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1 © EAS Consulting Group, LLC
Les Weinstein
FDA’s Center for Tobacco Products (CTP): Overview of Requirements & Advice on How to Navigate Through Them
WT North America Conference
Richmond, Virginia
May 12-14, 2015
2 © EAS Consulting Group, LLC
FDA Organization
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CTP Organization
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Office of Center Director (OCD)
Director
Mitch Zeller, JD
Office of Science (OS)
Director
RADM David Ashley, PhD
Office of Compliance and Enforcement (OCE)
Director
Ann Simoneau, JD
Office of Regulations (OR)
Director
Beverly Chernaik, JD
Office of Health Communication and Education
(OHCE)
Director
Kathleen Crosby
FDA’s Regulatory Scheme for Tobacco
• The Family Smoking Prevention and Tobacco Control Act (usually referred to as the Tobacco Control Act (TCA)) signed into law in June 2009, granted FDA authority to regulate tobacco products.
• FDA established the Center for Tobacco Products (CTP) to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use.
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How CTP Regulates Tobacco Products
CTP is authorized to:
• Require tobacco product manufacturers to register
• Establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness
• Establish limits on sale and distribution of tobacco products
• Require premarket review for new and modified risk tobacco products to protect the public health
CTP actions thus far:
• Restricting access and marketing of tobacco products to youth
• Banned cigarettes with characterizing flavors, such as candy and fruit
• Banned brand-name tobacco sponsorship of sporting events and concerts
• Enforcing minimum pack size of 20 cigarettes
• Requiring companies to report to FDA on Harmful or Potentially Harmful Constituents (HPHC) in tobacco products
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How CTP Regulates Tobacco Products (cont’d)
CTP actions thus far (cont’d):
• Educating consumers about the risks of tobacco products
• Requiring manufacturers to seek CTP authorization before marketing a new product or making changes to existing products
• Established processes for new tobacco products through three separate pathways to market: Premarket Tobacco Applications, Substantial Equivalence (SE) Reports, Modified Risk Tobacco Product (MRTP) Applications
• Issued decisions on small number of more than 4000 SE applications
• Prohibited use of terms that imply reduced risk (such as “light,” “mild,” or “low”) without CTP authorization as a MRTP
• Contracts with states to do retail inspections re: underage purchases and other violations; has issued more than 10,000 warning letters and some civil money penalties
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How CTP Regulates Tobacco Products (cont’d)
• CTP currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
• CTP has authority to regulate “tobacco products,” which are defined in part as any product “made or derived from tobacco” that is not a “drug,” “device,” or “combination product”.
• FDA does not currently regulate products such as e-cigarettes, cigars, pipe tobacco, waterpipe (hookah) tobacco, and novel products like nicotine gels and certain dissolvables, unless manufacturers make therapeutic claims. However, CTP has published a proposed regulation (the “deeming rule”) to bring these additional tobacco products under its authority. 135,000 comments have been submitted. The final regulation is estimated to be published in June 2015.
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What CTP Cannot Do
• Use the traditional FDA “safe and effective” standard for evaluating medical products. Instead, CTP evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole, including users and nonusers
• Ban any class of tobacco products, such as cigarettes
• Require the reduction of nicotine yields to zero
• Require prescriptions to purchase tobacco products
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CTP Offices• Office of the Center Director (OCD): Provides leadership, direction, management and coordination for
CTP. Also includes stakeholder relations, Ombudsman, executive secretariat.
• Office of Science (OS): Reviews and decides on premarket tobacco product applications: Substantial Equivalence (SE), Modified Risk Tobacco Products (MRTP), and New Tobacco Products. Relies on science to make regulatory decisions. Conducts own research to support regulatory science; partners with other government agencies to support research efforts; and provides funding opportunities for external research.
• Office of Compliance and Enforcement (OCE): Ensures that distributors, importers, manufacturers, and retailers comply with the Tobacco Control Act : inspections, investigations, monitoring and review activities. Develops and documents evidence to support enforcement actions. Manages state and territory retail inspection program; registration and listing, warning letters, civil money penalties. Includes Office of Small Business Assistance to help manufacturers and retailers understand the law and regulations.
