In a talk given at the International Conference on the Science and Regulation of Botanicals in Oxford, MS this week, Loren Israelsen, president of the United Natural Products Alliance, gave an overview of how the concept of herbal dietary supplements has changed in the 20 years since the passage of DSHEA in 1994. Israelsen’s talk amounted to a keynote address. Dr. Daniel Fabricant of the Food and Drug Administration also addressed the meeting, but because he was leaving FDA within days to take the helm of the Natural Products Association, he was not in a position to say much.
Industry though its own eyes
Israelsen, who has been a part of the business as a company executive, consultant and industry association leader since well before DSHEA’s inception, framed his talk around the different conferences that have brought industry leaders together through the past two decades. Looking at the titles of those conferences gives snapshots of how the industry saw itself at those times, Israelsen said.
“I went back and looked at the programs of all the conferences that have taken place in the past 20 years,” he told the audience. “I looked at it through the eyes of how we have educated ourselves through these gatherings.”
Israelsen began with a symposium program from a 1993 meeting in Philadelphia titled “Utilization of Medicinal Plants.”
First, there was medicine
There had been a history of plant usage by pharmacists in the United States that dates back into the 19th century. Compounding pharmacies that made their own herbal medicines on site from raw materials were commonplace, but as the power of drugs like penicillin became apparent and the modern pharmaceutical industry revved up, this approach fell by the wayside. There was a public faith in pharmaceutical science married to big business as a way to improve life overall.
But as doubts about the wisdom of that view started to creep in, companies seeking to offer natural health alternatives found that there was no easy way to categorize their products. And regulators are uncomfortable without a bin to put things in.
“In the beginning, it was all about herbal medicines,” he said. “The conversation about what you do with plants was always about medicine because there was no place else to put them in the United States.”
With its passage in late 1994, DSHEA, itself an amendment of the Food, Drug and Cosmetic Act of 1938, brought some clarity to this picture with its forthright definition of what a dietary supplement is, Israelsen said. But that was just the start of the process of how to nail down what these products were and to rationalize the way in which they were regulated, he added.
“We still retained that identity as botanicals as phytomedicines for some time after DSHEA,” Israelsen said.
Nipping the OTC route in the bud
In 1994, a proposal was put forth by Israelsen among others on behalf of a group called the European-American Phytomedicines Coaltion to include valerian in FDA’s monograph of over-the-counter night time sleep aids.
"European companies making botanical-based medicinal products were unable to sell their procucts in the US without a great deal of uncertainty," he said. "Could they sell their products as OTC drugs here? This first test case for valerian seeking OTC drug status as a sleep aid showed that FDA was resistant for natural products to be part of a modern drug review system.
"This avenue was cut off for the industry. FDA was saying we don’t see a future for botanicals and phytomedicines as OTC drugs in the US."
As DSHEA brought rationalization to the picture, the story started to become more about quality and safety, Israelsen said. As herbal products started to develop as dietary supplements within the sphere set by DSHEA, standardized botanical extracts started to become the main stem of the story as industry moved beyond lower-tech tinctures.
"Through 2005 was really the golden age of standardized plant extracts," Israelsen said.
Focus on quality
DSHEA gave rise to a robust industry that has grown at a reliable 6% to 7% annually, even through the recession, Israelsen said, giving rise the the $32 billion sector in the U.S. market today (as measured by Nutrition Business Journal). But threats to that growth continue to hover at the margins, including the activities of fly-by-night marketers who can gin up a product, make a profit and be gone before industry (or regulators) have a real chance to evaluate their activities and respond. This begs the question: Are barriers to entry in the industry simply too low?
In setting goals for improvement of the sector in the future, Israelsen put forth the following parameters: Industry should acknowledge that there is a problem with both the perception and the practice of quality and safety in herbal dietary supplements. He also advocated for industry to help fund joint US/China quality training and to provide templates for certificates of analysis, supplier qualifications and common adulterants. From FDA Israelsen sought a commitment to continue to cooperatively educate industry and a way to reward companies that are compliant with the law. The Oxford meeting is a venue where these threads can be woven together, Israelsen said.
“The best relationships are often facilitated relationships where there is mutual trust,” he said. “What we need to do is to take what we did this time and expand on it next time.”