CENTER FOR TOBACCO PRODUCTS

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Overview of Warning Letters for Online Retailers

OVERVIEW OF WARNING LETTERS 

FOR ONLINE RETAILERS

Presented by the Office of Compliance and Enforcement
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AGENDA

• Overview of Internet and Publication Surveillance

• Warning Letters

• Examples of Violations

• Responding to Warning Letters
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OVERVIEW OF INTERNET AND PUBLICATION SURVEILLANCE
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FDA’S REGULATION OF TOBACCO PRODUCTS

The Federal Food, Drug, and Cosmetic Act (FD&C Act): 

• Gives the FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own 

tobacco, smokeless tobacco and any other tobacco products that the agency, 

through regulation, deems to be subject to its tobacco product authorities.

• The Final Deeming rule, published on May 10, 2016, deems all products that 

meet the definition of a tobacco product under section 201(rr) of the FD&C Act, 

including components and parts, except accessories of newly deemed products, 

subject to FDA’s tobacco product authorities in Chapter IX of the FD&C Act and 

regulations. 

• The rule became effective on August 8, 2016.
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Component or Part is defined as any software or assembly of materials intended or 

reasonably expected:

• To alter or affect the tobacco product’s performance, composition, constituents or 

characteristics; or

• To be used with or for the human consumption of a tobacco product.

Component or part excludes anything that is an accessory of a tobacco product. 

Some examples of components and parts include cigar tobacco filler, filters, batteries 

for electronic nicotine delivery systems (ENDS), and cigar tips.

COMPONENTS OR PARTS
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FDA REGULATED TOBACCO PRODUCTS 

*ENDS = Electronic Nicotine Delivery System (example: e-cigarette, e-hookah, vape pens)

Examples of Tobacco Products 

Regulated Before Deeming Rule

Examples of Regulated Tobacco 

Products Under the Deeming Rule

• Cigarettes

• Cigarette tobacco

• Roll-Your-Own tobacco

• Smokeless tobacco

This includes the components, parts, and accessories of 

these products.

• ENDS*

• Pipe tobacco

• Cigars

• Hookah/Waterpipe tobacco

• E-liquid

• Dissolvable tobacco products not

already regulated by FDA

• Future tobacco products

This includes the components and parts of these products, but not 

their accessories.
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• CTP conducts routine surveillance of sales, distribution, marketing, and 

advertising activities related to regulated tobacco products on the Internet, 

including social media, and in publications.

• CTP has issued Warning Letters to regulated tobacco industry for violations 

of the Federal Food, Drug & Cosmetic Act (FD&C Act) and its implementing 

regulations.

CTP’S INTERNET AND PUBLICATION SURVEILLANCE
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• CTP issues Warning Letters to regulated tobacco industry for violations under the 

FD&C Act and its implementing regulations

• For example, Warning Letters have been issued to online retailers for the following 

violations:

 Selling tobacco products to individuals under the federal minimum age to purchase 

tobacco products.

 Offering for sale and/or advertising smokeless tobacco products, cigarette tobacco, 

roll-your-own tobacco, and covered tobacco products (other than cigars and pipe 

tobacco) without the required warning statement.

 Offering for sale new tobacco products without required marketing authorization, 

including ENDS products that were marketed and/or targeted to youth.

 Selling or distributing, in interstate commerce, tobacco products as modified risk 

tobacco products without an FDA order in effect.

INTERNET AND PUBLICATION SURVEILLANCE
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WARNING LETTERS AND COMPLIANCE ACTIONS
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Warning Letter

• Generally, FDA issues Warning Letters for violations of regulatory significance.

• A Warning Letter is an agency advisory action that is used to notify regulated 

industry of violations and achieve voluntary compliance with the FD&C Act. 

It is not a final agency action.

• A Warning Letter contains a description of cited violations and requests a 

response from a firm within 15 working days of the Warning Letter’s receipt. 

The response should describe corrective actions, including dates the violations 

were corrected, and a plan for maintaining compliance with the FD&C Act.

