On August 17, Nutra Ingredients published a Q&A with Claudia Lewis and Erin Maus on how wearables are impacting supplement brands. According to the article, as supplement companies expand into wellness technologies, they may be subject to CPSC requirements in addition to FDA regulations.
“CPSC has jurisdiction over the safety of ‘consumer products,’” Lewis explained when asked about regulatory overlap between FDA and the CPSC. “Technology-enabled wellness products intended to diagnose, treat, or prevent disease, or to affect the body’s structure or function are generally regulated by FDA as medical devices, and so are carved out from CPSC’s jurisdiction. However, many wellness products are not medical devices and so are regulated by CPSC.”
The article also touched on the most significant product safety risks that dietary supplement companies diversifying into wearables, smart packaging, and other consumer wellness products should be evaluating during product development.
“Offering new products always presents risk. But transitioning into new product regulatory territory must be approached with both care and intention,” Maus noted. “Dietary supplement companies diversifying into wearables or other consumer wellness products outside of FDA jurisdiction can find themselves for the first time subject to the U.S. Consumer Product Safety Commission’s mandatory safety standards, product testing, labeling and certification expectations, and reporting obligations.”
Click here to access the article.