FDA & FTC Regulatory Peril in Consumer Products
In today’s video, let’s talk some more about FDA and FTC issues in consumer products that focus on health, wellness, lifestyle or fitness.
I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve had the pleasure to advise over a thousand healthcare industry clients on healthcare and FDA legal issues. Our clients include healthcare startups that do lots of things like integrative medicine, functional medicine, coaching, telemedicine, maybe they have a management services organization or MSO serving as the management and marketing arm, whether they got a brick-and-mortar setting, via digital or mobile health, via glasses, via some way that transmits to humans.
They have a slew of innovative health, wellness, lifestyle and fitness products, both consumer products that are physical like gizmos you put in your briefcase. Maybe we won’t have briefcases by the time we launch this video. But there are things that are going to move the needle on your health, like my fitbit here. Okay, free product placement.
But two points in this video:
First, whenever you put out a consumer product that has a health, wellness, lifestyle or fitness component, the first question is whether the product could be considered a medical device that is subject to FDA medical device regulation.
To decide whether a device is subject to FDA medical device regulation is to determine the device’s “intended use.” To determine the intended use, the FDA looks at a product’s labeling claims, advertising matter, or oral or written statements by manufacturers or their representatives. So it could be something you say or state in your website. Now, generally, products are considered medical devices if they are intended objectively for a medical purpose.
Let’s look to the definition in the FDCA which is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man (meaning humans) or other animals.”
FDA also regulates radiation-emitting products. These include tanning and therapeutic lamps, black light sources, white light devices, art-form lasers, and infrared alarm systems.
Second point, is that you’d be amazed at how extensive FDA’s regulatory framework is, and just how much it covers, as well as how specific the legal rules can be.
As just one tiny example, one of our clients was interested in marketing a number of products that used light to do certain things, like help someone achieve weight loss, help someone achieve better sleep, whatever it was.
It turns out that FDA regulates so-called “light therapy devices” as Class II medical devices; one such device is cleared to treat wrinkles. Who would’ve thought that?
In our research, we found out that FDA had published a document called: Memo to the Conference of Radiation Control Program Directors on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths. You get the picture of how FDA speaks.
Now it’s very specific and very deep-in-the-weeds. The point is, FDA addressed this very fine point, and the client’s market opportunity had to be evaluated in light of FDA’s regulatory framework including everything that we unearthed in our research.
In this document, among other things, FDA addressed “lamps that emit red light.” Again, super, super specific, who would’ve guessed – this is FDA speak, and this is what you have to pay attention to when you put out a product to market that has to do with health, wellness, lifestyle and fitness.
Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.