WARNING LETTERS
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• It is regulated industry’s responsibility to ensure that their respective 

tobacco products and all related labeling and advertising on their respective 

websites, on any other websites (including e-commerce, social networking, 

or search engine websites), in any other media in which they advertise, and 

in any retail establishments comply with the FD&C Act and its implementing 

regulations.

• Failure to ensure full compliance with the FD&C Act may result in FDA 

taking regulatory action, including, but not limited to, civil money penalties, 

no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.

WARNING LETTERS
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Warning Letters are also posted on the FDA website

• Internet and Publication Surveillance: 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

• State Retailer Compliance Check Inspections: 

http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm

WARNING LETTERS
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EXAMPLES OF VIOLATIONS
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• Selling tobacco products to individuals under the federal minimum age to 

purchase tobacco products.

• Offering for sale and/or advertising smokeless tobacco, cigarette tobacco, 

roll-your-own tobacco, and covered tobacco products (other than cigars and pipe tobacco) without the required warning statement.

• Offering for sale new tobacco products without required marketing 

authorization, including ENDS products that were marketed and/or targeted 

youth.

• Selling or distributing, in interstate commerce, tobacco products as modified 

risk tobacco products without an FDA order in effect.

EXAMPLES OF VIOLATIONS
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• A retailer is defined as any person who sells tobacco products to individuals for personal 

consumption, or who operates a facility where vending machines or self-service displays 

are permitted (21 C.F.R. § 1140.3).

• Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age 

of sale of tobacco products from age 18 to 21 years. Under section 903(a)(7)(B) of the 

FD&C Act, tobacco products are misbranded if sold or distributed in violation of section 

906(d)(5) of the FD&C Act.

• FDA encourages online retailers to use adequate means of age and identity verification 

to prevent sales of cigarettes, smokeless tobacco, or covered tobacco products online to 

individuals under the age of 21 years. An example of age verification may include using 

an independent age and identity verification service that compares customer information 

against independent, competent, and reliable data sources, such as public records, to 

prevent the sale to individuals who are under 21 years.

SALES TO MINORS
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• The required nicotine warning statement must appear on packages and 

advertisements for "covered" tobacco products (except cigars and pipe tobacco) 

and roll-your-own/cigarette tobacco products.

• This required warning statement must also meet certain requirements, with 

respect to font, text, size, placement and formatting of the warning statement.

REQUIRED WARNING STATEMENT REGARDING 

ADDICTIVENESS OF NICOTINE
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• The United States District Court for the District of Columbia recently issued an 

order vacating the health warning requirements for cigars and pipe tobacco set 

forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s 

warning requirements for cigars and pipe tobacco back to the Agency. See 

Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 

(D.D.C. September 11, 2020). 

• Although the requirement has been vacated, cigar and pipe tobacco firms may 

choose to voluntarily comply with these health warning provisions.

WARNING STATEMENTS FOR CIGARS AND PIPE TOBACCO
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• Smokeless tobacco packages and advertisements must bear one of the four following 

warning label statements in accordance with an FDA-approved plan:

• WARNING: This product can cause mouth cancer.

• WARNING: This product can cause gum disease and tooth loss.

• WARNING: This product is not a safe alternative to cigarettes.

• WARNING: Smokeless tobacco is addictive. 

• These required warning statements must also meet certain requirements, with respect 

to font, text, size, placement and formatting of the warning statements on the package 

labels and advertisements.

• Lack of the required smokeless tobacco product warning label statements renders the 

product misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.

REQUIRED WARNING STATEMENTS FOR SMOKELESS 

TOBACCO 
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Cigarettes: In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and 

Advertisements” rule, establishing 11 new cigarette health warnings

• On August 18, 2021, a federal district court issued an order in the case of R.J. Reynolds 

Tobacco Co. et al. v. FDA, to postpone the effective date of the final rule. The new effective 

date of the final rule is October 11, 2022. FDA encourages firms to submit cigarettes 

plans as soon as possible, and in any event by December 12, 2021.

