Tobacco_Violation_Form_All_Comments

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: September 14, 2011
Status: Posted
Posted: October 14, 2011
Category: Association - D0003
Tracking No. 80f19bb6
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0002
National Association of Tobacco Outlets, Inc. - Comment

Submitter Information
Name: Thomas A. Briant
Address: United States,
Submitter's Representative: Thomas A. Briant, Executive Director and Legal Counsel
Organization: National Association of Tobacco Outlets, Inc.

General Comment
See attached file(s)

Attachments
National Association of Tobacco Outlets, Inc. - Comment, NATO Comments on FDA Tobacco
Product Reporting Violation Form

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12/5/2011

September 14, 2011
Comments on Tobacco Product Reporting Violation Form [Docket No. FDA-2011-N-0553]
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Food and Drug Administration Representative:
I am submitting these comments on behalf of the National Association of Tobacco Outlets, Inc.,
a national tobacco retail trade association, regarding the Food and Drug Administration’s intent
to collect specific information contained in a proposed Tobacco Product Reporting Violation
Form. The purpose of the FDA seeking approval from the Office of Management and Budget
for this Tobacco Product Reporting Violation Form is to accept consumer and other stakeholder
feedback and notification of potential violations of tobacco regulations under the Tobacco
Control Act.
In the official notice requesting comments published in the Federal Register on August 22, 2011,
the FDA has requested comments on four topics. Each of the topics is listed below followed by
NATO’s comments on that particular topic.
Topic 1: Whether the proposed collection of information is necessary for the proper
performance of FDA’s functions, including whether the information will have practical
utility.
The Tobacco Control Act does not contain any requirement that the FDA request or accept
notification of possible tobacco regulation violations from the public or other stakeholders. With
no directive from Congress in the provisions of the Tobacco Control Act to request or accept
information on potential violations, there is no demonstrated need to collect reports of potential
violations in order to allow the FDA to properly perform its regulatory functions.
In fact, under Section 103 of the Tobacco Control Act, the FDA was granted the authority to
contract with states to conduct compliance inspections on retailers and submit reports of
potential violations. The specific language granting this authority in Section 103 is as follows:

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“For a tobacco product, to the extent feasible, the Secretary shall contract with the States
in accordance with this paragraph to carry out inspections of retailers within that State in
connection with enforcement of this Act.”
The contracts entered into between the FDA and various states to conduct compliance
inspections on retail stores follow a very specific protocol that requires extensive training of state
agency personnel by the FDA regarding the terms of the Tobacco Control Act, how to conduct a
retail store compliance inspection, and how to recognize and report a potential violation of a
tobacco regulation. This strict protocol is used to ensure that inspectors are knowledgeable about
the Tobacco Control Act and that the inspections are conducted fairly and responsibly. If
Congress had intended the general public to be called upon to police retailers that sell tobacco
products and report potential regulatory violations, then such intent would have been stated
within the Tobacco Control Act itself.
Moreover, based on the FDA’s Center for Tobacco Products policy on issuing warning letters or
civil penalty violation letters to retailers, even a specially trained state compliance inspector is
not qualified to make a final decision on whether a retailer violated a tobacco regulation. Rather,
an official within the Center for Tobacco Products’ Office of Compliance is required to review
every state report in which a potential violation is cited and make an independent determination
whether a violation occurred and, if so, send out a warning letter or a civil penalty letter to the
retailer involved.
To reiterate this point, while the Tobacco Control Act allows the FDA to contract with the states
for compliance enforcement, the law is devoid of any language directing the FDA to reach out to
the general public and other stakeholders to report possible violation. Without any formal
training about the terms of the Tobacco Control Act and the actual tobacco regulations that
retailers must follow, the FDA cannot justify seeking OMB approval to request impromptu
reports from the public and possibly anti-tobacco advocacy organizations which would require
detailed knowledge about the law and specific information about a potential violation.
The information being requested by the FDA in these reports from the public would include: (1)
the date of the violation, (2) the product type (e.g., cigarette, roll-your-own tobacco, or
smokeless tobacco), (3) the tobacco brand name, (4) a description of the potential regulatory
violation, and (5) the name, address, phone number, website address and e-mail address of the
potential violator. If state agencies are required to undergo significant training to conduct retail
inspections and report possible violations, either the same standards need to be required of the
general public and other stakeholder groups or the FDA should consider not proceeding with the
reporting form. It is unrealistic to believe that the average citizen would have the knowledge and
qualifications to determine whether a retailer has possibly violated a tobacco regulation.
At the same time, an approval of the FDA’s violation reporting form by the OMB could result in
specific retailers being singled out for potential violation reports by members of the general
public or stakeholder organizations. How would such reports that target a specific retailer have
any utility to the overall goal of responsible enforcement of the Tobacco Control Act?

