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Premarket Review of Tobacco Products / 1
FDA Tobacco Project
A Dangerous Loophole in the Process for FDA Approval of
New Tobacco Products
The Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug
Administration unprecedented authority to regulate tobacco products.1 One of the most powerful
tools available to the FDA under the Tobacco Control Act is to decide whether or not a new
tobacco product can be introduced to the market.2 In theory, this gatekeeping role for the FDA
should allow it to prevent those products with the most potential to harm public health from ever
making it to retail store shelves.
However, the tobacco industry has exploited a loophole that allowed it to introduce thousands of
new addictive and deadly products without FDA authorization and the FDA has done very little
thus far to stop this manipulation. In fact, while the FDA has publicized its actions on some
product applications, it has failed to prioritize the removal of non-compliant, loophole-exploiting
products from the market. At the same time, it has continued to authorize new products for sale,
allowing the tobacco product market to grow.
This problem is mostly hidden from the public health community. The FDA has not made it a
priority to explain the fairly technical application approval process – or how the agency is
implementing this process – in sufficient depth, using terms that the general public can
understand. This fact sheet will explain the process for authorizing the marketing of new
products and provide information on FDA’s actions to date.
FDA Authority over New Products
The Tobacco Control Act creates three pathways by which the tobacco industry can receive FDA
authorization to put additional products on the market: 1) Premarket Tobacco Product
Applications, 2) Substantial Equivalence Reports, and 3) Exemptions from Substantial
Equivalence Reports. Each pathway has its own review process.
1) Premarket Tobacco Product Applications (PMTA)
The “Premarket Tobacco Product Application” pathway for new products is what most would
imagine when they learn that the Tobacco Control Act requires the FDA to decide whether or not
new products can enter the market. The FDA often refers to the pathway by the acronym,
“PMTA.” The pathway is intended to be the primary process for the FDA to decide whether it is
Premarket Review of Tobacco Products / 2
appropriate for new tobacco products to enter the market. This pathway should be used for any
products that are different from all other products marketed before February 15, 2007. An
application should be denied by the FDA if: 1) the product does not appropriately protect public
health,3 considering the product’s impact on initiation and cessation;4 2) the manufacturing
process for the product does not meet established standards;5 3) the labeling of the product is
false or misleading;6 or 4) the product does not meet a product standard set by the FDA.7
Little information is available regarding how the FDA reviews these applications because the
tobacco industry did not submit any applications of this type until August 2013 and then only
submitted four.8 The FDA had 180 days to approve or deny these applications,9 and in February
2014, the agency announced that it rejected the submissions because they were deficient.10
Because they were rejected and could be modified and then resubmitted, the FDA did not
disclose their contents.
2) Substantial Equivalence Reports (SE)
The “Substantial Equivalence Report” pathway, or the “SE” pathway, is the review process for
new products that are similar to products already on the market. This process is intended to be
used for products that have the same characteristics as products marketed as of February 15,
2007,11 or that have different characteristics that do not raise different questions of public
health.12
This product pathway requires a comparison between an existing product, which the FDA calls a
predicate product, and the new product yet to be marketed. If the FDA finds that the existing
product was commercially marketed (not test marketed) in the United States on February 15,
2007, it can be named as a predicate product on this type of application.13 A product that is
authorized for sale under this pathway can also serve as a predicate product on another
application even if the authorized product was not on the market until after February 15, 2007, as
long as the product is compliant with any product standards established by the FDA.14
3) Substantial Equivalence Exemption (SE Exemption)
The third method the industry can use to seek FDA authorization a new product is to file a
request for exemption from Substantial Equivalence stating that, for example,15 a new product is
so similar to a predicate product (described above) that the difference between the two is minor
and the submission of a full report demonstrating substantial equivalence is not necessary to
protect public health.16 The Tobacco Control Act provides an example of a product that might be
exempt from the SE report process: a product that is only different from an existing product
because an additive was deleted or added or where the level of an existing additive was increased
or decreased.17
Premarket Review of Tobacco Products / 3
Figure 1.
Premarket
Tobacco Product
Application
(PMTA)
Substantial
Equivalence (SE)
Substantial
Equivalence
Exemption (SE
Exemption)
Greatest Uniqueness of Product as Compared to Products
Already on the Market
Least
Greatest
Potential to Affect Public Health
Least
Greatest
Rigor of Scientific Review
Least
The Loophole that Allows Thousands of Products to Avoid Premarket Review
Under the first and third pathways listed above – the pathways for products that are entirely
different from products already on the market (PMTA) or for the products that the industry
claims should be exempt from the SE report process due to their similarity to products already on
the market (SE Exemption) – no products can be introduced to the market until after the FDA
has reviewed and approved the industry’s applications.
