Fidget Spinner: Should FDA Regulate or Leave Them Alone?     
​[Posted on: Thursday, June 1, 2017]

If you have young children, you must have a few spinning toys in your home, collectively called the “Fidget” spinners. The sellers of these seemingly innocuous “toys” make claims on their labels that should concern parents and regulators. But so far FDA has not shown any public desire to regulate these products. Fidget spinners are marketed as treatment for several neurological disorders such as ADHD, ADD, anxiety, autism, stress and behavioral issues in children. There have been no formal studies to verify these claims, nor have there been much support from experts. But the cleverly marketed toys have caught the imagination of parents and tens of millions of these have been sold in the last year alone. Fidget spinner, originally called “Finger spinners” were invented 20 years ago by a Florida-based inventor as a toy to entertain her young daughter and have been used for a long time by teachers, guidance counselors and therapists to help reduce fidgeting or small movements, especially of the hands and feet, caused by nervousness or impatience in children. In the last few years, they have become fad toy that comes in various shapes and colors, and are an inexpensive way to keep your kids occupied. But can one make such audacious medical claims and not be questioned by the FDA? So far FDA has not discussed these toys/devices publicly and there could be a few good reasons. First, there are hundreds of manufacturers for these devices; these devices are sold literally at thousands of stores and online. The fidget spinner industry is too large and diverse for FDA to regulate. Second, it is hard to imagine someone getting hurt by these toys. It would be hard, if not impossible, to link any adverse events to the use of fidget toys. There is no evidence that doctors are withholding needed prescriptions for drugs to treat ADHD, ADD and other diseases to try out fidget spinners instead. Third, there have been no known formal complaints to the Agency regarding these devices. While several schools have banned these devices, and others have warned students to not use them; the primary reasons for those were nuisance factor and not injury or personal safety. These products create a regulatory conundrum for the Agency; while the claims are clearly a concern, it would be hard for the Agency to justify taking them off the market. There are far more risky products that FDA has been unable to regulate much. The dietary supplement and the “wellness” industries are full of products that pretend to treat diseases but fly under the FDA radar for the same reason. The Agency has limited resources to regulate every statement made by a manufacturer except when there is an accident or complaint. From a purely technical point of view fidget spinners are at most Class I medical devices because of the low risk and treatment claims, which would require the manufacturers to register with FDA and follow QSR. However, from the practical point of view, it is better to let the sleeping dogs lie and not add the extra burden on the already over-extended FDA. This is similar to the approach taken for dietary supplements, lab developed diagnostics, Smartphone apps, and lab developed diagnostic tests (LDTs). This approach works by reducing unnecessary regulation of innocuous products.