The Legal Resource Center for Public Health Policy provides information and technical assistance on issues related to public health in Maryland.

Transcription

1 October 17, 2016

2 The Legal Resource Center for Public Health Policy provides information and technical assistance on issues related to public health in Maryland. The legal information and assistance does not constitute legal advice or legal representation. For legal advice, one should consult a lawyer licensed to practice law in their state.

3 What is it? Background on Tobacco Control Act and FDA s Deeming Authority What does it do? Summary of basic provisions What does it not do? Implications for state and locals

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5 Tobacco Control Act (TCA) gave FDA authority over tobacco products in 2009, requiring FDA to adopt certain requirements for ALL tobacco products under its authority Covered Cigarettes, Roll-your-own, Smokeless Not Covered Cigars, Pipe tobacco, Gels/Dissolvables, Hookah/shisha, ENDS

6 Sottera, Inc. v. FDA (2010) April 2009: FDA denies entry of NJOY and Smoking Everywhere e-cigarettes into the US The companies argue that e-cigarettes are not drug-devices but are tobacco products since the liquid nicotine is derived from tobacco RESULT: Court held FDA lacked authority to regulate e-cigarettes as drug-devices absent therapeutic claims (i.e. claiming they help people quit smoking)

7 April 25, 2014: FDA issues Notice of Proposed Rulemaking (NPRM) that deems products containing tobacco OR derived from tobacco as subject to the Tobacco Control Act August 8, 2014: Public comment period on proposed rule closes May 10, 2016: Final Rule published August 8, 2016: Final Rule becomes effective

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9 Tobacco Product (TP): Any product made or derived from tobacco intended for human use Component and Part: Anything that is integral to the use or composition of a TP I.e.: e-liquid Accessory: Products that can be used with, but not integral to the use or composition of, a TP I.e.: ENDS carrying cases, holsters, or lanyards; pipe tobacco pouches; cigar ash trays or humidors; hookah tongs or external burners Deeming rule does NOT extend statutory definition of tobacco product to accessories of newly deemed products

10 Newly Regulated Tobacco Product ENDS Pipe Tobacco Cigars Hookah Component/Part example E-liquid, refills, battery Pipe, pipe mouthpieces, pipe bowls Cigar wrapper, cigar tobacco filler, flavoring Heating charcoal or wood cinders, bowls, valves, hoses, hookah foil, mouthpieces

11 Cigars, e-cigarettes, hookah, pipe tobacco, dissolvable tobacco products, and any other product containing tobacco, or nicotine derived from tobacco Any future products that meet the statutory definition of tobacco product under the Act

12 E-cigarettes and other electronic delivery nicotine systems Pipe tobacco Dissolvables Hookah tobacco Cigars Novel and future tobacco products

13 Products that do not contain either tobacco or nicotine I.e., e-liquid that doesn t contain nicotine and herbal shisha that doesn t contain tobacco

14 Report product and ingredient listings Register with the FDA Report harmful / potentially harmful ingredients Have health warnings on product packages & ads Be subject to premarket review Not make reduced risk claims without scientific data & FDA approval Not use descriptors such as light, low, and mild Not make false or misleading claims in labels or ads Pay user fees (CTP is not taxpayer funded)

15 Minimum age (18) and ID requirements Vending machine sales prohibited (unless in 18+ facility) Distribution of free samples prohibited

16 Owners / operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products subject to registration requirements Includes vape shops acting as manufacturers (mix/prepare e-liquids for sale)

17 Obtain critical information regarding health risks of newly deemed products Keep track of establishments that manufacture, prepare, compound, or process tobacco products Take enforcement action against manufacturers who sell and distribute products with unsubstantiated modified risk claims, or false or misleading claims on labels or ads Prevent products from entering the market that are not appropriate for the protection of public health, not substantially equivalent to a predicate product, or are not exempt from substantial equivalence Subject newly deemed products to future regulations that the FDA determines are appropriate to protect public health

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19 Nothing! Federal laws and regulations only authorize federal agents to enforce State and local officials may not enforce federal law Therefore, the Deeming Rule does NOT directly affect enforcement of state and local law NO ENFORCEMENT CHANGES FOR STATE AND LOCALS NO FEDERAL PREEMPTION OF STATE AND LOCAL LAW

20 Locals can regulate: Use restrictions/ sales to minors Sale, distribution, possession and use of ENDS Vape shop regulation Product placement (ENDS only) Consult county attorney if considering any legislation

21 Supplementing state criminal penalties with local civil enforcement Imposing civil penalties Authorizing health department or designee to issue citations Nearly half the counties already have civil enforcement provisions For example, see Baltimore City Health Code

22 Tobacco Product vs. E-Cigarette: E-cigarettes are not tobacco products under state law; counties may regulate ENDS products at the local level Some legislation examples include: License/permit Taxation Indoor use Youth use Product placement For example, legislation in Montgomery county includes: 30% tax on wholesale e-cigarette price; use by minors prohibition; vaping prohibition in public indoor places; e-cigarette inclusion in product placement laws

23 Restrictions include: Zoning (i.e. distance from residential area, school, or other community) Hours of operation Age (customers and employees) Health & safety (i.e. safe handling restrictions) License/permit For example, Baltimore County requires vapor lounges to operate from 6-12 am Baltimore County Zoning Code 101.1

24 Locals can: Require ENDS retailers to store and display products in a location that is inaccessible to customers Impose civil enforcement of violations Federal law restricts placement of cigarettes and smokeless tobacco, but not ENDS At least 10 counties have laws restricting selfservice displays for tobacco products See Talbot County Code, through

25 The following actions have been filed against the FDA since the finalization of the Deeming Rule: Case Caption Court Filed Date Filed Nicopure Labs, LLC v. FDA AND Right U.S. District Court for the District of 5/10/16 to Be Smoke-Free Coalition, et al v. FDA (consolidated 6/28/16) Columbia Lost Art Liquids v. FDA U.S. District Court for Central District of 5/19/16 California Larry Faircloth v. FDA U.S. District Court for Southern District of 6/10/16 West Virginia Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC v. FDA U.S. District Court for the Southern District of Florida 6/1/16 John Middleton Company LLC v. FDA and U.S. Department of Health and Human Services Cyclops Vapor 2, LLC, et al v. FDA U.S. District Court for the District of Columbia U.S. District Court for the Middle District of Alabama, Northern Division 5/26/16 (pending notice of voluntary dismissal) 7/8/16

26 Brooke Torton, JD Legal Resource Center for Public Health Policy (410)