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What was once an undefined space for dietary supplements has become a regulated, burgeoning market.
By Duffy MacKay, ND, Council for Responsible Nutrition
In 1994, the year Congress enacted the Dietary Supplement Health and Education Act (DSHEA), I was finishing my final year of college at the University of California, Santa Cruz. Back then, DSHEA was the farthest thing from my mind, as I focused on finals and preparing to enter medical school. It wasn’t until a couple of years later when, midway through naturopathic medical school, I got my first glimpse of DSHEA’s influence.
My first industry job was at a company that had been around pre-DSHEA. It was the epitome of a mom and pop shop. The owner embodied the spirit of DSHEA; he very much believed that the products he sold were a means to stay healthy, and he wanted to be able to talk candidly with his customers about products’ health benefits and offer a wide variety of supplement products to his customers. I can just imagine his frustration a couple of years prior, pre-DSHEA, when FDA would have claimed his products did not have a place-no regulatory category nor definition. Pre-DSHEA, the vitamins and minerals and herbal and nutritional supplements that he believed were part of a healthy lifestyle were stuck in a gray area under federal law, and that meant FDA didn’t really know how to regulate them.
Before DSHEA, dietary supplements-sometimes referred to as “food for special dietary uses”-routinely fell somewhere in between the food, food additive, and drug categories. FDA objected to label claims made by supplement products because the agency considered structure-function claims solely the privilege of drugs. In fact, the agency wanted to call anything that exceeded the recommended daily allowance a drug, and it even tried to call blackcurrant oil a food additive because the ingredient was enclosed in a gelatin capsule. FDA was also reluctant to give consumers too much information about the burgeoning science behind supplement products unless the research was as definitive as the two randomized controlled trials (RCTs) required for new pharmaceuticals.
Indeed, pre-DSHEA was a time of confusion and uncertainty for the industry and consumers alike.
Consequently, the industry, including business owners like my former boss, as well as health-seeking consumers, was not happy. The regulation of dietary supplements as drugs would have put supplements out of reach for a large number of consumers. So, the industry asked Congress to get involved. Industry insisted that dietary supplements not only needed to be defined by law; they also needed their own regulatory category, complete with rights and requirements, that lay somewhere between the category of traditional food and drugs.
The passage of DSHEA was literally the defining point for the dietary supplements industry. The law now defines a dietary supplement as a product “intended to supplement the diet,” containing a vitamin, mineral, herb or botanical, amino acid, or other dietary substance, for use by man to supplement the diet-including concentrates, extracts, and combinations of those ingredients. It gave consumers and companies a clear definition of what a dietary supplement is and provided the industry with clear requirements for how to make these products, how to label them, and what kind of educational information to include. DSHEA also met consumers’ expectations by reassuring that dietary supplement companies were following a regulatory structure and that consumers could trust in what they read on the supplement label.
The gray area started clearing up.
As the industry was defined, it began to grow. What once was a modest-sized marketplace is now a significant one. And with that growth has come a level of maturity. Because of DSHEA, this industry is different than it was 20 years ago. This law has given our industry the ability to foster unique growth in product areas that can help people stay healthy. It has prompted self-regulatory and monitoring programs to help maintain consumer confidence. It has opened the door for more research, worldwide, to study the benefits of dietary supplements.
On this 20th anniversary of the passage of DSHEA, I think back to my former boss. Today’s retailers, product developers, and product line workers are just as passionate as he was about providing quality products that keep people well and improve their health. Today, the ground rules are clear and the marketplace well defined-literally. DSHEA has eliminated the gray area, and that has made all the difference for the dietary supplements industry and consumer health alike.
Duffy MacKay, ND, is the senior vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.
Photo © iStockphoto.com/Steve Debenport