Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 11 March 2014 | By Alexander Gaffney, RAC,
Can a YouTube video be a medical device, and should the US Food and Drug Administration (FDA) be cracking down on certain videos on the Google-owned network?
As reported by ABC, The Huffington Postand other news outlets, practitioners of "Autonomous Sensory Meridian Response" (ASMR) have been taking to YouTube in recent years. The practice focuses on relaxing noises, which practitioners claim cause a "relaxing" and "tingling" sensation in the body, resulting in a "calming sensation."
While proponents of the practice readily concede that "little scientific research [has been] conducted on the topic," they cite an array of benefits, ranging from general "pleasurable sensations" to specific medical claims.
"[P]eople who suffer from insomnia and regularly have difficulty getting to sleep can use ASMR videos to distract and relax them, and send them sleep when nothing else will," writes the anonymous author of one website, ASMRlab.com. "Some ASMR videos are designed specifically for this purpose," the author adds.
Indeed, that claim-that ASMR can treat or cure insomnia-has been the principle draw for more than a few practitioners. As profiled on ABC, the practice claims to be effective "with no pills, no side effects, no danger of addiction."
But at the same time, one doctor cited by ABC in its report warned that focusing on ASMR could prevent some patients from seeking help from medical professionals to treat their respective underlying conditions, which might not benefit from treatment via YouTube.
And therein lies a potential regulatory problem. Under the Federal Food, Drug and Cosmetic Act (FD&C Act), a medical device is defined as:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
FDA has long held that digital products, including software and mobile applications that run on phones, are medical devices. Similarly, the definition of medical device is fluid enough to allow nearly any product-even a YouTube video-to be a medical device so long as it claims to treat or cure a disease or condition, and is not a chemical entity.
So what, then, to make of ASMR videos?
The National Institutes of Health (NIH) recognize insomnia as a known sleep condition, and FDA has approved several drugs to help treat it, including Ambien (zolpidem) and Intermezzo (zolpidem tartrate sublingual tablets).
Clearly, then, it meets the second condition required of medical devices: that it be for a "disease or other condition."
The second condition-"intended for use in"-is the most important, however. Most ASMR YouTube videos are not themselves explicitly stating that they can treat insomnia, though some are. Certain websites, however, including ASMRlab, explicitly claim that "ASMR can help cure your insomnia."
"Whilst there are many different perspectives on insomnia cures, if you experience ASMR and insomnia then you should defiantly (sic) look into trying it out as an insomnia cure," the website states.
In that case, the ASMRlab website could find itself afoul of FDA regulations against promotion of a product for unapproved purposes, though it's not clear if FDA would go after the website since it doesn't market any products itself.
But for videos on YouTube created and marketed by users specifically as being a potential cure or treatment for insomnia, this raises an interesting question: Will FDA seek to shut these videos down? Many users sell advertising alongside their videos, meaning that they could stand to profit from a "medical device" that is against the FD&C Act.
FDA has cited promotional claims made in YouTube videos before, such as a 2012 letter to device manufacturer The Avalon Effect and a 2011 letter to device manufacturer 2035 Inc, but does not appear to have sent a letter regarding a YouTube video itself as a medical device.
It might also raise problems for Google, which has settled claims with FDA in recent years after it was found to be profiting from advertising used to market illicit pharmaceutical products.
While it's uncertain-even unlikely-that FDA will step in to police the area, it does prove an interesting regulatory case for future developments. And given the history of mobile medical applications-such as those which have purported to treat acne, alcoholism, pain, and stuttering-it's likely to be an area that regulators will be dealing with for years to come.
Tags: Sleep, Insomnia, ASMR, YouTube, Latest News, medical device