Extension of Certain Tobacco Product Compliance Deadlines

Extensionof

CertainTobaccoProductCompliance

DeadlinesRelatedtotheFinalDeeming

Rule

(Revised)*

Guidance for Industry

Comments may be submitted at any time for Agency consideration. Electronic comments

may be submitted to https://www.regulations.gov. Alternatively, submit written comments

to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630

Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified

with FDA-2017- D-2834.

For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-

877- CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT.

Additional copies are available online at

http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

You may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an

electronic copy of this guidance. You may send a request for hard copies to U.S. Food and

Drug Administration, Center for Tobacco Products, Attn: Office of Small Business

Assistance, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave.,

Silver Spring, MD 20993-2000.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Tobacco Products

March 2019

* This is the seventh revision to the first edition of this guidance, which issued in May 2017.

Contains Nonbinding Recom m endations

Table of Contents

I. INTRODUCTION ........................................................................................................... 1

II. BACKGROUND.............................................................................................................. 2

III. DISCUSSION .................................................................................................................. 3

A. FDA’s Extension of Certain Future Compliance Deadlines Related to the Final Deeming

Rule ................................................................................................................................................ 3

B. Compliance Policy for Certain Labeling and Health Warning Statement Requirements for

Cigars and Pipe Tobacco. ............................................................................................................ 3

C. Compliance Dates ......................................................................................................................... 4

IV. DOCUMENT HISTORY .............................................................................................. 15

Contains Nonbinding Recom m endations

ExtensionofCertainTobaccoProduct

ComplianceDeadlinesRelatedtothe

FinalDeemingRule

Guidance for Industry

I. INTRODUCTION

This guidance document is intended to assist any person who manufactures, packages,

sells, offers to sell, distributes, or imports for sale and distribution within the United States

newly regulated tobacco products, roll-your-own tobacco, and cigarette tobacco. This

guidance document discusses:1

· FDA’s extension of future compliance deadlines for certain provisions

under the May 2016 final Deeming rule

· Compliance Policy for Certain Labeling and Health Warning Statement

Requirements for Cigars and Pipe Tobacco

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and

This guidance was prepared by the Office of Regulations and the Office of Compliance and Enforcement in the Center for Tobacco Products at

FDA.

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; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81

FR 28974 (May 10, 2016).

This guidance represents the current thinking of the Food and Drug Administration (FDA or

Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or

the public. You can use an alternative approach if it satisfies the requirements of the applicable

statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for

this guidance as listed on the title page.

Contains Nonbinding Recom m endations

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.

II. BACKGROUND

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public

Law 111-31) granted FDA the authority to regulate the manufacture, marketing, and

distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless

tobacco products to protect the public health and to reduce tobacco use by minors. The

Tobacco Control Act also gave FDA the authority to issue regulations deeming other

products that meet the statutory definition of a tobacco product to be subject to chapter IX of

the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 901(b) of the FD&C Act).

In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all

products that meet the statutory definition of a tobacco product, except accessories of newly

deemed tobacco products, to be subject to FDA’s tobacco product authority. This included

electronic nicotine delivery systems (ENDS), cigars, waterpipe (hookah), pipe tobacco,

nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco

products that may be developed in the future (81 FR 28976).

Chapter IX of the FD&C Act now applies to newly regulated products, including sections

904(a)(1) and (4) (ingredient listing and health document submissions), 903(a)(4) and

(h) (establishment registration), 905(i)(1) (product listing), 907(a)(1)(B) (additional special

rules), 911 (modified risk claims), 904(a)(3) and 915 (harmful and potentially harmful

constituent reporting), 920 (labeling, recordkeeping, and records inspection), and 905 and

910 (premarket review requirements). The final rule also included several requirements that

apply to a subgroup of products referred to “covered tobacco products.”

