Natural Products Insider

MAR-APR 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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naturalproductsinsider . com 49 But he cautioned FDA must do its own independent tests and investigation. Industry leaders have not only urged FDA to use all its powers under the law to swiftly remove adulterated products from the market, but they stressed it's important to hold people accountable. Fabricant—FDA's former top dietary supplement offi cial—would like to see the agency bring more misdemeanor cases. The Federal Food, Drug & Cosmetic Act (FDCA) is known as a strict liability statute, and executives of companies can be held liable for a criminal misdemeanor without proof that they intended to violate the law. "The swiftness of it is a critical factor," Fabricant said. "People know, 'Hey, as soon as I introduce this [in] the market, the agency is going to be on the scene, and they're going to come after me with a misdemeanor.' "We know everyone wants to bring the big Eliot Ness case and take down Al Capone, but they took down Capone on tax evasion," Fabricant observed. "That wasn't exactly sexy at the time. In some ways, it's whack-a-mole, and when you start whacking enough moles, it doesn't have to be the kill shot." Industry attorney Marc Ullman feels FDA isn't whacking enough moles. He argued the agency is bringing too few enforcement cases for violations of the FDCA and failing to suffi ciently publicize criminal prosecutions. "You can't enforce against everybody," said Ullman, of counsel to Rivkin Radler LLP, in a phone interview. "You're never going to catch every criminal … so we rely on a deterrent effect. And absent a deterrent effect, how do you have an effective regulatory enforcement regime?" Israelsen, though, pointed out FDA faces resource constraints. "It takes so much time to do the analytical work to really know what you're dealing with [regarding] these spiked ingredients, and they're changing all the time," he said in a podcast interview, agreeing, "It's whack-a-mole." Amy Eichner, Ph.D., is USADA's special advisor for drugs and dietary supplements. She confi rmed a growing number of adulterated products on the market are being sold as supplements. The problem is contributing to athletes testing positive for banned substances like SARMs. "And it's whack-a-mole to the extreme," she said. It's a problem that continues to vex regulators. Even when FDA or Congress take action against a class of illegal substances marketed in sports supplements, for example, new potentially dangerous compounds emerge. "I think a legislative solution is one important step, but I don't think it's enough," Eichner said. "I think we need to have more, and I'm not sure what that 'more' is. Whatever it is, the end goal is to make it impossible or extremely uncomfortable for an unscrupulous or low-quality supplement company to exist." To that end, industry trade associations have urged companies to speak up when they identify adulterants in products falsely disguised as supplements. "When you see, 'Hey, take 20 minutes before sexual activity,' I think some of those tell-tale signs are out there still," Fabricant said, referring to red-fl ag claims often used to market adulterated and mislabeled products. "And when the industry sees them, they should tell the agency … and not just FDA but FTC," and state attorneys general as well. Legal: Industry Collaboration Absolute Quality, from Seed to Shelf. Since 1988 Absolute Absolute Absolute 425.637.1400 Over 125 Products Grown on our Own Farms in a Pristine Himalayan Environment "The end goal is to make it impossible or extremely uncomfortable for an unscrupulous or low-quality supplement company to exist." —Amy Eichner, Ph.D., USADA special advisor for drugs and dietary supplements

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