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Part 1 – Introduction to Civil Money Penalty and No-Tobacco-Sale Order Complaints - YouTube

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What do you need to know if you receive a Civil

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Money Penalty or a No-Tobacco Sale Order

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Complaint?

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We'll tell you in this special five-part edition

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of FDA's Tobacco Compliance Webinars.

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Welcome to this edition of FDA Tobacco Compliance

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Webinars - education and Information for retailers

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and small businesses, sponsored by the US Food

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and Drug Administration, and its Center for Tobacco

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Products.

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I'm David Racine.

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Thanks for joining us!

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The FDA has created this multipart webinar, called

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"CMP and NTSO Complaints," to assist you, retailers

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and small businesses, who have received a Civil

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Money Penalty or a No-Tobacco-Sale Order

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Complaint, which we also refer to as CMPs and

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NTSOs.

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We'll cover this topic in five parts.

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This episode is part 1, Introduction to CMP and

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NTSO Complaints.

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In part two, we cover How to Pay a CMP using the

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Online Payment Portal.

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Part three covers How to File an Answer and the

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Consequences for Not Filing an Answer.

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Part four reviews the Settlement Process.

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And Part five will go over the Hearing Process,

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including what happens before the hearing is

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conducted, during the hearing itself, and after

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the hearing.

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All five webinars are available on the FDA

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Tobacco Compliance 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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You can watch all five webinars in order, or skip

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ahead to a webinar topic of your choice.

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Now, let's start the first webinar.

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I'm joined by Lieutenant Brian Thomas from the

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Office of Compliance and Enforcement.

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Lt.

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Thomas will present the Introduction to CMP and

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NTSO Complaints.

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Lt.

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Thomas ...

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Thanks Captain Racine.

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This webinar, the first in our series of five, will

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focus on CMP and NTSO Complaints.

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Specifically, we will discuss: -- What is a

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Civil Money Penalty (also known as a CMP) -- What is

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a No-Tobacco-Sale Order (also known as an NTSO),

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and -- What is a Complaint.

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Included in this discussion will be: -- a

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description of what is in a Complaint, -- a

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description of the documents that accompany

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the Complaint, -- and an explanation of what

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happens after you receive a Complaint.

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A Civil Money Penalty, or CMP, is simply a monetary

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sum assessed for violations of the law.

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The Federal Food, Drug, and Cosmetic Act (known as

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the FD&C Act) gives FDA the authority to assess a

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CMP for violations of certain requirements of

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the Act.The monetary sum assessed is based on a

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published penalty schedule, and the amount

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varies depending upon how many violations of the

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tobacco regulations occur during a specified period.

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Because FDA's Center for Tobacco Products counts

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violations of the regulations when

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determining the CMP amount, an inspection

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could result in more than one violation.

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If a retailer is found to have violated certain

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requirements of the FD&C Act as listed in the

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Complaint, they may be liable for the amount of

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the CMP sought.

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A No-Tobacco-Sale Order, or NTSO, is an order

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prohibiting the sale of tobacco products at a

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retail establishment.

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A retailer who has repeated violations of the

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tobacco regulations may be subject to an NTSO order.

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Repeated violations are defined as five violations

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of certain tobacco regulations within a

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thirty-six month period that constitute a repeated

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violation.

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The maximum NTSO period that CTP intends to seek

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are 30 days for the first NTSO, 6 months for the

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second NTSO, and an indefinite period for the

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third or subsequent NTSO.

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FDA has compiled a glossary of common terms

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that you will encounter when dealing with CMPs and

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NTSOs.

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Please feel free to use this glossary when viewing

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this webinar series, or when reading your CMP or

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NTSO Complaint.

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The glossary is available as a download at the

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Tobacco Compliance Webinars page on the FDA

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website.

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We'll remind you how to find that website at the

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end of this webinar.

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Now we'll discuss what a CMP or an NTSO Complaint

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is, what you'll receive with your Complaint, and

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what happens after the Complaint is delivered to

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you.