903(a)(8) (labeling requirements), 904(c)(1) (timing of submissions), 905(b), (c), (d), and

In May 2017, FDA published the first edition of this guidance document, under which it

provided a three-month extension of all future compliance deadlines for requirements under

the final deeming rule. The May 2017 guidance applied to all categories of newly regulated

products, including ENDS (e.g., e-cigarettes and e-cigars), waterpipe (hookah), pipe tobacco,

and cigars, as well as the addictiveness warning requirement for RYO tobacco

and cigarette tobacco. The guidance noted that the three-month extension did not apply to

requirements under the final deeming rule where compliance deadlines already had passed,

such as mandatory age and photo-ID checks to prevent illegal sales to minors. It explained

that FDA would continue to enforce such requirements.

The final deeming rule defines covered tobacco product to include any tobacco product deemed to be subject to chapter IX of the FD&C Act

under 21 CFR 1100.2, but “excludes any component or part that is not made or derived from tobacco” (21 CFR 1140.3).

Contains Nonbinding Recom m endations

III. DISCUSSION

A. FDA’s Extension of Certain Future Compliance Deadlines Related to the Final

Deeming Rule

FDA is providing a further extension of certain future compliance deadlines for requirements

under the final deeming rule. This further extension applies to compliance deadlines relating

to premarket review requirements, specifically for substantial equivalence exemption requests

(SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product

applications (PMTAs).

The further extension of premarket review compliance deadlines covered by this guidance

applies to all categories of newly regulated products that were on the market on August 8,

2016, including ENDS (e.g. e-cigarettes and e-cigars), hookah, pipe tobacco, and cigars. The

compliance dates are being extended from November 8, 2017 (SE EX requests), May 8, 2018

(SE reports), and November 8, 2018 (PMTAs) to August 8, 2021 (SE EX requests, SE

reports, and PMTAs for newly regulated combustible tobacco products, such as most cigars,

pipe tobacco and hookah tobacco) and August 8, 2022 (SE EX requests, SE reports, and

PMTAs for newly regulated noncombustible tobacco products, such as most ENDS or e-

cigarettes).

The preamble to the May 10, 2016, final deeming rule explained that FDA was providing two

compliance periods: One for submission and FDA receipt of applications and one for

obtaining premarket authorization. It explained that under the latter compliance period:

Unless FDA has issued an order denying or refusing to accept the submission,

products for which timely premarket submissions have been submitted will be subject

to a continued compliance period for 12 months after the initial compliance period

described previously. For such products, FDA does not intend to initiate enforcement

for failure to have premarket authorization during this continued compliance period.

81 FR 29011 (May 10, 2016). The preamble further explained that this compliance policy did

not apply to any new tobacco product that was not on the market on August 8, 2016. Id.

FDA is revising the compliance policy relating to the period after FDA receipt of SE EX

requests, SE reports, and PMTAs for newly regulated products that were on the market on

August 8, 2016. Under this new compliance policy, there will be a continued compliance

period pending review of those applications (SE EX requests, SE reports, and PMTAs). This

compliance period will continue until the agency renders a decision on an application (i.e.,

issuance of: a Marketing Order; a No Marketing Order; a Refuse to File; or Refuse to Accept)

or the application is withdrawn.

B. Compliance Policy for Certain Labeling and Health Warning Statement

Requirements for Cigars and Pipe Tobacco.

Contains Nonbinding Recom m endations

On July 5, 2018, the U.S. District Court for the District of Columbia enjoined FDA from

enforcing the warning requirements for cigars and pipe tobacco (21 §§ CFR 1143.3 and

1143.5) until 60 days after the final disposition of the plaintiffs’ appeal in the case: Cigar

Ass’n of America v. FDA, No. 1:16-cv-01460 (D.D.C.) (order granting injunction pending

appeal); see also Cigar Ass’n of America v. FDA, No. 18-5195 (D.C.Cir.). FDA will not seek

to enforce the warning requirements for cigars and pipe tobacco until that order is lifted.

Additionally, FDA does not intend to enforce the section 903(a)(2) and 920(a) requirements

for cigars and pipe tobacco while the injunction remains in effect.

C. Compliance Dates

The new compliance dates for premarket applications are reflected in the chart in section

III.B., along with the compliance dates from the May 2017 guidance and the stay of

enforcement for cigar and pipe tobacco health warning statements described in section II.

