Q&A with Jennifer Symonds, Sr. Project Manager at Spherix Consulting Group
Q: What are Spherix Group's primary areas of expertise in regulatory consulting for dietary supplements and functional foods?
Jennifer: Spherix Consulting Group (SCG) is a team of scientists from multiple disciplines (toxicology, immunology, cancer biology, nutrition, physiology, chemistry) who have extensive experience conducting risk assessments to support regulatory submissions for dietary supplements and novel food ingredients worldwide. We specialize in New Dietary Ingredient Notifications (NDIN) for dietary supplements, Generally Recognized as Safe (GRAS) Determinations and Food Additive Petitions for food ingredients and infant formula ingredients in the United States and Novel Food Applications in Europe and Canada.
Q: How does your team assist companies in achieving compliance while maintaining innovation in product development?
Jennifer: Innovation in the food and dietary supplement space requires creativity, but also careful consideration of regulatory compliance. To assist companies in achieving compliance while maintaining innovation, we engage our clients early in product development and utilize our extensive scientific expertise and experience to identify and mitigate the potential regulatory hurdles that lay ahead in the development process.
Q: What recent regulatory changes have had the most significant impact on the dietary supplement industry, and how can companies adapt?
Jennifer: SCG has been helping clients interact with the FDA for over 30 years. We have found that the culture at FDA regarding new food and dietary supplement ingredients has become more conservative and wary of innovation. Although this culture change at FDA has not been codified into specific regulations, our past and ongoing conversations with the FDA for NDIN and GRAS submissions inform our strategies for new projects. For the supplement industry specifically, we anticipate that there will be a collision of cultures and goals with the newly reorganized Human Foods Program at FDA, which now encompasses the Office of Food Chemical Safety, Dietary Supplements and Innovation, juxtaposed against the backdrop of the new administration nominees Dr. Martin Makary and Robert F. Kennedy Jr. Whether the new administration’s policies can advance non-pharmaceutical solutions to healthcare issues or if the implementation of tariffs will damage supply chains and lead to adulteration and deterioration in the safety of dietary supplements, remains to be seen. SCG has decades of experience in the food and dietary supplement industry over the course of many administrations and shifts in culture at FDA. Regardless of political climate, or potential supply chain issues, we provide regulatory solutions that pass scientific scrutiny and are feasible for our clients.
Q: What are the main challenges companies face when navigating international regulatory requirements, and how does Spherix Group address these?
Jennifer: The main challenge in navigating regulatory requirements worldwide is that every jurisdiction has its own rules and regulations. Just because a product is compliant in one country does not mean it is suitable for use in the United States, and vice versa! We encourage our clients to have discussions with us regarding regulatory compliance early in product development to identify and develop a plan to satisfy multiple jurisdiction requirements. The last thing we want is for our clients to have to change the formulation of their ingredient to comply with a specific country requirement or to repeat an expensive study to conform to a country’s requirements. Our risk assessments can be tailored to the desired jurisdiction(s) to help clients meet their product development goals.
What are the most pressing regulatory issues currently facing the dietary supplement industry?
Jennifer: In our experience, the biggest issue our dietary supplement clients face is identity: how do you define your product? This is especially important for supplements that are botanical extracts. Botanically derived products can vary based on how the product is extracted or seasonal variability. Full characterization of a botanical extract is a challenging but necessary part of any regulatory submission. While it is not feasible to define every constituent of a complex product, we have developed strategies for our clients to define and set specifications for their products that demonstrate control of process and identity. Characterization of the product is one of the most important steps in overcoming a regulatory roadblock on the way to success.
Q: How can companies better integrate safety and compliance into their long-term business strategies?
Jennifer: Safety and compliance need to be built into the everyday culture of all departments of a company developing food ingredients or dietary supplements. We advise our clients about the steps they need to take to successfully integrate manufacturing goals, product safety testing, regulatory submission requirements and claim substantiation studies into their product development timeline.
Q: What do you foresee as the major regulatory trends or changes shaping the industry over the next five years?
Jennifer: FDA is becoming more and more concerned about the proliferation of “bioactive” ingredients in foods and by extension, we believe that their concern about unintended consequences of ingredient bioactivities may extend to the dietary supplement space. In many instances, requests from FDA have demonstrated that their standard for safety has moved beyond the “reasonable certainty of no harm” standard to a policy that is reminiscent of the precautionary principal approach. We recommend engaging the FDA in pre-notification meetings for all of our clients to understand how FDA’s understanding of the science that supports safety of new dietary and food ingredients can affect regulatory strategy.
In addition to pre-notification meetings, SCG also attends conferences and meetings to understand the changing culture at the FDA. In December, we attended a conference regarding regulatory nutrition hosted by the FDA and the NIH. One of the biggest topics during this conference was ultra-processed foods, or UPFs. There is mounting evidence that one of the contributors to poor health outcomes in Americans is the high percentage of UPFs in our diet. Although more research is needed, there is a growing consensus among the government agencies that some regulatory action needs to take place.
Dietary supplements and infant formula ingredients are both regulated by the Human Foods Program at FDA and can be considered UPFs. For example, dietary supplements and infant formula ingredients are often the products of multiple steps of production to isolate specific ingredients. It is impossible to safely provide many of these products to the American public without ultra-processing. Dietary supplement stakeholders need to be a part of the discussion surrounding the role of UPFs in a healthy American diet. Dietary supplements and infant formula have an important part to play in human nutrition and the health of Americans. SCG is closely watching the public discourse around UPF to see how regulation around these products may change in the future.
Q: What key steps should companies take now to prepare for potential regulatory shifts in the near future?
Jennifer: We advise using two strategies to mitigate the risk of changing perspectives at the FDA: first, hold pre-notification meetings with the FDA prior to a submission, and second, publish reports on your product in peer-reviewed journals.
We often meet with the reviewers at FDA prior to the submission of a GRAS Notice or NDIN to get feedback regarding the strategies used to demonstrate safety of a new ingredient. These meetings give us a valuable glimpse of the current culture and paradigms at the Human Foods Program that is otherwise very difficult to discern. We recommend requesting these meetings early in the development process to get the FDA’s feedback on the feasibility of the scientific and regulatory strategy for a new product. During these meetings, we have a discussion with the FDA toxicologists and chemists about the potential risks of a new ingredient and how we can mitigate those risks in the dossiers. In the past, SCG has received guidance regarding specific testing and methodology, as well as their opinions about data needed to support the safe use of a new ingredient.
The best way to establish a public record that a product is safe is to publish safety studies in a peer-reviewed journal. Publishing your studies confirms that there is a consensus in the scientific community regarding your safety conclusions.