Ullman Quoted in Natural Products Insider Article
October 25, 2019 | |Marc Ullman was quoted in a Natural Products Insider article, “DSHEA’s 25th Anniversary: Industry vets, critics respond.”
Exactly 25 years ago, President Bill Clinton signed a bill that has enabled the dietary supplement industry to flourish over the last quarter century. In the spirit of giving due consideration to the law’s successes and shortcomings, Natural Products Insider reached out to 18 sources within and outside the industry. Here is Ullman’s question and answer:
INSIDER: Looking back over the last 25 years, has FDA effectively used the enforcement tools that Congress granted the agency in DSHEA? Why or why not?
Ullman responded, “FDA has not come close to using the enforcement tools granted to it in DSHEA. The most obvious failure relates to new dietary ingredients, where the agency has simply refused to take any action to protect companies that have gone through the notification process. DSHEA is clear that any NDI for which no notification has been filed is adulterated. Going through the process is complex and can be costly. Yet FDA has no procedure in place, even one as simple as issuing an import alert against ingredients for which no NDI notification has been submitted. This has created a situation where scofflaws/criminals can knock off a branded ingredient and move their product (frequently containing potentially dangerous impurities) into the U.S. market with impunity.”
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