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Topic 2: The accuracy of the FDA’s estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions used.
Given the number of detailed facts that the FDA requests the public and stakeholders submit
about a potential violation, the time to collect that data may take significantly longer than the ten
minutes estimated by the FDA. Unless a member of the public is present in a store at the exact
time a potential violation occurs such as the sale of tobacco to a minor, that citizen may very
well need to remain in the store for a long period of time watching transactions before a situation
arises that might be considered a violation. Also, how is a member of the public supposed to
remember all of the detailed information that the FDA is requesting without also checking other
sources for such facts including the employee’s name, the employee’s e-mail address, the
website address of the store, etc. In short, the time burden estimated by the FDA appears to be
substantially lower than what may actually be the case in a real world situation.
Also, the notice published in the Federal Register does not describe the methodology used by the
FDA to estimate that some 1,000 reports of potential violations will be made each year for the
next three years. The only benchmark used by the FDA is the receipt of “several reports via the
Internet or e-mail” after the sale of flavored cigarettes was prohibited under the Tobacco Control
Act in September of 2009. How does receiving approximately three reports about flavored
cigarettes over a two year time span translate into 1,000 reports of potential violations each year
for the next three years? The validity of the FDA’s methodology cannot be supported or
contested when the FDA does not explain the methodology. If the FDA decides to pursue OMB
approval of the violation reporting form, then the FDA should consider rescinding this notice and
reissue the notice with a more detailed explanation of the agency’s methodology and
assumptions used to calculate the burden of reporting possible tobacco regulatory violations.
Topic 3: Ways to enhance the quality, utility, and clarity of the information to be collected.
As noted above, if the general public and stakeholder organizations are not required to undergo
extensive training on the specific regulatory requirements of the Tobacco Control Act, the
quality of potential violation reports will be very low and even suspect. Moreover, a scenario
could develop where members of the general public and/or stakeholder organizations target
certain retail stores for the purpose of filing reports of possible regulatory violations. This could
even rise to the level of harassment when a retailer abides by the tobacco regulations only to
have inaccurate or false reports filed by the public or stakeholder organizations. That kind of
behavior would call into question the very usefulness and utility of any such reports made to the
FDA. Moreover, has the FDA considered what corrective action the agency would take against
the person or entity that files a false or inaccurate report against a retailer? What is the retailer’s
recourse in the event a false or inaccurate report is filed? Are there any due process safeguards
afforded a retailer that finds itself the target of a false or inaccurate report?
Based on these scenarios and questions, allowing the public and stakeholder organizations to file
reports of potential violations may actually undermine the FDA’s ability to administer and
enforce the tobacco regulations. Rather, the most fair and reasonable means to report potential
violations of the tobacco regulations is through FDA sponsored state compliance inspection

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program that must be conducted according to a set of rules and utilizes knowledgeable inspection
officers that employ uniform inspection techniques.
Topic 4: Ways to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when appropriate, and other
forms of information technology.
The real burden of filing reports of potential regulatory violations will fall on the retailers that
are the subject of the reports. NATO’s understanding is that the FDA will need to follow up on
these reports and might involve additional compliance inspections of retailers. This will subject
retailers to greater scrutiny even though the reports may be inaccurate, lack specific facts, or be
outright false. The real question for the FDA and the OMB to consider is how to ensure that any
such reports of potential violations have a basis in fact and how to lessen the burden of
enforcement on law-abiding retailers that are targeted by members of the public or stakeholders.
Sincerely,
Thomas A. Briant
NATO Executive Director

15560 Boulder Pointe Road Minneapolis, MN 55347 1-866-869-8888 www.natocentral.org

Page 1 of 1

PUBLIC SUBMISSION

As of: December 05, 2011
Received: September 15, 2011
Status: Posted
Posted: October 14, 2011
Category: Private Industry - C0003
Tracking No. 80f1c9cf
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0003
Dan L Littlefield - Comment

Submitter Information
Name: Dan L Littlefield
Address:
OR,
Organization: The Smoke Shack

General Comment
The FDA's proposal to solicit reports of tobacco industry violations
from the general public does'nt bother me none; i'm not hiding any Jews in my attic.....Oh wait;
wrong century/country....
Sorry, forgot where I was for a moment.
Never mind

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 07, 2011
Status: Posted
Posted: October 14, 2011
Category: Association - D0003
Tracking No. 80f4ed83
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0004
NATO: National Association of Tobacco Outlets, Inc. - Comment

Submitter Information
Name: Thomas A. Briant
Address:
MN,
Submitter's Representative: Thomas A. Briant
Organization: NATO: National Association of Tobacco Outlets, Inc.

General Comment
See attached file(s)

Attachments
National Association of Tobacco Outlets, Inc. - Comment, NATO Supplemental Comments on
FDA Tobacco Product Reporting Violation Form

