Guidance for Industry      
 
 
 
Applications for Premarket  
Review of New Tobacco  
Products   
 
 
 
DRAFT GUIDANCE   
 
This guidance document is being distributed for comment purposes only. 
 
 
 
Comments and suggestions regarding this draft document should be submitted within 90 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 
Alternatively, electronic comments may be submitted to http://www.regulations.gov. All 
comments should be identified with the docket number listed in the notice of availability that 
publishes in the Federal Register. 
 
 
 
For questions regarding this draft guidance, contact the Center for Tobacco Products at (Tel) 1-877- 
287-1373 or refer to: 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services   
Food and Drug Administration   
Center for Tobacco Products   
 
 
 
September 2011    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
 
 
Guidance for Industry 
 
 
 
Applications for Premarket 
Review of New Tobacco 
Products 
 
 
 
 
DRAFT GUIDANCE 
Additional copies are available online at: 
http://www.fda.gov/TobaccoProducts 
You may also send an e-mail request to AskCTP@fda.hhs.gov to receive an electronic copy 
of the guidance. 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
 
 
September 2011    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Table of Contents 
 
 
I.  Introduction....................................................................................................................... 1 
 
 
II.  Background ....................................................................................................................... 2 
 
 
III.  Definitions......................................................................................................................... 3 
A.   Tobacco Product ........................................................................................................ 3 
B.  New Tobacco Product................................................................................................ 3 
 
 
IV.  Discussion ......................................................................................................................... 3 
A.   Who Submits a PMTA? ............................................................................................. 3 
B.  When Should You Submit a PMTA?......................................................................... 4 
C.  How Should You Submit a PMTA? .......................................................................... 6 
D.   How Will We Review a PMTA? ............................................................................... 8 
 
 
V.    Contents of a PMTA ......................................................................................................... 8 
A.   Full Reports of Investigations of Health Risks .......................................................... 9 
B.   Full Statement of All Components, Ingredients, Additives, and Properties, and of 
the Principle or Principles of Operation of the New Tobacco Product.................... 10 
C.   Full Description of Methods of Manufacturing and Processing .............................. 12 
D.   Compliance with Tobacco Product Standards ......................................................... 13 
E.   Samples and Components ........................................................................................ 13 
F.  P  roposed Labeling ................................................................................................... 14 
 
VI.  Information to support a showing that the new tobacco product is appropriate for the 
protection of public health ............................................................................................. 15 
A.   General Principles for Scientific Studies ................................................................. 16 
B.  Product Chemistry ................................................................................................... 17 
C.  Nonclinical Studies .................................................................................................. 18 
D.   Studies in Adult Human Subjects ............................................................................ 19 
 
 
VII. Investigational Use of New Tobacco Products ............................................................... 20 
A.   Exemptions for Investigational Use of New Tobacco Products .............................. 20 
B.  Studies Conducted Outside of the United States ..................................................... 22 
 
 
VIII. Confidentiality ............................................................................................................... 22    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
 
1  
   Guidance for Industry
 
 
 
 
Applications for Premarket 
Review of New Tobacco Products 
 
 
   
This draft guidance, when finalized, will represent the Food and Drug Administration's 
(FDA's) current thinking on this topic.  It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public.  You can use an alternative 
approach if the approach satisfies the requirements of the applicable statutes and 
regulations.  If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance. If you cannot identify the appropriate FDA 
staff, call the appropriate number listed on the title page of this guidance. 
   
 
I.  Introduction 
 
 
This draft guidance is intended to assist persons submitting applications for new tobacco 
products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 
21 U.S.C. 301 et seq.), as amended by the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act) (Public Law 111-31).  This draft guidance explains, 
among other things: 
 
  Who may submit a new tobacco product application under section 910 of the 
FD&C Act (21 U.S.C. 387j); 
  When to submit a new tobacco product application; 
  How to submit a new tobacco product application; 
  What information the FD&C Act requires you to submit in a new tobacco product 
application; and 
  What information FDA recommends you submit in a new tobacco product 
application. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
 
1 This guidance was prepared by the Office of Science and Office of Regulations in the Center for Tobacco 
Products at FDA. 
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II.  Background 
 
 
When you create a new tobacco product or modify a tobacco product in any way, you 
must obtain an order from FDA authorizing the marketing of the product before the 
product may be introduced or delivered for introduction into interstate commerce (section 
910(a)(2); 21 U.S.C. 387j(a)(2)). This includes "a change in design, any component, any 
part, or any constituent, including a smoke constituent, or in the content, delivery, or 
form of nicotine, or any other additive or ingredient (section 910(a)(1)(B)). 
 
Where a new tobacco product is not substantially equivalent to a tobacco product 
commercially marketed in the United States as of February 15, 2007 (see section 
910(a)(2)(A)(i)) or exempt from the requirement to obtain a substantial equivalence 
determination pursuant to regulation (see section 910(a)(2)(A)(ii)), you must submit a 
premarket tobacco product application (PMTA) under section 910(b) of the FD&C Act 
and receive a marketing authorization order under section 910(c)(1)(A)(i) prior to 
marketing the product. 
 
Section 910(c)(1)(A)(ii) of the FD&C Act requires that FDA deny a PMTA and issue an 
order that the product may not be introduced or delivered for introduction into interstate 
commerce where FDA finds that: 
 
  You have not shown that the product is appropriate for the protection of the public 
health; 
  The manufacturing methods, facilities, or controls do not conform to 
manufacturing regulations issued under section 906(e) (21 U.S.C. 387f(e)); 
  The proposed labeling is false or misleading; or 
  You have not shown that the product complies with any tobacco product standard 
in effect under section 907 (21 U.S.C. 387g). (Section 910(c)(2); 21 U.S.C. 
387j(c)(2)) 
 
Section 910(c)(1) of the FD&C Act requires that FDA issue an order stating whether the 
product may be introduced into interstate commerce "[a]s promptly as possible, but in no 
event later than 180 days after the receipt of an application." 
 
