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Loeb & Loeb Regulatory partner Kristen R. Klesh provides an insider perspective on health and wellness devices for personal use, from fitness trackers and beauty masks to products that incorporate artificial intelligence, and the variety of regulatory challenges clients encounter, including the sometimes overlapping regulation of these devices by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
How do you work with clients in the health and wellness device industry?
Broadly speaking, I work with clients in the fitness/wearables, mobile health app, nutrition and skin care space on their go-to-market strategies and throughout the life cycles of their products to ensure they comply with applicable FDA requirements. I also focus on the marketing of those products, looking at what the client wants to say about the product and making sure they have the data—so-called substantiation—to back up what they say on their website, labeling and social media, including what their influencers and other endorsers say about the product.
As an example in the wearable device category, if a client comes to us and says they want to bring a wearable ring to the market to help consumers track their health and fitness, our threshold question is: How, if at all, will the product be classified by the FDA?
The answer to this question is largely driven by the claims they want to make and the functionalities of the device. For example, if the ring claims to take measurements of your vitals—oxygen level, blood pressure, temperature—to monitor your health, it will be a regulated medical device. From there, we then consider what, if any, FDA authorizations will the product need to market this product based on the classification? And finally, from an advertising perspective, what substantiation do we need to support the product claims to reduce FTC, competitor and class action risks?
Once the client launches the product, I work day-to-day with their marketing team to make sure the client is complying with the regulatory requirements of both the FDA and the FTC. This ranges from labeling to advertising claims to third-party statements, as well as manufacturing and quality issues. For example, if the device is being offered as a general wellness wearable ring, the company cannot rely on influencers or consumer testimonials to claim that the product helps them reduce the risk of chronic disease or helped them monitor their blood pressure. This creates FDA and claim substantiation risk. And if an issue arises—a regulatory action or litigation claim that a company is making inappropriate claims about its product—I help resolve those issues.
What kinds of wearable devices in the health and wellness industry do you help clients bring to market, and what regulatory challenges do they face?
Clients that I work with in the health and wellness devices category, including wearables and other technology, largely fall into two buckets.
The first bucket involves brands and products that are aiming to avoid active regulation by the FDA as a medical device and instead fall within the more limited regulations that apply to a consumer product. These companies are looking for assistance in ensuring that they are not making any claims or including any features that would cause the product to be actively regulated as a medical device—and thus subject to a host of regulatory requirements. In the health and wellness space, these products are often referred to as “general wellness products,” or GWPs. With some limited exceptions, these GWPs are focused on making claims and features for maintaining your health—for example, tracking steps, logging sleep, enhancing learning capacity—but do not claim to treat or prevent a medical condition.
The second bucket involves products that make claims or include features that are clearly going to cause the device to be regulated by the FDA as a medical device. This would include devices that measure vital signs or those that provide pain relief. Similarly, beauty devices that involve LEDs or microcurrents for wrinkle reduction are also examples of regulated devices. In this bucket, companies are looking for advice to ensure that the products have all applicable FDA authorizations, meet quality requirements and are marketed consistent with FDA regulations—and substantiation.
For novel products, it can often be a very fine line between which claims and features cause a product to be subject to a significant set of regulations as a medical device as compared to a general wellness product that avoids such regulatory burdens.
How does the FTC regulate health and wellness devices, such as wearable devices directed for consumer use?
The FTC and FDA each have an equally important, but different, focus when it comes to evaluating devices in the consumer health and wellness industry. Generally speaking, the FDA tends to focus on “form over function” when it comes to labeling claims. The FDA wants the device to use the correct regulatory claims language consistent with its product category. For example, if the device is cleared only for “fine lines in the face,” then it should use this claim language while avoiding any broader claims, like “pain relief.” This is the same for the general wellness category, where the product must follow the FDA’s specific requirements for general wellness claims. If adhered to, the FDA will largely leave the company alone from a claims issue [standpoint], putting aside any safety or quality issues.
The FTC, on the other hand, focuses on marketing claims made by companies and their spokespeople. The agency’s focus is on whether the claims being made about the product are actually true—and backed up by science. Since December 2022, we’ve witnessed the FTC become increasingly focused on claims in the health and wellness industry, issuing its “Health Products Compliance Guidance” setting forth very exacting standards of the types of scientific data that a company must possess in order to substantiate health and safety claims. It is critical that all companies in this space carefully analyze and adhere to these requirements. Unlike the FDA, the FTC also has broad rules governing consumer reviews and endorsements/testimonials, including influencers, that are extremely relevant to the health and wellness industry. Most notably, the FTC acts similarly to a law enforcement body and can impose civil fines, unlike the FDA.
