VTA Annual Meeting Kevin Altman September 17, 2019
• Application must demonstrate that new tobacco product is appropriate for the protection of the public health • FDA must consider risks and benefits to population as a whole, including users and non-users of tobacco products • Currently Due May 11, 2020 2
• FDA must also consider: Ø Increased or decreased likelihood that existing users of tobacco products will stop using such products and Ø Increased or decreased likelihood that those who do not use tobacco products will start using such products 3
• FDA may refer application to Tobacco Products Scientific Advisory Committee (TPSAC) • FDA must act within 180 days of receipt of complete application • For now, up to one-year continuing compliance period (for 8/8/2016 products with applications filed by 5/12/2020) • Expect a change in compliance policy later this month on flavored ENDS 4
• “Submitted” = when complete application is delivered and received by CTP’s DCC • “Accepted” = when FDA completes a preliminary review and determines that the application on its fact contains all required information • “Filed” = when FDA completes a threshold review and determines that a complete, substantive review is warranted (results in filing letter or refusal to file letter) 5
1. Full reports of all investigations of health risks of new tobacco product 2. Full statement of components, ingredients, additives, properties, and principle(s) of operation of such tobacco product 3. Full description of methods, facilities, and controls used in manufacture, processing, packing, and installation 6
4. Explanation of how product complies with any applicable tobacco product standards 5. Samples of product and components 6. Specimens of proposed labeling 7. Any other relevant info FDA may require 8. Environmental assessment PLUS possible inspection of manufacturing and/or research sites 7
} Cover letter, executive summary, table of contents } May submit single submission for multiple products: clearly identify what content pertains to each distinct product } Identify trade secret/confidential information by submitting one un- redacted version and one marked- for-redaction version 8
} Full descriptive information for each product } Summary of all research findings, including health risks of the product, the product’s effect on tobacco use behavior among current users (including dual use), the product’s effect on tobacco use initiation among nonusers, and the product’s effect on the population as a whole } Detailed explanation of how data and info submitted supports APPH finding, including comparison of the health risks of the product to others currently on the market 9
} Full statement of components, ingredients, additives, including intended function } Description of properties, principles of operation } Information about container closure system } Constituent testing that reflects the range of operating conditions, use patterns and types of products likely to be used with the product } Final Guidance provides updated list of constituents 10
} Identify all manufacturing, packaging and control sites } Provide narrative description, list/summary of all SOPs and examples of forms for production steps, employee training, supplier controls, validation steps, product release procedures, complaint handling and corrective/preventative actions 11
} Full reports of investigations: ◦ That support and are adverse to your application ◦ Both nonclinical and clinical investigations assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure and consumer use profiles, novel components ◦ Conducted within and outside of U.S. 12
} It may be possible to support an order without conducting new nonclinical or clinical studies ◦ Literature reviews and meta-analyses ◦ Master files ◦ Bridging ◦ Instead of clinical studies, could use acute toxicological endpoints or other clinical endpoints with bridging information, potentially in tandem with nonclinical in vitro assays assessing toxicity associated with long term use of a tobacco product 13
} Thorough toxicological and pharmacological evaluation of ingredients, mixtures of ingredients, and aerosols } Strong scientific justification for potential daily exposure levels of users to ENDS product aerosol } In absence of tox data, may be able to use computational modeling using surrogate chemical structures 14
} Consumer perceptions } Likelihood of initiation and cessation by both users and nonusers of tobacco products (including vulnerable populations) } Product use patterns, user topography } Labeling comprehension, self-selection, and actual use } Human factors } Abuse liability } Biomarkers of harm and exposure? } Health Outcomes 15
} E-Liquids ◦ Components, ingredients, additives ◦ Flavors – tox, development, consumer perception and appeal (youth and adults) } Apparatus ◦ Design factors and parameters for batteries, atomizers and software ◦ Materials ◦ Power supply, charging source, electrical safety ◦ Schematics 16
} Applicants may propose specific sales and distribution restrictions to support a showing that the marketing of product would be APPH } For example, a restriction that decreases the likelihood that non-users of tobacco products will start using the new product } FDA may then consider the product in that context and include the proposed restrictions as mandatory conditions for marketing upon authorization 17
} Insufficient listing of ingredients, additives, and properties } Insufficient manufacturing information and labeling specimens } Lack of statement regarding compliance with product standards 18
Ø By working Together Ø Sharing Questions and Information Ø Sharing certain compliance costs (Tox work, literature review and behavioral science) Ø Building an alliance with common interests Ø Build a CITMA Model within VTA 19
} Competing companies working together in one organization with a common goal } Using retained professionals to inform you of all FDA compliance issues by developing Ø Write-ups on new rules and guidance so you understand the issues and how they affect your company Ø Communicating your concerns directly to the FDA while protecting company’s identity Ø Commenting to or meeting with the FDA, OIRA, SBA and OMB on all proposed rules or guidance Ø Strategies to comply with regulations Ø Templates to help you file information with the FDA Ø Guidelines as to how to perform various responsibilities 20
} Members see the value in sharing ideas and the costs associated with FDA compliance } More people working on an issue is better than a few } More feedback from the FDA due to constant communication with the FDA by legal counsel } Develop a valuable relationship with the FDA } FDA is a “Contact Sport” } VTA will become the prominent information base for E-Products 21
} Providing FDA compliance information to members is critical to members success } VTA would Still provide Legislative services on the ever under attack vapor segment } Pilot program in place for a common PMTA approach 22
} Working with member manufacturers and others to develop “model PMTA” } Meet the Minimal PMTA Standard by May 11, 2020 } “Appropriate for the protection of public health” filter } Pass/Fail Model } Establish scientifically valid, lowest possible cost protocols } Standardize filings across industry 23
} Address Statutory Obligations Product Characterizations • Manufacturing Description • HPHC • Stability • Environmental Assessment • Literature Review • Also: Define and implement plans, protocols and implementation strategies regarding the Guidance recommendations, including: Behavioral Testing –(Consumer use, label comprehension and youth access and appeal) PK studies Biomarkers? 24
} Chemical Testing, which is based on the composition of the e-liquids, i.e. the recipe • Pro Product chara racteri rization* • De Descripti tion of f th the manufa factu turing g process* • Ha Hazardo dous a s and P d Potentially Ha Hazardo dous C s Const stituents s (H (HPHCs) ) – in in the liq liquid id and the aeros osol ol • Pro Product stability y • En Environmental Assessment* • Rev Review ew of the e available e toxi xicological liter erature e based ed on yo your i ingredients
} Be Behavio ioral l Te Testin ing, whic ich is is based on the co cons nsume umer respons nse to the he product uct and nd labeling ng • Pha Pharmacoki kine netic (PK PK) stud udies • Pr Prevalenc nce stud udies • Pr Produc uct perception n stud udies • Ob Observationa nal stud udies • La Label co comp mprehension studies
} Behav Behavioral al T Test esting ng ◦ Gr Grou oup si simi milar ty type pes s of pr produ ducts ts to to redu duce numbe mber of of tests ◦ De Define la labeling ling s stra rategy f for p r pro roduct ucts Simp Simple le vs vs. complex lab labels ls ◦ Ma Maximize ze mo modeling g and bridgi ging g on Be Behavioral St Stud udie ies 27
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