December 30, 2015
Division of Dockets Management (HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of members of the Patient, Consumer, and Public Health Coalition
on the proposed rulemaking
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
[Docket No. FDA-2015-N-2002]
Regarding the above proposed rule, we are writing as members of the Patient, Consumer, and Public Health Coalition to recommend that the FDA broaden the rule’s focus to be more consistent with the public health intent of the law, which is necessary because of numerous changes in tobacco products that have been introduced since the law passed.
In the final rule regarding jurisdictional boundaries between the Center for Drug Evaluation and Research (CDER) and the Center for Tobacco Products (CTP), FDA should list the principles that it will apply to the regulation of products containing nicotine, regardless of which Center has jurisdiction. The FDA should regulate all nicotine-containing products with the goal of minimizing the risks of all of these products, such as e-cigarettes, and ensure that all Americans fully understand those risks.
In its proposed rule, FDA notes that nothing in Brown & Williamson or Sottera limits its authority or jurisdiction over products made or derived from tobacco as drugs or devices, if they fall under the disease prong definition. If a product claims to reduce nicotine withdrawal symptoms (cravings associated with quitting smoking) or prevents relapses, then the product is intended to cure or treat nicotine addiction. This brings it within the definition of a drug and under the FDA’s drug and device jurisdiction.
We agree with the FDA that “consumers are particularly susceptible to confusion where products made or derived from tobacco. . .make claims related to quitting smoking.”[i] Such claims should be scrutinized by the FDA to prevent consumers from becoming confused or misled. Disclaimers are insufficient because some manufacturers of e-cigarettes have made claims that do not meet the requirements for the marketing of drugs and devices. Scrutinizing these and other explicit or implicit claims for products now on the market should be an FDA priority.
In the Federal Register notice, the FDA concludes that it retains the ability to regulate tobacco products, if the claims relate to the effects of nicotine that were not commonly and legally made in the marketing of cigarettes and smokeless tobacco products prior to the date of the Supreme Court’s decision in Brown & Williamson. FDA states that tobacco products in this category would include those marketed to “maintain healthy lung function,” “relieve tension,” “support the immune system,” or “promote weight loss.”1 We strongly agree.
FDA cites a number of claims that would not lead a product to be categorized as a drug/device under the law. We agree that “claims related to satisfaction, pleasure and enjoyment,” would not cause the product to be categorized as a drug/device, nor would the promotion of products with lifestyle claims.1 The same is true for FDA’s categorization of claims such as “smoke-free” or “full taste and satisfaction” or “spit free tobacco pleasure.” However, FDA concludes that the claims “satisfying tobacco alternative” or that a tobacco product will provide the same effects as another tobacco product are tobacco claims;1 however, these claims each imply that the product provides an alternative to the nicotine in cigarettes. The implicit claim is that these products address a tobacco user’s nicotine craving, just as do products FDA concludes fall into the drug/device category. These types of claims should therefore not be permitted.
Today’s marketplace for nicotine products is much different from the one that existed when nicotine was available only in traditional tobacco products or through FDA-approved cessation products. Older FDA policies may no longer be adequate. Under the Sottera decision, e–cigarettes are to be treated as tobacco products unless their manufacturers make therapeutic claims. But FDA’s delay in adopting a final deeming rule has meant that e-cigarettes have been marketed with no regulation at all. As a result, e-cigarettes have become freely available, and are widely marketed, and will continue to be marketed even after the deeming rule is in effect. The FDA therefore needs to immediately implement regulatory policies that reflect today’s market.
In establishing jurisdictional lines between CDER and CTP, FDA should focus not only on the legal definitions of different products, but also on what division of responsibility best promotes the purposes of the regulation. The most effective regulatory policies should create incentives for manufacturers and sellers to develop products that can reduce addiction to and the risks of tobacco and nicotine products, encourage full cessation, and minimize use of any tobacco products by young people.
Current policies do not accomplish this goal. If products like e-cigarettes have a public health value, it would be to substantially increase the number of cigarette smokers who quit using tobacco completely or that deliver nicotine in the safest ways. However, manufacturers who wish to design products that are more likely to help smokers achieve either goal, and who want to promote them accurately and consistently with the evidence reviewed by FDA, face regulatory hurdles. In contrast, manufacturers who design and promote products as lifestyle choices, face few regulatory constraints. E-cigarettes should not be allowed to be promoted to initiate tobacco use, deter smokers from quitting , or encourage former smokers to reinitiate use. The FDA should ensure that consumers are aware of the risks of nicotine. Research should be required to determine how these products are used, by whom, and the exact risks and benefits before any health claims are permitted.
FDA should crack down on claims for products that have not been shown to be effective at helping smokers quit. FDA should focus on reducing the sale and marketing of nicotine-based products that appeal to youth and expand the market place for nicotine addiction. In order to avoid confusion in the marketplace, the same products should not be allowed to be marketed for cessation and for recreational purposes.
A comprehensive regulatory policy should include all the restrictions on marketing of all tobacco products subject to FDA jurisdiction that are included in the FDA’s 2010 regulations on cigarettes. In addition, the sale of nicotine-based products to minors on the internet has created a major public health problem. FDA regulations should be designed to minimize youth usage, such as prohibiting certain flavored e-cigarettes.
Regarding newly deemed products (such as e-cigarettes), FDA must establish strict requirements that the manufacturer demonstrate that it is free of dangerous toxins and can be manufactured consistently to FDA specifications.
In conclusion, we urge the FDA to go beyond the proposed rule and strengthen it to include the appropriate regulation of products made or derived from tobacco as drugs, devices, or combination products under the FD&CA. However, since the harm of these products is primarily from the nicotine and other substances in the vapor, and not from the device itself, these products should be regulated as drugs rather than devices or combination products.
American Medical Women’s Association
Connecticut Center for Patient Safety
MRSA Survivors Network
National Center for Health Research
Washington Advocates for Patient Safety
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com
[i] Food and Drug Administration (September 25, 2015). Proposed Rule: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.” http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-2002-0001