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October 7, 2011
Supplemental Comments on Tobacco Product Violations Reporting Form
[Docket No. FDA-2011-N-0553]
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Food and Drug Administration Representative:
I am submitting this set of supplemental comments on behalf of the National Association of
Tobacco Outlets, Inc. (NATO), a national tobacco retail trade association, regarding the Food
and Drug Administration’s intent to collect specific information contained in a proposed
Tobacco Product Violations Reporting Form (Form FDA 3779). NATO submitted an initial set
of comments on this docket to the FDA on September 14, 2011.
The purpose of this set of supplemental comments is to bring to the attention of the FDA how the
proposed Violations Reporting Form is contrary to and may likely violate Executive Order No.
13563 entitled “Improving Regulation and Regulatory Review” issued by President Barack
Obama on January 18, 2011. The intent of this Executive Order is to eliminate unnecessary and
wasteful government regulations. Below are NATO’s comments on how the proposed
Violations Reporting Form is contrary to and may violate two important sections of the
Executive Order.
Executive Order Section 1: General Principles of Regulation
This section of the Executive Order states, in part, that a regulation must (1) promote
predictability and reduce uncertainty, and (2) measure, and seek to improve, the actual results of
regulatory requirements.
Issuing a Violations Reporting Form to allow the public and other stakeholders to submit reports
of possible retail violations of FDA tobacco regulations decreases predictability and increases
uncertainty. This regulation essentially deputizes the public and other stakeholder groups
without any guidance or training about the FDA’s retail tobacco regulations to police retailers
that sell tobacco products. That is, neither the public nor other stakeholder groups will have the
benefit of being educated about retail regulations or how to identify a possible violation. This is

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in stark contrast to the FDA’s extensive training of state agency personnel in how to conduct
FDA sponsored retail compliance inspections. The result will likely be inaccurate and
unverifiable reports of possible violations filed by the public and other stakeholders that the FDA
would be obligated to corroborate in a manner that has yet to be determined.
In addition, the actual wording of the proposed Violations Reporting Form is vague and invites
unsubstantiated and even false reports of possible violations. Below is a copied section of the
actual form to report the “potential violation type”.
Potential violation type (choose all that apply)
␣␣␣␣ Sales to minors
␣␣␣␣␣ Flavored cigarette sales
␣␣␣␣␣ Advertising/promotion/marketing
␣␣␣␣␣ Free samples
␣␣␣␣␣ Vending machine/self-service display/direct access to cigarette or smokeless tobacco
␣␣␣␣␣ Sale of cigarettes in packs less than 20
␣␣␣␣␣ Other

It appears that the FDA drafted this form to make it as simple as possible for a person or
stakeholder group to fill out and report a possible violation. However, in doing so, the ambiguity
of the form itself and the vagueness of possible answers will guarantee ambiguous reports and
degrade, not improve, the results of the regulatory action.
An excellent example of a similar kind of ambiguity is found in “Break the Chain” brochures
drafted by FDA Center for Tobacco Products staff. Although the Tobacco Control Act as passed
by Congress only enacted regulations on cigarettes, roll-your-own tobacco and smokeless
tobacco products, the Break the Chain materials often refer to “tobacco products” without
limiting the reference to just cigarettes, roll-your-own tobacco and smokeless tobacco. Given
this inaccuracy in the FDA’s Break the Chain materials, how is an uneducated public expected to
know which kinds of tobacco products are regulated and which kinds are not subject to
regulation for purposes of submitting possible violation reports?
Even the Tobacco Product Violations Reporting Form itself makes no mention that possible
violations are limited to cigarettes, roll-your-own tobacco and smokeless tobacco products. By
not including any explanation about what tobacco products are regulated, the reporting form only
exacerbates the ambiguity for the public.
Moreover, while the form provides for reporting a possible violation on advertising, there are
two pending federal lawsuits challenging the FDA cigarette advertising restrictions and
regulations and the FDA has also postponed any enforcement action on the ban on outdoor
tobacco advertisements. Until these lawsuits and the outdoor advertising issue are finally
resolved, how can the FDA accept a report from the public or other stakeholder group that has a
check mark in the box for “Advertising/promotion/marketing”?
Regarding the “Free samples” answer, the brevity of this selection fails to inform the person
making a report which kind of tobacco products are covered by the ban on samples and does not
disclose the exemption for sampling smokeless tobacco products in adult-only facilities. This
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same exemption question would arise in the “Vending Machine/self-service displays” answer
selection since adult-only tobacco stores are allowed to have self-service displays of cigarettes,
roll-your-own tobacco and smokeless tobacco. The absence of an explanation of these
exemptions on the Violations Reporting Form will result in the filing of false reports against
retailers that are acting legally within the terms of the exemption.
In short, the Violations Reporting Form does not comply with either of the two requirements in
Section 1 of the President’s Executive Order because the form allows for inaccurate and even
false reports of possible violations, which only adds uncertainty to the enforcement of the
existing regulations.
Executive Order Section 3: Integration and Innovation
As a part of Section 3 of the Executive Order, federal agencies are required to promote
coordination, simplification and harmonization between agencies because “[s]ome sectors and
industries face a significant number of regulatory requirements, some of which may be
redundant, inconsistent or overlapping.” The proposed regulation for the Violation Reporting
Form is redundant and overlapping in several respects. First, the FDA tobacco regulatory law
requires the agency, where feasible, to contract with state agencies to conduct retail compliance
inspections to enforce the law. As a part of this mandate, the FDA trains state agency officials
about the tobacco regulations and how to identify potential violations. Since the FDA already
contracts with 35 states and the District of Columbia to conduct retail inspections, with a goal of
contracting with all 50 states in the near future, seeking the assistance of an untrained public to
report possible violations is redundant and inconsistent with the Congressional directive that the
FDA contract with only state agencies.
Second, although the Executive Order is meant to minimize redundancy among federal agencies,
there is another overlapping layer of retail compliance inspections at the local and state levels.
Many cities and states have adopted tobacco retail licensing laws that incorporate compliance
inspections on tobacco retailers as a routine method to ensure compliance. With the FDA
sponsored compliance inspections conducted by state agencies being a second means of
enforcement, adding a third layer of compliance reporting by the public and other stakeholder
groups is not only redundant, but simply unnecessary.
For the reasons outlined above, the FDA’s proposed notice of issuing a Tobacco Product
Violations Reporting Form is certainly contrary to and could very well violate the President’s
Executive Order. As a result, the FDA should rescind the notice to request approval of the
Violations Reporting Form from the Office of Management and Budget and not purse any further
action on this proposed regulatory matter.
Sincerely,
Thomas A. Briant
NATO Executive Director

