Inside FDA’s ODSP: Get to know the dietary supplement regulators

A small team of around 40 government employees in College Park, Maryland, is responsible for overseeing — and setting policies for — the vast dietary supplement market.

In this Q&A, Natural Products Insider profiles four supervisory officials in the Food and Drug Administration’s Office of Dietary Supplement Programs. They discuss their hobbies and unique backgrounds, what they find challenging and rewarding about their jobs, and their views on misconceptions about dietary supplements sold in the U.S.

CARA WELCH, director of the Office of Dietary Supplement Programs

Natural Products Insider: What are your current day-to-day responsibilities at FDA and what is your tenure at the agency?

Welch: I’ve been at the FDA for 10 years, always working in or around dietary supplements. Currently, I am the director of FDA’s Office of Dietary Supplement Programs. We are responsible for setting the policies and programs for FDA’s oversight of dietary supplements.

Natural Products Insider: Can you tell us something interesting about yourself that industry professionals outside the agency might not know?

Welch: I love to cook and bake (and eat!). Given our busy lifestyle and the “acceptable” range for my kiddos’ palate, I haven’t been as creative in the kitchen in recent years, but I am actively encouraging my children in their growing interest in baking. Then, to offset the baked goods, I like to run a couple times a week and am currently training for a half marathon.

Related:FDA makes the case for dietary supplement product listing requirement

Cara Welch gets ready to zipline on a recent family vacation.

Natural Products Insider: What do you find most rewarding about your job within the Office of Dietary Supplement Programs?

Welch: The opportunities we have to directly impact public health are the moments that stick with me. One example is our involvement in following up on an adverse event report (AER) that turned out to be products contaminated with high levels of lead and, ultimately, the products being seized. Another impactful moment is FDA’s warning letters and guidance document regarding pure and highly concentrated caffeine products. Caffeine is, of course, an ingredient in many dietary supplements; this guidance document was written to identify specific uses of caffeine that resulted in extremely dangerous products. Unfortunately, these actions were necessary in response to at least two deaths we were aware of, which is so sad, but I continue to hope our current position has served to protect the public from dangerous products.

Natural Products Insider: What do you find to be the most challenging aspect of your position?

Welch: Keeping forward movement on our long-term projects can be difficult in the midst of shifting priorities and day-to-day responsibilities. We have a relatively small office — about 40 employees — with a broad remit. This is exciting, of course, because every day brings about a different question to answer for almost each of our employees. But it can also be a challenge when our subject matter expert on a multiyear project is also the subject matter expert on a new priority activity that has developed in the meantime.

On a related note, we appreciate our stakeholders’ patience with some of our multiyear projects.

Natural Products Insider: In your view, what is the biggest misconception about dietary supplement products sold in the U.S.?

Welch: A common misconception we deal with is the misunderstanding of dietary supplement regulation. Of course, there are regular assertions that dietary supplements are not regulated. But on the other hand, we also deal with those who think FDA reviews — and even approves — all dietary supplements before they are sold. Addressing these misconceptions requires proactive and consistent messaging for all audiences.

Natural Products Insider: Finally, can you discuss an initiative within ODSP that you are currently spearheading that excites you?

Welch: DSHEA (Dietary Supplement Health and Education Act of 1994) was written for a marketplace that looks quite different from today’s market and, from FDA’s perspective, we believe our regulatory framework would benefit from modernization. I have spoken extensively about FDA’s proposal for a legislative change to establish a dietary supplement listing requirement and the potential benefits we envision to our program, including in a Natural Products Insider article last year. And beyond dietary supplement listing, we are aware of legislative priorities being proposed by interested parties, including industry and consumer advocates. All our stakeholders bring an important perspective to the conversation, and we look forward to working with them and Congress to strengthen the regulatory framework for dietary supplements in a way that works for regulators, regulated industry and, most importantly, consumers.

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HELLEN OKETCH, deputy director of the Office of Dietary Supplement Programs

Natural Products Insider: What are your current day-to-day responsibilities at FDA and what is your tenure at the agency?

Oketch: I joined ODSP in June 2023, so I have been at the FDA for just under a year. Before that, I worked at the United States Pharmacopeia (USP). As the deputy director of ODSP, my responsibilities include assisting the director in strategic planning and operational management across the office. I am responsible for managing the operations of our two divisions, namely the Division of Policy and Regulations Implementation that develops Federal Register documents, responds to citizen petitions, and provides policy and technical support for compliance and enforcement efforts as well as educating the industry. I am also responsible for the Division of Research and Evaluation that assesses the identity, regulatory status and safety of dietary ingredients and supplements. For example, we recently published the final administrative guidance for NDI (new dietary ingredient) notifications and continue to review and analyze the other sections.

Natural Products Insider: Can you tell us something interesting about yourself that industry professionals outside the agency might not know?

