The supplement industry’s search for better science

Walking into a Washington, D.C. courtroom on May 24 for the latest battle in their war with the Federal Trade Commission (FTC), the undisputed champions of pomegranate, POM Wonderful, appeared well-armed. The company had spent $35 million on research, according to legal briefs, and supported “more than 90 scientifi c investigations with over 65 studies on POM products, including 17 clinical trials.”

But those numbers did not impress FTC attorney Heather Hippsley. After the hearing, she told the swarming press that POM’s studies lacked adequate control-group comparisons, were too small, measured the wrong biomarkers, and that the company “repeatedly ignored warning signs that the marketing didn’t match the science.”

Just how this latest embarrassment in deceptive advertising will play out remains to be seen, but the moral of the story is already loud and clear: In an age when regulatory agencies crack down ever harder on claims, and policymakers cast sharper eyes on dietary supplement research as they update critical health recommendations, quality matters as much—if not more—than quantity.

“When I started 10 years ago, I used to do presentations about why companies should even do research,” says Jay Udani, MD, founder of Medicus Research, a contract research organization for the natural products industry. “Now, the conversations are all about how to do it better.”

In Search of Better Research

While many policymakers insist that the randomized controlled trial (RCT) The Supplement Industry’s Search for Better Science Attention shifts away from hard clinical endpoints to mechanisms of action and surrogate biomarkers should be held as the gold standard, some supplement industry leaders say such trials (originally designed for testing drugs) are ill fit for evaluating nutrients. Many in the industry are now calling for a new “evidence-based nutrition” paradigm. Meanwhile, the cash-strapped National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS) recently released five-year strategic plans which promise to pull back on splashy clinical trials (which to date have been largely disappointing) and instead prioritize studies exploring mechanisms of action and biological markers.

Udani believes it’s also time for companies to get smarter about designing their own trials on both ingredients and fi nished products, assuring at the onset that populations are appropriate, anticipated results are realistic, and that—if the outcome is positive—they can legally boast about it without treading into the dangerous waters of drug claims.

“A lot of the studies coming out now were designed years ago,” says Udani, a time when claims enforcement was less stringent and there was less understanding about the Dietary Supplement Health and Education Act (DSHEA). “In a lot of ways, they were set up to fail.”