Violation Code: 3120
FDA Violation
Charge Code: EPHEDALK
Violation Details
- Violation Code (ASC ID)
- 3120
- Charge Code
- EPHEDALK
- Description
- The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
- Legal Section
- 801(a)(3), 402(f)(1)(A); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 7/25/2023 | EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) 54FYY09 | Fayus EnterprisesNIGERIA |
| 7/25/2023 | EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) 54FYY09 | Fayus EnterprisesNIGERIA |
| 9/8/2022 | HERBALS & BOTANICAL TEAS, N.E.C. 54ECT99 | Qarshi Industries (Pvt) LtdPAKISTAN |
| 9/1/2021 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | QARSHI INDUSTRIESPAKISTAN |
| 10/19/2020 | EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) 54FCH09 | TAI HINGHONG KONG |
| 12/13/2019 | EPHEDRA (HERBAL & BOTANICAL TEAS) 54EBY09 | |
| 10/16/2019 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | |
| 7/18/2017 | EPHEDRA (HERBAL & BOTANICAL TEAS) 54EYT09 | |
| 6/9/2017 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | HANPOONG PHARM CO.,LTD.SOUTH KORE |
| 6/2/2017 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | HANPOONG PHARM CO.,LTD.SOUTH KORE |
| 6/2/2017 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | HANPOONG PHARM CO.,LTD.SOUTH KORE |
| 6/2/2017 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | HANPOONG PHARM CO.,LTD.SOUTH KORE |
| 6/2/2017 | HERBALS & BOTANICAL TEAS, N.E.C. 54EYY99 | HANPOONG PHARM CO.,LTD.SOUTH KORE |
| 11/30/2016 | EPHEDRA (HERBAL & BOTANICALS, NOT TEAS) 54FCF09 | SUN HERBAL PTY LTDAUSTRALIA |
| 10/20/2016 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBR99 |
Frequently Asked Questions
What is FDA violation code 3120?
3120 is an FDA violation code that indicates: "The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.". This violation is based on 801(a)(3), 402(f)(1)(A); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3120?
According to FDA Import Refusal data, there have been 76 import refusals issued for violation code 3120, affecting 51 unique firms.
When was the most recent refusal for violation 3120?
The most recent import refusal for violation 3120 was on July 25, 2023.
What products are commonly refused for violation 3120?
Products commonly refused under violation 3120 include: EPHEDRA (HERBAL & BOTANICALS, NOT TEAS), HERBALS & BOTANICAL TEAS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3120?
Violation code 3120 is based on 801(a)(3), 402(f)(1)(A); ADULTERATION of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.