Is At-Home Microneedling Being Banned? Latest on the FDA Review & Options

Trouble Buying Your Microneedling Supplies?

If you’ve been trying to buy microneedling pens or cartridges on Amazon or other platforms, you’ve probably noticed they’ve disappeared. Although no public announcement has been made yet, at-home microneedling devices are facing restrictions due to an ongoing FDA review – information I learned from a vendor’s website. Here I will post updates as the information becomes available.

Some Retailers Have Stopped Selling Microneedling Pens & Cartridges in the U.S.

Some major retailers, including Amazon and AliExpress, have halted the sale of microneedling pens and cartridges to U.S. customers due to the ongoing FDA review, which has yet to reach a conclusion. Additionally, I found a public FDA document detailing that Ekai, the manufacturer of the Dr. Pen, requested and received approval for it as a medical device, contributing to this situation. You can find full details below.

Currently, several websites continue to sell these products, although prices have increased, possibly reflecting concerns about future regulatory changes. While Temu remains one of the larger platforms still offering microneedling pens, Ekai, the main manufacturer of Dr. Pen, has stated they cannot verify the authenticity of products sold on sites like Temu or AliExpress. There are concerns that there may be some counterfeit products circulating on these platforms. Ekai is actively working to address this issue, ensuring that only authorized and legitimate products are available through verified channels. If you decide to purchase from these platforms, just be aware of any risks involved. Many home users have been purchasing microneedling pens and cartridges from a variety of online sources over the years, and it would have been so helpful if there had been a list of official resellers and more information available in the past.

Summary of the Situation

  • FDA Review: The FDA is currently reviewing the status of microneedling devices and cartridges for at-home use, with potential restrictions on the horizon.
  • Retailer Actions: Some major retailers, like Amazon and AliExpress, plus numerous other websites have limited or stopped selling these products in the U.S.
  • Current Availability: Only one major online retailer, Temu, is currently allowing vendors to sell these products. If you’re aware of more sites, feel free to share that in the comments.
  • Potential Future: If restrictions occur, it’s possible that only nano needle cartridges might remain available for consumer use through verified channels.

Disclaimer Posted on Some Retail Sites

This disclaimer is posted to the product pages on one of the big sites that sells microneedling devices. You can view it underneath the “add to cart” area here.

FDA Banning Microneedling at-Home

Investigating What’s Going On

Amazon Removed All Microneedling Pens and Cartridges

About a month ago, I noticed that Amazon stopped allowing vendors from selling microneedling pens and cartridges in the U.S. All of the items were removed. While no official ban has been announced, it’s possible this action was taken in response to the ongoing FDA review of these devices. The FDA has not yet made a final decision, and the regulatory process can be lengthy.

FDA’s Recent Endeavors to Ban Products from Public Use

In recent years, the FDA has intensified efforts to regulate and ban various products from at-home use. This has sparked significant pushback from consumers and advocates. In 2021, the FDA attempted to ban the supplement NAC, leading to its temporary removal from Amazon. But, thankfully it’s back on the market and available to the public.

Currently, the FDA is embroiled in a long ongoing process regarding the sale of another popular longevity supplement, NMN – as part of an effort to regulate its use or restrict it to prescription-only status.

FDA’s Review Process Here Seems Escalated

Typically, when the FDA initiates a review or investigation, companies receive notice but continue selling their products until a final decision is made. However, with microneedling devices, many platforms appear to be proactively removing these products before the FDA has reached a conclusion.

Contacting Resellers on Alibaba

FDA Microneedling Ban

Alibaba is another popular website where companies can purchase from manufacturers. Due to past work, I have an account on there and I used that to contact numerous companies regarding the Dr. Pen situation. What I discovered was that most of the people I heard back from, reassured me that they were resellers for Ekai and that Ekai was the main manufacturer of Dr. Pens. It does seem to be the case that there are other manufacturers producing the cartridges and some may be manufacturing the pens as well, but clarification is needed on that. It’s possible that they could have licensing agreements, but I have no information on that at this time.

In the process of communicating with resellers, I put in a couple of product sample requests – and this was prior to me learning about the potential FDA review, so I had no idea about it at the time. Immediately, I received an automated message letting me know that I could not request those items as they were restricted.

Who Is the Official Manufacturer of Dr. Pens?

Thanks to a knowledgeable and well-researched commenter on my YouTube channel, I’ve discovered that the main manufacturer of Dr. Pens is Guangzhou Ekai Electronic Technology Co., based in China. Ekai is recognized as the primary source for these devices, with most vendors acting as resellers. Be cautious, as some websites may claim to be the official manufacturer, when they are not.

Clarifying the Current FDA Situation with Dr. Pen

Based on publicly available data, here’s what you need to know about the current situation. Please note that the FDA review is ongoing, and I’ll share updates when received.

Timeline of Key Events

  • February 2023: Guangzhou Ekai Electronic Technology Co., Ltd. submitted a 510(k) premarket notification to the FDA, seeking approval to market the Dr. Pen Microneedling System in the United States.

FDA Approval

  • August 2023: The FDA granted 510(k) clearance, confirming that the Dr. Pen is substantially equivalent to other legally marketed microneedling devices. This approval allows Ekai to market the device for improving the appearance of facial acne scars in adults aged 22 and older, under prescription-use. For more details, you can access the full FDA letter here.

