Cross-posted on Stanford’s Law and Biosciences Blog
A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use. As I wrote last week, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction. And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.
As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices. Why is that?
The FDCA defines drugs and devices as products “intended for use” in the diagnosis, cure, mitigation, treatment, or prevention of diseases, or “intended to affect the structure or any function of the body.” And this definition is very broad.
The “disease” piece of the definition captures things like cancer therapies and artificial heart valves—products that fit comfortably within what many commonly understand to be drugs and devices subject to FDA regulation. But, because implicit claims about addressing disease can also cause a product to fall with the definition of a drug or device, this part of the definition also might capture things like baby monitors marketed as measuring breathing and oxygen levels. Depending on the circumstances, marketing a product as monitoring a baby’s oxygen levels may imply that the product is intended for use in preventing Sudden Infant Death Syndrome (SIDS)—and that overall impression may not be dispelled even if a company disclaims its intent that the monitor be used for preventing SIDS. After all, why else monitor an apparently healthy baby’s oxygen?
Moreover, the “structure/function” piece of the definition means that the legal definition of drugs and devices includes not just medical treatments but also a much broader category of products that may not be strictly “medical,” including many enhancement and wellness products that are intended to affect the body’s structure or function. For example, one of the companies developing an implantable “neuroprosthesis” describes it as intended for “cognitive enhancement.” As I’ve argued in the Journal of Law and the Biosciences, cognitive enhancement claims are likely claims about changing—improving—the function of the brain, which could cause a product to be device under the FDCA. And, indeed, the company’s website quotes a news story referring to its product as “medical device,” suggesting that the company itself believes its product to be subject to FDA oversight. This is perhaps unsurprising, we might expect FDA jurisdiction over a product designed to be implanted in the brain. But, because the definition of a device turns on a product’s intended use, the same holds true for many non-invasive neuro-enhancement technologies. (Anna Wexler has an article in the Journal of Law and the Biosciences that offers a detailed description of the kinds of claims that some non-invasive neuro-tech companies make.)
Likewise, many of the vaginal wellness products featured in the Gizmodo article (most of which Etsy has now removed, according to Gizmodo), seem to have been accompanied by structure/function, if not implicit or explicit disease, claims. Again we might expect the products marketed with claims about treating yeast or other infections to be subject to FDA oversight. But, because the definition of drugs and devices includes products intended to affect the body’s structure or function, the same holds true for the parade of—seemingly horrible, at least to me (e.g., ground-up wasp nests for insertion into the vagina?!)—products marketed for vaginal tightening and restoring elasticity. (Notably, these products cannot be dietary supplements—permitted to make structure/function claims and subject to less FDA oversight than drugs and devices—because, among other possible reasons, dietary supplements must be intended for ingestion, which these products are not.)
Now, just because the FDA has authority over products, does not mean that it will exercise that authority (see, e.g., FDA’s policy on low-risk, general wellness devices). But it is still helpful to understand when the FDA can oversee products. Particularly because, as Hank Greely tweeted, these kinds of products may highlight a culture clash between the FDA and some Silicon Valley companies (or companies that embody the Silicon Valley spirit, even if not located there) that are not used to the idea of a gatekeeper for their products.
1/2 Important piece in part bec/shows S Valley/FDA disconnect. Entrepreneur: “People assume that somehow we have this permission structure https://t.co/ZnNTGBLycq
— Hank Greely (@HankGreelyLSJU) June 6, 2017
To the extent there is a lack of understanding that the FDA’s jurisdiction extends beyond those products accompanied by explicitly “medical” claims, there is, at least, the potential for those not used to dealing with the agency to misunderstand the scope of the FDA’s jurisdiction.