# TS LAB · 66-41 · SLOVENIA — FDA import alert red lists: firms subject to detention without physical examination

For TS LAB · 66-41 · SLOVENIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SLOVENIA; product is Self Tanning Capsules | Self Tanning Capsules | Self Tanning Capsules; product code is 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/09/2025; address is Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA, verified against its source on 2026-09-16.

- **Firm:** TS LAB _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** SLOVENIA _(verified: appears in the quote below)_
- **Address:** Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA _(verified: appears in the quote below)_
- **Date published:** 06/09/2025 _(verified: appears in the quote below)_
- **Product code:** 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Self Tanning Capsules | Self Tanning Capsules | Self Tanning Capsules _(verified: each item appears in the quote below)_
- **FDA notes:** This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” _(verified: each item appears in the quote below)_

## What the source says

> TS LAB Date Published : 06/09/2025 Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.”

## The same source also states

> TS LAB Date Published : 06/09/2025 Goce Delceva 20 Jarksa , Ljubljana, SLOVENIA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/09/2025 Desc: Self Tanning Capsules Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Helps prevent sun related aging”, “…“Supports UV protection from within”, “… while protecting it from harmful UV damage…”, “…supports defense against UV- related skin aging.”

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).