions of a comprehensive nicotine regulatory policy and a continuum of risk.

The unfounded claim in the proposed rule that suggests congress did not have the forethought to grant the agency flexibility in applying the statute, especially with regard to a grandfather date for products for which the agency was not granted immediate authority to regulate, would unnecessarily tie the agency's hands as it seeks to implement an agency-wide science-based nicotine regulatory policy that is keyed to the continuum of risk.

A February 15, 2007 grandfather date would also inadvertently give an advantage to cigarettes, by allowing them a substantial equivalence pathway, and denying that same pathway to an entire class of products that the FDA itself recognizes may present an extraordinary public health opportunity.

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