Tuesday, September 10, 2019

On September 4, 2019, Michigan Governor Gretchen Whitmer announced soon-to-be-filed Emergency Rules banning the sale of flavored e-cigarettes in Michigan.[1] The proposed flavor ban, the first of its kind at the state-level, is being promulgated without any public notice and comment using the Michigan Department of Health and Human Services’ (MDHHS) emergency rulemaking powers. Once effective, the rules would ban the sale of flavored vapor and alternative nicotine products (except tobacco-flavored products) in stores and online, as well as restrict marketing and advertising of such products. Flavored combustible tobacco products such as menthol cigarettes, flavored cigars and hookah tobacco are not impacted by the new rules.

The Emergency Rules expand on state Senate Bills 106 and 155, which recently amended the Michigan Youth Tobacco Act to prohibit the sale of “vapor products” and “alternative nicotine products” to minors (under 18 years old).[2] But according to the Finding of Emergency, the e-cigarette flavor ban is needed, in addition to enforcing the age restriction, because Michigan “faces a vaping crisis among youth” that, in the MDHHS’s view, can be “attributed in large part to the appeal of flavored vapor and alternative nicotine products to youth as well as the advertisement by companies that glamorize use of nicotine products nationwide.” The emergency finding cites to last year’s well-publicized National Youth Tobacco Survey, which demonstrated a surge in teenagers who have tried an e-cigarette in the last 30 days.[3]That surge has largely been attributed to high nicotine-salt pod-systems like the Juul, but not the open-tank e-cigarettessold in the hundreds of small vape businesses located throughout Michigan. Neither the emergency finding nor the rules mention the impact the flavor ban will have on the majority of adult e-cigarette users who have used these flavored products to transition away from smoking cigarettes – and who may be forced to turn back to cigarettes or dangerous black market products. Michigan’s cigarette smoking rate remains among the highest in the nation – amongst both youth and adults – according to the U.S. Centers for Disease Control (CDC).

The Emergency Rules will become effective as soon as they are filed with the Secretary of State, possibly in the next 5-10 days.[4] Once filed, we anticipate businesses will be given thirty (30) days to come into compliance. Because these are Emergency Rules, however, they will be valid initially for six months, after which they can be renewed by the MDHHS once more for an additional six-month period.

Flavors Banned

The flavored vapor and alternative nicotine products subject to the sales ban are those that impart a characterizing flavor other than tobacco (Rule 1). Specifically, a characterizing flavor is defined as having a taste or aroma relating to food or drink of any sort except tobacco. Characterizing flavors include, but are not limited to, menthol, mint, wintergreen, fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverages, herbs, or spices. While the U.S. Food and Drug Administration (FDA) has focused on potentially limiting the sale and availability of flavored vapor products – excluding mint, menthol and tobacco e-cigarettes – the Michigan flavor ban will only permit tobacco flavored products to be sold.

Retailers Impacted

Under the Emergency Rules (Rule 2), retailers “shall not sell, offer for sale, give, transport, or otherwise distribute, nor possess with intent to sell, give, or otherwise distribute [hereinafter “sell or distribute”], a flavored vapor product, or flavored alternative nicotine product.” A retailer is defined broadly and includes “any person or body that operates a business engaging in the sale of vapor products or alternative nicotine products.” As confirmed by the Governor’s press release, the sales ban covers both brick-and-mortar stores and online sales within and into the state. The Emergency Rules also prohibit the transport intended for delivery to retailers of such products. Of note, there is a rebuttable presumption that a person possessing four (4) or more products with characterizing flavors intends to sell them at retail. Based on this, it appears that e-liquid manufacturers in Michigan producing flavored vapor products, even if only for sale outside of the state, would be considered possessing products with the intent to sell, and subject to penalties.

Brick-and-mortar retailers will also be restricted in where they can place advertisements for vapor and alternative nicotine products in their businesses (Rule 5). The Emergency Rules prohibit the placement of advertisements “within 25 feet of the point of sale…or greatest possible distance from the point of sale,” “within 25 feet of candy, foodstuff, or soft drinks” or placed “in such a manner that the advertisement can be readily seen by a person standing outside of the building at a distance of 25 feet.”

