Welcome to FDA's Tobacco Compliance Webinars -
Information and Education for Retailers and Small
Businesses, sponored by the U.S.
Food and Drug Administration and the
Center for Tobacco Products.
I'm David Racine - thank you for joining us today!
FDA's Office of Regulatory Affairs and the Center for
Tobacco Products collaborate to perform
inspections of domestic tobacco product
manufacturers.
Joining me today are my colleagues, David Keith
from CTP's Office of Compliance and Enforcement
and Gabriel Muniz from FDA's Office of Regulatory
Affairs within the Office of Medical Products and
Tobacco Operations.
David will provide an overview of the provisions
of the Food, Drug and Cosmetic Act, known as the
FD&C Act, and implementing regulations that apply to
tobacco products.
Gabriel will provide an overview of FDA
inspections and investigations.
You will notice that some of the slides have
reference boxes that link to relevant guidance
documents, letters, and past webinars that can be
found on FDA's websites.
We encourage you to review those materials in
addition to today's webinar.
Now, let me turn the program over to
David Keith.
David...
Thanks David. CTP oversees the implementation of The
Family Smoking Prevention and Tobacco Control Act
which gives FDA authority to regulate the
manufacture, distribution, and marketing of tobacco
products in order to protect public health.
The Office of Regulatory Affairs, or ORA, working
in collaboration with CTP, conducts inspections and
investigations of regulated tobacco firms
and facilities to assess compliance with the
tobacco law and regulations FDA enforces.
ORA is the lead office for all FDA Field activities.
Cadre Investigators from ORA's Tobacco Operations
Staff, or TOS, within the Office of Medical Products
and Tobacco Operations, or OMPTO, are considered
technical experts in inspectional and
investigative techniques in the specialized
functional area of Tobacco products.
Cadre investigators are responsible for conducting
comprehensive inspections and investigations of FDA
regulated Tobacco industry firms and manufacturing
facilities.
The Tobacco cadre receives training, including field
training, to ensure that each will possess the
knowledge, skills, and abilities necessary to
successfully support FDA's mission.
The Tobacco cadre may be accompanied by subject
matter experts from CTP's Office of Compliance and
Enforcement and both parties are credentialed
to carry out these inspections.
ORA supports CTP by inspecting tobacco
products and manufacturers, and
collecting regulated tobacco products for
sample analysis.
Section 905(g) of the FD&C Act directs FDA to inspect
every establishment registered with FDA that
is engaged in the manufacture, compounding,
or processing of a tobacco product.
FDA's inspectional authority can be found at
section 704 of the FD&C Act.
Section 704(a)(1) provides FDA with the authority to
inspect any factory, warehouse, or
establishment in which tobacco products are
manufactured, processed, packed, or held, for
introduction into interstate commerce or
after such introduction.
Therefore, if you own or operate a domestic tobacco
product manufacturing establishment, the topics
we cover in this webinar may be of interest to you.
FDA inspections will take place at any reasonable
time, within reasonable limits, and in a
reasonable manner.
This means that FDA can inspect at any time that
the establishment is generally open for
business conducting manufacturing
operations.Section 905(g) of the FD&C Act directs
FDA to inspect registered tobacco product
establishments at least once every two years.
And generally, these inspections will not be
pre-announced.
One of the pathways to market for a new tobacco
product is a Premarket Tobacco Application or
PMTA.
Upon receipt of a PMTA, the FDA will determine if
the application can be accepted and then filed
for substantive review.
As part of its review process, a pre-announced
inspection may be conducted.
This inspection may or may not be included as meeting
the requirement of Section 905(g) of the FD&C Act.
Now Gabriel will give an overview of FDA
inspections.
Thanks, David.
ORA has moved from a geographical structure
with regions and districts in charge of multiple
programs to a program based management
structure.
This Program Alignment effort is a plan to
modernize and strengthen the way the FDA fulfills
its public health role, enabling it to keep pace
with the acceleration of scientific innovation, the
global expansion of markets, and new
programmatic mandates.
It will allow the agency to form distinct
commodity-based and vertically integrated
regulatory programs including pharmaceutical
quality, food and feed, medical devices,
radiological health, and tobacco.
Under Program Alignment, the Office of Medical
Products and Tobacco Operations in ORA has a
dedicated team of investigators, referred to
as the Tobacco Operations Staff or the tobacco
cadre, whose primary focus is to conduct inspections
of tobacco product manufacturers.
Inspections and investigations help ensure
manufacturers are in compliance with the
applicable laws and regulations.
