The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and monitoring biometrics to managing pain. Depending on the device’s claims and functionality, such devices may also require U.S. Food and Drug Administration (FDA) premarket clearance, often via the so-called 510(k) pathway. To obtain FDA 510(k) clearance, a manufacturer must provide FDA certain information, and in some cases, device-specific data, demonstrating that the device is as safe and effective as a legally marketed device.
Obtaining FDA clearance can be time-consuming and expensive. However, for those devices that want to make certain claims regarding the ability to treat or prevent a disease or otherwise affect the structures/functions of the body, not only is premarket clearance required by FDA, but achieving this standard can also bolster credibility with consumers and retailers. Further, FDA clearance has historically served as a bit of a shield from class action plaintiffs and consumer watchdog groups challenging the substantiation for the core performance benefits. Yet, that protection is weakening. Plaintiffs are now more bullish and willing to challenge FDA-cleared wellness devices, particularly where the manufacturer makes aggressive testimonial claims about its device.
For example, the consumer watchdog group, TruthinAdvertising.org (TINA.org), recently raised concerns regarding the marketing of a few FDA-cleared wellness devices, despite FDA clearance. Specifically, TINA.org took issue with strong consumer testimonials and claims that a beauty device product was “proven” to deliver its performance benefits. Class action plaintiffs have also filed suit against 510(k) cleared wellness and beauty devices, alleging that FDA does not carefully vet the efficacy of 510(k) cleared products, but primarily focuses on safety. To be clear, FDA would certainly take issue with the plaintiffs’ position, given that the 510(k) process requires showing that the product as “safe and effective” as a legally marketed predicate device. While device manufacturers have pushed back on such lawsuits, some courts have been reluctant to fully grant the manufacturer’s motion to dismiss.
Where does this leave wellness device brands, particularly those that have (or are considering) FDA clearance for their device? A few considerations:
- FDA clearance may be unavoidable for certain wellness products due to their technology and/or claims to affect a disease or other health condition. Indeed, when considering whether to require premarket clearance for a wellness device, FDA will generally look to whether it regulates similar types of devices (e.g., red light therapy masks and microcurrent devices, among others).
- Even if FDA clearance is obtained, such clearance by no means negates the need for companies to have robust substantiation for all health and safety claims. For example, while FDA may clear a product’s overarching intended use for pain relief, if the company wants to make specific pain relief claims (e.g., “reduced pain by 20%” or “helps reduce pain in one week”), such claims must meet the FTC’s robust “competent and reliable scientific evidence” standard for health and safety claims.
- Brands must continue to ensure that claims made by others on the brand’s behalf (e.g., consumer, influencer and expert testimonials and endorsements) are consistent with the FDA-cleared intended use and the company’s own internal substantiation. This should be built into the company’s ad review process and addressed in any contract with an influencer or endorser.
Simply put, FDA clearance is a valuable (and at times necessary) standard for health and wellness brands, but ensuring that claims are adequately substantiated is key to reducing regulatory, competitor and class action risk.
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