The chart in section III.B has been revised from the first edition of this guidance, issued in

May 2017, to reflect this revised compliance policy.

For purposes of this guidance, FDA is using “future compliance deadlines” to refer to dates in

the future on which it intends to begin enforcement of certain requirements under the deeming

rule. Such dates include both (1) the effective date a particular requirement will become

effective as a matter of law (e.g., the effective date for the health warning requirements in 21

CFR part 1143) or (2) a compliance date that FDA has set as a matter of enforcement discretion,

stating that it does not intend to enforce a particular requirement that is already in effect for a

period of time in order to give industry more time to comply (e.g., compliance dates for various

provisions of the FD&C Act set forth in the preamble to the final deeming rule, see 81 FR

29006).

This guidance revises and updates the sixth edition of this guidance. As with the previous

editions, the compliance dates announced in this guidance supersede the compliance dates

included in any other guidance issued prior to this guidance.

The compliance dates for requirements under the final deeming rule are detailed in the

following chart. Requirements under the final deeming rule where compliance deadlines have

already passed are not affected by this guidance and are not listed on the chart.

See guidance, Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco (August 2018).

Contains Nonbinding Recom m endations

Table 1. Required Warning Statements

Provision

Products Affected

Requirement and Compliance Date

Under This Guidance

Product packages and ads must

contain the addictiveness

warning statement (21 CFR

1143.3(a) and (b)

• “WARNING: This product

contains nicotine. Nicotine is

an addictive chemical.”

• The warning must follow size

and format requirements.

Cigarette tobacco, roll-your-

own tobacco, and covered

tobacco products (other than

cigars and those covered

tobacco products that do not

contain nicotine)

FDA will not seek to enforce any of

the requirements relating to pipe

tobacco health warnings below until 60

days after the final disposition of the

plaintiffs’ appeal in the case: Cigar

Ass’n of America v. FDA, No. 1:16-cv-

01460 (D.D.C.) (order granting

injunction pending appeal); see also

Cigar Ass’n of America v. FDA, No.

18-5195 (D.C.Cir.).

Manufacturers, importers, distributors,

and retailers who direct their own

advertising:

Advertisements must bear the

addictiveness warning

August 10, 2018

Manufacturers cannot manufacture

products with noncompliant packages

August 10, 2018

Manufacturers cannot distribute such

products irrespective of the date of

manufacture

September 11, 2018

Retailers cannot offer for sale, sell,

distribute, or import products with

noncompliant packages manufactured

on or after August 10

, 2018 unless the

retailer falls with the retailer safe

harbor

August 10, 2018

Product packages and ads of

covered tobacco products that

do not contain nicotine may

Covered tobacco products that

do not contain nicotine

Manufacturers, importers, distributors,

and retailers who direct their own

advertising:

A retailer of any cigarette tobacco, roll-your-own tobacco, or covered tobacco products (other than cigars) will not be in violation of this section for packaging

that (i) Contains a health warning; (ii) I supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or

Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the

requirements of this section. 21 CFR 1143.3(a)(3)(ii).

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Provision

Products Affected

Requirement and Compliance Date

Under This Guidance

bear an alternative warning

statement:

• “This product is made from

tobacco.”

• Manufacturers must submit to

FDA a self-certification

• For more information, visit

FDA.gov and search for

“extending authorities”

Advertisements must bear the

alternative warning

August 10, 2018

Manufacturers cannot manufacture

products with noncompliant packages

August 10, 2018

Manufacturers cannot distribute such

products irrespective of the date of

manufacture

September 11, 2018

Retailers cannot offer for sale, sell,

distribute, or import products with

noncompliant packages manufactured

on or after August 10

, 2018 unless the

retailer falls with the safe harbor

August 10, 2018

Rotational cigar warning

statements on product

packages and ads (21 CFR

1143.5)

· Cigar product packages and

ads must contain warnings

that follow size format,

rotational, and distribution

requirements

· For more information, visit

FDA.gov and search for

“extending authorities”

Cigars

FDA will not seek to enforce any of

the requirements relating to cigar

health warnings below until 60 days

after the final disposition of the

plaintiffs’ appeal in the case: Cigar

Ass’n of America v. FDA, No. 1:16-cv-

01460 (D.D.C.) (order granting

injunction pending appeal); see also

Cigar Ass’n of America v. FDA, No.

