The Unfolding Story of At-Home Microneedling: What You Need to Know Now
If you have been trying to purchase microneedling cartridges lately and found it difficult, you are not alone. There is a very good reason for this, and the situation is far more complex than it first appears. The landscape has shifted dramatically, with the FDA now deeply involved in a process that is reshaping who can buy these devices and how they can be used.
The FDA’s New Role and the Manufacturer at the Center
The story begins with a major manufacturer: Guano EAI Electronic Technology Company, commonly referred to as EAI. This company produces many of the pens and cartridges on the market. In February 2023, EAI filed paperwork with the FDA seeking approval to market the Dr. Pen microneedling system in the United States. By August 2023, the FDA granted clearance.
This approval came with significant conditions. The device was cleared for improving the appearance of facial acne scars in adults age 22 and older, and it was classified as a Class II medical device—meaning it is subject to regulatory controls to ensure safety and effectiveness. Crucially, it was approved for prescription use only.
What happened next is the turning point. Because EAI submitted this paperwork, the FDA is now conducting a post-market review. This review is the reason so many websites have stopped selling these products to at-home users. Several resellers now display disclaimers that state: "The FDA is conducting a postmarket review. Dr. Pen microneedling cartridges are classified as medical prescription only and are available exclusively to licensed healthcare professionals... we'll verify your professional license before processing the shipment."
The Escalation: What It Means for At-Home Users
There is no official guidance yet banning these products for at-home use, but the atmosphere is tense. Some people are stocking up, sensing the window is closing. Others are noticing that even platforms like Alibaba now flag these items as "prohibited products." When I saw that message, I knew the situation had escalated.
This pattern feels familiar. It reminds me of other supplements—like NMN—where companies attempt to reclassify an over-the-counter product as a prescription drug. The logic is simple: making something a prescription can be enormously profitable. But for the consumer, it means losing access. When so many websites stop selling something, it is rarely because the case is closed. It is usually because the case is still ongoing, and companies are preemptively complying.
Where to Find Cartridges Now: A Practical Guide
If you are determined to purchase cartridges while they are still available, there are a few options left. I have personally bought from sellers on Temu, and so far, the quality has felt identical to the ones I used to buy from Amazon. I have also checked AliExpress and contacted manufacturers on Alibaba, but many are now refusing to sell.
The prices, however, are telling. I recently bought 20 M8 cartridges for $18, and now I see some listings for just $6 for 20. These deep markdowns suggest that sellers are trying to clear inventory before the restrictions become universal. If you plan to stock up, you might want to act before Temu also removes these listings.
What to Look For in a Cartridge: A Close-Up Insight
One thing I never realized before taking very close-up photos is how different the needles look depending on the number of needles in the cartridge. If you get a cartridge with a higher number of needles, the needles themselves are actually larger. For me, that is not ideal. I want the thinnest needles possible to create micro-injuries, not major trauma. When you see the close-ups, the difference is stark.
I personally prefer cartridges with 11 to 16 needles. They are so dainty and thin, causing less damage while still delivering excellent results. The 24-needle cartridges looked okay, but I would avoid anything with too many needles.
The Bottom Line
This is an evolving situation. No one knows for sure when the FDA will close its review or what the final outcome will be. In the meantime, the “wild west” era of purchasing cartridges is coming to an end. If you do decide to buy, do your own research, inspect what you receive, and make your own informed choice. The clock may be ticking, but for now, there are still options—if you are prepared to act.