What are the biggest challenges companies bringing health and wellness devices to market often face?
One of the biggest challenges in the wearable space is figuring out the fine line between a claim that causes the FDA to regulate the product as a device as compared to a nonregulated general wellness product. For example, a claim to “take vital signs” may be a regulated claim, while a claim to “track vital signs” may not be, depending on the device’s features. Similarly, a claim to exfoliate skin may not be a regulated claim, but a claim to exfoliate skin to help your SPF—drug—moisturizer work better would be a regulated device claim. Generally speaking, our Health & Wellness group has a good sense of what the FDA is going to scrutinize based on our years of practical experience engaging with the FDA on these types of issues.
Second, we find that clients can feel frustrated and handicapped when their science often outpaces the regulatory framework the FDA has in place. This plays out when clients, thinking more is better, have extensive scientific data to show their products work as intended. However, more data doesn’t always help clear FDA hurdles and can actually slow the process of bringing a product to market. The FDA will say: “Great! We’ve been waiting for this type of device. Here’s the door to premarket approval.” In reality, this is a much lengthier process and results in the company having heavier regulatory and compliance burdens.
More physicians seem to be advocating for the use of wearable devices to monitor patients’ medical conditions. Does this pose any problems for companies in the health and wellness space?
More and more, manufacturers are becoming aware that physicians are using their devices for a particular health-related use that would trigger heavier FDA regulation. Physicians have the full authority to use products for an appropriate medical purpose, even if it’s what we call off-label—not the use for which the product was originally marketed. So physician off-label use of a wearable device does not automatically trigger a regulatory issue.
However, if a company begins adopting these claims or engaging in practices with physicians or consumers that show the company “intends” their product to be used for a specific medical purpose for which the device is not authorized by the FDA, this could put the company at risk of the FDA pursuing enforcement action as an “unapproved” medical device in violation of FDA rules and regulations. This can be a very complicated area to navigate that needs to be done with caution, as the boundaries between permitted “scope of medical practice” and “off-label” use can become easily blurred.
With the rise of influencer marketing, are there any legal challenges in promoting wearable devices?
Using celebrities and influencers to market products is a key marketing strategy in the health and wellness space, where so much depends on peer-to-peer reviews and claims about products. Clients need to be aware that any claims made by influencers on their behalf will be viewed by both the FDA and FTC just the same as if the client made them directly. In some cases, influencers may not appreciate the nuances of claims and the regulatory requirements of claim substantiation. Helping both clients and influencers understand the subtleties involved is accomplished through contracts, training and providing examples of the standard the company expects in the product claim.
What emerging legal issues do you see in the health and wellness wearables space?
The use of artificial intelligence in wearable devices is a looming issue. As you can imagine, the use of AI makes it very challenging to classify a device and evaluate its risks. When wearable devices use AI technology that constantly reevaluates its algorithm, it may lead to the device operating differently over time.
For example, a client has a fitness service that relies on AI to provide prompts and coaching. If the device were to use the term “insomnia” (a medical condition) rather than “sleep support” (a wellness term), the FDA might look at it differently. It’s really important that AI-enabled devices are trained appropriately to differentiate terms like these. The FDA is issuing guidance right now for how companies can seek premarket authorization when a product uses AI so that the agency can evaluate the model and the algorithm.
How is Loeb helping clients in the wearable devices space navigate the regulatory challenges posed by the FDA and the FTC?
Our team is helping clients consider the most effective go-to-market strategies for their products based on each company’s business goals. If the company is a new startup that needs conversions/sales quickly, then we may recommend marketing the product as a “general wellness product” or Class I device first with more limited claims in an effort to limit roadblocks to bring the product straight to market and start converting sales. Then as the company grows, we can seek FDA clearance if the company wants to add more complex features. In contrast, if the company is focused on investors who want to see the FDA clearance from the outset, we advise on the most effective and efficient pathway to obtaining clearance/approval. We also help file and obtain FDA clearances for clients and advise on all other aspects of FDA compliance—manufacturing, import issues and the like.
We also help clients navigate the complex issues surrounding which claims cause the product to be a regulated device or a nonregulated general wellness product. In addition, we help put in place social media, influencer and marketing team “guardrails” so the company understands what it can and cannot say and has some agency to operate comfortably.
From a substantiation perspective, we perform scientific literature reviews to gather substantiation for the claims and help clients analyze the strengths and limitations of their scientific data. We also engage with third-party consultants and laboratories should our clients want to conduct safety testing, performance testing or otherwise.
Finally, we help clients when issues arise. This ranges from dealing with the FDA’s Import Division to FDA compliance issues over claims, as well as challenges by the FTC, the National Advertising Division and class plaintiffs related to advertising issues.
