Guidance for Industry 
 
Further Amendments to General 
Regulations of the Food and Drug 
Administration to Incorporate 
Tobacco Products (Revised)* 
Small Entity Compliance Guide 
Written comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, 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 
document contact the Center for Tobacco Products (CTP) at 1-877-CTP-1373. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
March 2023 
* This is the first revision to the first edition of this guidance, which issued in March 2012.  
    Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION......................................................................................................... 2 
II.  SUMMARY OF THE REGULATION AND THIS GUIDANCE ............................ 3 
III.  QUESTIONS AND ANSWERS ................................................................................... 3 
A.  What are the specific sections of the Code of Federal Regulations (CFR) which are 
impacted by this rule? ............................................................................................................ 3 
B.  How does this rule affect  1.21 of title 21 of the CFR? ..................................................... 3 
C.  How does this rule affect  1.101 of title 21 of the CFR? ................................................... 3 
D.  Does the revision to  1.101(b) alter FDAs enforcement policy regarding  
this section? .............................................................................................................................. 4 
E.  How does this rule affect  7.3 of title 21 of the CFR? ....................................................... 4 
F.  How does FDA define tobacco product? .......................................................................... 4 
G.  How does this rule affect  16.1(b) of title 21 of the CFR? ................................................. 4 
H.  Will FDA provide assistance for small businesses seeking additional information 
regarding this rule? ................................................................................................................ 5 
I.  What are the consequences if a company is found to be out of compliance? .................. 5 
J.  When does this rule become effective? ................................................................................. 5 
 
i    Contains Nonbinding Recommendations 
Guidance for Industry 
 
Further Amendments to General 
Regulations of the Food and Drug 
Administration to Incorporate Tobacco 
Products 
Small Entity Compliance Guide 
 
