FDA’s Import Operations: How FDA Regulates Imported Products



welcome to this edition of that VA tobacco compliance webinars education and information for retailers and small businesses sponsored by the US Food and Drug Administration and a center for tobacco products I'm David racing thanks for joining us in this series of webinars we help you retailers and small businesses better understand our work regulating tobacco and in today's edition we'll discuss importing tobacco products and FDA's import operations and joining me today to discuss the importing process is John verbatim from the division of import operations in FDA's office of regulatory affairs and lillian ortega deputy director of the division of enforcement and manufacturing in the office of compliance and enforcement we won't be taking any live questions during today's presentation however you can still send your questions to the center by emailing us at SCTP at FDA HHS gov or give us a call at 877 CTP 1373 now we also have a dedicated email address to help small businesses comply with the requirements of the Tobacco Control Act so if you're a small business you can email your questions to small biz dot tobacco at FDA dot HHS gov now his John verbatim we'll start off our presentation on FDA's import operations John thank you David the purpose of this webinar is to provide information regarding how FDA regulated tobacco products are imported the information I'm going to cover today includes an overview of FDA and import law including what we regulate information regarding section 801 of the federal Food Drug and Cosmetic Act referred to as the FD&C Act and the appears and or otherwise standard I will also discuss the import process and and to review detentions examinations and samples refusals import alerts and product codes now the FDA regulates many products including foods drugs medical devices cosmetics and the FDA also regulates tobacco products all imported products are required to meet the same standards as goods made domestically FDA provides consumer protection by enforcing the Food Drug and Cosmetic Act among other laws imports are primarily addressed in the Federal Food Drug Cosmetic Act section 801 imported FDA regulated products are subject to refusal of admission for appearing to be adulterated or misbranded based upon evidence adulterated tobacco products are defined in section 902 of the Food Drug and Cosmetic Act an example of an adulterated tobacco product is a tobacco product that consists in whole or in part of any filthy putrid or decomposed substance misbranded tobacco products are defined in section 903 of the Food Drug and Cosmetic Act an example of a miss branded tobacco product is a tobacco product with labeling that is false or misleading the requirements that a product not be adulterated or misbranded automatically applied to newly deemed products on the deeming rule effective date of August 8th 2016 however as we will explore in more depth later in this presentation FDA is establishing later compliance periods for certain provisions of the FD&C Act for these products for the tobacco products FDA regulated before August 8th 2016 and continues to regulate for example cigarettes and smokeless tobacco these requirements are already in effect FDA has jurisdiction over the products it regulates through the FD&C Act section 801 applies to those products at the time of entry section 801 of the FD&C Act states that if it appears from the examination of such samples or otherwise that the article has been manufactured processed or packed under in sanitary conditions or the article is forbidden or restricted in sale in the country in which it was produced or such article is adulterated or misbranded then that article shall be refused admission now the term appears provides FDA's standard of proof we can refuse entry to goods that appear to be adulterated or misbranded appear to be unapproved new drugs or appear to have been manufactured not in accordance with Good Manufacturing Practices the term or otherwise allows FDA to make admissible 'ti decisions using historical data examinations information from other sources or other evidence now that we've discussed FDA law regarding imports let's move on to the import process US Customs and Border Protection has Authority for all imported products entry is first made to CBP if the product is FDA regulated CBP forwards the product to FDA and FDA then begins its admissible 'ti process FDA enter reviewers are trained individuals who review entry declarations and evaluate the admissibility of a product and two reviewers have several options in regard to these products the entry reviewer can release the product request examination of the product requests additional information or documents or recommend detention of the product I'll discuss these options in more detail if a product is released it may be distributed FDA still has jurisdiction to regulate the product release of the product does not preclude FDA action if a problem is found later on after release now in this context an FDA detention is an administrative process it is not a physical hold of the product an importer has the right to take possession of the articles FDA can detain a product based upon the appearance of a violate the importer has the right to give evidence to refute this appearance this is known as the detention and hearing process after considering any such evidence that attention will either stand leading to a refusal or be overturned which leads to the release of the product the importer in consignee will receive an fda detention notice the detention notice will indicate our belief that the articles are subject to refusal provide the reason or reasons why make the importer or consignee aware of the right to provide testimony including evidence provide a time frame for a response and a contact name and number where the response is to be sent the importer can also petition to recondition the goods to bring them into compliance by either relabeling a misbranded product correcting an adulterated product or making a product not FDA regulated the reconditioning must be approved by FDA so for example a tobacco product package that does not include required package information such as an accurate statement of the quantity of the contents in terms of weight measure or numerical count could be relabeled and brought into compliance if approved by FDA if an insurer reviewer requests examination of a tobacco product the field personnel will examine the product for evidence