May 14, 2014

Stanton A. Glantz, PhD

FDA to kids: Not 18? No problem! Buy your e-cigs (and cigars and other tobacco products) online!

           In its latest version of “Where’s Waldo?,” FDA buried in the Paperwork Reduction Act of 1995 section of its recently published proposed deeming rule (79 FR 23142 at p. 23184) a gigantic loophole in its minimum age and identification restrictions for covered tobacco products: internet sales.  
 
           In addition to extending the agency’s tobacco authority to cover additional products, including e-cigarettes and cigarillos popular among young people, FDA also proposed restrictions requiring retailers to verify by means of photographic identification that buyers of tobacco products are at least 18 years of age.  With much fanfare, FDA touted these new proposed rules as a way “to prevent sales to underage youth” and to “reduce the public health burden of tobacco use on the American public, including youth.” (FDA press release, April 24, 2014) 
 
           However, the proposed rule includes an exception for “mail-order sales” which are permitted without the age verification requirements set forth in proposed section 1140.14(b)(2)(i) for newly covered tobacco products and which are also an exception to the age verification requirements and “direct, face-to-face exchange” requirements set forth in sections 1140.14(a)(2)(i) and 1140.14(a)(3) for cigarettes and smokeless tobacco.
 
           FDA states that the goal of the proposed minimum age and identification restrictions is to “reduce youth initiation of tobacco use, thereby reducing the number of people who suffer from tobacco-related illnesses and death” (FR 23160).  However, this goal cannot be achieved if FDA does not restrict internet sales of newly covered products such as e-cigarettes which are aggressively marketed and sold online to youth.
           
           Proposed sections 1140.14(a)(3) and (b)(3) would prohibit retailers from using any “electronic or mechanic device (such as a vending machine)” (FR 23204).  Explaining its reasoning for this, FDA states that “because the proposed rule would prohibit retailers from selling covered tobacco products to individuals without verifying that they are at least 18 years of age, FDA believes it would not be logical to allow such individuals to purchase such products from vending machines or other mechanical devices.” (emphasis added, FR 23178)  Nevertheless, FDA defies its own logic and allows such individuals to easily purchase these products via the Internet without face-to-face exchanges and without sufficient age verification. 
 
           Although FDA is deafeningly silent about Internet sales in the sections of the proposed rule where vending machine sales are discussed (FR 23160-162,  23178, 23204), it buries a brief note in the “Paperwork  Reduction Act of 1995”  section that “this prohibition on sales from electronic or mechanical devices is not intended to impact the sale of any tobacco product via the Internet” (emphasis added, FR 23184). 
 
           The seemingly contradictory messages found in the proposed rule have created confusion, leading major news media to interpret the proposed rule differently, with the NY Times initially reporting that internet sales would be prohibited by the proposed rule and the Washington Post reporting that internet sales would be allowed. 
           
           The dirty little secret is found in existing section 1140.16(c)(2)(i), originally issued back in 1996 when David Kessler was FDA comissioner, stuck down by the Supreme Court, and reinstated by Congress when it passed the Family Smoking Prevention and Tobacco Control Act in 2009.  This section provides that although retailers may not sell tobacco products in vending machines or self-service displays because these products may only be sold in a “direct, face-to-face exchange between the retailer and the consumer,” (section 1140.16(c)), “mail-order sales” are a permitted method of sale and an explicit exception. 
 
             FDA explicitly extends this exception to newly deemed products (cigars, e-cigarettes, etc) in the proposed rule in sections 1140.14(a)(2)(i) and 1140.14(b)(2)(i). 
 
           Back in the 1990s, the FDA originally proposed to prohibit mail-order sales but in its final rule published on August 28, 1996, FDA relented and made an exception for mail-order sales in response to comments from customers in rural and “isolated areas” such as prisons that eliminating mail-order sales would eliminate a convenient source of cigarettes for them (61 FR 44396 at p. 44459), and that there was “inadequate evidence demonstrating that young people use mail-order sales” because, among other reasons, that are not “patient enough to wait several weeks to obtain tobacco products.” (FR 44458, 44459)
 
           Things have changed a bit in the nearly 20 years since FDA enacted this rule, and the Sears-Roebuck catalog has been replaced by the Internet as the predominant way people, especially young people, buy merchandise.  And while patience may be a virtue, Amazon Prime guarantees two-day delivery, and gives students this service for free for the first six-months.  Nevertheless,  FDA’s reasoning for not prohibiting mail-order sales in 1996 apparently reflects their current thinking as well, since FDA refers to this rationale in its “Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” published in August 2013 (page 20, footnote 32).  
 
