This note is in response to the April 2014 FDA Docket No. FDA-2014-N-0189 requesting comment on proposed regulations for extending the authority of the FDA Center on Tobacco Products (CTP) to a number of tobacco products not covered by the 2009 Family Smoking Prevention and Tobacco Control Act (the Law).

FDA has proposed a set of regulations intended to bring almost all non-pharmaceutical, tobacco-related products under the authority of the CTP. This step requires CTP to demonstrate it has the authority and capability, within the current scope of its jurisdiction, to implement a regulatory structure that will protect and improve public health.

CTP’s performance to date is very much open to question, given its failures to propose regulations governing the manufacturing quality of products already under its jurisdiction; to process thousands Substantial Equivalent applications; and to communicate practical guidelines to manufacturers for New Product, Reduced Exposure and Modified Risk applications. Substantially increasing the numbers of products the CTP will regulate could make matters worse.

As a public health physician, I strongly support FDA regulation of all tobacco and nicotine-delivery products, provided that regulation is evidence-based, practical and reasonably streamlined in a way that will protect and enhance public health. Unfortunately, it appears CTP is nowhere near meeting this performance standard. The 24-month grace period built into the currently proposed deeming regulations may help sort out these internal problems, but there is nothing in the proposal that indicates CTP recognizes the problems exist.

Though I have no direct insight into the inner workings of CTP, their paralysis appears related to an unwillingness or inability to acknowledge that approval guidelines will expose the public to some degree of risk. This reluctance is compounded by substantial discrepancies between prescriptions in the text of the Law and what our “evidence base” suggests should be done to protect and improve public health.

As I see it, the discrepancies are so severe that, if CTP opts to implement the letter of the Law without administrative discretion to accommodate contrary evidence, FDA efforts will do more harm than good in terms of future rates of tobacco-related addiction, illness and death in the United States.

I respectfully urge FDA to consider alternate approaches in pursuit of public health objectives. After determining which approaches comport with our best evidence, the agency then could consider which actions would fall within a reasonable scope of administrative discretion, and which, if any, might require technical corrections by Congress.

In the best of all worlds, CTP would suspend further consideration of the proposed deeming regulations until it can demonstrate to Congress, industry and the general public that it is successfully executing its existing responsibilities. Only then should it proceed to release an amended set of deeming regulations for public comment.

Suspecting that this will not be done, I offer the following observations and recommendations.

These recommendations are largely based on the “continuum of nicotine delivery products.” They represent one public health physician’s opinion on best how to streamline the FDA regulatory process; bring it in line with the totality of scientific evidence, as opposed to research limited to each newly proposed product; and pave the way for substantial reductions in tobacco-related harms in the United States.

The tobacco control law was intended to reduce tobacco-attributable addiction, illness and death, while allowing adults who choose to do so to continue use of tobacco and non-pharmaceutical nicotine-delivery products. The law was not intended to eliminate such products from the American marketplace by imposing regulatory burdens so onerous that none but the largest of the “big tobacco” companies could comply.

Unfortunately, the Law includes a number of provisions that directly conflict with the evidence base. Discrepancies between the Law and the evidence base include, but are not limited to the following:

  1. Risk to non-users is based on the physical and chemical characteristics of the product, without regard to marketing or social factors;
  2. The presumption that fruit and candy flavors other than menthol are intended to attract children and teens to tobacco use, and that such flavoring is not required to make the lower-risk smokeless and nicotine-only products palatable to adult users;
  3. The presumption that any statement of reduced exposure or reduced risk is likely to attract large numbers of teens and other non-smokers to nicotine use;
  4. Emphasis on chemical analyses as a means of ascertaining the risk posed by a tobacco product, without regard to the lack of certainty regarding how much cancer, heart, lung and other disease risks can be attributed to any given chemical substance;
  5. Disregard of the American and Scandinavian epidemiologic literature demonstrating major difference in risk between cigarettes and smokeless and other tobacco and nicotine-only products.

Because of these discrepancies, proceeding further with implementation of the Law without due exercise of administrative discretion may do more harm than good, in terms of our collective ability to reduce tobacco-related addiction, illness, and death in the United States.

The Law, and CTP implementation to date, both appear to presume that each newly proposed tobacco product is so unique that research findings on similar products cannot be considered. This presumption so substantially increases the cost and difficulty of New Product applications that none have been fully submitted to date. This presumption also substantially increases the burden of processing such applications and denies FDA use of prior literature for baselines and benchmarks with which to judge such applications. The stakeholders who benefit from this presumption are those in the tobacco control community who would prefer to eliminate all tobacco and non-prescription nicotine delivery products, as well as the cigarette and pharmaceutical companies who would like the Law to protect them from competition from relatively low-risk smoke-free and nicotine-only products. However, the presumption does nothing to protect or enhance public health.

Fourteen specific recommendations are listed at the end of this report. Most, if not all, of them can be implemented without congressional action. Where congressional action is required to bring the Law into better concordance with congressional intent, such action should be requested.

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