of Filth decomposition packaging defects mishandling of products and misbranding among other things examinations may uncover the appearance of a violation also for examinations investigators and inspectors go out to the port or destination and conduct an examination of the shipment which may include a label review or a sample collection if a sample is collected it is packaged and shipped to the appropriate laboratory for analysis the appropriate documentation is completed and the data is recorded in FDA's database samples taken in the field are sent to the laboratory there a laboratory analyst performs the appropriate if apparent violations are discovered the detention and hearing process begins we discussed this process in slides 14 through 16 however if no violations are discovered FDA releases the product if a detained product cannot be brought into compliance FDA will refuse the entry a refused product may be exported or destroyed civil money penalties may be imposed if products are not exported or destroyed FDA has the authority to seize the product if certain criteria have been met I'll discuss import alerts import alerts could contain historical data showing commodities manufacturers or shippers countries of origin or a combination of the above that appeared to be producing or shipping products that violate the Food Drug and Cosmetic Act you can find import alerts at the website listed on this slide import alerts provide information to our field offices the field can use this information to detain goods without examining them this process keeps FDA from having to sample over and over again non-compliant products may be placed on and stay on an import alert until the product comes into compliance and firms importing violative products may be placed and stay on import alert until the firm demonstrates that it can produce a compliant product currently there are five industry-wide import alerts for tobacco products if a product falls into any one of these categories then the product will be detained without physical examination the categories are cigarettes or any component parts which contain a characterizing flavor other than tobacco or menthol cigarettes cigarette tobacco smoke less tobacco or roll-your-own tobacco which are labeled or advertised using the descriptors light low or mild without an authorizing FDA order smokeless tobacco products which do not have a required warning statement tobacco products which have been found to not be substantially equivalent and regulated tobacco products produced by an entity which has failed to pay required user fees the product codes for tobacco products are available in FDA's product code builder the industry code for tobacco products including newly deemed products is 98 the product code builder link is listed on this slide now my colleague Lillian Ortega will discuss in more details selected issues related to tobacco product imports Lillian thanks John you have just heard John discussed the import process this presentation will focus on how you can be in compliance with the requirements of the FD&C Act in order to facilitate efficient entry of your tobacco product failure to adhere to FDA's requirements can lead to regulatory measures such as refusal of admission for your tobacco product the agenda for this presentation will cover the scope background of the applicable law some of the statutory provisions that are currently in effect and resources that are available for tobacco product importers the scope of this presentation covers the pertinent issues provisions and resources related to tobacco product imports this presentation will also cover the regulatory requirements for newly deemed tobacco products for more information about other regulatory requirements please visit the web address on the slide I'd like to remind you that while today's webinar includes examples of relevant requirements for tobacco product importers and tobacco product products being offered for import you're responsible for ensuring you meet all the requirements of the FD&C Act and it's implementing regulations beginning without tobacco product adora t on june 22nd 2009 the President signed into law the Family Smoking Prevention and Tobacco Control Act which amended the FD&C Act to grant FDA new authority to regulate the manufacture marketing and distribution of tobacco products to protect public health and to reduce tobacco use by minors in addition to amending the Federal Food Drug and Cosmetic Act the Tobacco Control Act also amended the federal cigarette labeling and advertising act or F CLA a and D comprehensive smokeless tobacco health Education Act or CS th ei the Tobacco Control Act gave FDA the immediate authority to regulate cigarettes cigarette tobacco roll-your-own tobacco and smokeless tobacco the FD&C Act also allows FDA through regulation to deem all other tobacco products subject to its tobacco product authorities the FD&C Act defines tobacco products in part as any product made or derived from tobacco that is intended for human consumption as well as any component part or accessory of a tobacco product with publication of the final deeming rule fda extended is a regulatory authority to cover all products that meet the definition of a tobacco product including its components and parts except accessories of those newly regulated tobacco products when we discuss finish tobacco products we're referring to tobacco products including all components and parts sealed in final packaging intended for consumer use some examples of finished tobacco products are pipe tobacco cigars and electronic nicotine delivery systems as well as cigar tobacco filler hookah tobacco filters cigar tips and e-liquid flavours that are sealed in final packaging and attended for consumer use FDA intends to limit enforcement of many of the automatic provisions of the FD&C Act to finish tobacco products the term covered tobacco product is defined as all tobacco products deemed to be subject to the FD&C Act by the deeming rule except those components and parts that are not made or derived from tobacco some examples of covered tobacco products our pipe tobacco cigar cigar tobacco filler hookah tobacco and illiquid that are made or derived from tobacco it is also important to understand that some newly regulated tobacco products will be considered a finished tobacco product a covered tobacco product or both tobacco product importers may be distributors tobacco product manufacturers or both under the FD&C Act section 900 of the FD&C Act defines a