Under section 902(6)(A) of the FD&C Act (21 U.S.C. 387b(6)(A)), a tobacco product is 
deemed adulterated if it is a new tobacco product and it "does not have an order in effect 
under section 910(c)(1)(A)(i)" as necessary under section 910(a) of the FD&C Act. 
Under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), the introduction or delivery 
for introduction into interstate commerce of any adulterated tobacco product is a 
prohibited act. Violations of section 910 are subject to regulatory and enforcement action 
by FDA, including but not limited to, seizure and injunction. 
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III.  Definitions 
 
 
This section provides definitions of certain terms used in this guidance. 
 
A.  Tobacco Product 
 
 
Tobacco product means any product made or derived from tobacco that is intended for 
human consumption, including any component, part, or accessory of a tobacco product 
(except for raw materials other than tobacco used in manufacturing a component, part, or 
accessory of a tobacco product) (section 201(rr) of the FD&C Act; 21 U.S.C. 321(rr)). 
Thus, the term is not limited to products containing tobacco, but also includes 
components, parts, or accessories of tobacco products, whether they are sold for further 
manufacturing or for consumer use.  For example, cigarette rolling papers and filters are 
tobacco products, whether they are sold to consumers for use with roll-your-own tobacco 
or are sold for further manufacturing into a product sold to a consumer, such as a 
cigarette.  This term does not include an article that is a drug, a device, or a combination 
product as defined in the FD&C Act (section 201(rr)(2) of the FD&C Act; 21 U.S.C. 
321(rr)(2)). 
 
B.  New Tobacco Product 
 
 
A new tobacco product means any tobacco product (including those products in test 
markets) that was not commercially marketed in the United States as of February 15, 
2007; or any modification (including a change in design, any component, any part, or any 
constituent, including a smoke constituent, or in the content, delivery or form of nicotine, 
or any other additive or ingredient) of a tobacco product where the modified product was 
commercially marketed in the United States after February 15, 2007 (section 910(a)(1) 
of the FD&C Act). 
 
IV.  Discussion 
 
A.  Who Submits a PMTA? 
 
 
Persons seeking a marketing authorization order under section 910(c)(1)(A)(i) must 
submit a PMTA to FDA. 
 
The term "new tobacco product" is defined in section 910(a)(1) of the FD&C Act and 
includes any regulated tobacco products, including their components, parts, or 
accessories, whether sold for further manufacturing or for consumer use. 
 
At this time, FDA intends to limit its enforcement of the requirements of section 910 to 
finished, regulated tobacco products. These finished, regulated tobacco products include 
the products named in section 901(b) (i.e., cigarettes, cigarette tobacco, smokeless 
tobacco and roll-your-own tobacco) and tobacco products that may be deemed by 
  3    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
 
regulation to be subject to the FD&C Act, as well as the component parts of regulated 
tobacco products sold or distributed for consumer use (e.g., cigarette rolling papers, 
filters, or filter tubes sold separately to consumers or as part of kits). To avoid the 
submission of duplicative information, FDA does not intend at this time to enforce the 
requirements of section 910 for components of regulated tobacco products that are sold or 
distributed solely for further manufacturing into finished tobacco products. We anticipate 
receiving relevant information regarding such new tobacco products in the PMTA 
submission for the finished regulated tobacco product. Where there is a change to a 
component or ingredient of a finished tobacco product, that change constitutes a 
modification of the tobacco product and you must obtain the appropriate marketing 
authorization order for the finished tobacco product that contains the changed ingredient or 
component prior to marketing the finished tobacco product. 
 
B.  When Should You Submit a PMTA? 
 
 
Except as described below, you must submit a PMTA and obtain a marketing 
authorization order under section 910(c)(1)(A)(i) of the FD&C Act prior to the 
introduction or delivery for introduction of a new tobacco product into interstate 
commerce. As defined in section 910(a)(1) of the FD&C Act, a new tobacco product is 
any tobacco product that was not commercially marketed in the United States as of 
February 15, 2007 or any product that was commercially marketed as of February 15, 
2007 but which was subsequently modified. 
 
1.  Relationship of the PMTA process to section 905(j) substantial 
equivalence reports 
 
Section 910 of the FD&C Act provides that manufacturers of new tobacco products may 
submit a substantial equivalence report under section 905(j) (21 U.S.C. 387e(j)) and 
obtain a substantial equivalence order under section 910(a)(2)(A)(i) as an alternative to 
submitting a PMTA and obtaining a marketing authorization order under section 
910(c)(1)(A)(i). To obtain a substantial equivalence order, the 905(j) report must 
demonstrate that the product is substantially equivalent to a predicate product and 
otherwise in compliance with the FD&C Act (section 910(a)(2); 21 U.S.C. 387j(a)(2)) 
(for details on obtaining a substantial equivalence order see FDA's Guidance for Industry 
and FDA Staff Section 905(j) Reports: Demonstrating Substantial Equivalence for 
Tobacco Products).  Furthermore, a new tobacco product may be exempted from the 
requirement to obtain a substantial equivalence order or a marketing authorization order 
if the product is exempt from the requirements of section 905(j) pursuant to a regulation 
issued under section 905(j)(3).2 
 
For new tobacco products that are not exempt from premarket review pursuant to a 
regulation issued under section 905(j)(3), the following table details when you must 
 
 
 
2 See Tobacco Products, Exemptions from Substantial Equivalence Requirements (76 FR 38961, July 5, 
2011). 
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obtain a marketing authorization order prior to introducing your product into interstate 
commerce: 
 
If your new tobacco product . . .  Then . . . 
Is marketed before March 22, 2011 and  You may market your product unless and 
you submit a 905(j) report for the  until FDA issues an order stating that the 
product by March 22, 2011  product is not substantially equivalent or not 
in compliance with the FD&C Act. If FDA 
issues such an order, you must cease 
marketing the product and cannot market 
the product again without first obtaining a 
marketing authorization order from FDA 
under either section 910(c)(1)(A)(i) or 
910(a)(2)(A)(i) of the FD&C Act. 
Is marketed before March 22, 2011 and  You must cease marketing the product as of 
you did not submit a 905(j) report for  March 22, 2011 and cannot market the 
the product by March 22, 2011  product again without first obtaining a 
marketing authorization order from FDA 
under either section 910(c)(1)(A)(i) or 
910(a)(2)(A)(i) of the FD&C Act. 
Will be marketed on or after March 22,  You may not market the product without 
2011  first obtaining a marketing authorization 
order from FDA under either section 
910(c)(1)(A)(i) or 910(a)(2)(A)(i) of the 
FD&C Act. 
 