           Internet and social media marketing of tobacco products, including the more recent addition of e-cigarettes and other new products, is exploding, causing Internet sales of e-cigarettes and other tobacco products to skyrocket.  (Herzog, B., & Gerberi, J. (2013). Equity research: E-Cigs revolutionizing the tobacco industry. New York: Wells Fargo Securities.) The Internet serves as a significant means of acquiring these products, and is likely the predominant means of purchase for young people, where age verification is virtually non-existent or meaningless.  

  • An American Journal of Public Health study reported that almost 20% of cigarette-selling websites do not say sales to minors are prohibited, more than half require only that the buyer say they are of legal age (e.g., by clicking a button that says “I am over age 18”), another 15% require only that the buyer types in their date of birth, and only 7% require any driver’s license information. (Ribisl, K, et al., “Are the Sales Practices of Internet Cigarette Vendors Good Enough to Prevent Sales to Minors?,” AJPH 2002; 92(6):940-41).
  • Attorneys general from at least 15 states have conducted Internet stings and found that children as young as 9 years old were able to purchase cigarettes easily, with a New York sting operation finding that 24 of 26 websites sold to kids under 18. (Unger, JB, et al., “Are adolescents attempting to buy cigarettes on the Internet,” Tobacco Control 2001; 10:360-63 [citing Sherer, R, “States crack down on Web tobacco sales,” The Christian Science Monitor, Nov. 8, 2000 and ABC News, “Getting smokes online: Children buying cigarette with click of mouse,” March 6, 2001.])
  • A JAMA study found that more than 96% of minors aged 15-16 were able to find an Internet cigarette vendor and place an order in less than 25 minutes, with most completing the order in seven minutes. (Jensen, JA, et al., “Availability of tobacco to youth via the Internet,” JAMA 2004; 291(15):1837).
  • A study of 101 Internet websites selling tobacco products in California found that none of them complied with the California state laws regarding age and ID verification to stop sales to kids. (Williams, RS, et al., “Internet cigarette vendors’ lack of compliance with a California state law designed to prevent tobacco sales to minors,” Archives of Pediatrics and Adolescent Medicine 2006; 160:988-989.)
  • In a recent survey of popular e-cigarette manufacturers reported by the staff of several U.S. Congressional leaders, seven of the nine surveyed companies sell their products online, and there was wide variation in the use of age-verification to limit access to their websites and to purchase their products, with three companies allowing access to their sites without any age verification or confirmation at all, and three companies requiring buyers to merely click a button verifying that they are at least 18 years old. (Durbin, R., Waxman, H., Harkin, T et al. Gateway to Addiction? A Survey of Popular Electronic Cigarette Manufacturers and Targeted Marketing to Youth. April 14, 2014).

 
           The National Youth Tobacco Survey includes a question asking respondents if they’ve bought tobacco products online in the past 30 days.  In 2012, about 85,000 teens (.2% of the 42.4 million 10-19 year-olds in the U.S.) reported buying cigarettes, cigars, and smokeless tobacco online in the past month.  That's 1 million puchases by kids of tobacco products online in 2012.
 
            As internet use explodes among youth, these numbers are almost certainly much larger today.     
 
           FDA’s exception for internet sales in its newly proposed restrictions supposedly aimed at preventing youth sales demonstrates either a complete misunderstanding of youth purchasing behavior, or another example of the Obama OMB bowing to industry pressures to leave this lucrative source of e-cigarette and other tobacco product sales intact. 
             
           The FDA needs to remove this loophole from its final rule and, instead, require that internet sales of all tobacco products be subject to the same-face-to-face verification that the FDA proposes for all other sellers.
 
           To do this, the FDA should require that all internet sales require a that vendors obtain a certified receipt (at the vendor's expense) from the delivery agency that indicates:
 
1. The company providing the product and the nature of the products supplied.
2. The addressee receiving the product.
3. The person who signed for the product.
4. The person who delivered the product.
5. The specific form of identification that was used by the delivery agent to verify the age of the recipient.
 
This receipt would then be returned to the vendor (at the vendor's expense) and the vendor required to maintain these records, together with sales records, for a period of 5 years where they could be inspected and audited by the FDA and other law enforcement officials (such as state attorneys general).
 
            If this process is deemed too burdensome, the FDA could, of course, simply ban internet sales.
 
           We have submitted this information as a public comment to www.regulations.gov and urge others to do weigh in on this issue. It is comment 1jy-8c3i-wy64.
 