distributor as any person who furthers the distribution of its Abaco product whether domestic or imported at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption section nine hundred of the FD&C Act defines a tobacco product manufacturer to include any person who imports a finished tobacco product for sale or distribution in the United States as John discussed earlier during this webinar imported tobacco products are required to meet the same standards and requirements as domestic tobacco products many of the requirements that are currently in effect for tobacco products are described on the compliance enforcement and training webpage reference on this slide now that you know the types of tobacco products that are currently regulated by CTP we will discuss some of the statutory provisions of the FD&C act that are currently in effect for tobacco products and which are relevant to tobacco product importers section 907 a 1a of the Act establishes a tobacco product standard that bans cigarettes or cigarette tobacco containing any characterizing flavor other than tobacco and menthol flavor some examples of characterizing flavors are listed on this slide cigarettes containing a characterizing flavor are adulterated and subject to refusal for smokeless tobacco products section 3 of the comprehensive smokeless tobacco Health Education Act requires a product package to bear 1 the following labels warning this product can cause mouth cancer warning this product can cause gum disease and tooth loss warning this product is not a safe alternative to cigarettes warning smokeless tobacco is addictive the Act also includes requirements relating to formatting size and location of the health warnings it's a backhoe product manufacturer importer distributor or retailer must follow an FDA approved warning plan that covers the equal distribution and display of the required warning statements on packaging for each brand of product and the quarterly rotation in alternating sequence of the required warning statements in advertisements for each brand of the product the Tobacco Control Act also established statutory provisions on modified risk tobacco products a modified risk tobacco product is a tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products this includes products with a label labeling or advertising that contains the following descriptors light mild low or any similar distributors an FDA order under Section 9/11 G of the FD&C Act is required before any person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product the FD&C Act section 905 requires the owners or operators of all domestic establishments engaged in the manufacture preparation compounding or processing of a tobacco product to register their establishment with the FDA establishments which deal in tobacco products which were regulated by FDA before at the deeming rule such as cigarettes are already subject to this requirement while establishments that deal in newly regulated finished tobacco products must register by December 31st 2016 at this time establishments within any foreign country engaged in the manufacture preparation compounding or processing of tobacco products that do not manufacture prepare compound or process any tobacco products within the United States are not required to register with FDA please note that importers that repackage or otherwise change the container wrapper or labeling of any tobacco product package in the United States must register section 904 of the FD&C Act establishes requirements for submission of a listing of ingredients of tobacco products a manufacturer or importer is required to submit to FDA a listing of all ingredients including tobacco substances compounds and other additives that are added by the manufacturer to the tobacco paper filter or other part of each tobacco product by brand and by quantity in each brand and sub brand for tobacco products that are imported the required ingredient information is to be submitted by either the foreign manufacturer or the importer of the product manufacturers of newly deemed tobacco products such as cigars pipe tobacco and electronic nicotine delivery systems will be subject to a certain reporting requirements under the FD&C Act as of the effective date of the final deeming rule however at this time FDA intends to limit enforcement of those requirements to Finnish tobacco products as a reminder the term finished tobacco product refers to a tobacco product including all components and parts sealed in final packaging intended for consumer use like a closed end system or a liquid sold separately to the consumer for use in an open end system in contrast an e liquid that is sold or distributed for further manufacturing into a finished end product is not itself a finished tobacco product FDA does not intend to enforce such requirements for those products at this time the reporting requirements for finished tobacco products include ingredient listings health document submissions harmful and potentially harmful constituents or HP h c– testing and reporting registration of establishments and listing of products and premarket review requirements the deeming regulation provides specific compliance dates for each of these provisions which are identified here in the second column the rule also provides additional time to comply with the ingredient listing reporting and tobacco health document submissions for small-scale tobacco and product manufacturers FDA considers a small-scale tobacco product manufacturer to be a manufacturer of any regulated tobacco product that employs 150 employees or fewer and has annual total revenue of 5 million or less for more information about these requirements please review the companion small entity compliance guide ins that was published around the same date as the final deeming regulation which is available on the FDA website for newly regulated tobacco products importers of finished tobacco products are required to submit ingredient listings health documents and HP h c– testing and reporting on finished tobacco products at FDA however importers are not required to register their establishment unless their products with FDA unless an importer repackages or otherwise changes the container wrapper or labeling of any tobacco product for the newly regulated tobacco products the final rule establishes a specific warning that must appear on all covered tobacco product packaging and advertisement and cigarette and roll-your-own tobacco product packaging and advertisements a covered tobacco product is