2.  Relationship of the PMTA process to section 911 modified risk tobacco 
product applications 
 
Section 911(d) describes the statutory requirements for filing an application for a 
modified risk tobacco product (21 U.S.C. 387k(d)). A modified risk tobacco product is 
defined, in part, as "any tobacco product that is sold or distributed for use to reduce harm 
or the risk of tobacco-related disease associated with commercially marketed tobacco 
products" (section 911(b)(1) of the FD&C Act). Under section 911(l)(1), FDA is 
required to issue regulations or guidance, or any combination thereof, on the scientific 
evidence required for the assessment and ongoing review of modified risk tobacco 
products. 
 
Sections 910(b) and 911(d) of the FD&C Act describe separate applications for new 
tobacco products and modified risk tobacco products. Under section 911(l)(4) of the 
FD&C Act (21 U.S.C. 387k(l)(4)), FDA is required to issue regulations or guidance that 
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will permit you to submit a single application for any tobacco product that is a new 
tobacco product under section 910 and that you seek to commercially market as a 
modified risk tobacco product. Until that time, however, if you intend to market a new 
tobacco product as a modified risk tobacco product you must submit two separate 
applications  one to satisfy the requirements of section 910 and another to satisfy the 
requirements of section 911. 
 
3.  Relationship of the PMTA process to section 904 submission of listing of 
ingredients 
 
Section 904(c)(1) of the FD&C Act (21 U.S.C. 387d(c)(1)) requires that no later than 90 
days prior to introducing a new brand or subbrand into the market, the manufacturer of 
such product shall provide [to FDA] the information required under subsection [904](a). 
This information includes, but is not limited to, a listing of all ingredients of the tobacco 
product (section 904(a)(1)). Section 904(c)(2) of the FD&C Act requires that the 
manufacturer . . . advise [FDA] in writing . . . at least 90 days prior to the addition of or 
increase to an additive that has not been designated by FDA as an additive that is not a 
human or animal carcinogen. Section 904(c)(3) of the FD&C Act requires that the 
manufacturer notify FDA within 60 days of decreasing or eliminating any additive, or 
adding or increasing an additive that FDA has designated is not a human or animal 
carcinogen. FDA encourages you to submit the information required under sections 
904(c)(1), (2), or (3) prior to, or concurrent with, your PMTA and that you reference 
those submissions in your PMTA (for information on ingredient listing, see FDA's 
Guidance for Industry Listing of Ingredients in Tobacco Products). 
 
Please note that if you have submitted a PMTA and FDA issues an order authorizing 
marketing of the product under section 910(c)(1)(A)(i) of the FD&C Act within 90 days 
of receipt of a complete submission under section 904(c)(1) or (2), the product may not 
be delivered for introduction into interstate commerce until the conclusion of the 90 day 
period following the section 904(c)(1) or (2) submission.3 
 
C.  How Should You Submit a PMTA? 
 
 
FDA recommends that an application for premarket review of a new tobacco product 
include the following: 
 
  A cover letter (including the name and address of your company; an authorized 
contact's name, title, address, phone number, e-mail address, and fax number; the 
 
 
3 As discussed above, some new tobacco products may not be subject to the PMTA requirements, either 
because FDA has issued an order that the new tobacco product is substantially equivalent and in 
compliance with the requirements of the FD&C Act (see section 910(a)(2)(A)(i)), or because the product is 
exempt from the substantial equivalence requirements pursuant to a regulation issued under 905(j)(3) of the 
FD&C Act (see section 910(a)(2)(A)(ii)).  Such products must still comply with section 904(c) of the 
FD&C Act and, consequently, may not be introduced into interstate commerce until 90 days after FDA has 
received the necessary submission under section 904(c)(1) or (2) of the FD&C Act. 
  6    Contains Nonbinding Recommendations 
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name of your new tobacco product; any previous regulatory history, e.g., any 
prior section 905(j) decision); dates of any prior meetings with FDA about your 
tobacco product; and any request for review of your application by the Tobacco 
Products Scientific Advisory Committee (TPSAC)); and 
  An executive summary (including an overview of your application; a description 
of your tobacco product; a summary of nonclinical and clinical studies and major 
findings; and why you believe allowing marketing of your new tobacco product is 
appropriate for the protection of the public health). 
 
As set forth in section 910(b)(1) of the FD&C Act, and discussed in greater detail in 
section V of this guidance, your application must include: 
 
  Full reports of all investigations of health risks (including studies submitted to 
support your showing that the tobacco product is appropriate for the protection of 
the public health as discussed in Section VI below); 
  A full statement of all components, ingredients, additives, and properties, and of 
the principle or principles of operation of such tobacco product; 
  A full description of methods of manufacturing and processing (which includes a 
listing of all manufacturing, packaging, and control sites for the product, 
including the facility name, address, and telephone number, and a contact name 
for each facility including the contact's telephone number and e-mail address); 
  An explanation of how your product complies with any applicable tobacco 
product standards; 
  Samples of the product and its components; and 
  Specimens of proposed labeling. 
 
Furthermore, FDA's regulations implementing the National Environmental Policy Act of 
1969 require that "[a]ll applications... requesting agency action require the submission of 
an [environmental assessment] or a claim of categorical exclusion" (21 CFR 25.15(a)). 
Currently there are no categorical exclusions in place for tobacco products; therefore, you 
must submit an environmental assessment as part of your PMTA. You should refer to 21 
CFR Part 25 for additional information. 
 
If you do not submit information on any of the above items, please include a statement 
that the information is not being submitted and an explanation of why the information is 
not being submitted. 
 
