Reference Source

TS LAB · 66-41 · SLOVENIA

For TS LAB, import alert is 66-41; country is SLOVENIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 listed twice: Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA and Goce Delceva 20 Jarksa , Ljubljana, SLOVENIA, verified against its source on 2026-10-01.

Firm
TS LAB verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
SLOVENIA verified
Address
Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA verified
Goce Delceva 20 Jarksa , Ljubljana, SLOVENIA also listed
Date published
06/09/2025 verified
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. each item verified
Product
Self Tanning Capsules | Self Tanning Capsules | Self Tanning Capsules each item verified
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.” each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

TS LAB Date Published : 06/09/2025 Potok Pri Komendi 14 , Komenda, Osrednjeslovenska SLOVENIA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

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.”

— all from accessdata.fda.gov, retrieved 2026-09-15

The same source also states

TS LAB Date Published : 06/09/2025 Goce Delceva 20 Jarksa , Ljubljana, SLOVENIA

— accessdata.fda.gov, retrieved 2026-09-15

Source

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