Navigating botanical regulations: Spotlight on quality consistency, transparency & scientific proof

Industry experts are finding that EU and US regulatory frameworks for botanicals are becoming more stringent, requiring suppliers to ensure traceability, quality, and scientific substantiation of product benefits. Meanwhile, botanicals’ natural variability makes it challenging to achieve a consistent quality at scale. 

Nutrition Insight meets with Akay Bioactives, Greenvit, Phynova, MartinBauer Nutraceuticals, and Layn Natural Ingredients to discuss how these companies navigate strict regulations and quality expectations. 

Trisha Sugarek MacDonald, Ph.D., market development manager at Akay Bioactives, tells us that EU and US regulations are moving toward greater scrutiny, emphasizing substantiation, transparency, and safety.

“At the end of the day, it is about protecting the consumer. Botanicals supported by human data, with defined bioactives, and responsible sourcing are best positioned to succeed as the industry advances toward evidence-based nutrition.”

Rigorous regulations

Rafał Pietruszyński, CEO of Greenvit, foresees the regulatory environment becoming more stringent and science-driven. As focus areas, he highlights standardized ingredient definitions, substantiation of health claims, documentation and traceability requirements, and EU novel food and safety assessments.

“In the EU, regulatory authorities will likely require more detailed proof of safety and efficacy for botanicals used in supplements and functional foods,” he details. “In the US, increased scrutiny around identity, purity, and documented health outcomes is expected, particularly with standardized extracts entering official references like the US Pharmacopeia.”

“This evolution will benefit the industry by fostering trust and reducing ambiguity — but it also means that suppliers must invest in rigorous science, documentation, and compliance to compete on a global scale.”

Sugarek MacDonald says EU and US regulations are moving toward greater scrutiny, emphasizing substantiation, transparency, and safety.XiaoFei Gao, Regulatory Affairs, Quality and Manufacturing, at Phynova, notes that regulations in most mature botanical markets are moving toward greater clarity of definition, stronger characterization, and more robust substantiation.

“Regulators are placing increasing emphasis not only on safety, but also on how clearly ingredients are described, how consistently they can be produced, and how well the supporting evidence reflects the product as it is actually used in practice.”

“Compliance is no longer viewed solely as a final step before market entry, but increasingly as an integral part of ingredient design and lifecycle management,” she says.

EU legal system

Although the regulatory environment is moving toward greater scientific substantiation, clearer documentation, and increased transparency, Dr. Cytnhia Suarez-Rizzo at MartinBauer Nutraceuticals says that regional differences remain. She notes that in the EU, botanical health claims continue to sit within a complex framework.

Botanical claims have been “on hold” in the region since 2010 by the European Food Safety Authority, as the organization’s methodologies are ineffective to authorize complex foodstuffs like botanicals. As a result, EFSA has not authorized botanical health claims.

Suarez-Rizzo notes that, despite ongoing evaluation challenges, the direction remains clear. The emphasis is on well-designed human clinical data, precise extract characterization, and comprehensive safety dossiers.

“Sustainability and traceability are also becoming more prominent within broader EU supply chain legislation,” she continues. “Companies investing in robust documentation and high-quality research will be better prepared for future clarification of the claims landscape.”

Suarez-Rizzo advises companies to invest in robust documentation and high-quality research to prepare for future clarification of the claims landscape.Across the EU and US, Suarez-Rizzo notes that transparency is becoming non-negotiable, from full supply chain traceability to substantiated claims and clear labeling. “In the future, we can expect digital tools to further enhance ingredient verification and documentation.”

“For responsible botanical suppliers, these developments create differentiation. Strong scientific evidence, traceable sourcing, and regulatory preparedness build confidence,” she details. “At MartinBauer Nutraceuticals, we firmly believe that a clear and credible framework will continue to support long-term growth in the botanical nutraceutical sector.”

Phynova’s Gao says the European regulatory environment will likely remain rigorous.

“Expectations around documentation, product characterization, and the quality of scientific evidence continue to evolve, and companies are increasingly expected to anticipate these requirements early in product development rather than addressing them retrospectively.”

Innovations in the US

In the US, many botanicals are marketed as dietary supplements, which are regulated by the US FDA under the Dietary Supplement Health and Education Act (DSHEA). Supplements do not require pre-market authorization, but manufacturers must follow current good manufacturing practices.

