The FDA regulates all tobacco products, including e-cigarettes and vaping devices, under the Family Smoking Prevention and Tobacco Control Act. However, very few vaping products are actually FDA-approved. Here’s a look at the regulatory landscape regarding vaping products and what’s approved by the FDA.
1. FDA Approval and Authorization: What’s the Difference?
- Approval: This indicates that the FDA has reviewed a product's safety and efficacy, typically applicable to pharmaceuticals and medical devices.
- Authorization: The FDA uses a process called “Premarket Tobacco Product Application” (PMTA) to authorize new tobacco products, which includes most vaping products. If approved under PMTA, a product can be legally marketed.
No vaping products are "approved" by the FDA for general use, but certain products have been authorized for sale as part of the PMTA process.
2. PMTA and Authorized Products
- The PMTA process assesses whether a product meets the FDA’s “appropriate for the protection of public health” standard. This includes assessing the potential benefits for current adult smokers compared to potential risks for youth.
- As of now, a few brands have received FDA marketing authorizations, such as:
- Vuse Solo: In October 2021, the FDA authorized the Vuse Solo e-cigarette and its tobacco-flavored e-liquid pods.
- Logic Devices: The FDA has authorized several devices under the Logic brand, including Logic Power and Logic Pro, which are marketed with tobacco-flavored cartridges.
Note: The FDA has only authorized certain tobacco-flavored e-liquids. No other flavors, including menthol or fruit, have received FDA marketing authorization, largely due to youth appeal concerns.
3. Products Denied Authorization
- The FDA has issued denial orders for a significant number of PMTAs, especially those for flavored products. This includes various brands that manufacture fruit-flavored or sweetened e-liquids.
- These denial orders are part of the FDA’s effort to curb youth vaping by limiting access to flavored products that appeal to younger users.
4. Enforcement and Non-Authorized Products
- Any product not authorized by the FDA is technically illegal to market in the U.S., though enforcement has varied.
- Retailers and manufacturers face fines and legal actions if found marketing unauthorized products, though many remain on the market due to regulatory challenges and pending reviews.
5. Nicotine Cessation Products vs. Tobacco Products
- The FDA approves nicotine replacement therapies (NRTs) like patches, gums, and lozenges for smoking cessation but has not approved any vaping product for this purpose.
- E-cigarettes and vaping products marketed for cessation purposes require separate FDA approval as therapeutic products, which no vaping product has received.
What’s Next in FDA Regulation of Vapes?
- The FDA continues to review PMTA applications and is expected to rule on more products over time.
- The agency is also exploring policies to restrict flavored products, enforce strict labeling, and impose marketing regulations to protect minors.
In summary, while no vaping products are FDA-approved, a select few have been authorized for marketing under strict guidelines and are legally sold in the U.S. The ongoing FDA reviews aim to balance adult smokers' needs for alternatives with public health goals, particularly youth protection.