Oketch: I grew up on a tea farm and one of the first manufacturing processes I got to understand is how black tea is made, from the point of harvesting the tea leaves to drying, grinding and packaging. In those days, I wondered why fresh green tea leaves were not used to make tea, and one time my siblings and I did an experiment where we made tea using fresh green tea leaves. Unfortunately, the result of our experiment was a very bitter and unpalatable green tea drink! Fast forwarding to more recent times, I have been involved in examining the safety of concentrated green tea extracts as part of my work at USP. This has given me the feeling that my relationship with green tea has become an ongoing interest.

Hellen Oketch holds her watercolor painting of strawberries. Painting became one of her hobbies during the pandemic in 2021.

Natural Products Insider: What do you find most rewarding about your job within the Office of Dietary Supplement Programs?

Oketch: The most rewarding part of my job is knowing that I am contributing to protecting public health. At long last, I feel that I am able to apply the scientific knowledge and industry experience I have gained over the years to regulatory science and make a positive impact on people’s lives. An even better reward is the opportunity to work with highly talented, passionate and committed individuals, with each one doing their best to reach a common goal of protecting the public from harmful products. For example, seeing our efforts translating to removal from the market of products containing tianeptine or yellow oleander is the reason I wake up energized every morning and ready to go.

Natural Products Insider: What do you find to be the most challenging aspect of your position?

Oketch: Being new to the agency, what I find most challenging but interesting is understanding how the different parts of FDA work together. As an employee, I have gained a new appreciation of what it takes in terms of the number of players and the scientific, regulatory and legal knowledge needed for an action such as recall or warning letter or safety alert to happen — or for a guidance document to be developed.

Natural Products Insider: In your view, what is the biggest misconception about dietary supplement products sold in the U.S.?

Oketch: The biggest misconception about dietary supplements sold in the U.S. is that they are either not regulated or are approved by the FDA. I remember a conversation I had with one health care provider who insisted that dietary supplements are approved. I had to delve deep and explain that this not true and that what FDA does is a premarket safety review of new dietary ingredients and supplements containing new dietary ingredients and, if we have no concerns, acknowledge the notification without objections — not approve the ingredient or supplement. I think there is a real opportunity to educate the public to empower them to make informed decisions when it comes to dietary supplements, which many Americans use.

Natural Products Insider: Finally, can you discuss an initiative within ODSP that you are currently spearheading that excites you?

Oketch: Of the many activities that I am involved in, one that really speaks to me is the effort to increase stakeholders’ engagement via meetings or educational activities to better understand their needs, aspirations and pain points so that ODSP can address these appropriately and proactively as we develop policies and actions. I also see educational activities as improving all our stakeholders’ understanding of the regulations and ensuring protection of public health. I see such engagements contributing toward correcting the misconceptions about supplement regulations and empowering the public to better understand how dietary supplements are regulated. For example, we are exploring different opportunities to provide education to our various stakeholders, including training videos or partnering with others on a workshop.

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GERIE VOSS, director for Division of Policy and Regulations Implementation in the Office of Dietary Supplement Programs

Natural Products Insider: What are your current day-to-day responsibilities at FDA and what is your tenure at the agency?

Voss: As the director for the Division of Policy and Regulations Implementation, I manage the work of two branches: the Policy and Communications Branch and the Regulations Implementation Branch. My day-to-day responsibilities include drafting Federal Register documents and responding to citizen petitions and providing policy and technical support for compliance and enforcement efforts. Prior to joining ODSP, I was a supervisory regulatory counsel in the Center for Tobacco Products. I have worked at the agency approximately 14.5 years.

Natural Products Insider: Can you tell us something interesting about yourself that industry professionals outside the agency might not know?

Voss: I love to take photos of animals in their natural habitats and have been lucky enough to photograph animals in many faraway locations, including Kenya, Botswana, Rwanda, Borneo and the Galapagos. I also really love game shows and have appeared as a contestant on The Price is Right and Wheel of Fortune.

Gerie Voss gets ready to appear as a contestant on Wheel of Fortune in Century City, Calif. The episode was filmed on March 13, 2020, the last day the show filmed episodes before shutting down during the Covid-19 pandemic.

Natural Products Insider: What do you find most rewarding about your job within the Office of Dietary Supplement Programs?

Voss: I love that I get to work directly with such talented people in so many different disciplines (including science, communications, law and policy) at all different levels in the agency. 

Natural Products Insider: What do you find to be the most challenging aspect of your position?

Voss: It is never the same day twice, and there are many, many issues to address each day. It’s tough to juggle this with limited resources.

Natural Products Insider: In your view, what is the biggest misconception about dietary supplement products sold in the U.S.?

Voss: Despite our continuous messaging efforts, it appears that many people still believe that FDA approves all dietary supplements before they are sold to consumers and maintains a list of the available dietary supplements in the United States. While FDA supports efforts to afford the agency with mandatory listing authority, there are currently no requirements for manufacturers to list their products with FDA.

Natural Products Insider. Finally, can you discuss an initiative within ODSP that you are currently spearheading that excites you?

