The National Association of Tobacco Outlets (NATO) in a NATO News Bulletin on April 8, reported on the FDA’s issuance of marketing denial orders (MDOs) on April 8, 2022, to manufacturer Fontem US, LLC for several myblu electronic nicotine delivery system (ENDS) products. The MDOs issued involved the following ENDS products:
- myblu Device Kit
- myblu Intense Tobacco Chill 2.5%
- myblu Intense Tobacco Chill 4.0%
- myblu Intense Tobacco 2.4%
- myblu Intense Tobacco 3.6%
- myblu Gold Leaf 1.2%
- myblu Gold Leaf 2.4%
After further clarification from ITG Brands, and contrary to the statement in the NATO News Bulletin, these ENDS products are to be the subject of an administrative appeal to be filed with the FDA by ITG Brands. This means that these ENDS products do not need to be removed from the market immediately as the enforcement of the MDOs may be stayed by the FDA while the appeal is pending.
Also, in the accompanying announcement issued today by ITG Brands, the company states the following in response to the FDA issuance of the MDOs:
“As part of the marketing regulations for all vapor products in the United States, the FDA required manufacturers to file applications by September 2020. Since that time, the agency has been conducting scientific reviews of those applications. The FDA has been issuing its decisions regarding these products on a rolling basis since late last year. On April 8, the FDA issued marketing denial orders (MDOs) for a number of ITG Brands myblu pod-based vapor products.”
“We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached. We believe our products meet the regulatory requirements and plan to use the administrative appeals process to convince the agency that approval should be granted. Based on past practice, we expect the FDA will not seek to enforce the MDOs while this appeal remains ongoing, and we therefore expect the products to remain in the market during this period. We do not believe that there will be any short-term impact on the business.”
“All of our products remain available for sale and there is no legal prohibition against continuing to market the myblu vapor portfolio. Rest assured that we will indemnify and hold harmless all of our customers and business partners against any loss incurred related to the sales of our products – including actions taken by the FDA.”
NATO apologizes for any inconvenience the report issued earlier in the NATO News Bulletin may have caused.
State Legislative Bill Actions
State tobacco-related legislative bills that have been acted on by a state legislative committee or state legislature are listed below alphabetically by state:
Alaska: Senate Bill 45, which as amended, imposes a tax on electronic smoking products (including e-liquid) at the rate of 75% of the wholesale price, increases the legal age to purchase and possess tobacco and vapor products to 21 years of age, prohibits the sale of flavored electronic smoking products, and prohibits the distribution of electronic smoking products that are not clearly recognizable as a tobacco product, will be considered in the Senate Finance Committee on April 11, 2022.
California: Assembly Bill 1690, which bans the sale of cigarettes with single use filters, single use filters for cigars and single use e-cigarette devices, passed Assembly Health Committee on April 5, 2022.
Colorado: House Bill 1064, which prohibits the sale and distribution of all flavored cigarettes, tobacco products and nicotine products (including flavored synthetic nicotine products), passed the House Finance Committee as amended on April 4, 2022. The current version of the bill includes exemptions for hookah and premium cigars. The House Finance Committee also removed a provision that allowed the sale of flavored products in age restricted premises and replaced it with an amendment for tobacco/cigar lounges that exist only in gaming establishments. The bill is now in the House Appropriations Committee.
Connecticut: Senate Bill 139, which prohibits the sale of flavored ENDS/vapor products (excluding modified risk products as determined by the U.S. Secretary of Health and Human Services) and caps nicotine content at 35 milligrams/milliliter, failed the Joint Favorable deadline on April 1, 2022. Senate Bill 367, which prohibits the sale of flavored ENDS/vapor products; caps nicotine content at 35 milligrams/milliliter; requires dealers to maintain documentation of nicotine content; and increases penalties for sales violations, reported out of the Legislative Commissioners’ Office on April 5, 2022.
Rhode Island: Four flavor ban bills (HB7869/HB7870/HB7871/HB7881) were heard in the House Committee on Health and Services on April 5, 2002. The bills were recommended for further study, which allows the bills to be reconsidered in the future.