The tobacco cadre also investigates events to
ensure tobacco products, such as cigarettes,
e-cigarettes and other regulated products, are
not distributed as free samples, and to ensure
that smokeless tobacco product free samples are
distributed in accordance with FDA's regulations.
The Tobacco cadre documents observation and
collect evidence as necessary during an
inspection or investigation.
This map represents the coverage of the tobacco
operations program throughout the U.S.
and U.S territories.
As we discussed earlier, Section 704(a) of the FD&C
Act gives FDA authority to enter, at reasonable
times, any factory, warehouse, or
establishment, in which tobacco products are
manufactured, processed, packed, or held for
introduction into interstate commerce or
after such introduction.
FDA can also enter any vehicle being used to
transport or hold tobacco products in interstate
commerce.
FDA has authority to inspect, at reasonable
times and within reasonable limits and in a
reasonable manner, all pertinent equipment,
finished and unfinished materials, containers, and
labeling within such factory, warehouse,
establishment, or vehicle.
In the case of any establishment in which
tobacco products are manufactured, processed,
packed, or held, FDA's inspectional authority
extends to all things therein (including
records, files, papers, processes, controls, and
facilities) bearing on whether tobacco products
are adulterated or misbranded within the
meaning of the FD&C Act; whether the tobacco
products may not be manufactured, introduced
into interstate commerce, or sold, or offered for
sale; or otherwise bearing on a violation of the FD&C
Act.
There are limitations to FDA's inspectional
authority under the FD&C Act.
FDA is not authorized to request financial data,
sales data other than shipment data, or pricing
data.
FDA is also not authorized to request for review
personnel data other than data as to qualifications
of technical or professional personnel
performing functions subject to this Act.
An establishment inspection is conducted to
examine a facility to determine its compliance
with the laws and regulations administered
by FDA.
In general, the objectives of an FDA inspection are
to: Review the establishment's
manufacturing processes and operating procedures;
Observe and evaluate the establishment's
manufacturing and design operations; Document and
collect information; Identify violations of the
FD&C Act; Communicate potential violations
observed by the investigator and discuss
with firm management during the course of the
inspection and during the close out meeting; and
Document any corrective actions proposed by the
firm.
FDA conducts different types of inspections.
For example, comprehensive inspections involve a
complete review of the establishment and its
regulated products.
FDA may also conduct directed inspections, such
as for cause inspections in response to complaints
or recalls.
Additionally, premarket inspections may be
conducted as part of the review process for
Modified Risk Tobacco Product and Premarket
Tobacco Applications.
FDA's procedures for inspections can be found
in the Investigations Operations Manual or
"IOM." The IOM is the primary source for FDA's
policy and procedures for field investigators.
The IOM is accessible through the FDA's website
under the term "IOM." The IOM contains valuable
general information on inspectional policy and
procedures that apply for all FDA-regulated
establishments.
FDA updates the IOM annually.
FDA prepares for inspections by reviewing
the firm's history, including past complaints,
violations, submissions, and relevant provisions of
the law and regulations and guidance documents.
There are 8 chapters in the Investigations
Operations Manual.
The topics include administration,
regulatory, federal and state cooperation,
sampling, establishment inspections, imports,
recall activities and investigations.
This slide describes how FDA will typically
initiate an FDA inspection upon arrival at an
establishment.
The ORA lead investigator will request to meet with
the most responsible person at the firm.
This may be the owner, operator or agent in
charge of the establishment or other top
management official on site.
Each FDA representative will then introduce
themselves by name, title, and organization, and
display their credential.
The lead investigator will then issue a Form FDA 482,
Notice of Inspection, to the most responsible
person.
An excerpt of a sample Form FDA 482, Notice of
Inspection, is shown on the slide.
A Form FDA 482 contains the District Office's
Address & Phone Number; the name and title of the
most responsible individual at the firm;
the firm's name, address, and phone number;
information on the date and time that the
inspection was initiated; the FDA representatives'
names, titles and signature; and a statement
of FDA's authority to inspect under the FD&C
Act.
FDA will provide a copy of the signed Form FDA 482 to
the firm.
An FDA tobacco product inspection will typically
cover, but is not limited to, the following areas:
Administrative information of the establishment and
owners; a review of requirements and
submissions and reporting to the Agency, such as
establishment registration and product listing;
listing of ingredients; tobacco health documents;
packaging, labeling, and advertising requirements;
marketing authorization for new and modified risk
tobacco products; and reminding the
establishment of new compliance dates for newly
deemed tobacco products.