           Lauren Lempert found the comment buried in the Paperwork Reduction Acts section of the proposed deeming rule and did most of the work preparing this posting.  Rebecca Williams provided the estimate of the number of kids purchasing tobacco products online.
 

Comments

Comment: 

Stan - I am not sure how you calculated an estimate of 1 million kids buying tobacco products on-line during the previous year.  The survey data seem to indicate that 85,000 did so during the previous 30 days.  The only way I can see how you got to 1 million is by multiplying 85,000/month times 12 months/year = ~1 million/year.  If that is what you did, then you've assumed that different kids purchase on-line each month, which is most  likely not true.  Please correct me if I am wrong.
Gary Giovino

Comment: 

You're right.  The same kids could be making several purchases.
 
So I revised to the post to say 1 million "purchases by kids" a year.

Comment: 

Under the proposed deeming rule, no retailer may sell covered products to any person younger than 18 years of age.  Internet sellers are “retailers” for purposes of this provision and hence this prohibition applies to them.  If this prohibition is to be meaningful with regard to internet sales, it should be accompanied by strong requirements for age verification.  The language FDA has proposed requires clarification. 
 
With regard to cigarettes and smokeless tobacco products, the provisions of the PACT Act, P.L. 111-154, provide detailed requirements for age verification.  Any final deeming rule should, at a minimum, explicitly incorporate these requirements for deemed products as well.  FDA has authority under Section 906(d) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, to establish such requirements for sales of the deemed products.
 
Mark Greenwold

Comment: 

Back in 2011 the FDA announced  an Advanced Notice of Proposed Rule Making on /sites/tobacco.ucsf.edu/files/u9/FDA-2011-N-0467-0001%20-%20advance%20notice%20of%20proposed%20rulemaking%20on%20non%20face-to-face%20sales.pdf" target="_blank";"Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products" [Docket No. FDA–2011–N–0467] and solicticed public comments on "data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients.
 
Three are particularly relevant to the deeming rule.&nbsp;<strong;<em; (Not only should the FDA follow the recommendations in these comments, but they also will be very helpful to anyone preparing public comments on the deeming rule.)&nbsp; </em;</strong;
&nbsp;
Rebecca S. Williams, MHS, PhD,&nbsp; Kurt M. Ribisl, PhD,&nbsp; and Catherine Jo, BA from the /sites/tobacco.ucsf.edu/files/u9/UNC%20Comments%20on%20non%20face-to-face%20sales.pdf" target="_blank";University of North Carolina at Chapel Hill provided a detailed 22 page summary of the scientific evidence that demonstrated that internet sales of tobacco products were easly accessible to youth and that existing rules and procedures, including those my which sellers nominally conducted age verification were ineffective at preventing easy access to tobacco products.&nbsp; Their bottom line is:
<blockquote;
Non-face-to-face tobacco sales represent a major challenge to policy efforts to restrict youth access and collect taxes. Unless the FDA can develop, implement, and effectively enforce regulations to ensure that (1) minors are unable to obtain tobacco products through non-face-toface sales and (2) state and federal taxes are collected on all non-face-to-face sales, such sales should be banned. [page 2]
&nbsp;
</blockquote;
The /sites/tobacco.ucsf.edu/files/u9/National_Association_of_Attorneys_General_NAAG_Comment.pdf" target="_blank";National Association of Attorney Generals, provided a 19 page summary of the current legal situation, including "the results of a study that NAAG commissioned to test the effectiveness of age and identify verification methods used on the promotional websites of certain major tobacco companies."&nbsp; The Attorneys General's bottom line is:&nbsp;
<blockquote;
The basic conclusion we wish to convey in our comments is that, despite the enactment of the PACT Act, the existing legal framework with respect to non-face-to-face sales is not adequately protecting the public health. The reason for this conclusion is that, as discussed in more detail below, the promotion and sale of tobacco products through non-face-to-face sales continue to take place without adequate age and identity verification; such sales continue to evade state tax laws; and states' efforts to enforce their laws continue to be frustrated by jurisdictional limitations and the ability of direct sellers to put up new websites even if a state successfully enforces its law against such sellers.&nbsp; [page 2]
</blockquote;
&nbsp;
A /sites/tobacco.ucsf.edu/files/u9/2012-01-19%20CTFK%20and%20other%20PH%20Groups%20Comments%20on%20Non-face-to-face%20sales.pdf" target="_blank";large group of health organizations submitted a 16 page comment that summarized both the scientific data and legal problems that internet sales created for implementing effective tobacco control policies.&nbsp; Their bottom line is:
<blockquote;
Non face-to-face sales present a serious challenge both to effective enforcement of age verification requirements and to effective enforcement of state laws.&nbsp; As a result, remote sales threaten two of the most important pillars of tobacco control policy.&nbsp; ... FDA might consider requiring non-face-to-face sellers of tobacco prodcuts to agree to comply with all federal and state laws, to implement effective age verification measures, and to submit to regular inspections of their books and records as a condition of being permitted to sell such products.&nbsp; However, unless FDA can develop and implement regulations that ensure in practice that remote sales undermine neither age verification requirements not the enforcement of state laws, such sales should be prohibited.&nbsp; [page 5]
&nbsp;
</blockquote;
It is exceptionally troubling that after the FDA specifically invited public comment on these issues through a formal advanced notice of proposed rulemaking and these organizations invested considerable effort in preparing these sophisticated and detailed scientific and legal analyses, the FDA failed to even acknowledge any of this information in the proposed deeming rule, much less use it to propose either meaningful controls on internet sales or prohibit them all together (which these commenters make a strong case for doing).&nbsp;
&nbsp;
I have submitted this information, as well as the three comments discussed here, as a public comment so that this material will be in the current docket.&nbsp; (I am sure that the commenters will also be submitting their own updated comments, too.)
&nbsp;
<em;<strong;The FDA and the White House need to use this information in developing the final rule to ensure that the online sales loophole is closed.</strong;</em;
&nbsp;
The comment number is/sites/tobacco.ucsf.edu/files/u9/FDA-comment-resubmitting-internet-comments-1jy-8c53-tjmc.pdf" target="_blank"; /sites/tobacco.ucsf.edu/files/u9/FDA-comment-resubmitting-internet-comments-1jy-8c53-tjmc.pdf" target="_blank";1jy-8c53-tjmc.