As the health and wellness space evolves, we remain committed to helping our clients stay ahead of developments, bringing innovative and compliant products to market that align with their specific business goals.
How do you work with clients in the health and wellness device industry?
Broadly speaking, I work with clients in the fitness/wearables, mobile health app, nutrition and skin care space on their go-to-market strategies and throughout the life cycles of their products to ensure they comply with applicable FDA requirements. I also focus on the marketing of those products, looking at what the client wants to say about the product and making sure they have the data—so-called substantiation—to back up what they say on their website, labeling and social media, including what their influencers and other endorsers say about the product.
As an example in the wearable device category, if a client comes to us and says they want to bring a wearable ring to the market to help consumers track their health and fitness, our threshold question is: How, if at all, will the product be classified by the FDA?
The answer to this question is largely driven by the claims they want to make and the functionalities of the device. For example, if the ring claims to take measurements of your vitals—oxygen level, blood pressure, temperature—to monitor your health, it will be a regulated medical device. From there, we then consider what, if any, FDA authorizations will the product need to market this product based on the classification? And finally, from an advertising perspective, what substantiation do we need to support the product claims to reduce FTC, competitor and class action risks?
Once the client launches the product, I work day-to-day with their marketing team to make sure the client is complying with the regulatory requirements of both the FDA and the FTC. This ranges from labeling to advertising claims to third-party statements, as well as manufacturing and quality issues. For example, if the device is being offered as a general wellness wearable ring, the company cannot rely on influencers or consumer testimonials to claim that the product helps them reduce the risk of chronic disease or helped them monitor their blood pressure. This creates FDA and claim substantiation risk. And if an issue arises—a regulatory action or litigation claim that a company is making inappropriate claims about its product—I help resolve those issues.
What kinds of wearable devices in the health and wellness industry do you help clients bring to market, and what regulatory challenges do they face?
Clients that I work with in the health and wellness devices category, including wearables and other technology, largely fall into two buckets.
The first bucket involves brands and products that are aiming to avoid active regulation by the FDA as a medical device and instead fall within the more limited regulations that apply to a consumer product. These companies are looking for assistance in ensuring that they are not making any claims or including any features that would cause the product to be actively regulated as a medical device—and thus subject to a host of regulatory requirements. In the health and wellness space, these products are often referred to as “general wellness products,” or GWPs. With some limited exceptions, these GWPs are focused on making claims and features for maintaining your health—for example, tracking steps, logging sleep, enhancing learning capacity—but do not claim to treat or prevent a medical condition.
The second bucket involves products that make claims or include features that are clearly going to cause the device to be regulated by the FDA as a medical device. This would include devices that measure vital signs or those that provide pain relief. Similarly, beauty devices that involve LEDs or microcurrents for wrinkle reduction are also examples of regulated devices. In this bucket, companies are looking for advice to ensure that the products have all applicable FDA authorizations, meet quality requirements and are marketed consistent with FDA regulations—and substantiation.
For novel products, it can often be a very fine line between which claims and features cause a product to be subject to a significant set of regulations as a medical device as compared to a general wellness product that avoids such regulatory burdens.
How does the FTC regulate health and wellness devices, such as wearable devices directed for consumer use?
The FTC and FDA each have an equally important, but different, focus when it comes to evaluating devices in the consumer health and wellness industry. Generally speaking, the FDA tends to focus on “form over function” when it comes to labeling claims. The FDA wants the device to use the correct regulatory claims language consistent with its product category. For example, if the device is cleared only for “fine lines in the face,” then it should use this claim language while avoiding any broader claims, like “pain relief.” This is the same for the general wellness category, where the product must follow the FDA’s specific requirements for general wellness claims. If adhered to, the FDA will largely leave the company alone from a claims issue [standpoint], putting aside any safety or quality issues.
The FTC, on the other hand, focuses on marketing claims made by companies and their spokespeople. The agency’s focus is on whether the claims being made about the product are actually true—and backed up by science. Since December 2022, we’ve witnessed the FTC become increasingly focused on claims in the health and wellness industry, issuing its “Health Products Compliance Guidance” setting forth very exacting standards of the types of scientific data that a company must possess in order to substantiate health and safety claims. It is critical that all companies in this space carefully analyze and adhere to these requirements. Unlike the FDA, the FTC also has broad rules governing consumer reviews and endorsements/testimonials, including influencers, that are extremely relevant to the health and wellness industry. Most notably, the FTC acts similarly to a law enforcement body and can impose civil fines, unlike the FDA.
What are the biggest challenges companies bringing health and wellness devices to market often face?