As discussed later in this guidance, section 910(b)(1)(E) requires that you submit 
"samples of such tobacco product and of components thereof" as FDA may reasonably 
require. Samples of your new tobacco product and components should be sent to: 
 
Southeast Regional Laboratory 
U.S. Food and Drug Administration 
60 8th Street 
Atlanta, GA 30309 
  7    Contains Nonbinding Recommendations 
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You should submit these samples to FDA on the same date as your PMTA.  Each sample 
submission should be accompanied by a cover letter with information sufficient to link the 
sample(s) and/or component(s) to your premarket application, including your company's 
name and address, an authorized contact's name, title, address, phone number, e-mail 
address, and fax number, the name of your new tobacco product, and any other 
identifying information. You should also provide the shipping conditions used to submit 
the samples to FDA, the recommended storage conditions, the date of manufacture of the 
samples, and the dating period (shelf life). You should include a copy of this cover letter 
with your PMTA. 
 
While electronic submission of your application is not required at this time, FDA is 
strongly encouraging electronic submission to facilitate efficiency and timeliness of data 
submission and processing. FDA intends to provide and update information on its 
website on how you may provide an electronic submission to FDA (e.g., information on 
media and methods of transmission). 
Your application should be clearly labeled as a PMTA and sent to: 
 
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
D.  How Will We Review a PMTA? 
 
 
FDA will review your PMTA consistent with the requirements of section 910(c) of the 
FD&C Act. Under this section, FDA is required to review a PMTA "as promptly as 
possible, but in no event later than 180 days after the receipt of an application" (section 
910(c)(1)(A)).  After initial receipt of your application, FDA may request additional 
information about your PMTA as necessary. 
 
Under section 910(b)(2) of the FD&C Act, FDA may, upon your request or on its own 
initiative, refer your PMTA to TPSAC.  Please include any request that FDA refer your 
PMTA to TPSAC in the cover letter to your initial PMTA submission. Note that FDA 
has discretion in deciding whether to refer your PMTA to TPSAC. 
 
At any time, you may withdraw your PMTA.  You should notify FDA in writing of a 
decision to withdraw your application. This notification should be clearly labeled as a 
PMTA withdrawal and sent to the address previously listed for receiving PMTAs. 
 
V.  Contents of a PMTA 
 
 
Your PMTA must include the information discussed below that is required by section 
910(b)(1) of the FD&C Act. 
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A.  Full Reports of Investigations of Health Risks 
 
 
Section 910(b)(1)(A) of the FD&C Act requires that a PMTA contain "full reports of all 
information, published or known to, or which should reasonably be known to, the 
applicant, concerning investigations which have been made to show the health risks of 
such tobacco product and whether such tobacco product presents less risk than other 
tobacco products. FDA interprets the information required under this provision to 
include, not only investigations that support the application, but also any investigations 
that do not support, or are adverse to, the application. Information on both nonclinical 
and clinical investigations should be provided, including, but not limited to, any studies 
assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and 
consumer use profiles. Further, information on investigations concerning products with 
novel components, ingredients, additives or design features that are similar or related to 
those of the new tobacco product and investigations concerning products that share novel 
components, ingredients, additives or design features with the new tobacco product should 
also be provided so that FDA may adequately assess the health risks of the product.  To 
the extent the information is available, you should indicate the source of funding for all 
studies provided. 
 
FDA interprets "full reports of all information, published or known to, or which should 
reasonably be known to, the applicant" to include all information from investigations 
conducted both within and outside the United States.4  While all clinical investigations 
(both within and outside the United States) submitted to support your application should 
be conducted to ensure that the rights, safety, and welfare of human subjects have been 
protected, you must submit full reports of all information concerning relevant clinical 
investigations even if the study did not protect the rights, safety, and welfare of human 
subjects. 
 
For published studies concerning investigations which have been made to show the health 
risks of your tobacco product, you should provide a bibliography of the studies and an 
abstract for each study. You should also provide an explanation of the scope of the 
literature review you conducted to discover the relevant published studies, including how 
you identified, collected, and reviewed the studies. 
 
As discussed in section VI of this guidance, the data and information you submit in your 
PMTA must be sufficient to show that the marketing of your new tobacco product is 
"appropriate for the protection of the public health" (section 910(c)(4) of the FD&C Act). 
Your application should include a summary of the results of each study you submit to 
support your showing.  The summary should include, where available or reasonably 
obtainable: 
 
 
4 As discussed in section VII of this guidance, well-controlled investigations conducted outside the United 
States may be submitted to FDA in support of a PMTA.  If you submit a study or studies conducted outside 
the United States in support of your application, you should provide an explanation of how the rights, 
safety, and welfare of human subjects were protected or if you do not know and are unable to provide this 
information (e.g., because you were not the sponsor of those studies), you should explain why. 
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  A description of the study objective, 
  A description of the study design (or hypothesis tested), 
  A description of any statistical analysis plan, including how data were collected 
and analyzed, and 
  A brief description of the findings and conclusions (positive, negative, or 
inconclusive). 
 
In addition, for each study showing the health risks of your product, you should include, 
to the extent available or reasonably obtainable: 
 
  Documentation of all actions taken to ensure the reliability of the study and the 
protection of human subjects  for example, documentation of study oversight 
by an Investigational Review Board (IRB) duly constituted and operating under 
21 CFR Part 56, documentation of informed consent procedures such as 
appropriate procedures found in 21 CFR Part 50, and documentation of 
appropriate good laboratory practices such as those found in 21 CFR Part 58 
(see additional details provided in section VII of this guidance); 
  The original study protocol(s) and any amendments; 
  If investigator instructions were produced in addition to the protocol, copies of 
all such instructions; 
  The statistical analysis plan including a detailed description of the statistical 
analyses used, including all variables, confounders, and subgroup analyses, the 
reason for your choice of sample size (including calculations of the power of 
each study and the level of significance and/or confidence interval used), and 
any amendments; 
  All raw data (To facilitate our review, we request data in SAS-transport file 
format, created by a procedure that allows the files to be readily read by the JMP 
software. We also request that you provide data definition files that include the 
names of the variables, codes, and formats used in each dataset, and copies of 
SAS programs and any necessary macro programs used to create derived 
datasets and the results reported in the study reports.); 
  All versions of questionnaires used; 
  All versions of case report forms used; 
  All informed consent forms; and 
  A full report of the findings. 
 