Voss: Since I arrived in ODSP more than three years ago, I have been working with others to finalize the 2016 revised draft new dietary ingredient notification (NDIN) guidance. As ODSP has stated publicly, in response to stakeholder comments, the agency is separating the draft guidance into discrete sections as we finalize the draft guidance. Thus far, we have finalized and issued one guidance that mainly addresses NDIN procedures and timelines. Our work on finalizing other sections remains ongoing, and they are moving forward in the drafting and clearance process. It’s been so exciting to see parts of this long-term project become available to stakeholders. 

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PHIL YEAGER, director of Research and Evaluation in the Office of Dietary Supplement Programs

Natural Products Insider: What are your current day-to-day responsibilities at FDA and what is your tenure at the agency?

Yeager: I am a board-certified toxicologist and an attorney serving as the ODSP director of research and evaluation. The division has an Identity and Status Branch, a Safety Evaluation Branch, and staff in the immediate office. I am responsible for directing the regulatory science evaluations of dietary supplements from before submission of an NDIN, during notification and for dietary supplements on the market. This includes issues related to the identity, safety or regulatory status of dietary ingredients in dietary supplements. I lead the multidisciplinary subject matter experts (SMEs) evaluating regulatory science questions submitted to our office. The scope of these SMEs includes botany, chemistry, microbiology, toxicology and medicine. With the recommendations of these SMEs, I respond to inquiries from multiple sources, including academia, industry, advocacy groups, consumers, trade groups, other government agencies and more. I have served 16 years in the federal government, two as a patent examiner and 14 as a toxicologist for FDA.

Natural Products Insider: Can you tell us something interesting about yourself that industry professionals outside the agency might not know?

Yeager: I have a diverse background in science and law, but I also have considerable experience in theater. I worked for about 20 years in theaters with positions that include actor, fight coordinator, fight consultant, director, producer and as a member on a theater board of directors. I enjoyed re-creating a safe environment to perform staged fights in shows and bringing live entertainment to the audience. While I perform little work in the theater now, I continue to enjoy attending plays.

Phil Yeager takes a picture with his family dog, Fenris, around 2021.

Natural Products Insider: What do you find most rewarding about your job within the Office of Dietary Supplement Programs?

Yeager: The most rewarding aspect is the ability to use regulatory science to advance scientific knowledge and policy while also protecting public health. Leveraging scientific evidence in the FDA regulatory framework allows us to better inform and protect dietary supplement consumers.  This process is rewarding because dietary supplements encompass so many diverse products that connecting evidentiary support for each dietary ingredient in each dietary supplement can be very challenging. I find it exciting to gather and organize pieces of evidence in a complicated puzzle and support a position that a dietary ingredient or supplement will or will not be expected to meet a reasonable expectation of safety.

Natural Products Insider: What do you find to be the most challenging aspect of your position?

Yeager: ODSP is at the complex intersection of science and law. Our team must make scientifically supported risk assessment and risk management decisions within the legal regulatory framework provided by Congress. The most challenging aspect is the limited resources we have to resolve many complex regulatory science and risk assessment issues, especially with innovative advancements in food technologies. ODSP evaluates, analyzes and synthesizes scientific evidence from human, animal, in vitro, surrogate and other information within this regulatory framework to support the assessment of risk or safety for dietary ingredients or dietary supplements. Our team works hard to organize the synthesis of the best scientific evidence across different categories of information to support a regulatory science or regulatory policy decision.

Natural Products Insider: In your view, what is the biggest misconception about dietary supplement products sold in the U.S.?

Yeager: The biggest misconception is that many consumers think natural means safe, but I would rather address the next biggest misconception. The next biggest misconception is that a risk or safety evaluation is conducted on a single chemical from just the single source of the dietary supplement being reviewed at that time. While evaluations are often conducted on a single ingredient or product at a time, most consumers are realistically exposed to a combination of chemicals from diverse sources such as food, medicine, consumer products and the environment. These multiple chemicals may interact to produce harmful effects on a consumer. Thus, exposure from mixtures, multiple products — or both — may be important to consider in a safety evaluation.

Natural Products Insider: Finally, can you discuss an initiative within ODSP that you are currently spearheading that excites you?

Yeager: My overarching goal for leading the Division of Research and Evaluation is to optimize our ability to assess the safety and risks of dietary ingredients and dietary supplements. I am coordinating efforts to use the most current risk assessment methods and dietary ingredient-related research to leverage the best available science to inform ODSP decisions. I am leading the division to apply knowledge management principles to better use historical perspective and scientific advancements to inform our safety evaluations. 

Our division evaluates identity, regulatory status and safety in our assessments. In one recent example of this collaboration, we evaluated products adulterated with yellow oleander. Yellow oleander is shown to cause nerve, gastrointestinal (GI) and heart damage, and our actions led to recalls for these products. I am excited that we are continuing to protect consumers that might have used these harmful products.