The FDA Will Not Regulate Things That Increase the Flow of Your Qi

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The news came through draft guidance that the FDA published in January, through which it promises to exercise restraint when determining whether certain products are medical devices as defined by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 a 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 a “low risk.” A vendor cannot use this guidance as a loophole to deploy a highly risky product but avoid regulation by not making medical claims. So, products that use lasers, 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 The draft guidance helpfully includes a one-page decision tree.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 be 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, cosponsored 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.

Comments (5)

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  1. Devon Herrick says:

    Qi… is a term in Chinese culture that refers to the life force or natural energy that flows in living things…

    It seems to me that the Food, Drug & Cosmetic Act is written rather broad. Under the Food, Drug and Cosmetic Act a drug is defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man…

    I cannot help but think Qi is in there somewhere. For example, I would think a transcutaneous electrical nerve stimulation (TENS) would mainly stimulate my Qi. Yet, not only is a TENS device regulated by the FDA, it requires a 510(K) approval to market. A Pap Imi device creates electromagnetic pulses that I would think could definitely stimulate my Qi. The FDA blocked importing the machines back in 2007.

    • John R. Graham says:

      For some reason, your comment made me think of that famous book, “To Serve Man,” which was actually a cookbook!

  2. Big Truck Joe says:

    Hogwash! Find me a medical school in the west that teaches “QI”? You can’t regulate that which doesn’t exist. What’s next – a feng shui meter? Oy vey, what is this world coming to.

  3. Big Truck Joe says:

    I can see it now …. Dr Kim Chi has upped my dosage of QI to 15 milligrams three times a day after each meal so as to not interfere with my feng shui.

  4. wanda jones says:

    If you want a flash of rage at the FDA’s tendency to over-use its powers, look up their ruling on 23 and Me’s use of algorithms to counsel customers on their genetic risks. It essentially put the firm out of business for direct to consumer diagnostics in the genetic analysis s world. Stupid and completely medieval. AS QUOTED IN STEVEN LEVY’S BOOK, “DOCTOR, THE PATIENT WILL SEE YOU NOW; HIGHLY RECOMMENDED.

    W. Jones, San Francisco