B.  Full Statement of All Components, Ingredients, Additives, and 
Properties, and of the Principle or Principles of Operation of the New 
Tobacco Product 
 
 
As required in section 910(b)(1)(B) of the FD&C Act, your application must contain a 
"full statement of the components, ingredients, additives, and properties, and of the 
principle or principles of operation" of your new tobacco product. 
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1.  Components, ingredients, and additives 
 
Section 910(b)(1)(B) of the FD&C Act requires you to submit a full statement of the 
components, ingredients, and additives of your tobacco product as part of your PMTA. 
FDA interprets this requirement to mean that you must provide a complete list of 
uniquely identified components, ingredients, and additives by quantity in your new 
tobacco product as well as the applicable specifications and a description of the intended 
function for each. Components, ingredients, and additives include anything that may 
reasonably be expected to result directly or indirectly in becoming part of, or affecting the 
characteristics of, the finished new tobacco product. This includes, but is not limited to, 
for example, tobacco (including type(s)), paper, glue, additives, burn-rate controllers, and 
pH modifiers. 
 
For guidance on uniquely identifying components, ingredients, and additives and 
reporting their quantities, please refer to FDA's Guidance for Industry Listing of 
Ingredients in Tobacco Products. 
 
2.  Properties 
 
Section 910(b)(1)(B) of the FD&C Act requires you to submit as part of your PMTA a 
full statement of the properties of the tobacco product. FDA interprets a full statement 
of the properties of the new tobacco product to mean a full narrative description of the 
tobacco product, including: 
 
  A description of the form of the product (e.g., liquid, gel, dissolvable, 
combustible, chewable, dip, strip, stick, orb); 
  A description of the product dimensions and the overall construction of the 
product (using a diagram or schematic drawing that clearly depicts the finished 
product and its components with dimensions, operating parameters, and 
materials); 
  A description of all design features of the product (e.g., location of ventilation 
holes, heat source, paper porosity, coatings, nicotine concentration gradient); the 
description should specify nominal values or the explicit range of values as well 
as the design tolerance, where appropriate; 
  A description of tobacco blending, reconstitution, or manipulation; 
  A quantitative description of the performance criteria (e.g., burn rate, ventilation 
criteria, dissolution rate); 
  A description of how the product differs from similar, currently marketed tobacco 
products; 
  Summaries of the results of tests performed on the lot(s) represented by the 
submitted samples; and 
  Established shelf life of the product (you should include data establishing the 
stability of the product through the stated shelf life). 
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3.  Principles of operation 
 
Section 910(b)(1)(B) of the FD&C Act requires you to submit as part of your PMTA a 
full statement of the principle or principles of operation of the tobacco product. FDA 
interprets a full statement of the . . . principle or principles of operation to mean: 
 
  A full narrative description of the way in which a consumer will use the new 
tobacco product, including a description of how a consumer operates the product 
(e.g., whether a consumer places the tobacco product in the mouth or nose, 
whether a consumer ignites the tobacco product and by what means, whether the 
product is designed to be smoked, inhaled, swallowed, dissolved, sniffed, or 
chewed); 
  How long it takes for a consumer to consume a single unit of the product; and 
  Whether the product uses a heating source and, if so, a description of the heat 
source (e.g., burning coal or other substance, electric or butane, chemical reaction, 
carbon tip). 
 
C.  Full Description of Methods of Manufacturing and Processing 
 
 
As required in section 910(b)(1)(C) of the FD&C Act, you must provide a full description 
of the methods used in, and the facilities and controls used for, the manufacture, 
processing, and, where relevant, packing and installation of the new tobacco product.5 
 
You should provide a listing of all manufacturing, packaging, and control sites for the 
product, including the facility name and address, and a contact name and telephone 
number for each facility. Moreover, you should provide a narrative description, 
accompanied by a list and summary of all standard operating procedures (SOPs) and 
examples of relevant forms and records for the following categories of information: 
 
  Manufacturing and production activities, including a description of facilities and 
all production steps; 
  Managerial oversight and employee training; 
  Manufacturing processes and controls for product design and changes in products, 
including a hazard analysis that details the correlation of the product design 
attributes with public health risk, as well as any mitigations implemented; 
  Activities related to identifying and monitoring suppliers and the products 
supplied (including, for example, purchase controls and product acceptance 
activities); 
  Validation and verification activities used to ensure that the tobacco product 
matches specifications; 
  Testing procedures carried out before the product is released to market; and 
 
5 The requirement to provide a full description of methods of manufacturing and processing is separate and 
distinct from good manufacturing practice requirements, for which FDA will promulgate regulations 
pursuant to section 906(e) of the FD&C Act. When such regulations have been promulgated, they will 
contain specific information applicants should address in this section of an application. 
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  Handling of complaints, nonconforming products and processes, and corrective 
and preventative actions. 
 
FDA may request that you submit copies of selected SOPs if needed to enable FDA to 
more fully understand the methods used in, and the facilities and controls used for, the 
manufacturing and processing of the tobacco product. 
 
D.      Compliance with Tobacco Product Standards 
 
 
As required in section 910(b)(1)(D) of the FD&C Act, you must identify any tobacco 
product standard under section 907 of the FD&C Act that would be applicable to your 
new tobacco product, and provide adequate information that either shows that your new 
tobacco product fully meets the tobacco product standard or justifies any deviation from 
such standard. 
 
E.      Samples and Components 
 
 
You must provide with your PMTA samples of your new tobacco product and of 
components of your new tobacco product as FDA may reasonably require (section 
910(b)(1)(E)).  FDA may conduct its own testing and analyses of your new tobacco 
product and its components. Consequently, your PMTA should include a sufficient 
number of samples for FDA to conduct any testing and analyses. 
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For the categories of new tobacco products described below, FDA recommends that you 
provide the following number of samples necessary for FDA to conduct testing and 
analyses of your new tobacco product. If you believe a different number of samples is 
appropriate, you should explain why. 
 
