NOTE: This is an Amended Regulatory Impact Statement. The previous Regulatory Impact Statement is void upon
the Administrative Rules Division approval of this Amendment.
Recent amendments to the Federal Food, Drug, and Cosmetic Act to include a new subsection, 906(d)(5), Minimum
Age of Sale, which provides that “It shall be unlawful for any retailer to sell a tobacco product to any person younger
than 21 years of age.” The Act, aka Tobacco 21 or T21, was authorized by Congress and was signed by the President
on December 20, 2019. T21 applies to sales of tobacco products – including cigarettes, smokeless tobacco, hookah
tobacco, cigars, pipe tobacco, electronic nicotine delivery systems including e-cigarettes and e-liquids – to anyone
under 21 years of age.
Recent statistics show the use of electronic nicotine delivery systems (“ENDS”), including vapes, vaporizers, vape
pens, hookah pens, and e-cigarettes among youth under the age of 21 has increased exponentially throughout the
United States, including Michigan. As a result, in December of 2018, United States Surgeon General Jerome Adams
officially declared e-cigarette use among youth in the United States an epidemic, with serious health, both physically
and mentally, challenges. Flavored nicotine vaping products were identified in studies as the catalyst for either first
time use among high school and middle school students (81%) and continuous use of flavored nicotine vaping
products as appealing to youth continues. Therefore, in addition to the federal mandate to raise the age of tobacco
products to 21, the proposed rules are designed to prohibit the sale of flavored nicotine vaping products to reduce the
use and health consequences to Michigan youth when using these ENDS, as identified by the federal government as a
huge health concern by youth and young adults and requiring any ENDS distributor to have a formal FDA
authorization to market and sell these products or face enforcement measures effective September 9, 2020. See
Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market
Without Premarket Authorization (Revised) (April 2020).
A. Are these rules required by state law or federal mandate?
The proposed rules are not required by state law or federal mandate. They are being promulgated under the authority
of the Public Health Code, MCL 333.1101 - 333.25211. Further, there are currently several bills in progress in the
Michigan Legislature that address the prohibition of use of retailing practices for vaping products. See SB 0782,
0783, 0784, 0785, and 0786 (2020).
B. If these rules exceed a federal standard, please identify the federal standard or citation, describe why it is
necessary that the proposed rules exceed the federal standard or law, and specify the costs and benefits arising out
of the deviation.
The proposed rules do not exceed a federal standard. There is no federal standard prohibiting the sale of flavored
2. Compare the proposed rules to standards in similarly situated states, based on geographic location, topography,
natural resources, commonalities, or economic similarities.
As of this writing, Massachusetts, New Jersey, New York, and Rhode Island have permanent bans on the sale of
nicotine flavored vaping products. Eight states, including Michigan, issued emergency rules to temporarily ban the
sale of nicotine flavored vaping products —Massachusetts, Montana, New York, Oregon, Rhode Island, Utah and
A. If the rules exceed standards in those states, please explain why and specify the costs and benefits arising out of
Massachusetts has just implemented a law that took effect June 1, 2020. It limits who can sell them with an emphasis
on flavored nicotine products which includes the sale of flavored tobacco, including menthol cigarettes and chew, as
well as nicotine vaping products. These will be confined to just any licensed smoking bar where the products may
only be smoked and nowhere else. The same restrictions will be applicable to other flavored tobacco products which
include flavored chewing tobacco and menthol cigarettes. New Jersey implemented its law in January 2020. New
Jersey lawmakers approved a legislative package strengthening regulations on e-cigarettes, including a ban on
flavored-vaping products, in a growing campaign to fight tobacco use among young people. One measure stiffens
penalties for retailers selling tobacco and vaping products to people under the age of 21, while another forbids the use
of coupons or discounts to purchase tobacco and vaping products. The sale of vaping liquid that contains nicotine in a
concentration of more than 2% will also be prohibited. New York's law went into effect July 1, 2020 and provides for
the prohibition of the sale of flavored nicotine vapor products, and the second bans the sale of all tobacco and nicotine
vapor products in pharmacies. Most states have adopted similar standards that prohibit the sale of flavored tobaccos
and the sale of vaping products. Additional information on this topic may be updated at the time of the public hearing.