 
This guidance represents the Food and Drug Administrations (FDAs) 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 guidance is intended to help small businesses understand and comply with FDAs 
amendments to certain of its regulations to include tobacco products, where appropriate, in light 
of FDAs authority to regulate these products under the Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are 
subject to the same general requirements that apply to other FDA-regulated products. Parties 
must be in compliance with that final rule beginning on April 2, 2012. FDA has prepared this 
Small Entity Compliance Guide in accordance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121). 
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. 
2    Contains Nonbinding Recommendations 
II.  SUMMARY OF THE REGULATION AND THIS GUIDANCE 
In the Federal Register of April 14, 2011 (76 FR 20901), FDA published a proposed rule seeking 
to amend several provisions of its general regulations to reflect the Agencys new authority and 
mandate regarding tobacco products under the Tobacco Control Act (Public Law 111-31; 123 
Stat. 1776). The rule includes revisions to the document reporting requirements for FDA- 
regulated entities and the definition of product. In the Federal Register of February 2, 2012 
(77 FR 5171), FDA published the final rule, codified at 21 CFR parts 1, 7, and 16. 
III.  QUESTIONS AND ANSWERS 
A.  What are the specific sections of the Code of Federal Regulations (CFR) 
which are impacted by this rule? 
This rule amends  1.21, 1.101, 7.3, and 16.1 of title 21 of the CFR. 
B.  How does this rule affect  1.21 of title 21 of the CFR? 
Section 1.21(a) of title 21 provides that the labeling of FDA-regulated products 
shall be deemed misleading if it fails to reveal facts that are [m]aterial in light of 
other representations made or suggested by statement, word, design, device or any 
combination thereof; or [m]aterial with respect to consequences which may result 
from use of the article under: (i) The conditions prescribed in such labeling or (ii) 
such conditions of use as are customary or usual. With this rule change, tobacco 
product labeling also would be deemed misleading for similar failures to reveal 
material facts. This change is supported by section 903(a) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387c(a)), which states that a 
tobacco product shall be deemed misbranded if its labeling is false or misleading. 
Likewise, 1.21(c) of title 21 describes statements that are not permissible on 
labeling for FDA- regulated products. This final rule amends  1.21 to state that 
tobacco product labeling, like the labeling of other FDA-regulated products, may 
not have a statement of differences of opinion regarding the warnings on tobacco 
product packages or advertisements. This change is in accordance with sections 201 
and 204 of the Tobacco Control Act, as well as section 903(a) of the Tobacco 
Control Act generally. 
C.  How does this rule affect  1.101 of title 21 of the CFR? 
Section 1.101 outlines the notification and recordkeeping requirements for exports 
of FDA- regulated products under sections 801 or 802 of the FD&C Act (21 U.S.C. 
381 and 382) and section 351 of the Public Health Service Act (42 U.S.C. 262). 
Section 103(l) of the Tobacco Control Act specifically amends section 801 of the 
FD&C Act to include tobacco products on the list of FDA-regulated products that 
3    Contains Nonbinding Recommendations 
may be exported under this section. Therefore, this final rule revises  1.101(a) to 
indicate that this section also pertains to notifications records required for tobacco 
products pursuant to section 801 of the FD&C Act. 
D.  Does the revision to  1.101(b) alter FDAs enforcement policy 
regarding this section? 
The revision to  1.101(b) does not alter the enforcement policy described in the 
advance notice of proposed rulemaking that published in the Federal Register of 
June 1, 2004 (69 FR 30842). Thus, with regard to tobacco products, FDA intends to 
exercise enforcement discretion, as it does with exports generally, regarding the 
requirement for specific types of records under  1.101(b)(2) demonstrating that the 
exported product is not in conflict with the foreign countrys laws. 
E.  How does this rule affect  7.3 of title 21 of the CFR? 
Section 7.3 defines the term product to include all the specific items that are 
potentially subject to FDA's authority. This final rule amends  7.3 of the 
regulations to define product to also include tobacco products, as defined by the 
Tobacco Control Act. 
F.  How does FDA define tobacco product? 
Section 201(rr) to the FD&C Act defines tobacco product as any product made or 
derived from tobacco, or containing nicotine from any source, 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). The term tobacco product 
does not mean an article that under the Federal Food, Drug, and Cosmetic Act is: a 
drug (section 201(g)(1)); a device (section 201(h)); a combination product (section 
503(g)); or a food (section 201(f)) if such article contains no nicotine, or no more 
than trace amounts of naturally occurring nicotine. 
G.  How does this rule affect  16.1(b) of title 21 of the CFR? 
Section 16.1(b) lists the statutory and regulatory provisions that provide for the 
opportunity for a regulatory hearing. The final rule amends  16.1 to note those 
instances in the Tobacco Control Act where an opportunity for a regulatory hearing 
is specifically provided. They are: 
  Section 903(a)(8)(B)(ii) of the FD&C Act relating to the misbranding 
of tobacco products. 
4    Contains Nonbinding Recommendations 
  Section 906(e)(1)(B) of the FD&C Act relating to the 
establishment of good manufacturing practice requirements for 
tobacco products. 
  Section 910(d)(1) of the FD&C Act relating to the withdrawal of an order 
allowing a new tobacco product to be introduced or delivered for 
introduction into interstate commerce. 
  Section 911(j) of the FD&C Act relating to the withdrawal of an order 
allowing a modified risk tobacco product to be introduced or 
delivered for introduction into interstate commerce. 
H.  Will FDA provide assistance for small businesses seeking additional 
information regarding this rule? 
FDAs Center for Tobacco Products (CTP) has established an Office of Small 
Business Assistance in an effort to help small businesses access up-to-date 
information and comply with the requirements of the Tobacco Control Act. CTPs 
Office of Small Business Assistance can be reached at 
SmallBiz.Tobacco@fda.hhs.gov or at 1-877-CTP-1373  
(1-877-287-1373) Monday Friday, 9:00 a.m.  4:00 p.m. EDT. 
I.  What are the consequences if a company is found to be out of 
compliance? 
Violations of the FD&C Act could lead to, among other things, warning letters, 
criminal penalties, civil money penalties, injunction, seizure, and no-tobacco-sale 
orders. 
J.  When does this rule become effective? 
This rule becomes effective on April 2, 2012, which is 60 days after the rule 
published in the Federal Register. See 77 FR 5171. 
   
5    Contains Nonbinding Recommendations 
Document History 
March 2023Section IIIDefinition of tobacco product is updated to reflect statutory 
amendments made by the Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among 
other things, the legislation amends the definition of tobacco product in section 201(rr) of the 
FD&C Act to include products containing nicotine from any source. 
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