Juul Labs, Inc.
⚠️ Moderate Risk
FEI: 3013660768 • San Francisco, CA • UNITED STATES
FEI Number
3013660768
Location
San Francisco, CA
Country
UNITED STATESAddress
560 20th St, , San Francisco, CA, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
TPLABFALSE
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(1) in that it appears that its labeling is false or misleading.
TPNICWARN
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/19/2020 | 98LCB10ADVANCED PERSONAL VAPORIZER, KIT | Division of Northeast Imports (DNEI) | |
| 5/19/2020 | 98MCB07ENDS CARTRIDGE | Division of Northeast Imports (DNEI) | |
| 3/31/2020 | 98MCB07ENDS CARTRIDGE | 3888TPLABFALSE | Division of Northern Border Imports (DNBI) |
| 3/31/2020 | 98MCB07ENDS CARTRIDGE | 3888TPLABFALSE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Juul Labs, Inc.'s FDA import refusal history?
Juul Labs, Inc. (FEI: 3013660768) has 4 FDA import refusal record(s) in our database, spanning from 3/31/2020 to 5/19/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Juul Labs, Inc.'s FEI number is 3013660768.
What types of violations has Juul Labs, Inc. received?
Juul Labs, Inc. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Juul Labs, Inc. come from?
All FDA import refusal data for Juul Labs, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.