# Biotanico, Inc. · 99-39 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Biotanico, Inc. · 99-39 · TAIWAN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is TAIWAN; product is CLEAR SKIN FORMULA (tablets); product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C; date published is 10/12/2023; address is No. 1 Nanke 1st Rd. , Xin Shi Qu , Tai Nan Shi, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Biotanico, Inc. _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** TAIWAN _(verified: appears in the quote below)_
- **Address:** No. 1 Nanke 1st Rd. , Xin Shi Qu , Tai Nan Shi, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 10/12/2023 _(verified: appears in the quote below)_
- **Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. _(verified: appears in the quote below)_
- **Product:** CLEAR SKIN FORMULA (tablets) _(verified: appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e) of the Act because the product fails to completely or accurately declare the place of business, of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the article is not in accordance with 21 CFR 101.36. Section 403(s)(2)(C) of the Act because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). _(verified: appears in the quote below)_

## What the source says

> Biotanico, Inc. Date Published : 10/12/2023 No. 1 Nanke 1st Rd. , Xin Shi Qu , Tai Nan Shi, TAIWAN 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 10/12/2023 Desc: CLEAR SKIN FORMULA (tablets) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e) of the Act because the product fails to completely or accurately declare the place of business, of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) of the Act in that the presentation of the nutrition information on the labeling of the article is not in accordance with 21 CFR 101.36. Section 403(s)(2)(C) of the Act because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).