Additional information is also described in the May
6, 2016 FDA letter to industry, titled "Notice
to Industry: Additional Tobacco Products Now
Regulated by the Food and Drug Administration."
Inspections will also cover administrative
information of the establishment.
Examples of administrative information include, but
are not limited to: Firm contact information (name,
address, phone, fax, e-mail); Who the most
responsible individual is; Information on the firm
history, which may include:The legal status
of the firm, for example, corporation, partnership,
limited liability corporation; The
organization of the firm, for example, the parent
corporation and any subsidiaries, if any;
Number of persons employed; Hours of
operation; Names, titles, and addresses of top
management officials; Other administrative
information that may be obtained may include: List
of regulated tobacco products manufactured,
distributed, packed, labeled, promoted, or
advertised; Information on interstate commerce, such
as: Where regulated products are shipped, for
example, estimated percentage of products
shipped out of state and exported; General
promotion and distribution patterns; Documentation of
interstate commerce may be collected.
The roles and responsibilities of the
responsible individuals and the names and titles
of all persons interviewed; and
Manufacturing and design operations.
Now, David will discuss the provisions of the FD&C
Act and implementing regulations that are
currently in effect and may be covered during a
tobacco product establishment inspection.
David ...Thanks.
First, let's cover what products are regulated
under FDA's tobacco product authorities.
Previously, Chapter IX of the FD&C Act applied only
to cigarettes, roll-your-own tobacco,
smokeless tobacco, and cigarette tobacco.
On August 8, 2016, FDA finalized a rule extending
FDA's authority to all other categories of
tobacco products meeting the statutory definition
of a tobacco product, except accessories of such
products.
These products include but are not limited to
electronic nicotine delivery systems,
dissolvables, pipe tobacco, hookah tobacco,
cigars, nicotine gels, and any novel future tobacco
products.These newly regulated tobacco product
manufacturers are subject to FDA inspection.
Generally, these inspections will determine
your establishment's compliance with chapter 9
of the FD&C Act.
On these slides, you will see many of the
requirements that may apply to tobacco product
manufacturers under the FD&C Act and its
implementing regulations.
These slides also provide resources and references
related to these requirements, such as
links to the text of the provision, related
guidance documents, and other previously released
webinars on these topics.
As Gabriel previously mentioned, FDA's tobacco
cadre may inquire about documents or information
related to these requirements during a
manufacturing inspection.
Please note that this may not be an exhaustive list
of requirements.
We encourage you to review the FDA website, as well
as the links provided in the resources and
references column, for further details, such as
compliance dates for newly deemed tobacco products.
Now Gabriel will explain how FDA inspections
conclude.
An FDA inspection will conclude with a close-out
discussion between the FDA representatives and firm
management.
At this close-out discussion, any
observations will be discussed.
If necessary, a Form FDA 483, Inspectional
Observations, will be issued for significant
objectionable conditions.
During the close-out discussion, the firm's
responses to observations and timeframes given for
corrections and/or corrective action will be
reported.
A copy of a sample Form FDA 483 is provided and
can be obtained at FDA's website under IOM.
FDA will prepare a final report of the inspection,
known as an establishment inspection report or EIR.
The EIR will describe the information discussed and
collected during the inspection.
Additional information on the content of the EIR can
be found in the IOM available on FDA's
website.
Once the inspection is closed, FDA's Field
Management Directive or "FMD" - 145 provides
guidance and criteria for releasing a copy of the
EIR to the establishment.
The EIR will be provided to the most responsible
individual identified during the inspection.
It may take several weeks or months before a copy of
the EIR will be provided.
That concludes our presentations.
David...Thanks gentlemen.
We understand that FDA inspections are new to
some parts of the tobacco product industry.
We have some great resources for you on our
website, and we encourage you to review these
materials.
Please also check our website often for updates
and sign up for the Center's "CTP News" and
"CTP Connect" email services.
If you have any questions regarding the topics
discussed in this webinar, please contact
AskCTP@fda.hhs.gov or 1-877-287-1373.
In addition, the Office of Small Business Assistance
provides technical and other non-financial
assistance to support small tobacco maufactuers
in complying with the FD&C Act.
The Office of Small Business Assistance can be
contacted by email at SmallBiz.Tobacco@fda.hhs.gov.
Let me thank Gabriel Muniz and David Keith for their
presentations.
Most of all thank you for your participation in this
webinar brought to you by the Center for Tobacco
Products - protecting our kids, and the nation's
health from tobacco.
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