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Part 4 – The Settlement Process for a Civil Money Penalty or a No-Tobacco Sale Order Complaint - YouTube

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In Part 4 of our five part webinar "CMP and NTSO

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Complaints," Rosemarie Purcell with the Office of

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Compliance and Enforcement provides those who've

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received a Civil Money Penalty or No-Tobacco Sale

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Order Complaint with an overview of the Settlement

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Process.

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Coming up now in this edition of FDA's Tobacco

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Compliance Webinars.

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Thank you for watching part 4 of our webinar on

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CMP and NTSO Complaints.

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I'm Rosemarie Purcell with CTP's Office of Compliance

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and Enforcement.

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This webinar is the fourth in a series of five

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webinars to assist retailers, who have

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received a Complaint for a CMP, also referred to as a

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Civil Money Penalty, or an NTSO, also referred to as

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a No-Tobacco- Sale Order.

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Throughout this webinar, we will focus on the

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Settlement Process for CMPs and NTSOs.

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The FDA has created five separate webinars in this

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series.

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The other webinars are: Part 1: Introduction to

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CMP and NTSO Complaints,

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Part 2: How to Pay a CMP

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using the Online Payment Portal; Part 3: How to

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File an Answer and the Consequences for Not

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Filing an Answer; and Part 5: The Hearing Process,

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including what happens before the hearing is

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conducted, during the hearing, and after the

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hearing.

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All five webinars are available on the FDA

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Tobacco Compliance Webinars page: Type "FDA

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Tobacco Compliance Webinars" in the search

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bar on the main FDA homepage, and follow the

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FDA Tobacco Compliance Webinars link in search

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results.

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Webinars are organized by year.

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You can watch all five webinars in succession or

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you can skip ahead to a webinar or topic of your

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choice.

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During this webinar, we will focus on how you can

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settle your CMP or NTSO case with the FDA's Center

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for Tobacco Products.

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Specifically, we will discuss - What is

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Settlement?

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- What is a Settlement Conference?

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- What will be discussed during the Settlement

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Conference?

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- And, what is the Settlement Agreement?

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So, what is Settlement?

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A settlement conference is simply a meeting between

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you and the FDA's Center for Tobacco Products to

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discuss your case.

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Settlement discussions are an efficient method for

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resolving your case without proceeding to a

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hearing.

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You can resolve your CMP or NTSO case through

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settlement, where you and FDA's Center for Tobacco

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Products agree to a reduced penalty amount or

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NTSO period.

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Settlement can occur at any time after you have

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received your Complaint, and before a final

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decision has been reached in your case.

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If settlement cannot be reached, your case will

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proceed through the hearing process.

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We will discuss the hearing process in detail

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in the fifth webinar.

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A settlement conference takes place by telephone

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only.

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Settlement conferences are not held in person.

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To settle your case, you must contact FDA's Center

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for Tobacco Products and arrange for a settlement

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conference.

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The purpose of a settlement conference is

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for both sides to discuss the appropriateness of the

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penalty sought.

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These settlement conferences are typically

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informal.

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If you are represented by an attorney, FDA's Center

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for Tobacco Products will communicate with you

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through your attorney, so your attorney should

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attend the settlement conference.

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To request a settlement conference, you can

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contact FDA's Center for Tobacco Products by phone

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or email.

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The contact information is listed on the slide.

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Contact information and additional details on how

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to resolve your case outside of a hearing by

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scheduling a settlement conference are outlined in

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the cover letter that accompanies the Complaint

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sent to you by the FDA's Center for Tobacco

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Products.

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When you contact the FDA's Center for Tobacco

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Products, please provide your name, your contact

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information, and the FDA docket number.

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The FDA docket number can be found on the cover

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letter that accompanies your Complaint.

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Once you provide FDA's Center for Tobacco

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Products with your contact information and FDA docket

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number, we will contact you to set up a mutually

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agreeable date and time to discuss your case.