18-5195 (D.C.Cir.).

Manufacturers, importers, distributors,

and retailers who direct their own

advertising:

Advertisements must bear one of the

required warnings

August 10, 2018

A retailer of any covered tobacco products that do not contain nicotine and may bear the alternative warning statement will not be in

violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product

manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued

license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this section.

Contains Nonbinding Recom m endations

Provision

Products Affected

Requirement and Compliance Date

Under This Guidance

Manufacturers cannot manufacture

products with noncompliant packages

August 10, 2018

Manufacturers cannot distribute such

products irrespective of the date of

manufacture

September 11, 2018

Retailers cannot offer for sale, sell,

distribute, or import products with

noncompliant packages manufactured

on or after August 10

, 2018 unless the

retailer falls with the safe harbor

August 10, 2018

Point-of-sale warning

statement requirement for

cigars sold individually without

packaging (21 CFR

1143.5(a)(3))

· Specific placement and

formatting requirements

· Sign must bear all six required

warnings

· For more information, visit

FDA.gov and search for

“extending authorities”

Cigars sold individually

without packaging

FDA will not seek to enforce any of

the requirements relating to cigar

health warnings below until 60 days

after the final disposition of the

plaintiffs’ appeal in the case: Cigar

Ass’n of America v. FDA, No. 1:16-cv-

01460 (D.D.C.) (order granting

injunction pending appeal); see also

Cigar Ass’n of America v. FDA, No.

18-5195 (D.C.Cir.).

August 10, 2018

Cigar warning plans on how

warnings will be randomly

displayed and distributed on

packages and rotated on

advertisements must be

submitted to and approved by

FDA (21 CFR 1143.5(c)(1))

Cigars

August 10, 2017

A cigar retailer will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by

the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau

(TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this

section.

Contains Nonbinding Recom m endations

Provision

Products Affected

Requirement and Compliance Date

Under This Guidance

For more information, visit

FDA.gov and search for

“extending authorities”

Contains Nonbinding Recom m endations

Table 2. Premarket Review Requirements

Compliance Period

Products Affected

Compliance Date Under This

Guidance

Compliance period for

manufacturers to submit a

substantial equivalence

exemption request (section 910

of the FD&C Act)

For more information, visit

FDA.gov and search for

“substantial equivalence”

New,

newly deemed finished

tobacco products

9, 10

that were

on the market as of August 8,

2016

August 8, 2021 (combustible tobacco

products)

August 8, 2022 (noncombustible

tobacco products)

Compliance period for

manufacturers to submit a

substantial equivalence

exemption report (section 910

of the FD&C Act)

For more information, visit

FDA.gov and search for

“substantial equivalence”

New, newly deemed finished

tobacco products

that were on

the market as of August 8, 2016

August 8, 2021 (combustible tobacco

products)

August 8, 2022 (noncombustible

tobacco products)

Compliance period for

manufacturers to submit a

premarket tobacco product

application (PMTA) (section

905 of the FD&C Act)

New, newly deemed finished

tobacco products

that were on

the market as of August 8, 2016

August 8, 2021 (combustible tobacco

products)

August 8, 2022 (noncombustible

tobacco products)

A “new tobacco product” is 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.

FDA has defined “finished tobacco product” as a tobacco product, including all components and parts, sealed in final packaging intended for consumer

use (e.g., filters or filter tubes sold separately to consumers or as part of kits).

