Reference Source

TS LAB · 66-41 · SLOVENIA

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
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
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 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.”

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 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.”

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

Source

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