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Retailers receive CMP or NTSO Complaints when the

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FDA's Center for Tobacco Products has evidence that

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indicates an establishment violated the Tobacco

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Control Act.

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The FDA's Center for Tobacco Products initiates

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a CMP or NTSO action by serving a Complaint upon

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the retailer or its representative.

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Serving the Complaint simply means that the

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Complaint has been delivered to you.

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In most cases, you will receive your Complaint at

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your retail establishment through a mailing service,

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such as UPS or the US Postal Service.

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Now let's turn our attention to the Complaint

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itself.

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A Complaint is the legal document that identifies

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the statutory or regulatory violations that

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are the basis for seeking a CMP or NTSO.

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In other words, the Complaint tells you the

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information that FDA's Center for Tobacco

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Products is using to seek the CMP or the NTSO.

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The Complaint also identifies the amount of

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the CMP or the duration of the NTSO that FDA's Center

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for Tobacco Products is seeking.

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The Complaint has several sections that provide

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important specific information.

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The first section is called the Introduction.

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The Introduction identifies the parties to

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the Complaint.

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In a CMP or an NTSO action, the parties are

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the FDA's Center for Tobacco Products and the

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retailer.

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The Introduction also sets forth the amount of the

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CMP sought or the duration of the NTSO sought.

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The next section of the Complaint is called the

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Legal Authority section.

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The Legal Authority section sets forth the

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laws governing the sale and distribution of

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tobacco products and the authority for a CMP and/or

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NTSO.

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This is the first page of a sample CMP Complaint.

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On the far-right side it is titled: "Administrative

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Complaint for Civil Money Penalty." An NTSO

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Complaint looks just like a CMP Complaint, except it

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is titled: "Administrative Complaint for

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No-Tobacco-Sale Order." As you can see, the heading

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or the caption, identifies you, the retailer, as the

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Respondent for this Complaint.

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Throughout the CMP or NTSO process, you will be

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referred to as the Respondent and the Center

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for Tobacco Products at FDA will be referred to as

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the Complainant.

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The caption also lists the docket numbers for the

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Complaint.

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We will discuss docket numbers in more detail

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later in this presentation.

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The first page of the Complaint contains the

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Introduction section and begins the Legal Authority

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section.

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The Current Allegations section of the Complaint,

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among other things, provides the most recent

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facts and circumstances forming the basis for the

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action.

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It sets forth the name and address of your

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establishment.

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In CMP Complaints, this section also provides the

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brand names of the tobacco products that were

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involved in the violation, the dates and times of the

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most recent violations, and the specific laws that

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you allegedly violated.

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The Previous Case History section provides

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information about the retailer's previous CMP

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and NTSO history, including the dates and

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specific regulatory violations alleged in

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previous Complaints, and the outcome of those

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actions.

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If this is your first CMP, there will not be a

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Previous Case History section.

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The Complaint will also have a section titled

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Responding to the Complaint.

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This section provides you with specific information

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on how and when to respond to the Complaint.

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If you choose to contest the matter, you must take

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action within 30 days of receiving the Complaint by

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filing an Answer or successfully requesting an

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extension.

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If you take no action, you could be issued a default

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judgment.

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Answers, extensions, and default judgments will be

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explained in detail in our third webinar: How to File

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an Answer and Consequences for not Filing an Answer.

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The Complaint also informs you that you have the

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right, but are not required, to obtain an

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attorney to represent you in this case.

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Your Complaint will be accompanied by several

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documents.

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One of them is the cover letter.

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The cover letter is addressed to your retail

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establishment.

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The subject line of the cover letter will state

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whether a CMP or NTSO Complaint is included, and

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will include your establishment name and

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street address, case docket numbers, and the

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retailer case number.

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Docket numbers and the retailer case number are

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used to identify your case and are used in filing

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documents, when paying CMPs online, during the

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settlement process, and during the hearing

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process.

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We will address when and how you will use docket

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numbers and retailer case numbers during each

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relevant webinar in this series of five webinars.

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The cover letter also sets forth the amount of the

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CMP or duration of the NTSO sought, and provides

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contact information for the FDA's Center for

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Tobacco Products.

