April 2, 2019 | STAT
5 ways to address the challenges of direct-to-consumer health products by Anna Wexler and Steve Joffe
So far, questions about safe and appropriate marketing and use have reverberated mainly within individual professional domains. We believe that thinking about these products as part of a larger problem can yield valuable insights.
Since 1976, the Food and Drug Administration has acted as a gatekeeper for companies bringing medical devices to the market. Today, however, many companies bypass the FDA by marketing quasi-medical products directly to consumers for “wellness” or “lifestyle” purposes. The technology or technique is often still experimental, with limited evidence about safety and effectiveness. This situation leaves researchers and health professionals concerned about unvalidated products being offered directly to the public, while forcing consumers to navigate ambiguous — and sometimes misleading — claims.