any tobacco product deemed to be subject to the FD&C app but excludes any component or part that is not made or derived from tobacco this addictiveness warning is warning this product contains nicotine nicotine is an addictive chemical this warning must appear on packages for these products that are manufactured of 24 months after final publication of the rule and manufacturers must not introduce these products into domestic commerce without the warning statement as of 25 months after final publication of the rule regardless of when the products were manufactured the addictiveness warning statement must also be included in all advertisement for covered tobacco products and cigarette tobacco and roll-your-own tobacco this requirement takes effect 24 months after final publication of the rule for cigars this warning is only one of the six required warning statements under the final rule which we've discussed later in this presentation for product packages the warning statement must be on two principal display panels the area of the warning statement must cover at least 30% of each of the principal display panels for tobacco product advertisements the warning statement must occupy at least 20% of the upper portion of the advertisement and keep in mind that there are other specific formatting requirements contained in the new rule which are similar to those currently required for smokeless tobacco products for the newly regulated tobacco products products that are made or derived from tobacco but do not contain nicotine the product packages and advertisements may bear an alternative warning statement this product is made from tobacco instead of the addictiveness warning if the manufacturer of the product has it has submitted a confirmation statement to the FDA certifying it is true and accurate that the product does not contain nicotine and that the manufacturer has data to support the statement please see the small entity compliance guide ins for more information on this alternative warning statement for products that are too small to bear the required addictiveness warning all the alternative warning statement the warning may be displayed on a tag permanently affixed to the tobacco product package cigar manufacturers and importers are required to display one of the six warning statements on their product packages advertisement including the addictiveness warning statement cigar packages and appetizers must bear one of the six warning statements and be displayed distributed and rotated according to an FDA approved warning plan like smokeless tobacco products cigar manufacturers and importers are required to display warning statements in accordance with an FDA approved warning plan that ensures the six cigar warning statements are randomly displayed and distributed on product packages and rotated quarterly in an alternating sequence for advertisements cigar warning plans must be submitted to FDA for our review and approval which should be submitted by the responsible manufacturer importer distributor or retailer of the cigar product cigar warning plans must be submitted within twelve months of the publication date of the regulation which is May 10th 2017 submitters may voluntarily submit their warning plan sooner than the twelve months for FDA review and approval based on our experience with the review of smokeless tobacco warning plans the amount of time it took to review and approve the submitted warning plans was variable depending on the completeness quality and quantity of submissions FDA expects that many will submit their warning plans near the due date of 12 months after the publication of the rule you should keep these factors in mind in deciding when to submit your warning plan again submitters are welcome to voluntary submit their warning plans as soon as possible if you have any questions please do not hesitate to contact us at SCTP at FDA HHS gov manufacturers distributors and importers must display the new warning on all advertisements and packages of newly manufactured covered tobacco products cigarette tobacco and roll-your-own tobacco these this requirement takes effect 24 months after final publication of the rule in addition manufacturers must include the new warnings on packages of products that are introduced into domestic as of 25 months after the publication date of the rule regardless of the date of the manufacturer there are also other specific packaging labeling and advertising requirements for regulated tobacco products described in section 903 of the FD&C Act generally tobacco product packaging and advertisements are prohibited from being false or misleading product labels labeling and advertising must bear certain required statements and required statements must be prominently placed on the tobacco product labels labeling or advertisement this slide provides the compliance dates for the newly regulated tobacco products the FD&C Act gives FDA authority to collect user fees from manufacturers and importers of certain tobacco products such as cigarettes snuff chewing tobacco and roll your own tobacco with the passing of the deeming rule manufacturers and importers of cigars and pipe tobacco are now subject to user fees as well more information about user fees may be found in the updated user fee rule published on the same day as the final deeming rule for more information on the statutory provisions described in this presentation please see the page on products guidance and regulations found at our website you can see a link for this on the slide the link for the guidance documents that FDA has issued is also provided on this slide the regulatory procedures manual provides helpful information regarding the import process you can find a link to the regulatory procedures menu on this slide as well additional resources for tobacco product importers can be found at our Center for tobacco products website for general inquiries contact CTP via email or phone at SCTP at FDA HHS gov or 1 877 CTP 1373 small businesses can email us at small business gov at our website you can sign up for this week in CTP to receive weekly email updates from the Center for tobacco products that concludes my presentation David thanks John thanks Lillian this concludes today's webinar I'd like to close by thanking all of you for your participation in today's broadcast which is brought to you by the set of a tobacco products protecting our kids and the nation's health from tobacco

Leave a Reply

Your email address will not be published. Required fields are marked *