One of the biggest challenges in the wearable space is figuring out the fine line between a claim that causes the FDA to regulate the product as a device as compared to a nonregulated general wellness product. For example, a claim to “take vital signs” may be a regulated claim, while a claim to “track vital signs” may not be, depending on the device’s features. Similarly, a claim to exfoliate skin may not be a regulated claim, but a claim to exfoliate skin to help your SPF—drug—moisturizer work better would be a regulated device claim. Generally speaking, our Health & Wellness group has a good sense of what the FDA is going to scrutinize based on our years of practical experience engaging with the FDA on these types of issues.
Second, we find that clients can feel frustrated and handicapped when their science often outpaces the regulatory framework the FDA has in place. This plays out when clients, thinking more is better, have extensive scientific data to show their products work as intended. However, more data doesn’t always help clear FDA hurdles and can actually slow the process of bringing a product to market. The FDA will say: “Great! We’ve been waiting for this type of device. Here’s the door to premarket approval.” In reality, this is a much lengthier process and results in the company having heavier regulatory and compliance burdens.
More physicians seem to be advocating for the use of wearable devices to monitor patients’ medical conditions. Does this pose any problems for companies in the health and wellness space?
More and more, manufacturers are becoming aware that physicians are using their devices for a particular health-related use that would trigger heavier FDA regulation. Physicians have the full authority to use products for an appropriate medical purpose, even if it’s what we call off-label—not the use for which the product was originally marketed. So physician off-label use of a wearable device does not automatically trigger a regulatory issue.
However, if a company begins adopting these claims or engaging in practices with physicians or consumers that show the company “intends” their product to be used for a specific medical purpose for which the device is not authorized by the FDA, this could put the company at risk of the FDA pursuing enforcement action as an “unapproved” medical device in violation of FDA rules and regulations. This can be a very complicated area to navigate that needs to be done with caution, as the boundaries between permitted “scope of medical practice” and “off-label” use can become easily blurred.
With the rise of influencer marketing, are there any legal challenges in promoting wearable devices?
Using celebrities and influencers to market products is a key marketing strategy in the health and wellness space, where so much depends on peer-to-peer reviews and claims about products. Clients need to be aware that any claims made by influencers on their behalf will be viewed by both the FDA and FTC just the same as if the client made them directly. In some cases, influencers may not appreciate the nuances of claims and the regulatory requirements of claim substantiation. Helping both clients and influencers understand the subtleties involved is accomplished through contracts, training and providing examples of the standard the company expects in the product claim.
What emerging legal issues do you see in the health and wellness wearables space?
The use of artificial intelligence in wearable devices is a looming issue. As you can imagine, the use of AI makes it very challenging to classify a device and evaluate its risks. When wearable devices use AI technology that constantly reevaluates its algorithm, it may lead to the device operating differently over time.
For example, a client has a fitness service that relies on AI to provide prompts and coaching. If the device were to use the term “insomnia” (a medical condition) rather than “sleep support” (a wellness term), the FDA might look at it differently. It’s really important that AI-enabled devices are trained appropriately to differentiate terms like these. The FDA is issuing guidance right now for how companies can seek premarket authorization when a product uses AI so that the agency can evaluate the model and the algorithm.
How is Loeb helping clients in the wearable devices space navigate the regulatory challenges posed by the FDA and the FTC?
Our team is helping clients consider the most effective go-to-market strategies for their products based on each company’s business goals. If the company is a new startup that needs conversions/sales quickly, then we may recommend marketing the product as a “general wellness product” or Class I device first with more limited claims in an effort to limit roadblocks to bring the product straight to market and start converting sales. Then as the company grows, we can seek FDA clearance if the company wants to add more complex features. In contrast, if the company is focused on investors who want to see the FDA clearance from the outset, we advise on the most effective and efficient pathway to obtaining clearance/approval. We also help file and obtain FDA clearances for clients and advise on all other aspects of FDA compliance—manufacturing, import issues and the like.
We also help clients navigate the complex issues surrounding which claims cause the product to be a regulated device or a nonregulated general wellness product. In addition, we help put in place social media, influencer and marketing team “guardrails” so the company understands what it can and cannot say and has some agency to operate comfortably.
From a substantiation perspective, we perform scientific literature reviews to gather substantiation for the claims and help clients analyze the strengths and limitations of their scientific data. We also engage with third-party consultants and laboratories should our clients want to conduct safety testing, performance testing or otherwise.
Finally, we help clients when issues arise. This ranges from dealing with the FDA’s Import Division to FDA compliance issues over claims, as well as challenges by the FTC, the National Advertising Division and class plaintiffs related to advertising issues.
As the health and wellness space evolves, we remain committed to helping our clients stay ahead of developments, bringing innovative and compliant products to market that align with their specific business goals.
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