Natural Products Insider

MAR-APR 2019

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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4 INSIDER March/April 2019 In the News The head of FDA in February announced a goal to implement "one of the most signifi cant modernizations of dietary supplement regulation and oversight in more than 25 years." A quarter century after Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has thrived with tens of billions of dollars in annual sales, the majority of U.S. adults taking supplements and an estimated 50,000 to 80,000 products on the U.S. market. But in a lengthy statement revealing plans to strengthen the agency's regulation of dietary supplements, FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency's policies and capacity to manage emerging risks. "To continue to fulfi ll our public health obligations we need to modernize and strengthen our overall approach to these products," Gottlieb said. "Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA." Gottlieb made the announcement before news broke that he planned to depart FDA in early spring 2019, leaving various regulated industries questioning how his resignation would impact the agency's agenda. Dangerous Ingredients, NDI Notifi cations The commissioner announced several steps to advance FDA's policy goals, including novel ways to communicate more readily when the agency is concerned that an ingredient marketed in supplements is unlawful and potentially dangerous. Second, Gottlieb suggested FDA is working to encourage the submission of new dietary ingredient (NDI) notifi cations. For years, FDA offi cials have emphasized the notifi cation process represents the agency's only opportunity to evaluate new ingredients in supplements before they are placed on the market. Gottlieb revealed plans to issue more guidance and modernize FDA's approach to NDI notifi cations. "We're continuing to develop guidance for preparing NDI notifi cations to ensure FDA can thoroughly review the safety of these ingredients," he said. "In conjunction with this effort, we're planning to update our compliance policy regarding NDIs." The commissioner planned to hold a public meeting in the spring concerning "responsible innovation." [Editor's note: Whether the meeting will take place was unknown at press time given Gottlieb's resignation.] "I expect the feedback received during this meeting will be essential as we move to modernize our approach toward NDIs," the commissioner said. "We'll look to address other challenges that may act as barriers to dietary supplement innovation and safety." Modernizing DSHEA The commissioner also announced plans to start a public dialogue over modernizing DSHEA, and he said FDA has heard from stakeholders who want to open such talks. "While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful," he said. "We believe there may be opportunities to modernize DSHEA for the future, while preserving the law's essential balance." For example, some stakeholders have supported the idea of a mandatory product registry. Currently, supplement companies can register their products with voluntary systems, including a label database maintained by the Offi ce of Dietary Supplements (ODS) within the National Institutes of Health (NIH); and a product registry called the Supplement OWL (Online Wellness Library) spearheaded by the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement industry. The law does not mandate registration of dietary supplement products, making it exceedingly diffi cult for FDA to track the growing number of products on the market. "A mandatory listing requirement could provide signifi cant benefi ts by facilitating effi cient enforcement of the law and establishing new mechanisms to identify bad actors who put the public at risk and undermine consumer confi dence in the entire industry," Gottlieb said. The commissioner said he is interested in hearing from stakeholders beyond changes to the law so that his agency can regulate the industry in a manner that refl ects its current state while continuing to protect consumers' access to supplements that are safe and compliant with the law. Public Health, Public-Private Partnership Gottlieb said his agency will continue to take steps to protect the public health and develop new enforcement strategies to protect consumers. He highlighted a batch of 12 warning letters and fi ve online advisory letters recently made public and sent to companies whose products are allegedly being marketed as unapproved new drugs. "We're already making our internal processes more effi cient for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients," the commissioner said. For example, he cited: • New guidance in April 2018 and subsequent warning letters in June to protect consumers from products marketed in bulk and containing pure and highly concentrated caffeine; • A warning to consumers to refrain from purchasing Rhino male enhancement products that contain active ingredients in FDA-approved prescription drugs; and • Warnings to companies for making unproven claims that their products containing tianeptine treat opioid use disorder. FDA Commissioner Announces Plan to Improve Oversight of Supplements by Josh Long

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