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Who participates in the settlement conference?

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- You, the retailer; - Your attorney, if you have

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one; - FDA's Center for Tobacco Products

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representatives.

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Now let's turn our attention to what is

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discussed during the settlement conference.

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During the settlement conference, you should be

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prepared to discuss any specific facts or

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circumstances that you feel should reduce your

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CMP amount or NTSO period.

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These are called mitigating factors.

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The following are some examples of information or

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facts that might be considered during

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settlement discussions.

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These factors are also the same factors that the

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Administrative Law Judge, or ALJ, would be required

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to consider at the hearing.

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The ability to pay the penalty.

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This may include, but is not limited to,

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information related to income, assets, and

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information about revenue from tobacco sales.

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The effect the proposed penalty has on the retail

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establishment's ability to continue to do business.

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The history of prior violations at the

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establishment.

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The degree of culpability.

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As the owner of the retail establishment, you are

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responsible for the actions of your employees.

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Any fine or penalty you already have paid to your

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State for the same violation.

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Any other unique circumstances that you

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believe should lower the penalty amount or NTSO

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duration.

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We encourage you to inform FDA's Center for Tobacco

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Products of these facts during settlement

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conferences, as they may help FDA's Center for

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Tobacco Products in determining an appropriate

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settlement for the case.

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Additionally, if you have taken steps to prevent

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future sales of tobacco products to minors, it is

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very important that you inform FDA's Center for

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Tobacco Products of such actions.

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We will now look at some examples of mitigating

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factors that have helped to reduce penalties sought

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during settlement conferences.

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- Establishing disciplinary sanctions for

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employees who sell tobacco products to minors or

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violate other tobacco regulations.

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- Additional employee training regarding sale of

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tobacco products, including preventing sales

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to minors.

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- Requiring employees to verify age by way of

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photographic identification using an

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electronic scanning device.

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- Or, enrollment in voluntary compliance check

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programs, also known as secret shopper programs.

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This list of examples is not exhaustive.

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You may have implemented other policies or changes

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that help prevent sales of tobacco products to

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minors.

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If that is the case, you should inform FDA's Center

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for Tobacco Products of those measures.

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FDA's Center for Tobacco Products may request

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documents to support any facts or circumstances

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that help reduce a penalty during settlement

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discussions.

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Examples of such documents include: - Financial

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documents related to tobacco sales and revenue,

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showing how much of your total revenue is made up

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of tobacco sales.

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- Documents related to financial hardship that

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you may be having.

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- Documentation of any actions you have taken to

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ensure compliance after receiving a Warning

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Letter, CMP, or NTSO in the past.

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This list of examples is not exhaustive.

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FDA's Center for Tobacco Products may request, and

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you may propose, other documents or evidence that

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could help in settlement discussions.

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Now let's discuss what happens if you and the

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FDA's Center for Tobacco Products agree to settle

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your case.

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The next few slides will discuss the settlement

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agreement separately for CMPs and NTSOs, because

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the process is slightly different for each.

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Let's start with CMPs.

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If you reach a settlement with FDA's Center for

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Tobacco Products for a CMP Complaint, you will

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receive a letter summarizing the settlement

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discussions.

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Your letter will include: - the agreed upon reduced

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penalty amount, - the date that the payment is due,

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- and detailed instructions on how to

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acknowledge the violations in the CMP Complaint and

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pay the agreed upon amount.

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Remember, all CMPs should be paid through the online

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payment portal unless alternate arrangements

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were made during the settlement conference.

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For more detailed instructions on using the

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online payment portal, please watch our second

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webinar in this series: How to Pay a CMP Using the

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Online Portal.

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Once you acknowledge the violations and FDA

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receives payment, we will notify the ALJ by

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submitting a document called the "Notice of

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Settlement Agreement," or NSA.

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The NSA will state that your case was resolved

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through the settlement agreement, you have made

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sufficient payment, you acknowledged that the

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violations outlined in the CMP Complaint occurred,

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and requests that the ALJ close the case.

