Happy 25th birthday, DSHEA! Now, is it time to change you?

October 15, 2019, marks the 25^th anniversary of the Dietary Supplement Health and Education Act (DSHEA), the 1994 law that gave dietary supplements in the U.S. a regulatory category of their own. DSHEA opened the door to the $40 billion market that exists today.

The dietary supplement industry today looks very different from the industry that existed when DSHEA became law. More products enter the market each year-thousands more than existed in 1994-presenting new ingredients, formulations, delivery formats, and advertising claims. Consumers can purchase products from a multitude of retail channels, and supply chains grow more complex and global each year. All the while, emerging ingredients like hemp cannabidiol (CBD) are putting a spotlight on what happens when market demand for a supplement outpaces FDA’s regulatory oversight. And companies illegitimately selling misbranded or adulterated products masked as dietary supplements continue to operate under the radar.

FDA, the industry, consumers, and industry critics alike are aware of the need to maintain appropriate oversight of a market whose growth shows no sign of slowing, because one thing is for certain: consumers want access to dietary supplements. FDA is now actively looking into whether dietary supplement regulations need to be, in the agency’s words, “strengthened” and “modernized” so that FDA can effectively monitor the market. In May, FDA held a public meeting called “Responsible Innovation in Dietary Supplements,” with the mission of “giv[ing] interested parties an opportunity to present ideas for facilitating responsible innovation in the dietary supplement industry.” Industry stakeholders, advocates, and critics highlighted what’s needed, including from the agency itself. At the meeting, Steven Tave, director, Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition at FDA, estimated the number of products on the market today at 50,000 to 80,000, compared to the 4,000 products that existed when DSHEA passed.

Ahead, we asked a handful of supplement industry stakeholders about how DSHEA has aged-and what a DSHEA 2.0 should look like. What, if any, changes to the law are needed? What changes are needed in the way FDA polices the market?

At the end of the day, more consumers are turning to dietary supplements to proactively support their health and, crucially, to fill nutrient gaps they otherwise would have difficulty addressing. The hope is that the industry and its regulators can work together to address regulatory gaps, protect these consumers with a robust and well-regulated market, and ensure consumers can freely, confidently, and affordably access the products they need.

Photo © AdobeStock.com/Tanya