15560 Boulder Pointe Road Minneapolis, MN 55347 1-866-869-8888 www.natocentral.org

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 17, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f540d1
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0006
Anonymous - Comment

Submitter Information
Organization: Circle-K

General Comment
The FDA does not have the authority to request violation reports from the public. FDA's state
inspectors are highly trained. The public has no training on howto perform an inspection. The
public may have other motives by targeting law abiding retailers. Inaccurate reporting will cause
undue burden on a law abiding retailer.

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 17, 2011
Status: Posted
Posted: November 03, 2011
Category: Consumer Group - B0003
Tracking No. 80f543d8
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0007
Brenda Fisher - Comment

Submitter Information
Name: Brenda Fisher
Address:
WA,
Submitter's Representative: Thomas Briant
Organization: NATO

General Comment
1. The Family Smoking Prevention and Tobacco Control Act granting the FDA the authority to
regulate tobacco products does not contain any provision allowing the FDA to request possible
tobacco regulation violation reports from the public or other stakeholder groups.
2. The FDA has currently contracted with 38 states and the District of Columbia to conduct retail
compliance inspections and these state inspectors receive extensive training on the tobacco
regulations, how to conduct a compliance inspection, and how to recognize a potential tobacco
regulation violation. This same training requirement is not required of the public or other
stakeholder groups which means that they may not be knowledgeable enough about the tobacco
regulations to understand what may or may not be a violation. The result could be the filing of
inaccurate or false violation reports.
3. The use of this reporting form could also lead to members of the public and stakeholder groups
targeting and harassing law-abiding retailers by submitting inaccurate or possibly even false
violation reports.

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4. An inaccurate or false report will result in the FDA inspecting a law-abiding retailer and
burdening the retailer with unnecessary regulatory inspections.
5. President Barack Obama issued Executive Order No. 13563 in January of 2011 requiring
government agencies to eliminate wasteful and unnecessary regulations. Authorizing the public
and anti-tobacco organizations to report possible retail violations is unnecessary because state
agencies have been thoroughly trained to conduct these inspections. This kind of action is contrary
to the President's Executive Order.
6. The form proposed by the FDA for reporting possible violations is so general that the possible
violations listed are vague and will lead to inaccurate, misleading and false reports. This kind of
vagueness is also in conflict with the specific requirements of the President's Executive Order.

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 19, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f56253
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0008
Kocolene Marketing, LLC - Comment

Submitter Information
Organization: Kocolene Marketing, LLC

General Comment
Dear FDA Representative,
In regards to the FDA tobacco product violation reporting form...as a leader in the tobacco
store/convenience store industry, I am aware of the Family Smoking Prevention & Tobacco
Control Act giving the FDA the authority to regulate tobacco products. However, I am unaware of
the act allowing the FDA to request tobacco regulation violation reports from the public or other
groups. Is the public properly trained to check for compliance? The tobacco rules and regulations
are quite complicated these days. Having untrained people reporting violations could result in
inaccurate or false violation reports. This could damage the reputation of a business. Doesn't all
this go against President Obama's executive order #13563 filed earlier this year to STOP
unnecessary regulations such as this?
-Andrea Myers
Executive Vice President
Kocolene Marketing, LLC
Seymour, IN
30 retail stores

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f56c27
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0009
Cumberland Farms Inc. - Comment

Submitter Information
Name: Anne Flint
Address:
MA,
Organization: Cumberland Farms Inc.

General Comment
Cumberland Farms takes responsibility for and pride in being a "responsible retailer". That being
said, we support the FDA's program of contracting states for the retail compliance inspections. We
believe that the extensive training that these inspectors receive qualifies them to conduct these
inspections. However, we DO NOT support the FDA's plan to allow the public and anti-tobacco
organizations to report possible retail violations. It is our understanding that this same training
will not be required of the general public. This type of uneducated reporting could lead to groups
targeting and harassing responsible retailers by submitting inaccurate or possibly even false
violation reports. These inaccurate reports could result in extra work for both the FDA and the
retailers who are selling legal products.

