Relax: The FDA Will Not Regulate Things That Increase The Flow Of Your QiCommentary by John R. Graham
February 04, 2015
Qi, as I understand it, is a term in Chinese culture that refers to the life force or natural energy that flows in living things and, perhaps, the entire universe. Many Americans know about it through Chinese traditional medicine or martial arts. If you are a fan of such practices, you will be glad to learn that the Food and Drug Administration (FDA) has recently announced that it has no plans to regulate items which claim “to increase, improve, or enhance the flow of qi” as medical devices.
Well, that is a relief to many, I suppose. Nevertheless, it invites the question: Why is the law governing the regulation of medical devices so poorly written that it gives the FDA so much power that it has to re-assure us that it won’t regulate our qi-quickening gadgets?
The news came through draft guidance that the FDA published in January, through which it promises to exercise restraint when determining whether certain products are medical devices as defined by the 1976 amendments to the Food, Drug, and Cosmetics Act. The products addressed are those which help with “general wellness” and “promote a healthy lifestyle,” but pose low risk to peoples’ safety.
“General wellness” means that the product’s claims cannot make any reference to diseases or conditions. For example, a product which promises to help you manage your weight is exempt. However, if it offers to cure your obesity, it will be regulated as a medical device. Further, the guidance clarifies that this exemption will only apply to products with “low risk.” A vendor cannot use this guidance as a loophole to deploy a highly risk product but avoid regulation by not making medical claims. So, products that use laser, radiation, or implants will continue to be regulated. The draft guidance helpfully includes a one-page decision tree.
The guidance specifies “exercise equipment, audio recordings, video games, software programs and other products” (although I suppose “other products” is not really very specific). The inclusion of exercise equipment is especially alarming. Exercise equipment has been around for generations. The term includes baseball bats, snowboards, and running shoes. Why, in 2015, has it become necessary for the FDA to clarify that it will not regulate these items?
The guidance is a welcome dose of common sense from the FDA. However, it punctuates the need to revisit and rewrite the FDA’s authorizing legislation. The most pressing concern is the risk that the FDA will regulate smartphone apps and related software as medical devices. As with “wellness products,” the FDA itself issued common-sense guidance last year concerning mobile apps, through which it promised to exercise “enforcement discretion.”
That guidance has given investors and entrepreneurs the green light to pour billions of dollars into digital health. However, some legislators recognized that the threat of FDA over-regulation can only stopped by legislation that updates the almost four-decade old medical-device amendments, which give the FDA this regulatory authority. Representative Marsha Blackburn (R-TN) introduced the SOFTWARE Act last year, which would exempt clinical software and health software from FDA regulation. An updated version, co-sponsored by Representative Gene Green (D-TX) will soon be introduced in the House of Representatives.
The SOFTWARE Act is part of the 21st Century Cures initiative, a worthy effort by the House Energy and Commerce Committee to upgrade the entire apparatus of medical innovation in the U.S. A big piece of this effort is to update the legislative language that grants authority to the century-old FDA. If it needs to be updated to clarify that the FDA cannot regulate skateboards or yoga mats, Congress should do that too.