Type of New  Recommended 
Tobacco Product  Number of 
Samples 
Cigarette and  4,000 pieces 
cigarette-like tobacco  (approximately 
products  20 cartons) 
Roll-your-own  4,000 grams 
tobacco 
Smokeless tobacco in  200 pieces 
pre-measured units of 
use (e.g., moist or dry 
snuff in sachets) 
Loose smokeless  200 grams 
tobacco (e.g., chewing 
tobacco, moist snuff) 
Finished component  200 pieces 
tobacco products sold 
separately to 
consumers (e.g. 
cigarette rolling paper) 
 
In addition to samples of your finished tobacco product, the FD&C Act requires that you 
provide samples of the components (e.g., tobacco filler, filter(s), and/or paper(s)) of your 
new tobacco product as FDA may reasonably require. FDA will request samples of 
component parts of your new tobacco product if needed. In addition, as part of your 
PMTA you should provide summaries of the results of any tests you performed on the 
lot(s) represented by the submitted samples. 
 
F.  Proposed Labeling 
 
 
As required in section 910(b)(1)(F) of the FD&C Act, the PMTA must include specimens 
of all proposed labeling for your new tobacco product. Labeling is defined in section 
201(m) of the FD&C Act as, "all labels and other written, printed, or graphic matter (1) 
upon any article or any of its containers or wrappers, or (2) accompanying such article," 
and includes labels, inserts/onserts, instructions, and other accompanying information or 
materials (21 U.S.C. 321(m)). 
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VI.  Information to support a showing that the new tobacco 
product is appropriate for the protection of public health 
 
 
The information provided in the application described in section V.A of this guidance 
should present data and information sufficient to enable FDA to make a finding that the 
marketing of a new tobacco product is "appropriate for the protection of the public 
health" (section 910(c)(4) of the FD&C Act). The statute provides that the basis for this 
finding shall be determined: 
 
with respect to the risks and benefits to the population as a whole, including users 
and nonusers of the tobacco product, and taking into account  
 
(A)  the increased or decreased likelihood that existing users of tobacco products 
will stop using such products; and 
 
(B) the increased or decreased likelihood that those who do not use tobacco 
products will start using such products. 
 
Section 910(c)(2)(A) of the FD&C Act requires that FDA deny applications where there 
is a lack of a showing that permitting such tobacco product to be marketed would be 
appropriate for the protection of the public health.6 
 
Under section 910(c)(5)(A) of the FD&C Act, whether a new tobacco product is 
appropriate for the protection of public health shall be determined when appropriate... 
on the basis of well-controlled investigations.7  Therefore, FDA recommends that you 
provide data from the studies described below. 
 
FDA also recommends you provide a detailed explanation of how the data and 
information provided in the application support a finding that introducing your new 
tobacco product to the market is appropriate for the protection of the public health. FDA 
recommends that your explanation include a comparison of the new tobacco product to 
tobacco products currently on the market. 
 
 
 
6 In addition, the statute provides that FDA shall deny applications under section 910(c)(2) where: 
 
(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or 
packing of such tobacco product do not conform to the requirements of section 906(e); 
(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in 
any particular; or 
(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in 
effect under section 907, and there is a lack of adequate information to justify the deviation from 
such standard. 
 
7 In addition, section 910(c)(5)(B) provides that if the Secretary determines that there exists valid scientific 
evidence sufficient to evaluate the tobacco product, the Secretary may authorize that the determination 
whether the new tobacco product meets the public health standard be made on the basis of such evidence. 
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FDA requests comment on how best to evaluate whether an applicant has demonstrated 
that a new tobacco product is appropriate for the protection of the public health. We 
request comment on what product chemistry, nonclinical, and adult human subject 
studies could be used to demonstrate that the marketing of the product is appropriate for 
the protection of the public health. We also request comment on establishing a baseline 
for determining whether a new product affects the likelihood that tobacco users will quit 
or the likelihood that non-users will start using such products. 
 
A.  General Principles for Scientific Studies 
 
 
Under section 910(c)(4) of the FD&C Act, your new tobacco product will be evaluated to 
determine whether the product is appropriate for the protection of the public health 
considering the risks and benefits, including the health risks of the product and the 
likelihood of changes in initiation and cessation rates. These considerations will allow 
for an evaluation of the impact of the new tobacco product on morbidity and mortality for 
the population as a whole. In demonstrating the public health impacts of the product, 
data from your well-controlled scientific investigations should address, among other 
things, the following questions: 
 
(1) How do the health risks associated with your product compare to the health risks 
of other products on the market? How do the health risks of switching from another 
tobacco product to your product compare to the health risks associated with quitting 
the use of tobacco products? How do the health risks associated with your product 
compare to never using tobacco products? Accordingly, your scientific studies 
regarding health risks of your new tobacco product should allow for a comparison of 
the health risks of your tobacco product to the risks associated with quitting, using 
other tobacco products, and never using tobacco products. 
 
(2) How will your new tobacco product affect the likelihood that current tobacco 
users will cease using tobacco products? In making this evaluation, you should 
address the attractiveness of your product and product labeling to current tobacco 
users (especially to those users interested in quitting smoking), the addictiveness and 
abuse liability of your product, and cessation rates associated with users who switch 
to your new tobacco product. Additionally, you should provide evidence regarding 
the likelihood that your new product will be used concurrently with other tobacco 
products currently on the market. Your evaluation of the impact of the introduction 
of your new tobacco product on cessation rates should provide data on the 
attractiveness, addictiveness, and cessation rates of your new tobacco product as 
compared to other tobacco products currently on the market. 
 
(3) How will your new tobacco product affect the likelihood that never-users and 
former-users of tobacco products will use your new tobacco product? In making this 
evaluation, you should address the attractiveness of your product and product labeling 
to never-users and former-users of tobacco products (especially to those segments of 
the population that may be particularly likely to initiate or reinitiate tobacco use), as 
well as the addictiveness and abuse liability of your product. To provide a full 
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evaluation of the impact of your product on the market and on the population as a 
whole, your scientific evaluations should provide data on how the attractiveness and 
addictiveness of your product compares to that of products currently on the market. 
You should specify what product features may enhance the attractiveness/appeal of 
your product to children and adolescents and what product features may minimize the 
attractiveness/appeal of your product to children and adolescents. 
 
All of your scientific evaluations should use control groups of comparator products and 
use various tobacco use levels sufficient to address the questions and considerations 
above. For example, in evaluating the health risks of your product, clinical studies 
should provide data on biomarkers for users of other tobacco products as well as 
biomarkers for quitters and never-users. Similarly, product chemistry evaluations should 
compare your new products chemistry to other tobacco products currently on the market. 
 