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f57244
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0010
Megan Ann Wisbrock - Comment

Submitter Information
Name: Megan Ann Wisbrock
Address:
IA,
Organization: Kum and Go

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain any provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting

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and harassing law-abiding retailers by submitting inaccurate or possibly even false violation
reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama’s Executive Order No. 13563 required government agencies to
eliminate wasteful and unnecessary regulations. Authorizing the public and anti-tobacco
organizations to report possible retail violations is unnecessary because state agencies have been
thoroughly trained to conduct these inspections. The proposed FDA action is contrary to the
President's Executive Order.
For the r

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5728d
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0011
Jeffrey Steinbock - Comment

Submitter Information
Name: Jeffrey Steinbock
Address: United States,
Organization: Uhle Tobacco Company

General Comment
I am concerned about the lack of safeguards to prevent persons with other intentions, from
submitting false claims against retailers.

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: DoNotPost
Category: Individual Consumer
Tracking No. 80f57315
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product
Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco Product
Reporting Violation Form
Document: FDA-2011-N-0553-DRAFT-0012
Anonymous - Comment

Submitter Information
Address:
IA,
Organization: Kum & Go

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain any provision allowing
the solicitation or reporting of possible tobacco regulation violations from the public or other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail compliance
inspections. As part of the contract, state inspectors receive extensive training on the tobacco regulations,
how to conduct a compliance inspection and how to recognize a potential tobacco regulation violation. The
training requirement for state inspectors would not be required of the public or other stakeholders. As such,
reports would be made by those who do not possess knowledge of tobacco regulations or understand what
may or may constitute a violation. The result may very well be the filing of inaccurate or false violation
reports. An inaccurate or false report will result in the inspection of law-abiding retailers and burdening the
retailer with unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting and
harassing law-abiding retailers by submitting inaccurate or possibly even false violation reports.
Furthermore, the form proposed by FDA is so general and vague that it virtually invites inaccurate and
misleading reports.
Finally, President Obama’s Executive Order No. 13563 required government agencies to eliminate wasteful
and unnecessary regulations. Authorizing the public and anti-tobacco organizations to report possible retail
violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not pursue any further action on this proposed
regulatory matter.

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Page 1 of 1

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5729b
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0012
Fred Hoyt - Comment

Submitter Information
Name: Fred Hoyt
Address:
LA,
Submitter's Representative: Fred Hoyt
Organization: K & F Inc

General Comment
Most States, as does Louisiana, have a FDA Policeing authority with the power to cite warnings
or infractions. Why would we need to create a whirlwind of "public witch hunting" for possible
violators. This would only present a bottleneck for the agency in charge of running down these
"leads"?????
Please do not inhibite the ATC from doing their job!!!!

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Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: DoNotPost
Category: Individual Consumer
Tracking No. 80f57301
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-DRAFT-0013
Jodi A. Gehrts - Comment

Submitter Information
Name: Jodi A. Gehrts
Address:
IA,
Organization: Kum & Go, LC.

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting
and harassing law-abiding retailers by submitting inaccurate or possibly even false violation

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Page 2 of 2

reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

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Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5734d
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0013
John T Feldman - Comment

Submitter Information
Name: John T Feldman
Address:
IA,
Organization: Kum & Go, L.C.

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting

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and harassing law-abiding retailers by submitting inaccurate or possibly even false violation
reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

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Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5740e
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0014
Keith Clark - Comment

Submitter Information
Name: Keith Clark
Address:
IA,
Organization: Kum & Go

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting

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and harassing law-abiding retailers by submitting inaccurate or possibly even false violation
reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

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Page 1 of 1

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 20, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5788d
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0015
Jeffrey H Toole - Comment

Submitter Information
Name: Jeffrey H Toole
Address:
WA,
Submitter's Representative: Owner
Organization: Tobacco, Beer & More

General Comment
I oppose the fact that anyone could submit a false or misleading complaint against a retailer.
The FDA has contracted with states to do compliance checks. These people have been trained on
what the law is.
There is nor provision in the Family Smoking Prevention and Tobacco Control Act giving the
FDA the authority to ask untrained people to report possible violations.
This would and additonal and unnecessary paper work for the FDA.
As stated above, I oppose this additional form of checks being conducted by untrained people.

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PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 21, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f581c0
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0016
Richard L Ginther - Comment

Submitter Information
Name: Richard L Ginther
Address:
IA,
Submitter's Representative: Richard Ginther
Organization: Kum & Go

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.

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The use of the proposed reporting form may lead to members of the public and others targeting
and harassing law-abiding retailers by submitting inaccurate or possibly even false violation
reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

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12/5/2011

October 21, 2011
Division of Dockets Management (HFA – 305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re:

Agency Information Collection Activities; Proposed Collection; Comment
Request; Tobacco Product Reporting Form
Docket No. FDA—2011—N—0553

