Although aspects of the eight-year-old Food Safety Modernization Act are still being rolled out, FDA has taken on a new modernization endeavor: dietary supplements. Similar to the expansive touting of FSMA as the most sweeping reform of our food safety laws in more than 70 years, outgoing FDA Commissioner Scott Gottlieb has heralded the agency’s newly announced dietary supplement policy advancement plan as “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” But – and this is a big but – it’s not going to take a decade to get this plan implemented. Based on the requirements of the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA has already sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs. The products bear unproven claims to prevent, treat or cure serious diseases and health conditions, such as Alzheimer’s, diabetes, cancer and opioid addiction. Although dietary supplements can, when substantiated, claim potential health benefits, they cannot claim to prevent, treat or cure diseases like these, as that could discourage consumers from seeking FDA-approved medical products. Why, after 25 years, is FDA doing this now? Besides the possibility that Gottlieb may have wanted to start the push before he retired, his statement on the new efforts notes that in the years since 1994, the dietary supplement market has grown from a $4 billion industry comprised of about 4,000 unique products to more than $40 billion, with more than 50,000 – and possibly more than 80,000 – different products. Dietary supplements have become a routine part of the American lifestyle with three of every four Americans taking vitamins, minerals and/or herbs regularly; four in five older consumers doing so; and one in three children. Gottlieb, himself, stated, “I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan.” But, as the popularity of supplements has grown, so have the number of products with unproven or misleading health claims, leading Gottlieb to express concern that changes in the supplement market may have outpaced the evolution of FDA policies and capacity to manage emerging risks. So, in late 2015, FDA created the Office of Dietary Supplement Programs (ODSP) three years ago, recognizing that keeping up with the evolving marketplace meant giving dietary supplement regulation more attention and making it a higher priority. In December 2017, Gottlieb established a Dietary Supplement Working Group to identify opportunities in the agency’s organizational structures, processes, procedures and practices for modernization. And now, FDA is committing to new priorities for more effective oversight of the industry while preserving consumers’ access to lawful supplements. Thus, FDA has established three priorities: Ensuring safety to protect consumers from harmful products. Maintaining product integrity to ensure dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and they are consistently manufactured according to quality standards. Fostering an environment where consumers and health care professionals can make informed decisions before recommending, purchasing or using dietary supplements New steps to achieve this include: Communicating to the public as soon as possible when there is a concern about a dietary supplement on the market. FDA is developing a rapid-response tool to alert both consumers and industry to unlawful and potentially dangerous ingredients. Ensuring the regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation through the submission of new dietary ingredient (NDI) notifications. To enable this, FDA is developing guidance for preparing NDI notifications, will be updating its NDI compliance policy, and planning a public meeting this spring on responsible innovation. Continuing to work closely with the industry and collaborating on research and a shared understanding. FDA has established the Botanical Safety Consortium, a public-private partnership which will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote safety and effectiveness. Developing new enforcement strategies and taking action to protect public health, such as the warning and advisory letters previously noted and other actions taken throughout 2018. Engaging in public dialogue for feedback from dietary supplement stakeholders, such as whether additional steps to modernize DSHEA are necessary and the potential of designing a product listing regime to protect consumers and level the playing field for responsible industry participants. In the coming months, FDA will provide additional details on the steps it is taking to implement these priorities to protect the public from potential safety issues while promoting innovation and efficiency in the marketplace. So, if you are in the dietary supplement industry you need to pay attention to the increasing focus from FDA, and as with all things TAG does with our clients, focus on prevention but be ready to react if and when there is a problem. IA Rule Guidance Updated FDA has released the second installment of the draft guidance document for FSMA’s Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). FDA integrated the second installment into the first, adding new chapters and appendices and making minimal changes to the first installment. Keep an eye on this space next week as we provide an overview of the new guidance. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