In addition, your studies should follow a pre-specified statistical analysis plan for data 
analysis to ensure the validity of your conclusions. 
 
FDA encourages persons who would like to study their new tobacco product to meet with 
the Office of Science at the Center for Tobacco Products to discuss their investigational 
plan prior to distributing the product for investigational purposes (see section VII, 
below). 
 
B.  Product Chemistry 
 
 
Product chemistry, while not determinative of issues related to the public health impact of 
your new tobacco product, is relevant to our evaluation of the health risks and 
addictiveness of your product and provides context for evaluating other nonclinical and 
clinical data submitted in support of your PMTA. 
 
For each new tobacco product, you should report the levels of harmful and potentially 
harmful constituents (HPHC), including smoke constituents, as appropriate to the 
product.8  For new tobacco products that are smoked (e.g., cigarettes), quantitative levels 
should be determined in smoke generated using both the ISO and Canadian Intense 
smoking regimens. If an alternative to these testing methods is used, you should provide 
the basis for your selection of the alternative method. 
 
FDA recommends reporting HPHC information in a tabular format using separate 
columns, in the order listed below (from left to right) for each of the following: 
 
  The constituent name, 
  The constituent's common name(s), 
 
 
8 For a discussion of harmful and potentially harmful constituents, including smoke constituents, in tobacco 
products or tobacco smoke, see FDA's Guidance for Industry and FDA Staff "Harmful and Potentially 
Harmful Constituents" in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and 
Cosmetic Act. 
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  The corresponding Chemical Abstract Services number, 
  The unit of measure, 
  The level measured for the submitted product (with 95% confidence intervals), 
  The sample size, and 
  The method of measuring and reference quotes. 
 
FDA recommends separate tables for results generated using the ISO and Canadian 
Intense smoking regimens. Documentation should be provided showing that the 
laboratories used to produce measurements have accreditation by a nationally or 
internationally recognized external accreditation organization. Documentation of such 
accreditation should be included in your application. 
 
C.  Nonclinical Studies 
 
 
Nonclinical studies provide important probative information regarding the health risks 
and addictiveness of tobacco products. While nonclinical studies alone generally are not 
sufficient to support a determination that the product is appropriate for the protection of 
the public health, the information from these studies provides insight into the mechanisms 
of disease incidence caused by a tobacco product and more generally provides context for 
the data regarding health risks and addictiveness obtained from human studies. 
 
Your nonclinical investigation should evaluate the toxicity, abuse liability, and 
carcinogenicity of your new tobacco product as compared to other tobacco products on 
the market. 
 
You should generate data to evaluate these product properties using some combination of 
in vitro, in vivo, and/or ex vivo studies. The study designs should include adequate sample 
sizes (test samples or animal numbers) for robust statistical analyses and a range of 
biologically relevant concentrations. The models used in your studies should be 
sufficiently sensitive to the endpoint being evaluated. You should provide evidence and 
an explanation of the sensitivity and probative value of the nonclinical model chosen. 
For example, if you choose an Ames mutagenicity assay as part of an evaluation of the 
carcinogenicity of your tobacco product, you should explain: 
 
  Why the assay is appropriate for evaluating your tobacco product, 
  How the Ames assay has been used historically, 
  What scientific evidence there is that the assay is useful in evaluating 
carcinogenicity and mutagenicity, 
  The choice of strain of test bacteria, 
  The choice of method of product administration, and 
  What scientific evidence there is that the assay is sensitive enough to demonstrate 
a dose-response relationship and distinguish between tobacco products. 
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For in vivo studies, the test product should be administered through the route 
representative of human exposure, where feasible. 
 
D.  Studies in Adult Human Subjects 
 
 
The primary goal of investigations in adult human subjects is to evaluate the health risks 
of a new tobacco product by assessing the effects of the new tobacco product on human 
health and behavior (i.e., pattern of use and tobacco use topography, toxicant exposure 
and biological effect, abuse potential, and consumer perception). These studies will 
provide FDA with important information to enable it to determine whether the product is 
appropriate for the protection of the public health. 
 
Study protocols should specify the study design, conduct, and statistical analysis plan for 
analyzing the data collected to ensure the validity of the results. The extent to which the 
procedures in the protocol are followed and data analysis methods used are pre-specified 
will contribute to the degree of confidence in the final results and conclusions of your 
study. The interpretation of statistical measures of uncertainty of the effects of tobacco 
products and tobacco products comparisons should involve consideration of the potential 
contribution of bias to the p-value, confidence interval, or other inferences. 
 
Your studies in adult human subjects should provide the following evaluations of your 
tobacco product: 
 
  Tobacco user exposure to tobacco-related compounds; 
  Tobacco user health risk and disease incidence; 
  Tobacco product use patterns (e.g., smoking topography, frequency of use, and/or 
use by different age groups), including evaluation of consumers' use of the new 
tobacco product concurrently with other products already on the market; 
  Abuse liability and addictiveness; 
  Consumer perceptions including risk perceptions based on the product itself, as 
well as on the packaging and labeling of the new tobacco product; and 
  Cessation rates for users of the new tobacco product. 
 
You should conduct studies so as to ensure that the study findings are generalizable to the 
population of U.S. tobacco users and non-users as a whole. This requires careful 
consideration of study size, subject selection, and study duration. You should design 
subject selection to ensure sampling of a population that reflects the diversity of the U.S. 
adult tobacco user population. In addition, you should consider oversampling of 
populations particularly likely to be affected, whether positively or negatively, by the entry 
of a new tobacco product onto the market. 
 
Based upon the endpoint(s) to be evaluated in a particular clinical investigation, you 
should identify the control group to be used.  For example, in a study designed to assess 
the effect of a new tobacco product on disease risk, the study might include multiple 
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comparator groups based on tobacco use levels (e.g., smokers of less than 10 cigarettes 
per day, smokers of 10 or more cigarettes per day, and former users). 
 
