Illinois General Assembly - Full Text of HB5482
Illinois General Assembly

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Full Text of HB5482  101st General Assembly




State of Illinois
2019 and 2020


Introduced , by Rep. Robert Rita


New Act

    Creates the New Tobacco Product Certification Act. Provides that by a specified date every new tobacco product manufacturer whose new tobacco products are sold in the State shall execute and deliver a certification to the Department of Revenue with specified information. Requires new tobacco product manufacturers to notify the Department within 30 days of receiving an order issued by the U.S. Food and Drug Administration with regard to a new tobacco product or of any notice of action taken by the U.S. Food and Drug Administration affecting the ability of the new tobacco product to be introduced or delivered into interstate commerce for commercial distribution. Requires new tobacco product manufacturers to pay a fee to the Department not to exceed $500. Provides that a violation of the Act shall result in a $500 civil penalty. Allows the Department to adopt rules that are necessary and proper to implement and enforce the Act. Contains other provisions.

LRB101 20458 CPF 70023 b






HB5482LRB101 20458 CPF 70023 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 1. Short title. This Act may be cited as the New
5Tobacco Product Certification Act.
6    Section 5. Definitions. In this Act:
7    "Alternative nicotine product" means any noncombustible
8product containing nicotine without the presence of tobacco
9leaf that is intended for human consumption, whether chewed,
10absorbed, dissolved, or ingested by any other means.
11"Alternative nicotine product" does not include: any tobacco
12product or vapor product; any product regulated as a drug or
13device by the U.S. Food and Drug Administration under
14Subchapter V of the federal Food, Drug, and Cosmetic Act; or
15any nontobacco food product in which nicotine is a naturally
16occurring compound.
17    "Cigar" means any roll for smoking, except cigarettes, made
18chiefly of tobacco or any substitute for tobacco. "Cigar"
19includes any tobacco product manufactured or packaged as a wrap
20or as a hollow tube made, wholly or in part, from tobacco that
21is designed or intended to be filled by the consumer with loose
22tobacco or other fillers.
23    "Department" means the Department of Revenue.



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1    "Finished new tobacco product" means any new tobacco
2product that will not be subject to any additional processing
3before sale to a consumer.
4    "New tobacco product" means any alternative nicotine
5product, cigar, or vapor product that:
6        (1) was not commercially distributed or sold,
7    including, but not limited to, products distributed or sold
8    in test markets, in the United States on or before February
9    15, 2007; or
10        (2) was modified in design, contains a component or
11    part that was modified, changed in the content or amount of
12    any additive or ingredient at any time after February 15,
13    2007, and for which the U.S. Food and Drug Administration
14    has issued a regulation or other formal guidance
15    determining that the modification or change alters the
16    product to such an extent that it is no longer
17    substantially equivalent to a product commercially
18    distributed or sold on or before February 15, 2007.
19    "New tobacco product manufacturer" means any person who
20manufactures, fabricates, assembles, processes, mixes,
21prepares, labels, repacks, or relabels a finished new tobacco
22product. "New tobacco product manufacturer" includes, but is
23not limited to, an owner of a brand or formula for a new
24tobacco product who contracts with another person to complete
25the fabrication and assembly of the product to the brand or
26formula owner's standard.



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1    "Vapor product" means any noncombustible product that
2employs a heating element, power source, electronic circuit, or
3other electronic, chemical, or mechanical means, regardless of
4shape or size, that is intended to aerosolize a liquid or other
5substance containing nicotine. "Vapor product" includes any
6electronic cigarette, electronic cigar, electronic cigarillo,
7electronic pipe, electronic hookah, vape pen, vaporizer, or
8similar product or device, any component or part of such
9product or device, and any container or cartridge containing a
10liquid or other substance containing nicotine that has been
11manufactured to be used with or in a vapor product. "Vapor
12product" does not include any product regulated as a drug or
13device by the U.S. Food and Drug Administration under Chapter V
14of the federal Food, Drug, and Cosmetic Act.
15    Section 10. Manufacturer certification.
16    (a) Beginning June 1, 2020 or 30 days after a premarket
17tobacco application submission deadline is issued by the U.S.
18Food and Drug Administration, whichever is later, a new tobacco
19product manufacturer whose new tobacco product is sold in this
20State, whether directly or through a distributor, retailer, or
21similar intermediary, shall execute and deliver on a form
22prescribed by the Department a certification to the Department
23certifying, under penalty of perjury, the following:
24        (1) a premarket tobacco application has been submitted
25    to the U.S. Food and Drug Administration with respect to



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1    each new tobacco product that is sold in this State by the
2    new tobacco product manufacturer; and
3        (2) the date the premarket tobacco application was
4    submitted to the U.S. Food and Drug Administration.
5    A certification under this subsection shall include a copy
6of the cover page of the premarket tobacco application with
7evidence of receipt of the application by the U.S. Food and
8Drug Administration.
9    (b) The Department shall maintain a directory on its
10website and make available to the public a list of all new
11tobacco products that may lawfully be distributed or sold in
12this State. The Department shall add each new tobacco product
13that is compliant with subsection (a) to the new tobacco
14product directory within 30 days after receipt of proper
15certification under this Section.
16    (c) Notwithstanding subsections (a) and (b) of this
17Section, if a new tobacco product manufacturer can demonstrate
18to the Department that the U.S. Food and Drug Administration
19has issued a rule, guidance, or any other formal statement that
20temporarily exempts a new tobacco product from the federal
21premarket tobacco application requirements, the new tobacco
22product may be added to the new tobacco product directory under
23subsection (b) upon request by the new tobacco product
24manufacturer if the new tobacco product manufacturer provides
25sufficient evidence that the new tobacco product is compliant
26with federal enforcement discretion.



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1    Section 15. Manufacturer notification. Any new tobacco
2product manufacturer who has made a certification as required
3under Section 10 shall notify the Department within 30 days of
5        (1) an order issued by the U.S. Food and Drug
6    Administration with regard to a new tobacco product under
7    21 U.S.C. 387e or 21 U.S.C. 387j; or
8        (2) any notice of action taken by the U.S. Food and
9    Drug Administration affecting the ability of the new
10    tobacco product to be introduced or delivered into
11    interstate commerce for commercial distribution.
12    Section 20. Fee. The Department shall designate a fee not
13to exceed $500 per new tobacco product to be paid by each new
14tobacco product manufacturer. The fee shall reasonably reflect
15the cost incurred by the Department for:
16        (1) processing the certification required under
17    Section 10 and the notification required under Section 15;
18    and
19        (2) operation of the directory required under
20    subsection (b) of Section 10.
21    Section 25. Noncompliance; rebuttable presumption; civil
23    (a) Beginning July 1, 2020, it is unlawful for any



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1manufacturer, distributor, or retailer to distribute or sell
2any new tobacco product that has not sufficiently complied with
3the new tobacco product certification requirements under
4Section 10 or notification requirements under Section 15.
5    (b) There is a rebuttable presumption that an alternative
6nicotine product, cigar, or vapor product distributed or sold
7in this State that is not listed on the directory described
8under subsection (b) of Section 10 is being distributed or sold
9unlawfully in this State.
10    (c) A knowing violation of this Act shall result in a civil
11penalty of $500. Each distribution or sale in this State of a
12new tobacco product that is not listed on the directory
13described under subsection (b) of Section 10 shall constitute a
14separate violation.
15    Section 30. Rules. The Department may adopt rules that are
16necessary and proper to enforce and implement this Act.