Ban on Advertising Imagery and Fraudulent or Misleading Terms or Statements

The Emergency Rules also impact how flavored products can be advertised in the state. Specifically, the use of “imagery explicitly or implicitly representing a characterizing flavor” when selling or distributing vapor or alternative nicotine products will be prohibited. Retailers are further barred from advertising using “fraudulent or misleading” terms or statements (Rule 3). Fraudulent and misleading terms are defined as those which are likely to induce false or unevidenced beliefs regarding the properties of the products, and include, but are not limited to terms such as “‘clean;’ ‘safe;’ ‘harmless;’ ‘healthy.’” The use of such “modified risk” claims, however, are already prohibited by the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act.[5]

Expansion of 21 CFR § 1140.32 Advertising Restrictions

The Tobacco Control Act and its implementing regulations in 21 CFR § 1140 set forth certain advertising restrictions that apply to cigarettes and smokeless tobacco products, but do not currently apply to e-cigarettes or other “deemed” products at the federal level. Michigan’s Emergency Rules expand the scope of the “restrictions on advertising set forth in 21 C.F.R. § 1140.32” to “apply with equal force to vapor products, and alternative nicotine products” (Rule 4). 21 C.F.R § 1140.32 (titled “Format and content requirements for labeling and advertising”) requires that labeling and print advertising be in black text against a white background, unless in an adult-only facility or in a publication directed at adults (at least 85 percent readership by adults and less than 2 million under 18 readers). The regulation further prohibits the use of music and sound effects in audio advertisements and limits video ads to static black and white text with spoken words.

Penalties for Violations

A person who violates any provision of the Emergency Rules is guilty of a misdemeanor, punishable by imprisonment for not more than six months, or a fine of not more than $200, or both, as set forth by MCL 333.2261. Rule 2 (retailer violations) are calculated on a per-item and per-transaction basis and may be punished cumulatively, while violations of Rule 3 (use of fraudulent/misleading terms), Rule 4 (labeling and advertising), and Rule 5 (placement of ads) are calculated daily, with each 24-hour period during which the violation occurs constituting a separate violation.

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[1] See Governor Gretchen Whitmer’s Press Release: Governor Whitmer Takes Bold Action to Protect Michigan Kids from Harmful Effects of Vaping: Michigan becomes the first state to ban flavored nicotine vaping products. https://www.michigan.gov/whitmer/0,9309,7-387-90487-506450–,00.html. The Governor’s official twitter account reposts this Washington Post article: https://www.washingtonpost.com/health/michigan-becomes-first-state-to-ban-flavored-e-cigarettes/2019/09/03/34f234c6-ce4c-11e9-8c1c-7c8ee785b855_story.html.

[2] See Governor Gretchen Whitmer’s Press Release: Gov. Whitmer Signs Bills to Ban Sales of Nicotine Products to Minors, Orders Agencies to Act on E-Cigarettes. https://www.michigan.gov/whitmer/0,9309,7-387-90487-499010–,00.html; Senate Bills 106 and 155 passed in the Michigan Senate on April 23, 2019, and in the Michigan House on May 15, 2019. “Vapor product” is defined as “a noncombustible product that employs a heating element, power source, electronic circuit, or other electronic, chemical, or mechanical means, regardless of shape or size, that can be used to produce vapor from nicotine or any other substance, and the use or inhalation of what simulates smoking…includes an electronic cigarette, electronic cigar, electronic cigarillo, electronic pipe or similar product or device [hereinafter referred to as ‘vapor products’] and a vapor cartridge or other container of nicotine or other substance in a solution or other form that is intended to be used with or in [vapor products].” “Alternative nicotine product” is defined as “a noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. Alternative nicotine product does not include a tobacco product, a vapor product, food, or a product regulated as a drug or device by the United States Food and Drug Administration…” See State of Michigan 106 2018-2019 Regular Session (Mich. 2019). https://www.legislature.mi.gov/documents/2019-2020/billenrolled/Senate/pdf/2019-SNB-0106.pdf.

[3] See Karen A. Cullen, et al., Notes From the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students – United States, 2011-2018, MORBIDITY AND MORTALITY WEEKLY REPORT, MMWR) (2018): https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm.

[4] See Governor Gretchen Whitmer’s Press Release: Governor Whitmer Takes Bold Action to Protect Michigan Kids from Harmful Effects of Vaping: Michigan becomes the first state to ban flavored nicotine vaping products. https://www.michigan.gov/whitmer/0,9309,7-387-90487-506450–,00.html.

[5] See FDCA § 910, 21 USC § 387k.