Dietary Supplement Official: FDA Cant Freeze in Time

An FDA official who regulates dietary supplements on Monday emphasized the importance of research as her office of 26 employees strives to keep pace with changes in the market over the last 22 years.

In 1994, there were an estimated 600 supplement manufacturers in the United States producing about 4,000 products, with annual sales of at least US$4 billion, Congress noted in the Dietary Supplement Health and Education Act (DSHEA).

Today, there are more than 7,000 registered facilities, 75,000-plus products on the market (according to the National Institutes of Health (NIH)), and the industry is valued at up to $40 billion, reported Cara Welch, Ph.D., senior advisor to FDA’s Office of Dietary Supplement Programs (ODSP).

Speaking Monday during the 17th Annual Oxford International Conference on the Science of Botanicals in Mississippi, Welch observed DSHEA imposed most dietary supplement requirements over two decades ago.

“But the industry didn’t freeze in time," she said. “It has grown. It has changed. It’s become more complex. And neither can we—FDA—freeze in time for 22 years."

We can’t regulate the market like we did 22 years ago," Welch continued. “We can’t regulate it as if it were the mid-90s. We have to expand and adjust our enforcement techniques [and] our priorities to keep up with this complex industry."

Research plays an important role in enabling ODSP to adjust to the times and achieve its objectives, including protecting the public health.

For instance, Welch cited research examining how herbs interact with the human body. Such toxicological research can show an ingredient is dangerous, or demonstrate an absence of harm.

“Maybe, there aren’t potential interactions," Welch acknowledged. “Maybe, the research that we are undertaking demonstrates that there isn’t a link between this herb and this drug or…this herb isn’t actually a problem in the body."

Welch also cited the importance of developing analytical methods to detect dangerous compounds in products. During the conference, one of Welch’s colleagues at ODSP was scheduled to discuss a method for analyzing anti-diabetic, anti-obesity, and cholesterol-lowering drugs in botanical supplements labeled for blood sugar management.

“Having these methods on hand, and established in our laboratories, is really important," Welch said. “For FDA, it helps us identity the products that are tainted with these drugs and hopefully get them out of consumers’ hands as soon as possible."

Removing such adulterated products from the market contributes to ODSP’s No. 1 priority: protecting consumers.

Said Welch: “It’s always going to be our top priority."