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The FDA's Center for Tobacco Products will send

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you a paper copy of the NSA when it is filed with

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the Departmental Appeals Board, or DAB.

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Now let's discuss the Settlement Agreement for

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an NTSO complaint.

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If you reach an agreement with the FDA's Center for

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Tobacco Products for an NTSO Complaint, FDA's

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Center for Tobacco Products will send you the

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Settlement Agreement for signature The Settlement

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Agreement will require acknowledgment of the

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violations alleged in the Complaint, and will

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contain all the agreed-upon terms of

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settlement, including the agreed-upon NTSO duration

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and the start and end dates for the NTSO.

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The Settlement Agreement will also specify a

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penalty for failing to meet the terms of the

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agreement.

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The Settlement Agreement must be signed by the

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retailer and returned to FDA's Center for Tobacco

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Products by the requested due date.

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Failure to do so may void the agreement.

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Once FDA's Center for Tobacco Products receives

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the signed Settlement Agreement from you, the

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FDA assigned attorney will then sign the Settlement

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Agreement.

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This signed Settlement Agreement with both

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signatures notifies the court that you and the

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FDA's Center for Tobacco Products have reached a

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settlement in your case.

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FDA's Center for Tobacco Products will file the

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signed Settlement Agreement with the DAB and

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will mail you a copy of the Settlement Agreement

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filed with DAB.

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As previously discussed in this webinar, settlement

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can occur at any time after you have received a

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Complaint, and before a final decision has been

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reached for your case.

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However, the settlement process is separate from

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the hearing process.

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Your participation in the settlement process does

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not delay any deadlines set by the ALJ.

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You must meet all of the ALJ-set deadlines and

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requirements associated with your case until the

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Notice of Settlement Agreement is filed and the

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ALJ officially closes your case.

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This includes the requirement that you

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submit an Answer within 30 days after receiving the

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Complaint.

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Please view the third webinar in our series: How

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to File an Answer and Consequences for Not

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Filing an Answer, during which we discuss the

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process for submitting an Answer.

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If an Answer is filed by the deadline, but no

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settlement is reached, the case will proceed through

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the hearing process.

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Please view our fifth and last webinar in this

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series, The Hearing Process, for more

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information.

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This concludes our discussion on Settling a

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CMP or NTSO.

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To summarize the material that we have covered in

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this webinar: - We have discussed what settlement

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is, and when it can occur.

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- We have explained what the Settlement Conference

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is, and how to request one.

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- We discussed mitigating factors that could help

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reduce your penalty.

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And we have described the Notice of Settlement

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Agreement, when the Notice is sent to you, and what

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the Notice contains.

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Please remember the Notice of Settlement Agreement

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starts the process of closing your case, and

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that process differs slightly depending on

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whether you received a CMP or a NTSO Complaint.

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Now that we've covered the basics of the Settlement

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Conference process for CMP or a NTSO Complaint, we

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encourage you to visit the other webinars in the

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series to help you understand the CMP and

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NTSO complaint process.

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The previous webinars in this series were: - Part

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1: Introduction to CMP and NTSO Complaints; - Part 2:

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How to Pay your CMP using the online portal; - Part

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3: How to File an Answer and Consequences for Not

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Filing an Answer The remaining webinar will

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explore: - Part 5: The Hearing Process All five

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webinars are available on the FDA Tobacco Compliance

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Webinars page.

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To access the webinars, visit www.fda.gov and type

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"FDA Tobacco Compliance Webinars" in the search

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bar.

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Follow the FDA Tobacco Compliance Webinars link

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in the search results to find all available

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webinars.

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The webinars are organized by year.

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Thank you for watching part 4 of our webinar on

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CMP and NTSO Complaints, brought to you by the

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FDA's Center for Tobacco Products, whose mission is

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to protect our kids and the nation's health from

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the dangers of tobacco.

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