Legal
FTC Non-compete Ban Blocked by Judge
By Patrick O’Brien, JD, General Counsel, American Med Spa Association (AmSpa) The Federal Trade Commission’s (FTC’s) rule that would ...
Posted By Kate Harper, Tuesday, December 11, 2018
By Alex R. Thiersch, CEO of the American Med Spa Association (AmSpa)
Aquagold Fine Touch is a channeling device offered for sale by Aquavit Pharmaceuticals that has become extremely popular in the medical aesthetics industry. It delivers micro-droplets of a variety of drugs—typically including Botox and other toxins, as well as fillers—into the skin. What's more, its manufacturer claims the treatments it provides are pain-free.
Unlike a typical Botox treatment, in which the drug is directly injected and paralyzes the muscle, an Aquagold Fine Touch treatment is essentially microneedling. It delivers tiny amounts of the drug with which it is loaded over a wide area—much wider than a Botox treatment can manage. It is suitable for sensitive areas where Botox is impractical or impossible, such as the neck, and because the doses are much smaller than typical toxin treatments, it tends to result in skin that looks more natural and vibrant. Patients who wish to avoid the "frozen" look that Botox and other toxins often produce are embracing this technology.
As is typically the case when such a product emerges, we at AmSpa are getting a ton of questions about who can actually perform Aquagold Fine Touch procedures. The treatment appears to be very straightforward—a provider simply applies the device to the skin like a stamp. Its simplicity raises an obvious question: Can an esthetician or licensed vocational nurse (LVN) perform this procedure?
It's good that we're getting these questions because it shows that medical spa owners and operators care about remaining compliant, but because technology moves faster than the law, it's sometimes difficult to determine what the answers are when new technology emerges. However, we can use what we know about similar treatments and technologies to determine the most prudent course of action until government agencies make their rulings.
Simply put, the Aquagold Fine Touch is essentially a microneedling device, so a lot of the issues we'e addressed in recent years regarding microneedling are likely also going to apply to it. Every state that has looked into microneedling has found it to be a medical treatment, so a good-faith exam must be performed before the procedure, and if a doctor is not administering the treatment him- or herself, it must be properly delegated.
Unfortunately for practices that would like to use unlicensed practitioners to perform Aquagold Fine Touch procedures, this takes them out of the scopes of practice for estheticians and LVNs. In addition, the fact that Botox and fillers are being administered raises the question of whether or not this represents an injection and, therefore, if it can be administered only by a registered nurse or, in some cases, a nurse practitioner, physician assistant or physician.
The only conclusion we can draw with any sort of certainty is that Aquagold Fine Touch will be regulated in much the same way as microneedling, both in terms of medical board rulings and FDA approval, which has become a bit of a sticking point for microneedling products recently. Additionally, mixing different drugs together, as many doctors do with the Aquagold Fine Touch device, may represent a violation of pharmaceutical regulations, as many IV bars are finding out. Does a practice need to be registered as a pharmacy and have pharmaceutical oversight? Can nurses do it? Can LPNs? Who is qualified, capable and allowed to do this under the law?
Unfortunately, I don't have all these answers at the moment, but I am going to find out, so stay tuned to AmSpa for more about Aquagold Fine Touch treatments. Thus far, it has been very safe and very well received, but the industry needs to have a firmer grasp on the regulatory issues surrounding it.
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