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

Contains Nonbinding Recom m endations

Compliance Period

Products Affected

Compliance Date Under This

Guidance

For more information, visit

FDA.gov and search for

“premarket tobacco product

applications”

Contains Nonbinding Recom m endations

Table 3. Other Provisions

Provision

Products Affected

Compliance Date Under This

Guidance

Registration of establishments

engaged in the manufacture,

preparation, compounding, or

processing of tobacco product

and product listings (section

905(b), (c), (d), (h), and (i)(1) of

the FD&C Act

Newly deemed finished

tobacco products

For entities engaged in the

manufacture, preparation,

compounding, or processing of

tobacco products in the United States

prior to August 8, 2016, and

continuing operations after August 8,

2016:

October 30, 2017

For entities first engaging in the

manufacture, preparation,

compounding, or processing of

tobacco products in the United States

on or after August 8, 2016:

Immediately upon first engaging in the

manufacturing of a tobacco product

Ingredient listing (section

904(a)(1) of the FD&C Act

For more information, visit

FDA.gov and search for “tobacco

ingredients”

Newly deemed finished

tobacco products

For products on the market on August

8, 2016:

May 8, 2018,

November 8, 2018, for small-scale

tobacco product manufacturers

May 8, 2019, for small-scale tobacco

product manufacturers impacted by

recent natural disasters

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

FDA considers “small-scale tobacco product manufacturers” to be a manufacturer of any regulated tobacco product with 150

employees or fewer and annual total revenues of $5,000,000 or less.

For a complete list of the areas that have been impacted by recent natural disasters, please visit

https://www.fda.gov/TobaccoProducts/NewsEvents/ucm579265.htm.

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Provision

Products Affected

Compliance Date Under This

Guidance

For products entering the market after

August 8, 2016:

90 days prior to marketing

Harmful and potentially

harmful constituents (HPHCs)

(section 904 and 915 of the

FD&C Act)

For more information, visit

FDA.gov and search for “HPHC”

Newly deemed finished

tobacco products

6 months from the publication date of

a final guidance regarding HPHC

reporting under section 904(a)(3)

9 months from the publication date of a

final guidance regarding HPHC reporting

under section 904(a)(3), for small tobacco

product manufacturers.

For products entering the market after the

publication date of a final guidance

regarding HPHC reporting under section

904(a)(3):

90 days prior to marketing

Tobacco health documents

(section 904(a) (4) of the FD&C

Act)

Newly deemed finished

tobacco products

November 8, 2017, for small-scale

manufacturers

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

In the preamble of the final deeming regulation, FDA indicated that it intends to issue guidance regarding HPHC reporting (and later a

testing and reporting regulation under section 915) with enough time for manufacturers to report given the 3-year compliance period. At this time, FDA

has not published a final HPHC reporting guidance, and as a result, we are providing a revised compliance date based on when a final HPHC reporting

guidance is issued.

For this compliance policy, the term “small tobacco product manufacturer” has the meaning given that term under the statute, i.e., a tobacco product

manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer under the preceding

sentence, the employees of a manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control

with such manufacturer.

Note that while the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly

deemed tobacco products), FDA intends to limit enforcement of the premarket authorization requirements to newly regulated finished

tobacco products at this time.

FDA considers “small-scale tobacco product manufacturers” to be a manufacturer of any regulated tobacco product with 150

employees or fewer and annual total revenues of $5,000,000 or less. The compliance deadline for submission of tobacco health documents for entities other

than small-scale tobacco products manufacturers has already passed (February 8, 2017) and is not affected by the extension announced in this guidance.

Contains Nonbinding Recom m endations

Provision

Products Affected

Compliance Date Under This

Guidance

For more information, visit

FDA.gov and search for “tobacco

health documents”

May 8, 2018, for small-scale tobacco

product manufacturers in areas

impacted by recent natural disasters

Prohibition on the introduction

into interstate commerce of

products that contain “light,”

“low,” “mild,” or other similar

descriptors in the label,

labeling, or advertising of such

products without a modified

risk tobacco product order in

effect (section 911 of the FD&C

Act)

For more information, visit

FDA.gov and search for

“modified risk”

All newly deemed finished

tobacco products

Stop manufacturing: November 8,

2017

Stop distribution into interstate

commerce: December 8, 2017

Tobacco products will be

considered misbranded unless

they bear a label containing the

following information (section

903(a)(2) of the FD&C Act):

· The name and place of

business

· Quantity of the contents

· Percentage of domestic and

foreign-grown tobacco

· The statement: “Sale only

allowed in the United States”

All newly deemed finished

tobacco products in package

form

For cigars and pipe tobacco, FDA does

not intend to enforce this requirement

while the injunction issued in Cigar

Ass’n of America v. FDA, No. 1:16-cv-

01460 (D.D.C.) (order granting

injunction pending appeal) remains in

effect. See Guidance Compliance

Policy for Certain Labeling and

Warning Statement Requirements for

Cigars and Pipe Tobacco (August

2018).

