November 18, 2015

Stanton A. Glantz, PhD

UCSF TCORS public comment to FDA on when tobacco products should be regulated as drugs/devices or by CTP

The UCSF TCORS has just submitted the following public comment to the FDA:
Comment on
FDA’s Proposed Regulations: 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
November 18, 2015
Cessation and “satisfaction” claims cause confusion for consumers, so any products making such claims should be regulated under FDA’s drug/device authorities.
            FDA’s proposed rule attempting to clarify when products made or derived from tobacco should be regulated as drugs, tobacco products, or modified risk tobacco products is a necessary and positive step towards minimizing confusion for consumers and thereby protecting the public health.   Currently, many non-cigarette products that are made or derived from tobacco (such as e-cigarettes, cigars, smokeless tobacco/chew, and snus) make marketing claims (either explicit or implicit) that communicate that they are frequently used, are intended to be used, or can be used to help quit smoking, to alleviate nicotine cravings, or to provide the same nicotine hit or “satisfaction” as conventional cigarettes.  Some alternative products make other unsubstantiated therapeutic claims that they deliver vitamins, boost energy, cure sleeplessness, and aid weight loss. These claims confuse consumers and lead them to think that these products, like other FDA-approved cessation products such as nicotine gum or patches, or other drugs and supplements such as sleeping pills and multi-vitamins, are effective for cessation, treating nicotine addiction and withdrawal, or managing vitamin deficiencies, and are harmless or less harmful than cigarettes.  That manufacturers sometimes accompany these obvious therapeutic or modified risk claims with legalese disclaimers to evade regulation does not cure the problem. 
FDA’s final rule should clearly and directly provide that any and all claims made about products – including claims distributed in both conventional and new social media formats – that either explicitly or implicitly suggest that the product can or might be used for smoking cessation, to cure or treat nicotine addiction, to provide the same “satisfaction,” “nicotine fix,” and other pleasures of smoking, or for other therapeutic uses, shall be regulated under FDA’s drug/device authority
The proposed rule’s reliance on the basic statutory definitions of “drugs” and “devices” and the two-prong test that would treat a product made or derived from tobacco as a drug or device if it is either: (1) intended for use in diagnosing, curing, mitigating, treating, or preventing a disease (the “disease prong”); or (2) intended to affect the structure or function of the body in any way that is different from effects of nicotine that were “customarily” claimed in marketing prior to the March 2000 Brown & Williamson decision (the “structure/function prong”) is appropriate.  However, any marketing claims made prior to March 2000 would necessarily have been made prior to the August 2006 legal decision in United States v. Philip Morris,[2] which uncovered the tobacco industry’s fifty-year history of defrauding the public about the physiological and addictive effects of nicotine.  Therefore, FDA’s proposal does not go far enough; FDA should also consider claims suggesting that a tobacco product will provide the same “satisfaction” or nicotine hit as conventional cigarettes and/or provides an alternative way to get the same “pleasures of smoking” to fall within its drug and device authority.
            In two previous comments to the FDA,[3],[4] incorporated herein, we presented evidence of cessation claims made by companies selling and manufacturing e-cigarettes and other tobacco products. Here we provide additional scientific evidence and examples of cessation and other therapeutic claims made by manufacturers of e-cigarettes and other non-cigarette products made or derived from tobacco.  Moreover, we demonstrate that consumers are confused by these claims, and we show that these claims fall within FDA’s drug and device authority because:

  1. The manufacturers make explicit and implicit claims in advertisements that these products are smoking cessation aids and have other therapeutic uses;


  1. Confusing cessation and therapeutic claims are made in both mainstream media as well as in blogs, testimonials, and social media formats that are especially attractive to youth and young adults;


  1. The placement of e-cigarettes and other alternative tobacco products near smoking cessation devices in retail stores confuses consumers;


  1. Cessation and therapeutic claims influence adult, older adult, and adolescent smokers’ misperceptions about the supposed benefits and relative harms, risks, and addictive properties of e-cigarettes and other non-cigarette products.  These claims confuse consumers, lead them to believe that these products are safe and effective like FDA-approved nicotine replacement therapies and other therapeutic purposes, and encourage initiation and ongoing use of non-cigarette tobacco products. Therefore, products made or derived from tobacco that make these claims should be subject to regulation by FDA as a drug, device, or a combination product; and


  1. Claims suggesting that a tobacco product provides “satisfaction,” a “nicotine fix,” or other “pleasures of smoking” are claims about the pharmacological affects of nicotine, and therefore should be regulated under FDA’s drug/device authority.

Further, we show that:

  1. Many claims made by manufacturers that non-cigarette tobacco products are less harmful than conventional cigarettes should be regulated as modified risk tobacco claims;


  1. FDA’s economic impact analysis does not appropriately analyze the costs and benefits of the proposed rule; and


  1. FDA’s proposed rule should be modified to strengthen FDA’s ability to protect the public health.

Companies should not be permitted to market the physically identical or similar tobacco products as both medicinal and recreational. In such cases, FDA should regulate both products under its drug/device authority to prevent confusion for consumers.  FDA must be vigilant in monitoring the market to ensure that companies do not try to introduce and market physically identical or similar tobacco products that differ only in name and/or packaging or nearly identical products under both its Center for Drug Evaluation and Research (CDER) and its Center for Tobacco Products’ (CTP) by making cessation or therapeutic claims about one of the products (causing it to be regulated as a drug/device) and making recreational claims about the other product (causing it to be regulated as a tobacco product). Additionally, no tobacco product should be permitted to use CTP’s substantial equivalence pathway if the predicate product to which it is being compared entered the market through CDER.  Any product that is substantially equivalent to a product regulated by CDER must also be regulated by CDER.
This is just the first part of the comment.  The full comment, including the figures, is 29 pages long.  It is available here.   The tracking number is 1jz-8mbt-v7hf .

[1] Lauren Lempert, Janine Cataldo, Benjamin Chaffee, Lauren Dutra, Bonnie Halpern-Felsher, Jim Lightwood, Pam Ling, Wendy Max, Lucy Popova, Kathryn Ross, Justin White, Stanton Glantz

[2] United States v. Philip Morris USA Inc., 449 F. Supp. 2d 1 (D.D.C. 2006),aff’d in part & vacated in part, 566 F.3d 1095 (D.C. Cir. 2009) (per curiam), cert. denied, 561 U.S. ___, 130 S. Ct. 3501 (2010).

[3] Grana R., Ling PM, Barnes RL, Lempert L, Glantz SA.  (2013). Comment submitted regarding Feed and Drug Administration actions related to Nicotine Replacement Therapies and smoking-cessation products; report to Congress on innovative products and treatments for tobacco dependence; public hearing; extension of comment period. Tracking # 1jx-835b-n9ph.

[4] Dutra LM, Grana RA, Lempert L, Cataldo JK, Glantz  SA, Halpern-Felsher BL, Ling PM, Popova L, Walsh M. (2014). FDA should prohibit e-cigarette marketing that promotes false health claims. Docket No. FDA-2014-N-0189. June 3, 2014.  Tracking # 1jy-8cgs-l1sq


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