Class II Medical Device

  • Class II Medical Device: The Dr. Pen Microneedling System is classified as a Class II medical device, subject to regulatory controls to ensure safety and effectiveness.

This post may contain affiliate links & if you purchase through them I will earn a small commission. I only promote products I believe in.

My Experience with Microneedling Treatments at Home

If you’re new to my website and youtube content, then you may not know that I have been doing at-home microneedling treatments for the last 5+ years, with incredible results. I live in an extremely rural area, and it’s not feasible for me to get a treatment done in a clinic nearby, as we have none. I’d need to drive for two hours to get to a larger city to have this done, probably for a couple hundred dollars per treatment. And, that’s not worth it to me. In addition, I trust myself more than I trust an esthetician doing the procedure. When I first started doing the treatments, I gained all my knowledge on how to do them from Penny of Penn Smith Skincare, through her Youtube videos. There are a lot of doctors on Youtube who will advise against doing this at home, yet there are also many who understand that some of us will choose to do it, and they are open to creating content sharing tips on how to do it safely and effectively. Here you can check out my before and after microneedling results.

Stocking Up

As I have been investigating this situation, I’ve noticed a significant shift in availability, especially after receiving a notification from Alibaba that I could no longer request certain products. Recognizing that the situation appears to be escalating, I made the decision to stock up on supplies while I still could. It seems that this is still an option at the time of writing this, because the FDA’s review has not yet concluded.

I opted to purchase from Temu, where I found that Dr. Pen A6 cartridges were affordable. The A6 is one of the original Dr. Pen’s and so it’s older. Surprisingly, it is also pricier than some of the newer pens being sold on Temu. The link to Temu is an affiliate link. If you decide to use it, I will get a small commission on purchases and you should get 30% off of your order with the link or code: “acn120083.” If you download the app, you may get more discounts or money off, but it’s totally up to you. I downloaded it previously, but prefer to shop on the computer instead.

When it comes to stocking up, I want to emphasize that this is a personal choice I’ve made and if you’re considering stocking up as well, please do your own research and make an informed decision that feels right for you, according to the laws in your country. And, whatever you do is at your own risk.

Keep in mind that while the FDA hasn’t reached a final decision yet, the availability of these products may change soon. Since there is no official guidance or announcements from the FDA, it seems we have a small window of opportunity to continue purchasing. It’s hard to know based on the total lack of information from the FDA.

Before You Purchase Any Cartridges

There’s a lot of confusion about the microneedling cartridges available, as there are a variety of sizes with various numbers of needles. I recently took ultra closeup photos of a variety of needle cartridges, and you can see all of those photos of microneedling cartridge photo closeups here. I highly recommend checking that out before stocking up.

Websites That Continue to Sell Microneedling Pens

A variety of websites still appear in Google searches for microneedling Dr. Pens. But, many of them have noticed stating they will only sell to licensed professionals now. If you can find one selling to the public, please share it in the comments below. If these websites are official resellers for Ekai, I believe it’s likely that they will restrict sales to medical professionals only, rather than to at-home users. While I can’t say this for certain, it appears to be the case for the website I shared earlier, which explicitly disallowed home users from making purchases and included a detailed warning and disclaimer in the “add to cart” section. This is just speculation, as the situation is developing.

Google Ads Are Still Running

When the FDA decided to go after NMN over the past few years, Google ads were also impacted. Companies pay for ads to promote their products and it can be an important part of their advertising, growth, and revenue. It seemed serious when Google stopped allowing companies to run ads on any NMN products.

When it comes to the current situation and microneedling supplies, so far companies are still promoting microneedling pens and cartridges through Google ads. So it does not appear to the be at the point where the FDA or government has intervened through Google yet and maybe they never will. But, they could potentially change their practices and who they sell to.

Ongoing Situation

It’s important to note that this situation is still unfolding. The only concrete information available at this time includes the FDA approval letter and a disclaimer from another website stating that the product is now only available through prescription. As developments occur, I will keep you updated.

For Future Updates

Please subscribe to my youtube channel Life and DIY and also join my newsletter below, to stay notified. Check back here for all updates on this situation. I will continue to add to this article as I find out any updates. Also, you can follow me on Reddit and discuss it there, or in the comment section below here.

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Before Buying Microneedling Pens and Cartridges – Check Out the Closeups 1st!
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mrgekko

mrgekko here, tried to post this on youtube but they keep deleting my post. ​Great that you could confirm that Ekai was the manufacturer of Dr Pen. Before i ordered my M8 i emailed them and asked if it was Ekais M8 that was sold on Ali Express but i didn’t get at straight answer from them and i think that was because they sell to other companies that say that they are the original Dr Pen and Ekai is ok with that and just want to manufacture and sell as much as possible. I have also seen pens that… Read more »

DIYlover

It isn’t about increasing money for a company in China. Read this statement, especially the bottom section. It’s an economic “war” and FDA is masking it.
https://www.whitehouse.gov/briefing-room/statements-releases/2024/05/14/fact-sheet-president-biden-takes-action-to-protect-american-workers-and-businesses-from-chinas-unfair-trade-practices/

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