The duration of the study should be sufficient to ensure that the endpoint(s) studied can be 
adequately assessed to provide clinically meaningful and statistically valid and robust 
findings. For example, a study of the products effect on cessation from tobacco use may 
take longer than an assessment of the tobacco products use topography. 
 
VII.  Investigational Use of New Tobacco Products 
 
A.  Exemptions for Investigational Use of New Tobacco Products 
 
 
FDA plans to issue regulations pursuant to section 910(g) (21 U.S.C. 387j(g)) providing 
conditions under which tobacco products may be exempted from the requirements of 
section 910 when used for investigational purposes.  Until these regulations are issued, 
FDA will consider exercising discretion in enforcing the premarket review requirements 
of Chapter IX of the FD&C Act, in some circumstances, for the purposes of 
investigational use of new tobacco products. Applicants who would like to study their 
new tobacco products should contact the Office of Science at the Center for Tobacco 
Products to discuss submission of a study protocol and/or study endpoints for 
investigations intended to support a PMTA. 
 
You should send your request for a meeting in writing to the Director of the Center for 
Tobacco Products Office of Science at the following address: 
 
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
The meeting request should include adequate information for FDA to assess the potential 
utility of the meeting and to identify FDA staff necessary to discuss proposed agenda 
items, including the following: 
 
  A brief statement of the purpose of the meeting, including the name of your new 
tobacco product, a brief description of the product, and the role of your planned 
study(s) in overall product development plans; 
  A list of your specific questions grouped by discipline; 
  A proposed agenda, including objectives and outcomes expected from the 
meeting; 
  A list of all individuals (including titles) expected to attend the meeting on your 
behalf; and 
  An investigational plan for evaluating whether your product is appropriate for the 
protection of the public health, including a summary of your proposed study 
protocol(s). 
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We recommend that the summary of your proposed study protocol(s) include the 
following information: 
 
  Study objective(s); 
  Study hypotheses; 
  Background information (a brief description of the new tobacco product and any 
regulatory history); 
  Study design; 
  Study population (number of subjects to be enrolled, inclusion/exclusion criteria, 
comparison group(s)); 
  Human subject protection information including IRB information; 
  Primary and secondary endpoints (definition and success criteria); 
  Statistical analysis plan (description of the statistical methods to be employed, the 
reason for your choice of sample size, including calculations of the power of each 
study and the level of significance and/or confidence level to be used); 
  Data collection procedures; and 
  Duration of follow-up and baseline and follow-up assessments. 
 
Pre-meeting preparation is critical for achieving a productive discussion or exchange of 
information. After FDA schedules a meeting, we request that you submit a fully 
paginated meeting package, organized according to the final agenda, containing a 
detailed description of your new tobacco product, the status of product development, an 
investigational plan for evaluating whether the product is appropriate for protection of the 
public health (including a summary of your proposed study protocols), the specific 
questions to be discussed, and background information relevant to those questions. 
 
FDA's receipt of a complete meeting package, including clearly articulated questions for 
FDA, well in advance of a meeting will enable FDA staff to review the information 
adequately and is therefore important to achieving a productive meeting. 
 
While the design of studies will be discussed on a case-by-case basis, at this time FDA 
does not intend to enforce the premarket review requirements in Chapter IX of the FD&C 
Act with respect to the use of tobacco products in studies that follow the specifications 
listed below that will help ensure that the studies are well-controlled, data derived from 
such studies are reliable, and study subjects are adequately protected. 
 
For all studies (both clinical and nonclinical) you should: 
 
  Limit direct distribution of the product to qualified and appropriately trained 
investigators 
  Not promote or test market an investigational tobacco product for commercial 
distribution, 
  Account for receipt, use, and disposition of all investigational product(s), and 
  Label the product for investigational use only. 
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For clinical studies, you should: 
 
  Take measures to ensure the reliability and validity of the study, for example 
through sound study design and adherence to the study protocol. In addition you 
should ensure that all studies are conducted such that the rights, safety, and welfare 
of human subjects have been protected in accordance with ethical principles 
acceptable to the world community and that the data are scientifically valid. One 
approach to implementing such measures would be to conduct the study in 
accordance with appropriate provisions found in 21 CFR Part 50 (informed 
consent of human subjects) and ensure that the IRB oversight is governed by 21 
CFR Part 56 (IRB review and approval of clinical investigations). Additional 
information about informed consent and IRBs may be found in FDA's guidance 
documents. Applicants with specific questions about human subject protections 
are encouraged to contact the Center for Tobacco Products. 
  Ensure that all study subjects receiving product be current tobacco product users 
at least 21 years of age. 
 
For nonclinical studies, you should: 
 
  Take measures to ensure the reliability and validity of the study. One approach to 
implementing such measures would be to follow good laboratory practices as 
specified in 21 CFR Part 58.  Additional information about good laboratory 
practice regulations may be found in FDA's guidance documents. Applicants 
with specific questions about good laboratory practice regulations are encouraged 
to contact the Center for Tobacco Products. 
 
B.  Studies Conducted Outside of the United States 
 
 
You may submit studies of new tobacco products conducted outside the United States as 
part of your PMTA.  All studies conducted outside the U.S. should be conducted to 
ensure that the rights, safety, and welfare of human subjects have been protected in 
accordance with ethical principles acceptable to the world community and that the data 
are scientifically valid and applicable to the U.S. population. The investigator should 
conduct these studies in conformance with international standards for good clinical 
practices or obey the laws and regulations of the country in which the research is 
conducted, whichever affords the greater protection of human subjects. These patient 
protection and data integrity measures help ensure that data from studies conducted 
outside the United States constitute well-controlled investigations (see section 
910(c)(5)(A) of the FD&C Act) that provide reliable data to FDA. 
 
VIII.  Confidentiality 
 
 
Information submitted under section 910 of the FD&C Act may include, but is not 
limited to, a companys non-public, trade secret, or confidential commercial information. 
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Several laws govern the confidentiality of new tobacco product information submitted 
under section 910, including sections 301(j) and 906(c) of the FD&C Act (21 U.S.C. 
331(j) and 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of 
Information Act (FOIA) (5 U.S.C. 552) as well as FDAs implementing regulations. 
 
FDAs general regulations concerning the public availability of FDA records are 
contained in 21 CFR Part 20. 
  23