Deeming Regulations and

InstantGMP™ Vape

Deeming Regulations• Federal Regulations on e-cigarettes released May, 2016• FDA will regulate e-cigarettes as tobacco products• All manufacturers will have to submit Premarket Tobacco

Product Application (PMTA) for each product• Small enterprises (<150 employees,

<$5M) have 24 months to make submissions• FDA will not enforce regulations for 36

months

Tobacco Product Manufacturer• Any person, including any repacker or relabeler, who manufactures,

fabricates, assembles, processes, or labels a tobacco product“• Includes "repackaging, or otherwise changing the container, wrapper

or labeling of any tobacco product package• FDA regulates the manufacture of all new products, including those

manufactured at the retail level• All manufactures must register with the FDA by the end of 2016 and

must comply with manufacturing and PMTA requirements• Implication: retail stores can no longer make small or custom batches

Deeming Regulations

• Free samples cannot be distributed• There will be minimum age and identification restrictions to

prevent sales to underage youth• Health warnings on labels/packaging will be imposed• Vending machine sales will be prohibited except in facilities that

never admit youth

Predicate Product• PMTA must be made for every product unless there is substantial

equivalence with a predicate product• Official predicate product is one on the market as of February 15,

2007• Almost no one has a predicate product• Cole/Bishop amendment attached to Agriculture Appropriations Bill

would set predicate date to when deeming regulations became effective this year

Why Deem E-Cigarettes as Tobacco Products?• To prevent young people from using these products• To make the public aware of FDA’s safety concerns• To allow FDA to study their health risks and benefits• To ensure that other potentially harmful constituents are not

present

Premarket Tobacco Product Application• Full reports on health risks (e.g. carcinogins, toxicity of ingredients)• Statement of components, ingredients and properties of product• Description of methods, facilities and manufacturing controls• Reference showing product meets standards

Requirements for Components, Ingredients and Additives• Full statement of components, ingredients and additives included in a PMTA• Components - include the device that holds the liquid nicotine• Quantity of each ingredient in the e-liquid• Specifications for each component and ingredient• Description of intended function of each• Analytical test results on at least 3 batches

Preparing Product Properties for Submission

• Form, dimension, construction• Design features• Performance criteria• All of above = device

specifications

Manufacturing Facilities• Listing of all manufacturing, packing and control sites• List and summary of all standard operating procedures

(SOPs)• Examples of relevant forms and records

Manufacturing Controls•Manufacturing and production activities• Description of all production steps• Master Batch Records (how production will be done)

and• Batch Production Records (how production was done)

• Personnel oversight and training• Design and change control

Quality Controls for Tobacco Products• Quality is “Meeting Specifications” • Controls for quality include:• Design and change control• Supplier identification and monitoring• Purchasing controls and incoming product acceptance • Release testing procedures of finished product • Validation that product meets specifications• Handling of non-conforming products and complaints

Regulations Timeline – Our Predictions in 2014• New tobacco regulations deeming e-cigs as tobacco products

draft issued in 2014• Our guess was that by 2018 e-cigs and e-liquids will need to

meet FDA regulations and get premarket approval before selling• Guess was accurate

Summary• E-Cig and E-Liquid manufacturers are now regulated• Premarket Tobacco Product Applications will have to be filed

for every product• Good Manufacturing Practices will underpin the

manufacturing requirements• SOP list must be submitted with PMTA

Deeming Regulations and InstantGMP™ Vape• E-Liquid Manufacturers must prepare PMTAs for each product

• Needs facility and manufacturing information including list of ingredients• List all SOPs, forms, templates and quality control specifications

• InstantGMP™ Vape – manufacturing software for e-liquids• Helps manufacturers collect data manufacturers needed to prepare PMTA• Provides documentation of specifications required for PMTA• Establishes traceability between vendor’s raw materials used in manufacturing and

products sold to customers

• Vape SOPs• Meets requirements for Standard Operating Procedures needed in PMTA