Natural Products Insider

MAY-JUN 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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Legal: FTC Enforcement populations, such individuals suffering from various diseases like Alzheimer's disease and cancer, people desperate to lose weight, and Baby Boomers who may have bad joints or declining memories. "Those tend to be priorities for FTC because they see this population is vulnerable to especially strong marketing claims in those areas," Al-Mondhiry said. If a dietary supplement company is making advertising claims in the areas of cognitive or joint health, or weight loss, for example, it should have "solid science" to substantiate its claims, the lawyer said, "because it's an area that FTC is watching." Attorney Ben Mundel said, "It's harder to get things done" at the commission these days since the agency is currently staffed with two rather than fi ve commissioners. As an associate in Washington with Sidley Austin, Mundel was one of the trial lawyers who successfully defended Bayer Corp. in an FTC lawsuit over whether his client's advertising claims for a probiotic supplement were adequately substantiated. The government's expert argued Bayer's claims were unsubstantiated because the company failed to conduct RCTs. However, the district court pointed out, Bayer produced nearly 100 studies to support its claims for its supplement, Phillips' Colon Health. "As two other courts have held, competent and reliable scientifi c evidence does not require drug-level clinical trials, and the government cannot try to reinvent this standard through expert testimony," U.S. District Judge Jose Linares wrote in his 2015 opinion. It remains to be seen whether FTC will continue to favor RCTs to support dietary supplement claims under certain conditions. "We have not seen any new direction or guidance [by] senior leadership at the FTC regarding enforcement in the dietary supplement industry," Mundel said. "Until senior leadership changes course, we may see the FTC enforcement actions continue to try to ignore the Dietary Supplement Health and Education Act of 1994 [DSHEA] and ignore the FTC's own guidance on dietary supplement substantiation." Although Linares' decision doesn't preclude FTC staff lawyers from continuing to favor RCTs, Mundel said the Bayer decision remains signifi cant. "Companies can now have some comfort in the fact that courts and judges will recognize that DSHEA and the FTC guidance … don't impose a randomized controlled trial standard," he said. Instead, companies must support their advertising claims with "competent and reliable scientifi c evidence," as articulated in FTC's dietary supplement advertising guidance, Mundel said. "I expect the FTC to return to the fl exible substantiation standard," said John Villafranco, a partner in Washington with the law fi rm Kelley Drye & Warren LLP. "And while RCTs may constitute solid support for claims, they are not always required—and certainly not two RCTs." 2018 SUBMISSIONS ARE NOW OPEN. The 7th annual SupplySide CPG Editor's Choice Awards recognizes innovative finished products in a variety of categories in the Supplement and Food and Beverage markets that were launched between Summer 2017 and by August 22nd, 2018. SUBMIT YOUR ENTRY TODAY To learn more about the SupplySide CPG Editor's Choice Awards, visit:

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