事件：6月24日，思摩爾發佈公告：公司客戶NJOY的四款非菸草味電子煙產品通過FDA相關審查，獲得了PMTA授權。
Smoore’s customer NJOY gets US FDA approval for four non-tobacco vape flavors
Event:
Smoore announced on 24 June that major customer NJOY has cleared regulatory clearance by the US Food and Drug Administration (FDA) to sell four non-tobacco-flavored e-cigarette products after filing premarket tobacco product applications (PMTA).
政策轉變：美國FDA首次批准非菸草味電子煙產品，意義重大！
據FDA官網消息，FDA正式宣佈四款來自NJOY品牌的薄荷醇電子煙通過了相關審查，拿到了PMTA授權，它們分別是：NJOY ACE Pod Menthol 2.4%、NJOY ACE Pod Menthol 5%、NJOY DAILY Menthol 4.5% 和 NJOY DAILY EXTRA Menthol 6%。上述產品前兩款爲NJOY旗下換彈式產品ACE的兩款不同尼古丁含量的薄荷醇煙彈；後兩款則是NJOY旗下不同尼古丁含量的薄荷醇一次性產品DAILY。
Policy change:
the US FDA cleared a major hurdle on 21 June 2024 when it approved non-tobacco-flavored e-cigarette products for the first time. The authority announced four menthol e-cigarettes under the NJOY brand have obtained PMTA authorization: Ace Pod Menthol 2.4%, Ace Pod Menthol 5%, Daily Menthol 4.5% and Daily Extra Menthol 6%. The pods refer to replaceable cartridges, while the latter two are disposable vapes, with each product indicating a different nicotine level.
這一消息的公佈有着兩大重要意義：
1）這是時隔742天后，FDA再次爲電子煙給出PMTA授權；據FDA官方數據庫顯示，上一次FDA給出電子煙的PMTA授權還要追溯到2022年6月10日的兩款產品，也同樣是來自NJOY品牌，爲兩款菸草口味的一次性產品NJOY DAILY；
2）薄荷醇電子煙終於被FDA認可了其安全性，首次爲非菸草口味給出PMTA授權；同樣據FDA官方數據顯示此前已經給出的23個SKU的口味僅有菸草口味，並不包括任何非菸草口味。
TF takeaways:
•Back in favor:
this round of e-cigarette PMTA approvals follows a 2-year hiatus after 10 June 2022, when the FDA authorized for sale two tobacco-flavored disposable vapes, also under the NJOY brand: Daily Rich Tobacco 4.5% and Daily Extra Rich Tobacco 6%.
•Non-tobacco-flavor liberation:
we interpret the FDA nod as recognition of the reduced-harm role of menthol vapes as this is the first time the US authority has cleared PMTA for non-tobacco flavors. Prior to this, the 23 SKU flavors previously approved covered only tobacco flavors.
行業方面，此次爲FDA首次批准薄荷醇調味電子煙，標誌着電子煙產品減害性得到了認可，未來符合技術及安全性要求的合規企業有望受益。
Compliant product potential with recognition of vaping’s reduced-harm role
Industry milestone:
we believe that recognition of the reduced-harm role of e-cigarettes expands market prospects for compliant companies that fulfill technical and safety requirements.
公司優勢：公司供應所有NJOYLLC已獲批產品，有望長期受益合規市場發展
此次4款授權產品均由公司代工，除此之外公司還參與多款其他獲批產品代工。公司客戶NJOYLLC已通過菸草產品上市前申請途徑獲10款新型菸草產品的營銷許可令（包括1款NJOY ACE封閉式電子煙設備、5款NJOY ACE菸草口味及薄荷醇口味封閉式電子煙彈、4款NJOYDAILY菸草口味及薄荷醇口味一次性電子煙）。今年思摩爾均供應NJOY LLC已獲批的這 10款產品。
Smoore’s competitive edge:
as the supplier of all 10 of NJOY’s FDA-approved products, we expect Smoore will benefit from a growing compliant product market over the long term. It manufactures not just NJOY’s four newly authorized products but also many others. NJOY has PMTA approval to sell 10 new-tobacco products: 1 Ace closed-system vaping device, 5 Ace tobacco and menthol-flavored closed-system cartridges and 4 Daily tobacco and menthol-flavored disposable vapes. Smoore’s 2024 pipeline covers all 10 of NJOY’s approved products.
薄荷醇味產品較受歡迎，有望拉動公司銷量增長。
據CDC，2023年美國電子煙市場出貨量中薄荷醇味產品佔比約30%，佔換彈式產品出貨量約50%，是美國市場重點品類。公司作爲NJOY的供應商，有望充分受益。
Rise of menthol cartridges:
we believe Smoore will ride the market trend as menthol-flavored new-tobacco products gain popularity and drive sales growth. Menthol-flavored products account for about 30% of total shipments in the US e-cigarette market in 2023, according to the CDC, with cartridge products accounting for about 50% of the shipments, representing a major category in the US market. As the NJOY supplier, Smoore is set to reap the full benefits of this market potential.
未來隨着PMTA審覈標準逐漸明確，審批速度可能加快，從而推動執法力度的加強，龍頭品牌市佔率有望繼續提升。
不合規產品可能會加速淘汰，市場競爭格局將逐步迴歸到良性狀態。中長期來看，我們認爲美國電子煙市場的“類菸草化管理”大勢所趨，監管趨嚴背景下大品牌、大公司的資源、技術儲備可以應對不斷提升的准入門檻和監管成本，龍頭品牌的競爭力和市場佔有率有望繼續提升。
Rise of legal market benefits big players:
we believe regulatory management of the US vaping market similar to that of the tobacco market is inevitable. As PMTA criteria become more visible with stronger enforcements in the legal market, we expect the pace of vape product approvals will speed up in the future. Tightening regulations would raise entry barriers and compliance costs, which only big brands and corporations’ sizable resources and technological firepower would be able to handle. Hence, leading brands would increase competitiveness and market share as non-compliant producers exit the market. We believe this will shape a more benign competitive landscape over time.
