|
The U.S. Food and Drug Administration (FDA) is issuing this message as a part of FDA’s continued outreach efforts to assist the import community.
Electronic Nicotine Delivery Systems (ENDS) are regulated by the FDA. These products are commonly called vapes, vape pens, electronic cigarettes, e-cigs, personal vaporizers, mods (modified e-cigarettes), cigalikes (cigarette like e-cigarettes), pod systems, and vape tanks.
ENDS products (and all other FDA-regulated products) imported into the U.S. must comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Chapter 9) and Title 21 of the Code of Federal Regulations. Failure to comply with an applicable FDA legal requirement may subject the party making entry to various enforcement actions.
FDA has observed that some ENDS products are being misclassified, or inappropriately disclaimed, bypassing FDA’s review of the entry data needed to determine admissibility. ENDS products fall within FDA’s regulatory scope and are subject to FDA review. Entry data transmitted to FDA through CBP’s Automated Commercial Environment (ACE) should be accurate and timely, since incomplete or inaccurate data may delay admissibility decisions and affect interdiction of products that lack Premarket Tobacco Authorization (PMTA).
Parties submitting entries for FDA regulated products, whether a formal (e.g. type 01) or informal entry (e.g. type 11), are responsible under existing law for exercising reasonable care when making entry, including the proper classification of ENDS products. Meeting these obligations helps ensure all applicable legal requirements are addressed.
FDA encourages parties submitting entries for FDA-regulated products to review transmitted data for accuracy and timeliness. The following resources are provided to assist in ensuring that data for ENDS products is properly submitted:
Resources and Tips for Entering ENDS Products
|
|
|
|
