This past January, the U.S. Food and Drug Administration released its draft guidance on general wellness products, in an effort to help mHealth developers distinguish between products that the FDA will regulate and those that don't need oversight.
To help developers and provider distinguish between the two classifications, Worrell has come up with the following graphic.
According to Sarah diFrancesca, an associate in the healthcare and life sciences regulatory group at Cooley LLP, the FDA defines a general wellness product as having:
1. An intended use that relates to maintaining or encouraging a general state of health or a healthy lifestyle; or
2. An intended use claims that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that health lifestyle choice may play an important role in health outcomes for the disease or condition.
Furthermore, the FDA's draft guidance points out that it won't regulate general wellness products if they're intended only for general use and they present a low risk to the user's safety.
So what passes muster and what doesn't? Take a look at the infographic to find out.
