On May 12th, the FDA issued marketing refusal orders (MDOs) to 10 companies that produced and sold a total of approximately 6500 flavored electronic cigarette oils and electronic cigarette products. These companies are not allowed to sell or distribute these products in the United States, and retailers selling these illegal products may face the risk of FDA enforcement actions.


The pre market tobacco product application (PMTA) for various flavoring e-cigarette products did not provide sufficient evidence to indicate that allowing the sale of these products is suitable for protecting public health. Some rejected product flavors include citrus, strawberry cheesecake, cool mint, and menthol.


Since the spring of 2020, the FDA has received over 26 million applications for new tobacco products, most of which are e-cigarette products. Today's action further drives the FDA's continuous progress in reviewing and issuing decisions. So far, the FDA has completed the review of over 99% of applications and taken action.


Science is the cornerstone of the FDA tobacco product review process, "said Dr. Matthew Farrelly, Director of the Science Office of the FDA Tobacco Product Center. The decision to reject approximately 6500 products today is based on insufficient scientific evidence provided in the application. We will continue to ensure that all new tobacco products undergo robust and scientific pre market assessments to determine whether they meet appropriate public health standards for legitimate sales


The FDA evaluates PMTA based on public health standards, which consider the risks and benefits of the product to the entire population. As part of reviewing the PMTA of these companies, the FDA considered whether the products in the application exhibited additional benefits for adult smokers compared to tobacco flavored electronic liquids and e-cigarette products, which may outweigh the significant risks known to seasoning agents for electronic liquids and e-cigarette products targeting adolescents. The evidence submitted by the applicant is insufficient to prove this benefit, resulting in today's refusal order.


The applicant has a responsibility to provide sufficient scientific evidence to prove that marketing a new tobacco product is suitable for protecting public health, "said Brian King, director of the Tobacco Products Center. So far, no flavored e-cigarette product has met the scientific adequacy standards, including in this case. However, if the applicant wants to meet this standard, the FDA will approve the product

Companies that have obtained MDO include:

Imperial Steam Co., Ltd

Wild Man Enterprise

Big Era Electronic Cigarette

SWT Global Supply Company

Great Lakes steam

DNA Enterprise LLC dba mecha sauce

Absolute Steam Company

ECBlend Limited Liability Company

The FDA did not disclose the names of the other two companies that received MDO to protect potentially confidential commercial information (CCI).

The FDA remains committed to ensuring that all members of the industry - manufacturers, importers, distributors, and retailers - comply with the law. Tobacco products subject to negative decisions, including those subject to MDO, shall not be sold, distributed, or marketed in the United States. Such products shall not be introduced or delivered for the purpose of introducing interstate trade. If the product has already been launched, it must be removed from the market or face law enforcement risks.