Gao notes that the US framework is more flexible compared to EU regulations. At the same time, she says expectations around substantiation, transparency, and quality assurance are steadily increasing.

“As a result, many companies are placing greater emphasis on building robust safety and documentation packages from the outset, recognizing that a well-structured evidence base supports both regulatory compliance and long-term credibility in the market.”

Jim Roza, CSO at Layn Natural Ingredients, adds that the US system offers more options for introducing a new herbal extract than the rigorous and complex novel food process in the EU.

Gao notes that natural variables, like cultivar selection, growing conditions, harvest timing, and processing, must be carefully managed.“In the US, we have the New Dietary Ingredient Notification (NDIN) through the FDA, which has been very controversial since its inception as part of DSHEA. Even after new NDIN guidelines have been introduced, many companies have chosen to use the self-affirmed generally recognized as safe (GRAS) process to avoid NDINs because of its requirements, which many argue are too restrictive.”

He explains that this has led the Department of Health and Human Services to redo the GRAS process because it can act as a loophole for introducing ingredients that do not meet a high degree of safety. “Depending on the outcome, this could lead to a restrictive environment,” he suggests.

Quality at scale

Gao from Phynova notes that the botanical ingredients’ composition complexity compared to single-molecule active ingredients makes it challenging to ensure a consistent quality at scale. As botanicals are derived from living plants, natural variables — for example, cultivar selection, growing conditions, harvest timing, and processing — must be carefully managed.

“Ensuring consistent quality at scale, therefore, depends on strong supplier partnerships, well-defined specifications, and reliable analytical approaches to confirm identity and key quality attributes, alongside ongoing efforts to deepen characterization as scientific tools and understanding advance.”

“Another challenge lies in maintaining consistency when scaling up production,” she continues. “Moving from pilot to commercial volumes often involves adjustments in processing or manufacturing parameters.”

Gao cautions that even relatively minor changes can influence performance characteristics or regulatory considerations, which makes structured change management processes and close collaboration between R&D, quality, supply chain, and regulatory functions essential.

“In practice, scaling a botanical ingredient is as much an exercise in process discipline and cross-functional alignment as it is in manufacturing capacity.”

“In addition, supply-chain resilience and transparency have become increasingly important. Consumers, brand partners, and regulators expect clear traceability, sustainability considerations, and rigorous control of contaminants. This means safety and quality must be managed throughout the entire supply chain, rather than relying solely on finished-product testing.”

The experts note that supply-chain resilience and traceability are key, urging companies to manage safety and quality throughout the supply chain.She says that, increasingly, this has led to a greater focus on “trust architecture,” ensuring systems, controls, and documentation that demonstrate an ingredient meets specifications today and will continue to do so in the future, consistently and transparently.

Ensuring consistency and traceability

Layn Natural Ingredients’ Roza notes that finding reliable, sustainable sources that are free from adulteration is one of the main challenges in sourcing botanical wellness ingredients. “Aligning with companies that can offer full transparency and traceability can help avoid this pitfall.”

“Adulteration, either intentional for economic gain or due to poor-quality oversight, continues to be a significant problem for the nutraceutical industry. The Botanical Adulterants Prevention Program, for example, just recently issued two new industry alerts this year for turmeric and ginseng.”

Sugarek MacDonald from Akay Bioactives underscores that plants are naturally variable, with differences in soil, climate, harvest timing, and processing influencing their bioactive levels. As such, she highlights the importance of strong supply-chain control or vertical integration to ensure batch-to-batch uniformity.

“At Akay Bioactives, we address this through our vertically integrated farming programs in India and Cambodia that enable full traceability, as exemplified by our curcumin and fenugreek sourcing.”

“On the formulation side, taste, solubility, and practical dosing remain challenging, which is why delivery technologies like FenuMat and taste-masking systems like FlavorOptix are important to achieving efficacious doses and improving sensory experience,” Sugarek MacDonald adds.

Pietruszyński from Greenvit highlights that standardizing botanical ingredients and extracts can overcome challenges in variability. He adds that robust specification and analytics are also key to ensuring consistent performance and regulatory-safe quality.

“Berry extracts must be delivered with reliable potency (e.g., polyphenols or anthocyanins) and acceptable stability in common delivery formats (capsules, tablets, sticks, or functional foods),” he details.

“Greenvit’s approach addresses these scaling realities by emphasizing standardized branded extracts (e.g., Aronvit and Eldervit) with defined bioactive targets and solvent-free, modern processing.”