Similarly, for any industry applications filed after March 22, 2011, under the second pathway –
seeking FDA approval to sell new tobacco products because they are similar to other products
already on the market (SE) – the new products cannot be sold until the FDA grants permission.
However, industry applications that were filed under the SE pathway by March 22, 2011 are
treated differently. The Tobacco Control Act states that the new products listed in these
Premarket Review of Tobacco Products / 4
applications can be introduced to the market and stay on the market until the FDA reviews the
applications and decides to require that the product be removed from the market. The
applications that fall within this category are called “Provisional Substantial Equivalence” or
“Provisional SE” reports, all other SE reports are called “Regular” SE reports.
With its sophisticated knowledge of the Tobacco Control Act and instinct for profit-seeking at
the expense of public health, the tobacco industry orchestrated a massive exploitation of this
loophole in the new product authorization process. The industry flooded the FDA with
Provisional SE reports just before the March 22, 2011 deadline, bringing the total number of
Provisional SE reports to 3,517.18 This activity is striking considering that the industry filed only
959 Regular SE reports after March 22, 2011,19 and only 63 total product applications under the
pathways that are entirely subject to premarket review (4 PMTAs and 59 SE Exemption
requests).20 This means that 77% of the 4,539 applications that the FDA has received to allow
new products to enter the market were submitted through the loophole that allows the industry to
sell the products before they can be reviewed by the FDA.21 Figure 2 attempts to put this tactic
into perspective.
Figure 2.
59
Tobacco Product Applications
4
959
PMTA
(preapproval required)
Regular SE
(preapproval required)
3,517
Provisional SE
(can enter the market
without preapproval)
SE Exempt
(preapproval required)
While the FDA publicizes its actions on pending SE reports, even considering the actions taken
on Regular SE reports, the total amount of FDA action in the context of all SE reports is very
small. The agency’s action with respect to Provisional SE reports is even smaller. In the four
years since the vast majority of the Provisional SE reports were submitted, the FDA has only
acted on 11 Provisional SE reports.22 After 181 industry withdrawals, 3,325 reports remain,
representing products that can be sold to consumers even though they have not been subject to
any federal oversight. In addition, only 142 of these reports are currently under scientific
Premarket Review of Tobacco Products / 5
review.23 The FDA’s stated commitment to prioritizing Regular rather than Provisional SE
reports perpetuates this problem caused by the loophole.24 Figure 3 shows FDA action for
Regular and Provisional SE reports separately as well as all both categories combined.25
Figure 3.
Provisional SE Reports - Regular SE Reports - 959 total
(preapproval required)
3,517 total
(can enter the market
without preapproval)
11
All SE Reports - 4,476
total
144
181
133
521
486
305
3,84
6
3,325
FDA Action
(denial, approval, or refusal to accept)
Industry Withdrawals
Pending Reports
Because Regular SE reports represent products that are not yet on the market, delayed review of
these reports poses no threat to public health. However, delaying action on Provisional SE
reports, as the FDA continues to commit to doing, allows the tobacco industry to continue to sell
deadly and addictive products that have not been scrutinized by the FDA.
The Proposed Deeming Regulation Multiplies the Problem
The public health threat caused by the FDA’s continued delay on Provisional SE reports will be
multiplied if the FDA finalizes the Deeming Regulation as it is currently proposed.26 The
proposed regulation will bring additional classes of tobacco products under the FDA’s regulatory
authority. According to the agency’s proposal, the FDA expects to receive 54 PMTAs, 4,208 SE
reports, and 1,402 SE Exemption requests in the first two years after the regulation takes effect.27
These estimates may be low because the FDA expects that the regulation will result in over
13,000 new products being brought under its authority and long delays in the finalization and
implementation of this rule will allow more tobacco products to be introduced in the interim. All
of these new product applications will need to be reviewed, as will the FDA’s existing backlog
of applications. That problem cannot be avoided.
Premarket Review of Tobacco Products / 6
However, the FDA has proposed to defer enforcement of premarket review of all new products
that would now fall within its jurisdiction – regardless of the pathway – for 24 months following
the regulation’s implementation. While a delay in the FDA’s approval or denial of the sale of
new products may not normally be a grave concern of the public health community, the FDA
proposes to establish that 24-month window as a new provisional period, meaning that the FDA
would allow the tobacco industry to market even more new products until the FDA reviews the
applications for those products and decides whether to order the products removed from the
market.