WARNING STATEMENTS FOR CIGARETTES
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• All deemed new tobacco products, including ENDS products, must receive premarket authorization from FDA to 

be legally marketed.

• FDA is prioritizing enforcement of the premarket review requirements for certain ENDS products, including 

against retailers selling such products. Specifically, FDA is prioritizing enforcement against:

 Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);

 All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate 

measures to prevent underage persons’ access; and

 Any ENDS product that is targeted to youth or whose marketing is likely to promote use of ENDS by youth.

• Per court order, premarket applications for many new tobacco products on the market as of August 8, 2016, 

including ENDS, were due to FDA by September 9, 2020. New tobacco products marketed without required 

marketing authorization risk FDA enforcement (except for “premium cigars”). See link below for FDA's 

enforcement priorities:

• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronicnicotine-delivery-system-ends-and-other-deemed-products-market

TOBACCO PRODUCTS WITHOUT REQUIRED MARKETING 

AUTHORIZATION
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FDA has issued warning letters to companies for

marketing unauthorized ENDS products that

imitate packaging for food products such as

Twinkies, feature cartoon characters such as

SpongeBob SquarePants, and resemble children’s toys

such as a video game system or smartwatches.

WARNING LETTERS 
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WARNING LETTERS 

FDA has issued over 100 warning letters to companies who manufacture and 

operate websites selling ENDS products, specifically e-liquids, that lack premarket 

authorization, advising them that selling these products is illegal, and therefore they 

cannot be sold or distributed in the U.S. The firms did not submit a premarket 

tobacco product application (PMTA) by the Sept. 9, 2020, deadline.
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Section 911(a) provides that:

• No person may introduce or deliver for introduction into interstate commerce any 

modified risk tobacco product without an order in effect, issued pursuant to section 

911(g) of the FD&C Act.

• Modified Risk Tobacco Product (MRTP) means 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).

MODIFIED RISK TOBACCO PRODUCTS
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FDA has issued Warning Letters to firms for selling or distributing ENDS products that 

were labeled or advertised as presenting a lower risk of tobacco-related disease, 

being less harmful than one or more other commercially marketed tobacco products, 

or having a reduced level of exposure to a substance, without a marketing order in 

effect, in violation of section 911 of the FD&C Act. For example:

• “Vaping is used as (sic) safer and healthier alternative to smoking.”

• “The Rosy has two separate departments for the battery and juice, which certain 

physicians believe decreases turbulence and consumption of harmful metals, 

including aluminum, lithium, cranium [sic], and others.”

WARNING LETTERS
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RESPONDING TO WARNING LETTERS
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• Once the Warning Letter is received, the firm should take prompt action to correct 

the violation(s) cited in the letter.

• A Warning Letter contains a description of cited violations and requests a response 

from a firm within 15 working days of the Warning Letter’s receipt.

• The violation(s) cited in the Warning Letter are not intended to be an all-inclusive 

statement of violations associated with their tobacco products and marketing 

activities.

WARNING LETTER RESPONSES
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What to include in your response:

• Describe your plan to mitigate and correct the violation(s) identified in the Warning 

Letter as well as any additional corrective actions taken.

• Include dates which corrective actions were taken.

• Describe your plan for maintaining compliance with the FD&C Act.

Failure to ensure full compliance with the FD&C Act may result in FDA taking 

regulatory action, including, but not limited to, civil money penalties, no-tobacco-sale 

orders, criminal prosecution, seizure, and/or injunction.

WARNING LETTER RESPONSES
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How to Respond:

• Send your response within 15 days of warning letter receipt, by email or in writing.

• Send emails to CTPCompliance@fda.hhs.gov or any other email addresses listed in 

the warning letter.

• Send written responses to the following address:

DPAL-WL Response, Office of Compliance and Enforcement

FDA Center for Tobacco Products, c/o Document Control Center

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

• Include in your response any unique identifier stated in the Warning Letter for tracking.

• If you have questions, contact the phone number identified in the Warning Letter.

WARNING LETTER RESPONSES
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