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The cover letter also outlines the various

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options for responding to the Complaint.

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These options are: Option 1: Acknowledge that the

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violations occurred and pay the full penalty

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amount.

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This option exists only for CMP cases.

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Please view the second webinar in this series

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"How to Pay a CMP Using the Online Payment Portal"

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to learn more about the acknowledgment and payment

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process.

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Option 2: Settlement.

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Please view the fourth webinar, "The Settlement

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Process" to learn more.

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Option 3: Request a hearing.

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We cover that in the fifth webinar, "The Hearing

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Process." And Option 4: Request an extension of

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time to file an Answer.

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Watch the third webinar, "How to File an Answer and

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Consequences for Not Filing an Answer" to learn

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more.

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Finally, you will find information on how to

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submit documents.

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In addition to the cover letter, FDA's Center for

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Tobacco Products encloses with the Complaint:

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inspection documents and photos related to the most

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recent inspection that led to the CMP or NTSO action.

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For example, you may see a report by the inspector,

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photos of the evidence collected during the

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inspection, or a photo of your retail establishment

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from the outside.

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Once the Complaint has been delivered to you, the

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FDA's Center for Tobacco Products files the

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Complaint with the US Department of Health and

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Human Services, Departmental Appeals

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Board, also known as the DAB.

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"Filing" means submitting a copy of the Complaint to

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the DAB.

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The filing of a Complaint for a CMP or an NTSO

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officially opens an administrative enforcement

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action.

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The DAB employs several Administrative Law Judges

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(also known as ALJs) in its Civil Remedies

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Division, or CRD.

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The CRD ALJs provide impartial, independent

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review of administrative actions such as CMP and

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NTSO cases.

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The ALJs are qualified under the Federal

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Administrative Procedure Act to conduct hearings on

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the record.

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For more information regarding the DAB, visit

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the DAB website at the link provided in the

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slide.

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A CRD ALJ will be assigned to each Complaint filed

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with the DAB.

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The ALJ determines the procedures and outcomes of

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the Complaint based on submissions from both

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sides.

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Once the DAB has a copy of the Complaint and the ALJ

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is assigned, the ALJ will send information about the

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procedures to be followed for each specific case to

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you and the FDA's Center for Tobacco Products.

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The roles and responsibilities of the

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ALJs are discussed in more detail in the webinar on

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the Hearing Process.

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This concludes our introduction to CMP and

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NTSO Complaints.

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To summarize the material we have covered in this

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webinar: - We have defined a CMP.

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- We have defined a NTSO.

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- We have discussed what a Complaint is and what

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information is included in a Complaint.

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- We reviewed what is included in the cover

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letter and the other documents that accompany a

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Complaint.

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- We have discussed the entity that conducts CMP

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and NTSO hearings.

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And finally, we provided you a glossary of terms

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that may be helpful as you watch the other webinars

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in this series, or as you read through the CMP or

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NTSO Complaint that was delivered to you.

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Now that we've covered the basics of a CMP and NTSO

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Complaint, we encourage you to view the other

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webinars in the series to help you understand the

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CMP and NTSO Complaint processes.

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The remaining webinars are: - Part 2: How to pay

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a CMP using the online payment portal; - Part 3:

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How to File an Answer and consequences for not

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filing an Answer; - Part 4: The Settlement Process;

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and - Part 5: The Hearing Process We have additional

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webinars available to provide more detailed

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background information regarding CMPs and NTSOs,

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such as how violations are counted and what amount of

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CMP or duration of NTSO may be assessed.

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In particular, please watch: - Retail Compliance

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Check Inspections: An Overview for Tobacco

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Retailers from 2016; and Guidance for Industry:

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Determination of the Period Covered by a

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No-Tobacco-Sale Order and Compliance With an Order

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from 2015.

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You can find these webinars on the same

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Tobacco Compliance Webinars page as this

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webinar.

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As a reminder, you can find all of our webinars

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by typing "FDA Tobacco Compliance Webinars" in

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the search bar on the main FDA homepage.

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Thank you for watching part 1 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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