The U.S. Food and Drug Administration (FDA) has been actively regulating the vaping industry through the issuance of Marketing Denial Orders (MDOs). As of June 6, 2024, the FDA has issued 311 MDOs to 286 companies.
MDO Issuance Trends
Yearly Breakdown of MDO Issuance
- 2021: 258 MDOs
- 2022: 4 MDOs
- 2023: 14 MDOs
- 2024 (up to June 6): 35 MDOs
Analysis of Issuance Trends
- 2021: Marked by a significant crackdown with 258 MDOs.
- 2022: A dramatic decrease with only 4 MDOs issued.
- 2023: Slight increase to 14 MDOs.
- 2024: A notable resurgence with 35 MDOs issued by mid-year, indicating a 150% increase compared to the entire previous year.
Company-Specific Data
- Fontem US, LLC: The company receiving the highest number of MDOs.
Implications of Increased MDO Issuance in 2024
Court and FDA Actions
- Court Revoked: 9 times
- Rescinded: 3 times
- Stayed: 3 times
- Partially Revoked by Court: 1 time
- Voluntarily Withdrawn by FDA: 2 times
- Partially Withdrawn by FDA: 2 times
- Partially Withdrawn by FDA after Court Stay: 1 time
- Appeals Rejected by Court: 1 time
Analysis of Outcomes
- Court Revocations: Account for 40% of decisions, indicating that judicial reviews often favor appellants.
- Court Stays and Rescissions: Each account for 13%, showing that a substantial number of cases lead to temporary halts or full rescissions of MDOs.
- Rejected Appeals: Only 5.26%, suggesting that while difficult, appeals can lead to positive outcomes.
FAQ
What is a Marketing Denial Order (MDO)?
An MDO is issued by the FDA when a Pre-Market Tobacco Application (PMTA) fails to demonstrate that a product meets regulatory standards for safety and public health.
How many MDOs has the FDA issued as of June 2024?
As of June 6, 2024, the FDA has issued 311 MDOs to 286 companies.
Which company has received the most MDOs?
Fontem US, LLC is the company with the highest number of MDOs.
What has been the trend in MDO issuance over the years?
MDO issuance peaked in 2021 with 258 orders, dropped significantly in 2022 and 2023, but saw a resurgence in 2024 with 35 MDOs by mid-year.
What are the possible outcomes of an MDO appeal?
Possible outcomes include court revocation, rescission, stay, partial revocation, voluntary withdrawal by FDA, and partial withdrawal by FDA.
How successful are companies in appealing MDOs?
Companies have had a relatively high success rate in appealing MDOs, with 40% of appeals leading to court revocations and 13% each resulting in stays or rescissions.