• Office of Regulations (OR): Develops, drafts and coordinates clearance of proposed and final regulations (which have the force and effect of law), draft and final guidances (which are FDA’s current thinking on a topic and do not bind the agency or the public).
• Office of Health Communication and Education (OHCE): Develops campaigns to help educate the public, especially youth, about tobacco products, pursuant to FDA’s authority to regulate the marketing and sales of tobacco products.
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Navigating the Office of Science (OS)
• Submissions: Submit premarket related applications (SE, MRTP, New Tobacco Products) according to guidances and other available information specific to the type of submission.
• OS Contact: Regulatory Health Project Manager (RHPM) will be your primary contact. RHPM and you will be in touch by email and phone. If your RHPM is not responsive or timely, complain to his/her supervisor/manager or CTP Ombudsman.
• Meetings: Tobacco product manufacturers, researchers, importers, or investigators may request a meeting (in-person or conference call) with OS to get assistance relating to research and development of particular tobacco products. Usually a meeting request should be sent prior to filing a tobacco product submission, but some meeting requests are sent, and accepted, during the review of a premarket submission. Follow the procedures in the May 2012 Guidance on “Meetings with Industry and Investigators on the Research and Development of Tobacco Products”.
• Appeals: If you receive an adverse decision from OS (or elsewhere in CTP) you may appeal it by using 21 CFR (Code of Federal Regulations) 10.75. Under Section 10.75, "an interested person outside the agency may request internal agency review of a decision through the established agency channels of supervision or review," which is appealing up the supervisory chain of command. For example, if a division director signed a letter denying a premarket application, you could appeal up to the OS director. If the OS director signed the letter, you could appeal up to the Center Director. For further information, contact the CTP Ombudsman who coordinates this process for the Center.
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CTP OMBUDSMAN Ella Yeargin, JD is the CTP Ombudsman
• Investigates complaints, facilitates resolution of disputes & responds to inquiries
• Neutral and impartial
• Fairness
• Confidentiality
• Independence
Ombudsman’s 2014 Annual Report
• Received137 contacts from: general public/consumers (63%), tobacco companies (22%), retailers (10%), distributors (1%), trade associations (1%) and others
• Most common subject matter: e--cigarettes (including deeming) (43%),Substantial Equivalence (12%), retailer compliance/inspections (12%), media campaigns (7%), FDA website (4%), smoking bans (3%), Harmful and Potentially Harmful Constituents (HPHC) (3%)
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Two-way Communication with CTP
• Sign up for FDA email updates on tobacco products at http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm176164.htm
• Watch CTP compliance webinars http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm220111.htm
• Attend and sign up to speak at TPSAC (Tobacco Product Scientific Advisory Committee) meetings http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/default.htm
• Attend and speak at, or watch and submit questions to, CTP public meetings
• Send in written comments on proposed rules as well as on draft and final guidances http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
UCM314421.pdf. CTP must consider every comment received before issuing the final version.
• Submit a Freedom of Information Act (FOIA) request for documents not on FDA’s website http://www.fda.gov/regulatoryinformation/foi/default.htm
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Two-way Communication with CTP (cont’d)
• Tobacco Industry Inquiries: [email protected]
• Small Business Industry Questions: [email protected]
• General Consumer Inquiries: [email protected] or 877-287-1373 (9 AM to 4 PM East Coast Time)
• Formal Correspondence: [email protected]
• Meeting Requests: [email protected]. Include a proposed agenda and attendee list.
• Contact the Ombudsman: [email protected] or call 301-796-3095
• All written correspondence should be sent to the following address:
Center for Tobacco Products (CTP)
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring MD 20993-0002
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Connect with CTP on Social Media
• Follow @FDATobacco on Twitter
• Visit FDA on Facebook
• Watch FDA on YouTube
• Browse photos on Flickr
• Subscribe to CTP RSS feeds:
Tobacco News
Tobacco Retailer Information
• Listen to CTP podcasts
• Learn more about tobacco regulation on the FDA Voice Blog
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• Questions?
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Thank You