The National Association of Convenience Stores (“NACS”) appreciates this opportunity
to provide comments on the Food and Drug Administration (“FDA” or the “Agency”) Notice
regarding the tobacco product reporting violation form.1 As further articulated below, we
believe permitting members of the public to report alleged violations of FDA’s tobacco
regulations is unjustified.
NACS is an international trade association representing more than 2,100 retail and 1,500
supplier company members. NACS member companies do business in nearly 50 countries
worldwide, with the majority of members based in the United States. While 49 of the top 50
convenience store companies in the United States are members of NACS, the majority of our
members are small, independent operators. More than 70 percent of our membership is
composed of companies that operate ten stores or less, and more than 60 percent of our
membership operates five stores or less. Nearly 40 percent of our membership operates a single
store.
Sales of cigarette and other tobacco products comprise more than 36 percent of the instore sales at convenience stores, and thus are vital to the economic viability of the convenience
store industry. NACS and its members are committed to selling all of our merchandize in a
lawful manner; we have devoted a substantial amount of time and resources to ensuring that
convenience store operators are equipped to comply with federal, state, and local tobacco
regulations. This includes our work with We Card, a non-profit organization of which NACS is
a founding member that provides tobacco retailers with multi-level training and educational
products and services. We Card helps retailers prepare employees to set clear expectations and
provide continuous feedback in an effort to prevent underage access to tobacco.
In addition to We Card, NACS has provided both formal and informal guidance to its
members regarding FDA’s restrictions on tobacco sales and marketing. This has taken the form
of legal memoranda, seminars and webinars, and individual correspondence with membership.
Our guidance has been based on the language of the Tobacco Control Act and its implementing
regulations, as well as the guidance documents FDA has released for industry.
The law and regulations in this area do not raise the concept of members of the public
reporting possible regulatory violations. Congress included no directive in the Tobacco Control
1

76 Federal Register 52333 (August 22, 2011).

Act that FDA accept such reports, and FDA included little indication in its guidance documents
that this would be part of its enforcement strategy. Indeed, FDA’s “Guidance for FDA and
Tobacco Retailers [on] Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco
Retailers” includes no reference to members of the public reporting alleged violations to FDA.
FDA’s Draft Guidance on “Compliance with Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” contains no notice to
retailers that FDA will be permitting members of the public to report alleged violations. Instead,
it limits all discussion of this prospect to the final sentence of the document noting the website
and phone number individuals can use to report alleged violations. This, to us, is emblematic of
the various issues we have had with (and filed comments on) the Agency’s regulatory process,
whereby industry is not provided with a clear picture of the regulatory environment and FDA’s
plans.
Beyond the fact that retailers were given little notice that their customers may be
masquerading as vigilante FDA enforcement agents, this policy will be of little utility to the
Agency. Members of the public have a minimal understanding of the intricacies of FDA’s
tobacco regulations. In part due to the complexity of its regulations, FDA requires state agents
who conduct compliance inspections to submit to an extensive training program regarding the
Tobacco Control Act’s terms, how to properly inspect retail outlets, and how to recognize and
report a potential violation. Without such measures, state agents would not be able to adequately
inspect for violations.
By contrast, members of the public at large lack any formal training as to how inspections
can be conducted and even as to the terms of the statute they would be enforcing. In requiring
agents of states with which it contracts to conduct retailer inspections to be tested, FDA rightly
recognized that conducting inspections requires a certain amount of knowledge and skill. We
urge the Agency not to forget this fact as it moves forward.
Finally we are happy that FDA recognizes that its authority in regard to these inspections
is limited. “Callers are able to report potential violations of the Tobacco Control Act and FDA
will conduct targeted follow up investigation based on information received.”2 Thus, it appears
that the Agency does not plan on issuing Warning Letters or civil money penalties solely based
on reports by members of the public (as it does for reports by state inspection agents).
This limitation must remain in place in order to avoid conflict with the Tobacco Control
Act which only allows FDA or states with which it contracts to perform inspections that may
lead to actual violations under the law. The Tobacco Control Act lists various means by which
FDA can conduct retailer inspections.3 By listing those methods which are permissible,
Congress excluded any additional methods (such as inspections by members of the public).
“Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or in

2

76 Fed. Reg. 52334 (emphasis added).
21 U.S.C. §372(a) (permitting federal officers of HHS to conduct examinations, and allowing HHS to contract with
states to carry out inspections).

3

ancillary provisions.”4 This was the foundation of the Supreme Court’s reasoning in concluding
in the mid-1990s that FDA lacked the authority to regulate tobacco.5 It also underlays the
statutory canon expressio unius est exclusion alterius (the inclusion of one is the exclusion of
others), which stands for the proposition that “Where Congress explicitly enumerates certain
exceptions to a general prohibition, additional exceptions are not to be implied, in the absence of
a contrary legislative intent.”6
We appreciate that the FDA recognized these limitations and will not issue Warning
Letters or civil money penalties based on reports filed by members of the public and instead will
only do so based on its own (or a state’s) inspections.
*

*

*

*

*

We appreciate the Agency’s willingness to consider our comments, and stand ready to
provide any further assistance to the Agency as it moves forward.
Sincerely yours,

Lyle Beckwith
Senior Vice President, Government Relations

4

Whitman v. American Trucking Ass’ns, Inc., 531 U.S. 457, 468 (2001). See also MCI Telecommunications Corp.
v. AT&T, 512 U.S. 218, 231 (1994) (conferral of authority to “modify” rates was not a cryptic conferral of authority
to make filing of rates voluntary).
5
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 160 (“Congress could not have intended to delegate a
decision of such economic and political significance to an agency in so cryptic a fashion.”).
6
Andrus v. Glover Const. Co., 446 U.S. 608, 616-17 (1980).

Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 21, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f58415
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0018
Levin Ginsburg - Comment

Submitter Information
Name: Jonathan M. Weis
Address:
IL,
Submitter's Representative: N/A
Organization: Levin Ginsburg

General Comment
RE: Comment Regarding Docket No. FDA-2011-N-0553 (Agency Information Collection
Activities; Proposed Collection; Comment Request; Tobacco Product Reporting Violation Form)
Dear Food and Drug Administration:
Our comments are set forth on the uploaded attachment to this coment. We are submitting these
comments because we are a law firm that focuses a portion of our practice representing the
interests of tobacco manufacturers, distributors and retailers. This comment addresses FDA’s
intent to collect specific information contained in a proposed tobacco product reporting violation
form, no. 3779.
Jonathan M. Weis
Partner
Levin Ginsburg
180 North LaSalle Street, Suite 3200
Chicago, IL 60601-2800

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Page 2 of 2

312-368-0100

Attachments
Levin Ginsburg - Comment, SCAN9856_000

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Page 1 of 1

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 21, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f5847f
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0019
Anonymous - Comment

Submitter Information
Address:
PA,
Submitter's Representative: Lee Silverman
Organization: Klafter's Inc.

General Comment
I want submit a comment in regard to the proposal under consideration for allowing the general
public the authority to police retail tobacco dealers for supposed tobacco violations. Aside from
the fact that no where in the Family Smoking Prevention and Tobacco Control Act is this
authority granted, how would any individual, other than a trained agent, have an idea of what is or
what is not a violation? To support this, even the agency inspectors have not been able to establish
consistent methods yet. This move would open the door and give the ability for every and any
individual that has an issue or grudge against any retail business the use of this authority as a
means of causing financial and time loss to a business by filing fraudulent reports whether on
purpose or by accident. There are so many inspections taking place at the retail level by qualified
agents that the last thing needed is an untrained general public being asked to be whistle-blowers
for in an area that they have no formal knowledge. I would think that any filed complaint would
be open to scrutiny legally causing unnecessary expense and time to the business and FDA. In
addition, I would think that fraudulent reports could open the accuser to a legal action by the
business. Businesses selling tobacco are well aware of the requirements that need to be adhered to
and the last thing needed are untrained individuals using non specific reporting formats indirectly
representing the interests of the FDA

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Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 21, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f58497
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0020
Charles Walter Campbell - Comment

Submitter Information
Name: Charles Walter Campbell
Address: United States,
Organization: Kum & Go, L.C.

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting
and harassing law-abiding retailers by submitting inaccurate or possibly even false violation

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Page 2 of 2

reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites
inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

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12/5/2011

Page 1 of 2

PUBLIC SUBMISSION

As of: December 05, 2011
Received: October 21, 2011
Status: Posted
Posted: November 03, 2011
Category: Private Industry - C0003
Tracking No. 80f586db
Comments Due: October 21, 2011
Submission Type: Web

Docket: FDA-2011-N-0553
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco
Product Reporting Violation Form.
Comment On: FDA-2011-N-0553-0001
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tobacco
Product Reporting Violation Form
Document: FDA-2011-N-0553-0021
Jason Bassett - Comment

Submitter Information
Name: Jason Bassett
Organization: Kum & Go, L.C.

General Comment
The Family Smoking Prevention and Tobacco Control Act granting The U.S. Food and Drug
Administration (FDA) the authority to regulate tobacco products does not contain a provision
allowing the solicitation or reporting of possible tobacco regulation violations from the public or
other stakeholders.
Currently, FDA has contracted with 38 states and the District of Columbia to conduct retail
compliance inspections. As part of the contract, state inspectors receive extensive training on the
tobacco regulations, how to conduct a compliance inspection and how to recognize a potential
tobacco regulation violation. The training requirement for state inspectors would not be required
of the public or other stakeholders. As such, reports would be made by those who do not possess
knowledge of tobacco regulations or understand what may or may constitute a violation. The
result may very well be the filing of inaccurate or false violation reports. An inaccurate or false
report will result in the inspection of law-abiding retailers and burdening the retailer with
unnecessary regulatory inspections. In addition, false or inaccurate reports would further drain
precious state resources that would be better used in monitoring non-compliant retailers.
The use of the proposed reporting form may lead to members of the public and others targeting
and harassing law-abiding retailers by submitting inaccurate or possibly even false violation
reports. Furthermore, the form proposed by FDA is so general and vague that it virtually invites

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inaccurate and misleading reports.
Finally, President Obama's Executive Order N. 13563 required government agencies to eliminate
wasteful and unnecessary regulation. Authorizing the public and anti-tobacco organizations to
report possible retail violations is unnecessary and contrary to the President's Executive Order.
For the reasons stated above, I respectfully request FDA not purse any further action on this
proposed regulatory matter.

https://fdms.erulemaking.net/fdms-web-agency/component/contentstreamer?objectId=090...