For RYO, cigarette tobacco and

deemed products other than cigars and

pipe tobacco

August 10, 2018

For a complete list of the areas that have been impacted by recent natural disasters, please visit

https://www.fda.gov/TobaccoProducts/NewsEvents/ucm579265.htm.

FDA issued a Draft Guidance titled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Food, Drug, and

Cosmetic Act Requirements to Vape Shops,” for public comment, which, among other things, included a compliance policy relating to section

903(a)(2)(C). When finalized, the guidance will reflect the agency’s current thinking on the topics contained therein.

FDA similarly does not intend to enforce the requirements under section 920(a) for cigars and pipe tobacco while the injunction remains in effect.

Contains Nonbinding Recom m endations

Provision

Products Affected

Compliance Date Under This

Guidance

All required label and labeling

statements must be prominent

and in such terms that render

it likely to be read and

understood (section 903(a)(3) of

the FD&C Act)

All newly deemed finished

tobacco products

November 8, 2017

Contains Nonbinding Recom m endations

IV. DOCUMENT HISTORY

May 2017 – First edition of guidance issued.

August 2017 – Three-Month Extension of Certain Compliance Deadlines Related to the Final

Deeming Rule is revised to reflect changes to premarket review compliance policy related to

“deemed” tobacco products. Specific revisions include the following:

· Title – Removal of “Three-Month” to reflect the inclusion of extended compliance deadlines

for premarket review policy.

· Section II – Added explanation of extension of compliance policies included in May 2017

first edition of guidance.

· Section III.A – Added explanation of previous premarket review compliance policy and

summary of revised premarket review compliance policy for deemed tobacco products.

· Section III.B – Updated chart to include revised premarket review compliance policy, and

third column revised from “new compliance date” to “compliance date under this guidance”

to provide additional clarity.

October 2017 — (1) Revised compliance date for “Registration of establishments engaged in the

manufacture, preparation, compounding, or processing of a tobacco product and product listings” to

reflect the date extension found in the “Registration and Product Listing for Owners and Operators of

Domestic Tobacco Product Establishments” guidance issued in September 2017; (2) Revised

compliance date for “Ingredient listing” to provide a six-month extension for tobacco product

manufacturers and importers impacted by recent natural disasters; and (3) Revised compliance date

for “Tobacco health documents” to provide a six-month extension for tobacco product manufacturers

and importers in areas impacted by recent natural disasters.

November 2017 — Revised compliance date for “Ingredient listing” to provide a six-month extension

for all tobacco product manufacturers and importers, regardless of whether the manufacturer or

importer is in an area impacted by recent natural disasters, as described in the October 2017 edition of

this guidance.

August 2018 — Section II and compliance dates in section III in this guidance are revised to

reflect a stay of enforcement of the warning requirements for cigars and pipe tobacco (21 CFR 1143.3

and 1143.5) after the United States District Court for the District of Columbia granted plaintiffs’

motion for an injunction pending appeal. Cigar Ass’n of America v. FDA, No. 1:16-cv-01460

(D.D.C.) (order granting injunction pending appeal) as well as FDA’s intention to not enforce the

requirements under sections 903(a)(2) and 920(a) of the FD&C Act for cigars and pipe tobacco while

the injunction remains in effect.

— Clarifying and corrective edits made throughout the guidance.

November 2018 — Revised compliance date for “Ingredient listing” to provide a six-month

extension for small-scale tobacco product manufacturers and importers impacted by recent

Contains Nonbinding Recom m endations

natural disasters.

March 2019 — Revised the HPHC reporting compliance date to six-months, and nine-months for

small tobacco product manufacturers, from the publication date of a final guidance regarding HPHC

reporting under section 904(a)(3).