ON! Plus Nicotine Pouches In FDA PMTA Authorized Product List

ON! Plus Nicotine Pouches In FDA PMTA Authorized Product List

The US Food and Drug Administration (FDA) has updated its official website list of authorized products, disclosing that the ON! Plus nicotine pouches has passed PMTA review and obtained Marketing Grant Order (MGO). This means that ON! Plus has become the second nicotine bag brand after ZYN to pass PMTA and obtain FDA market access approval. As of the time of writing this article, the FDA has not issued a separate press release regarding this decision.

After the publication of this article, the FDA has officially issued a press release confirming that six ON! PLUS nicotine pouche products have passed PMTA review and obtained Marketing Grant Orders (MGOs). The press release shows that the batch of authorizations was completed under the FDA Nicotine pouche Review Pilot Program and the review was completed in a “record time”. Reference documents: FDA Authorizes 6 Nicotine Pouch Products, Completing Review in Record Time | FDA

This update means that ON! Plus has become the second nicotine pouches brand to pass PMTA and obtain FDA market access approval, following ZYN under Swedish Match. As of now, the FDA has not issued a separate press release regarding this decision, but has disclosed relevant information through updates to the authorized product page.

According to the “Nicotine Pouch Products Authorized by the FDA” page on the FDA official website, the ON! Plus products obtained from MGO this time include the following specifications

1. On! PLUS Nicotine Bag 6mg (Mint)
2. On! PLUS Nicotine Bag 9mg (Mint)
3. On! PLUS Nicotine Bag 6mg (Tobacco)
4. On! PLUS Nicotine Bag 9mg (Tobacco)
5. On! PLUS Nicotine Bag 6mg (Wintergreen)
6. On! PLUS Nicotine Bag 9mg (Wintergreen)
The above-mentioned products have been included in the FDA authorized nicotine pouche product list, which also includes ZYN nicotine pouche products that have previously passed PMTA and obtained MGO.

At present, the FDA’s policy on vape products is very strict. No China vape factory or vape manufacturer has been authorized by PMTA. Its extremely high cost threshold and strict standards will become unattainable for Chinese vape companies. Search for relevant reports about FDA:  Search result-|vape factory | vape china | vape manufacturer