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NATO Update: State Emergency Vaping Regulations & FDA Order on Eight Modified Risk Tobacco Product Applications

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their October 23rd online bulletin. Reposted with permission.

Update on State Emergency Vaping Regulations

As part of NATO’s continued reporting on state actions regarding restrictions on the sale of electronic cigarette and nicotine vapor products, below is an update on litigation and other state actions that have occurred this week.

State of Rhode Island:  Today, the Vapor Technology Association and a vape shop retailer filed a lawsuit and a motion for a temporary restraining order against the Rhode Island Department of Health and the agency’s emergency regulations to prohibit the manufacture, distribution, sale or offering for sale of flavored vaping products.  A hearing on the motion for a temporary restraining order will be scheduled.  In the meantime, the emergency rule remains in effect.

State of Utah:  On October 22, 2019, seven Utah-based vape shops filed a lawsuit and a motion for a temporary restraining order against the Utah Department of Health and the agency’s emergency regulations than ban the sale of flavored vaping products.  A hearing on the motion for a temporary restraining order will be scheduled.  In the meantime, the emergency rule remains in effect.

State of Washington:  On October 20, 2019, the Vapor Technology Association and a vape shop retailer filed a lawsuit and a motion for a temporary restraining order against the Washington State Board of Health and the agency’s emergency regulations to prohibit the sale of all flavored electronic nicotine devices, including flavored THC vapor products, but excluding tobacco-flavored and marijuana-flavored vapor products.  A hearing on the motion for a temporary restraining order is scheduled for October 28, 2019.  In the meantime, the emergency rule remains in effect.

Chart of State Emergency Rules:  An updated chart on the status of state emergency rules regarding vapor products is below:

State Emergency Rule Effective Dates Judicial Action
Massachusetts Banned the sale and display of all vaping products. September 24, 2019 (expires January 25, 2020 unless extended) Lawsuit filed October 1, 2019 in U.S. District Court. On October 21, 2019, the Suffolk County Superior Court issued a temporary restraining order staying enforcement of the Massachusetts Emergency Rule unless the state begins proceedings under state law to hold a public hearing on prohibiting the sale of all vaping products.
Michigan Prohibits the sale of flavored nicotine vapor products and applied tobacco advertising restrictions to nicotine vapor products. October 2, 2019 Three lawsuits filed. Preliminary injunction issued on October 16, 2019 staying enforcement of the Michigan Emergency Rule.
Montana Prohibits the transportation, distribution and sale of flavored vaping products. October 22, 2019 Lawsuit filed. On October 18, 2019, Ravalli County District Court issued a temporary restraining order prohibiting the enforcement of the emergency rule. A preliminary injunction hearing is scheduled for October 30, 2019.
New York Prohibits the possession, manufacture, distribution, offer to sell, or sale of flavored e-liquids or a product containing flavored e-liquids, except tobacco-flavored and menthol-flavored e-liquid products. Pending legal action Lawsuit filed. On October 3, 2019, Appellate Division of the New York Supreme Court issued a temporary retraining order prohibiting emergency rule from going into effect.
Oregon Prohibits the sale of all flavored nicotine vapor products. October 15, 2019 Petition for Review filed. On October 17, 2019, Court of Appeals issued a temporary stay of the enforcement of the emergency rule.
Rhode Island Prohibits the sale of all flavored electronic nicotine delivery system devices. October 4, 2019 Lawsuit filed on October 23, 2019 seeking a temporary restraining order and injunction against the Rhode Island Emergency Rule.
Utah Prohibits the sale of all flavored electronic nicotine devices, except in “retail tobacco speciality businesses”. October 7, 2019 Lawsuit filed on October 22, 2019 seeking a temporary restraining order and injunction against the Utah Emergency Rule.
Washington Prohibits the sale, offer to sell, or possession with intent to sell of flavored electronic vapor products, excluding tobacco-flavored and marijuana flavored vapor products, including on-line.

Requires display of a sign of warning of the risk of lung disease associated with the use of vapor products. The ban on the sale of flavored electronic vapor products shall remain in place for 120 days until February 7, 2020.

October 10, 2019 (expires February 7, 2020) Lawsuit filed on October 20, 2019 seeking a temporary restraining order and injunction against the Washington Emergency Rule. A hearing on the motion for a temporary restraining order is scheduled for October 28, 2019.

States Not Taking Action:

Arizona: Governor Ducey does not believe the state should ban the sale of flavored nicotine vaping products.

California: Governor Newsom supports a ban, and has ordered increased enforcement of existing laws, but did not issue any prohibition in light of the Legislature’s failure to pass such a bill in the recent session.

Minnesota: Governor Walz has acknowledge that the state lacks the authority to restrict sales of nicotine vapor products.

Ohio: Governor DeWine has acknowledged that state agencies lack the authority to ban nicotine vapor or flavors by executive order or administrative rule.

FDA Issues Order on Eight Modified Risk Tobacco Product Applications

Swedish Match General Snus Products Receive FDA Orders

On October 22, 2019, the FDA issued the first ever modified risk orders to Swedish Match USA, Inc. for the following eight General Snus smokeless tobacco products:

  • General Loose
  • General Portion Original Large
  • General Dry Mint Portion Original Mini
  • General Mint Portion White Large
  • General Portion White Large
  • General Classic Blend Portion White Large – 12 count
  • General Nordic Mint Portion White Large – 12 count
  • General Wintergreen Portion White Large

This action allows the products to be marketed with the following modified risk claim:

“Using General Snus instead of cigarettes puts you at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The modified risk orders do not permit Swedish Match to make express or implied statements that the product is endorsed or approved by the FDA, or that the FDA deems the product to be safe for use by consumers.  The modified risk orders issued by the FDA are effective through October 22, 2024.