Hadithi za FDA #002 — Kiwanda cha Vyakula vya Baharini cha Vietnam Kilipoteza Usajili Wake na Hakikujua kwa Miezi 14

Kampuni ya vipodozi iliyoko Istanbul ilikuwa imejenga alama imara kote Uturuki, nchi za Ghuba, na sehemu za Ulaya Mashariki. Walitengeneza bidhaa za utunzaji wa ngozi za ubora wa juu — krimu za unyevu, seramu, visafishaji, krimu za macho. Msambazaji wa Marekani alipowakaribia kuhusu kuingia soko la Marekani, walidhani mchakato ulikuwa sawa na walivyofanya EU: sajili kiwanda, orodhesha bidhaa, fuata kanuni za uwekaji lebo.

Walikuwa sahihi kuhusu bidhaa zao nyingi. Lakini bidhaa moja — krimu yao ya kila siku inayouzwa zaidi — ilikuwa na tatizo hawakutarajia kamwe.

Tatizo

The moisturizer contained SPF 15 sun protection. In Turkey and the EU, sunscreens are cosmetics. In the United States, any product with an SPF claim is an over-the-counter drug regulated under the FDA's sunscreen monograph (21 CFR Part 352). This is not a technicality. It is one of the most fundamental classification differences between US and EU cosmetics regulation.

Kama dawa, krimu ilihitaji usajili wa taasisi ya dawa chini ya 21 CFR Part 207, Msimbo wa NDC Labeler, orodha ya bidhaa ya dawa katika muundo wa SPL, paneli ya Drug Facts kwenye lebo (si orodha ya viungo vya vipodozi), uzingatiaji wa monograph ya krimu za jua za OTC kwa viungo hai na viwango, na ada za kila mwaka za mtumiaji chini ya GDUFA. Kampuni haikuwa na chochote kati ya hivi.

Tulifanya nini

Tuliainisha portfolio yao yote ya bidhaa — SKU 23 — na kutambua bidhaa zipi zilikuwa vipodozi chini ya MoCRA na zipi zilivuka kuwa dawa. Krimu ya SPF ilikuwa dawa pekee. Tuliwapa chaguzi mbili: ondoa madai ya SPF na utengeneze upya kama krimu ya vipodozi, au sajili kama taasisi ya dawa na orodhesha bidhaa kama dawa ya OTC. Walichagua kuondoa madai ya SPF kwa soko la Marekani na kutengeneza upya toleo lisilo na SPF. Kisha tukasajili kiwanda chao chini ya MoCRA, tukaandika orodha ya bidhaa 22 zilizobaki za vipodozi, na kupitia lebo zao kwa uzingatiaji wa Marekani.

Nini kingetokea

If they had shipped the SPF moisturizer to the US as a cosmetic, the product would have been an unapproved new drug — one of the most serious violations in the FDA's enforcement framework. The FDA routinely issues Warning Letters for this exact scenario, and Warning Letters are published on FDA's public database, searchable by any potential US buyer. A single product with the wrong classification could have poisoned their entry into the entire US market.

Ikiwa unauza bidhaa za utunzaji wa ngozi, nywele, au utunzaji wa kibinafsi na huna uhakika kama yoyote kati yake ni dawa nchini Marekani, hiyo ndiyo swali la kwanza kujibu — kabla ya kusajili chochote. Tembelea fdabridge.com/cosmetics au fdabridge.com/drug.