12/5/2011

LEVIN GINSBURG

180 NORTH LASALLE STREET • SUITE 3200
CHICAGO, ILLINOIS 60601-2800
312.368.0100

ATTORNEYS AT LAW

October 21, 2011

201 1 OCT 2b A II : 00

Via Certified Mail, Return Receipt Requested and Email Transmission Via regulations.gov

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852

RE: Comment Regarding Docket No. FDA-2011-N-0553 (Agency Information Collection
Activities; Proposed Collection; Comment Request; Tobacco Product Reporting
Violation Form)
Dear Food and Drug Administration:
We are submitting these comments because we are a law firm that focuses a portion of our
practice representing the interests of tobacco manufacturers, distributors and retailers. This
comment addresses FDA's intent to collect specific information contained in a proposed tobacco
product reporting violation form, no. 3779, which would replace the current form 3734 titled
"Information Regarding Cigarettes With Characterizing Flavors." According to FDA, it is
requesting Office of Management and Budget (OMB) approval for a new collection of
information to accept consumer and other stakeholder feedback and notification of potential
violations of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking
Prevention and Tobacco Control Act of 2009 (the "Act"). Part of FDA's related enforcement
strategy is to accept information from the public about alleged violations of the Act and to allow
callers to report potential violations of the Act so that FDA can conduct targeted follow up
investigations based on information received. In order to expedite this reporting, FDA has
developed a form that will be used to solicit this information from the caller (FDA Form 3779,
Tobacco Product Violations Reporting), which is expected to replace current FDA Form 3734
for Cigarette Flavor Ban Violations. FDA wishes to post the new form on its website so that
information may be submitted by the public by completing the form online. There are several
comments we wish to make with respect to the notice. Certain of these comments echo the
National Association of Tobacco Outlets' comments. Furthermore, the comments below set
forth reasons why there should not be any reporting form posted by FDA, but that if one is
posted, it should be the new Form 3779, with a few caveats.
First, the Act does not contain any requirement that FDA seek out or request comments from the
general public regarding potential violations of the Act. Within the last several months, FDA has
contracted with various state agencies to conduct inspections of retail premises and no doubt is
expending great resources in doing so, making it unnecessary to request information from the

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LEVIN GINSBURG
ATTORNEYS AT LAW

Page 2
Division of Dockets Management (HFA-305)
Food and Drug Administration
October 21, 2011

public regarding alleged violations. Furthermore, Illinois, where we are located, as well as most,
if not all, States have city, county as well as statewide tobacco investigatory enforcement units
which routinely enforce local ordinances and state law relating to tobacco, and can and do report
to FDA. It is unlikely that any member of the public is as highly trained as an FDA investigator,
or the various state agencies with which FDA has contracted, regarding the terms of the Act, how
to conduct an inspection and how to recognize a potential violation. As a result, FDA could find
itself dealing with inaccurate reports and reports which do not even address a violation of the Act
but which FDA nonetheless has to spend time and taxpayer dollars reviewing. This type of
permissiveness with respect to general reporting from the public can lead to anti-tobacco
organizations filing unjustified and frivolous reports and industry competitors filing unjustified
and frivolous reports against one another. This will result in low quality reports of very little, if
any, value. Neither the proposed form 3779 nor current form 3734 requires that the report be
filed under oath subject to penalty of perjury. Given the risks (detailed above) associated with
allowing anybody to file a report, there should be some assurance that if form 3779 is approved
that it will not be abused. The repercussions to businesses that are subject to false or unjustified
reports can be severe, and there should be repercussions agthnst the person filing false or
unjustified and frivolous reports.
Form 3779 must also state very clearly at the top that possible violations are limited to only
cigarettes, roll-your-own tobacco and smokeless tobacco and not any and all imaginable tobacco
products. We understand that the fourth line of the proposed form stating "Description of
Product Type" references: "cigarette, smokeless, roll-your-own, and other." We strongly suggest
that the term "other" be removed because it leaves so much to the imagination and will not make
any sense to the general public or even many trained investigators. For example, members of the
public and even trained investigators may not be aware that FDA is not authorized to regulate
pipe tobacco under the Act. Reports regarding pipe tobacco would result in a waste of time and
resources. In addition, for clarification purposes the word "tobacco" should be added after
"smokeless" and "roll-your-own."
In conclusion, it would be most appropriate for there to be no tobacco product reporting forms
posted. If an interested consumer or stakeholder is truly interested in reporting a violation, it
goes without saying that they can always contact or write to FDA. However, if a reporting form
is to be posted, the new form 3779 is certainly an improvement over form 3734 which is
woefully inadequate and insufficient, as it does not cover any potential violations but for those
related to flavored cigarettes. If nothing else, form 3779 is preferable, but the product
description section should only reference: "cigarettes, smokeless tobacco and roll-your-own
tobacco."

LEVIN GINSBURG
ATTORNEYS AT LAW

Page 3
Division of Dockets Management (HFA-305)
Food and Drug Administration
October 21, 2011

Should you have any questions with respect to the foregoing, please do not hesitate to contact
me. Thank you for your consideration.

Sincerel

JO THAN M. WEIS
[email protected]
JMW/dl

Jonathan M. Weis
Levin Ginsburg
180 North LaSalle Street
Suite 3200
Chicago, IL 60601

I

7196 9008 9040 0542 4819
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