IMPACT OF FDA REGULATION ON CHINESE E-CIG, E-LIQUID AND VAPOR MANUFACTURERS
The 2014 Cecmol China ECIG Forum came to a close successfully last week , Amanoo has involved in the whole Forum during Sep. 2 to Sep.4 2014 . The Speech gave by Ron Tully ( VP of The National Tobacco of USA ) will be a good instruction of Chinese Manufactures like Amanoo.
US FOOD & DRUG ADMINISTRATION
• FDA given statutory/legal authority to regulate tobacco product in 1999 under Family Smoking and Tobacco Protection Act (Tobacco Control Act)
• Created a new Center For Tobacco Products
• Industry pays $750m in user fees each year to fund the FDA. Agency has over 600 employees.
• All tobacco companies must register, and all individual brands and sub-brands, and their ingredients must be registered
DEFINITION OF A TOBACCO PRODUCT
• Anything “made” or “derived” from tobacco
• Any ‘additive’ or ‘component’ of a tobacco product
• The TCA does not address non-tobacco-derived and synthetic nicotine – as such these products are not subject to regulation by FDA if no therapeutic/cessation or other health related claim are made.
WHAT IS CURRENTLY REGULATED?
• Currently regulated products include e-cigarettes, cigarette tobacco, smokeless tobacco
• Currently regulated components include e-cigarette papers, cigarette tubes and cigarettes and smokeless additives and flavorings.
DEEMING REGULATIONS
• FDA issued for comment a proposed deeming regulation that will extend its statutory authority to regulate additional tobacco products and components of tobacco products
• Newly deemed products will include cigars, hookah (shisha) tobacco, pipe tobacco, e-cigarettes and e liquids and novel tobacco products.
• To be considered a newly deemed tobacco product, it must be ‘made’ or ‘derived’ from tobacco.
HOW WILL E-PRODUCTS BE IMPACTED?
• Any e-product made or derived from tobacco will be subject to FDA regulation as a tobacco
product
• E-liquids containing tobacco derived nicotine
• E-liquids containing tobacco derived flavor extracts
• E-cigarettes or cartomizers containing liquids made or derived from tobacco
• Components of e-cigarettes/vaporizers that are marketed or used by the consumer with tobacco, for example, batteries, clearomizers
FDA REQUIREMENTS – ONCE DEEMED
• All manufacturers, importers must register with FDA
• All brands, sub-brands must be registered with the FDA including
• Packaging and marketing samples
• Ingredients used in the manufacture of a tobacco product
• Health related information on a product
• Manufacturing facilities in China will be subject to inspection for ’adulteration’ or ‘misbranding’ of products
FDA REQUIREMENTS – ONCE DEEMED
• Ban on the use of ‘modified risk claims’ – cannot use words such as ‘light’, ‘mild’, ‘safer’, ’healthy’ on packaging or in brand marketing
• Testing of ingredients to show the levels of hazardous or potentially hazardous components (HPHC List) of a tobacco product, for examples the tested levels of nitrosamines,benzo(a)pyrenes, formaldehyde, etc
FDA REQUIREMENTS – ONCE DEEMED
• Good Manufacturing Practice
• May raise issues for Chinese manufacturers between different customer supplied from the
same factory
• Health warnings on Packaging and Advertising, for example, ‘NICOTINE IS ADDICTIVE’ALL OF THE ABOVE WITHIN 24 MONTHS of ENACTMENT
DEEMING – DEADLINES
• Establishment registration and product listing to be specified by FDA based on timing of publication of Final Rule
• Ingredients listing – 6 months from effective date of Final Rule
• Health document submission – 6 months from effective date
• Modified risk descriptor removal – 1 year from effective date to cease manufacture, 13 months
from effective date to cease distribution
SOME POSITIVES FROM DEEMING
• No ban on internet sales of deemed products (all sellers are required to ID consumers under 27)
• No self-service display restrictions for deemed products (other than a vending machine ban)
• No ban or limitations on types of advertising of deemed products
• No ban on flavors in deemed products (but there could be future rulemaking on ‘product standards’)
DEEMING -GRANDFATHER DATE
• Feb 15, 2007 statutory ‘grandfather’ date for currently regulated tobacco product remains
the same for newly deemed products
DEEMING – TIMING
• General misbranding prohibitions, requirement to label product with its established name, and requirement to include name and “brief statement” in all advertising and other printed materials – 1 year from effective date
• Warning statement requirements – 24 months + 30 days from publication of Final Rule
• All other labeling requirements – 2 years from publication of Final Rule • HPHC physical state, smoke/vapor analysis – 3 years from effective date
DEEMING REGULATION
• The Tobacco Control Act requires that any tobacco product not on the market after February 15, 2007 must file:
• A ‘substantial equivalence’ (SE) report proving that the product being registered is the same or identical to a product that was on the market prior to the February 15, 2007 date. This requires companies to show they have a ‘predicate’ product upon which to base the SE. Or must file:
• A Pre-Market Tobacco Application (PMTA), which requires a complete analysis of all aspects of a product, including design, manufacture, integrity parameters, HPHC ingredients testing, consumer use studies, marketing impact studies, and a requirement to demonstrate through epidemiological and other survey data that the use of the product does not raise new issues of public health among smokers, non-smokers and the public.
DEEMING EGULATION – EFFECTIVE DATE
• Comment period (August 8, 2014) – multiple issues on which industry offered comment.
• FDA will review comments and submit proposed final rule -could take 18-24 months.
• Final rule likely published late 2015/ early 2016
• Potential industry litigation on the 2007 ‘grandfather’ date or other issues (e.g., ‘premium cigar’ exemption and warning labels, etc.)
OTHER USA LEGISLATIVE ISSUES
• Bills are currently in Congress now to regulate:
• Marketing and advertising of e-products through the Federal Trade Commission
• Safety of e-cigarettes, liquids and devices through the Consumer Product Safety Commission
• US Federal Paraphernalia Statutes – claiming that a device is suitable for use with a controlled substance can make the device subject to importation controls by US Customs