Comment: 

Thank you, Stan, for calling attention to this huge exception to the rules intended to prevent easy access to tobacco products by minors -- rules to help protect a new generation from the addiction that has harmed the generations before them.&nbsp; I'm sure many of us haven't paid much attention to 21 CFR 1140.16(c)(2)(i), which very clearly exempts mail-order sales from the requirement of face-to-face sales of cigarette products.&nbsp; Replicating this exception for e-cigarettes and cigars makes no sense: what FDA needs to do is eliminate the exception, not just for newly-deemed tobacco-related products, but for <em;all </em;tobacco products, by not replicating it in the deeming regulations <em;and </em;immediately noticing a modification of its existing rules.
&nbsp;
As you say, times have changed.&nbsp; It may have seemed logical to allow mail-order sales in the late '90s, when there was hardly any e-commerce.&nbsp; Also, the notion that teenagers wouldn't <em;patiently wait </em;for delivery of cigarettes may have made sense then.&nbsp; But today delivery is even <em;faster </em;than the two-day Amazon Prime example you cite.&nbsp; Google Shopping Express and others promise <em;same-day delivery from local stores</em;.&nbsp; They may not be selling cigarettes or e-cigarettes now, but this model will be replicated: I can see "buy cigarettes/e-cigarettes at our online store; orders will be fulfilled locally and delivered (by Addiction Express?) within hours."&nbsp; So the mail-order exception is in my mind, as you refer to it, a huge loophole for teenagers to get cigarettes.&nbsp;
&nbsp;
Surely fine minds can figure out an enforceable verification methodology if there really is a “need” for mail-order cigarette/tobacco products, as has been suggested earlier by FDA, for people in rural areas and people too disabled (including by emphysema?) to purchase cigarettes face-to-face.&nbsp; Methods exist for delivery of certain prescription medications, for example.&nbsp;
&nbsp;
Given enforcement issues, I would like to see a registration requirement for those who engage in the mail-order sale of tobacco products.&nbsp; Shippers would be required to verify that the seller sending out packages is registered before agreeing to accept them for delivery.&nbsp; (And the major shippers would surely comply.)&nbsp; If there is registration, there is something to take away if the rules for age verification are violated.&nbsp; It shouldn’t be made difficult to <em;get </em;registered, but just be a requirement.&nbsp; Since regulating sales via the Internet is well-nigh impossible, one has to look "downstream" to the delivery mechanisms to have control.&nbsp;
&nbsp;
Again, thanks for publicizing this gusher of a loophole in the regulations.
&nbsp;
Marsha N. Cohen
Hon. Raymond L. Sullivan Professor of Law
<em;Founding Executive Director, Lawyers for America</em;
UC Hastings College of the Law
200 McAllister Street
San Francisco, CA 94102
415.565.4676
&nbsp;

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