The FDA can solve this problem and best protect public health by taking two steps. First, it must
prioritize its review of existing Provisional SE reports filed under the loophole created by the
Tobacco Control Act. Second, the FDA’s Deeming Regulation must not create another loophole
in the premarket review process by allowing a provisional period for new tobacco product
applications for the products that will fall under its jurisdiction in the future.
For more in-depth information on the FDA’s review of tobacco product marketing applications,
see the Consortium’s Tobacco Product Applications webpage with other resources on this topic,
including our FDA Premarket Review Video Series.
Last updated: April 2015
The Tobacco Control Legal Consortium provides information and technical assistance on issues
related to tobacco and public health. The Consortium does not provide legal representation or
advice. This document should not be considered legal advice or a substitute for obtaining legal
advice from an attorney who can represent you. If you have specific legal questions,
we recommend that you consult with an attorney familiar with the laws of your jurisdiction.
Notes
1
Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111–31, 123 Stat. 1776 (2009)
(codified at 21 U.S.C. § 387).
2
21 U.S.C. § 387j.
3
21 U.S.C. § 387j(c)(2)(A).
4
21 U.S.C. § 387j(c)(4).
5
21 U.S.C. § 387j(c)(2)(B).
6
21 U.S.C. § 387j(c)(2)(C).
7
21 U.S.C. § 387j(c)(2)(D).
8
U.S. FOOD AND DRUG ADMIN., Total Number of Product Submission Received or Filed in the Month,
http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-product-submissionsreceived&fy=all (last visited December 3, 2014).
9
21 U.S.C. § 387j(c)(1)(A).
10
U.S. FOOD AND DRUG ADMIN., Tobacco Product Marketing Orders,
http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm (last visited
December 3, 2014); U.S. FOOD AND DRUG ADMIN., Brief Summary of “Refusal-to-File” Determinations,
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
(last visited May 13, 2014).
Premarket Review of Tobacco Products / 7
11
21 U.S.C. § 387j(a)(3)(A)(i).
21 U.S.C. § 387j(a)(3)(A)(ii).
13
21 U.S.C. § 387e(j)(1)(A)(i).
14
21 U.S.C. § 387e(j)(1)(A)(i).
15
An applicant may also indicate that a report “is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the public health,” or that “an exemption is
otherwise appropriate.” 21 U.S.C. § 387e(j)(3)(A)(ii)-(iii).
16
21 U.S.C. § 387e(j)(3).
17
21 U.S.C. § 387e(j)(3).
18
U.S. FOOD AND DRUG ADMIN., Cumulative Number of Substantial Equivalence (SE) Provisional
Reports Received, http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OSprovisional-SE-reports&fy=all (last visited December 3, 2014).
19
Id.
20
U.S. FOOD AND DRUG ADMIN., Total Number of Product Submission Received or Filed in the Month,
http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-product-submissionsreceived&fy=all (last visited December 3, 2014). All application totals current through September 30,
2014.
21
Id.
22
U.S. FOOD AND DRUG ADMIN., FDA News Release, FDA Issues First Orders to Stop Sale, Distribution
of Tobacco Products, Feb. 21, 2014,
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386707.htm (last visited
December 3, 2014).
23
U.S. FOOD AND DRUG ADMIN., Cumulative Number of Substantial Equivalence (SE) Provisional
reports received, http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-provisionalSE-reports&fy=all (last visited December 3, 2014).
24
See, e.g., U.S. FOOD AND DRUG ADMIN., TOBACCO PRODUCTS, WEBINARS, April 10, 2013, available at
http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductR
eviewandEvaluation/SubstantialEquivalence/ucm304518.htm; U.S. FOOD AND DRUG ADMIN., TOBACCO
PRODUCTS, WEBINARS, April 24, 2012, available at
http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductR
eviewandEvaluation/SubstantialEquivalence/ucm304518.htm; U.S. FOOD AND DRUG ADMIN., TOBACCO
PRODUCTS, WEBINARS, August 21, 2012, available at
http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductR
eviewandEvaluation/SubstantialEquivalence/ucm304518.htm.
25
FDA data on incoming applications is current through September 30, 2014, while the number of
industry withdrawals and FDA actions is current through November 30, 2014.
26
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; Proposed Rule, 79 Fed. Reg.
23,142 (proposed April 25, 2014) (to be codified at 21 C.F.R. pt. 1100, 1140, and 1143); see also
Tobacco Control Legal Consortium, FDA Takes Small Steps to Expand Tobacco Regulation (2014),
available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-fdatakesmallstepexpandtobaccoregulation-2014.pdf. For more information regarding the FDA’s proposed
Deeming Regulation, see the Consortium’s FDA Tobacco Action Center webpage about the FDA’s
regulation of other tobacco products.
27
Id.
12