A changing tide of organic standards – article

As the organic industry evolves, pullulan, a polysaccharide polymer used in manufacturing dietary supplement capsules, exemplifies the complex relationship between growing consumer demand for clean, traceable ingredients and the challenge of supplying healthier alternatives. Derived from the fermentation of starch, the availability and integration of USDA Organic certified pullulan into organic encapsulated products has been key to increasing the availability of organic dietary supplements, while maintaining a focus on organic integrity and sustainability.

According to the 2024 Organic Trade Association Survey, U.S. certified organic product sales soared to a new high of $69.7 billion in 2023, up 3.4 percent, reflecting robust market dynamics. Despite the challenges of retail price inflation, consumers remain committed to health and sustainability, consistently choosing products with the USDA Organic label. This consumer loyalty has prompted the organic market to optimize supply chains and recalibrate business costs, helping absorb the impacts of higher retail prices. This strategic adjustment supports sustained sector growth, with 2023 witnessing organic food sales of $63.8 billion and non-food sales of $5.9 billion.

Amidst this backdrop, the role of organic pullulan becomes increasingly significant. It's not just about the compound’s ability to ensure product integrity; it symbolizes the growing consumer demand for clean, traceable ingredients and embodies the challenges faced by manufacturers as they pivot away from synthetic additives. It remains central to discussions about market needs and the shift towards healthier product options, illustrating the dynamic interplay between consumer expectations, regulatory policies and industry innovation.

Until now, pullulan has been on the National Organic Standards Board’s (NOSB) national list of ingredients allowed to be used in organic products in a non-organic form because an organic version did not exist or was not available in supplies needed to meet market demand. Now, as organic markets evolve, one manufacturer has an organic option for encapsulation, allowing brands to create a 100% organic product from filling to capsule. The debate now stands whether the NOSB should remove non-organic pullulan from its list of allowed ingredients or allow non-organic versions to still be used for a period of time to ensure the supply of organic pullulan can consistently meet demand.

"Every five years, the NOSB reviews materials on the national list to ensure they still meet legal and regulatory standards. This review is crucial for confirming that non-organic materials like pullulan continue to meet safety and necessity standards," says Gwendolyn Wyard, a founding partner at Strengthening Organic Systems and an expert in regulatory affairs. Such rigorous processes are essential, explains Wyard, not only for compliance but also for maintaining the consumer trust that is vital to the organic label’s integrity.

Recently, Bright Pharma Caps Inc., situated in Hood River, Oregon, launched the world's first National Organic Program (NOP) Certified organic pullulan capsules. "The organic market is expanding, and we saw an opportunity to innovate by providing a much-needed organic capsule option," shares Tess Barr, co-founder Bright Pharma Caps and an esteemed figure in the formulation industry.

Crafted from organic pullulan, these capsules are produced through the fermentation of black fungi on a foundation of organic starches and sugars. Though the process may sound mystifying, formulators and consumers needn’t worry. The capsules still meet diverse dietary requirements, including vegetarian, kosher and halal standards.

As the next NOSB vote on pullulan looms, the organic industry is at a critical crossroads. The decision to keep or remove non-organic pullulan from the national list will significantly affect the dynamics of the organic supplement market. "We really need to assess how much is being utilized. Previously, the Organic Trade Association estimated that pullulan capsules had an economic value of around $825 million. Understanding this economic impact is crucial for making informed decisions about its future on the national list," explains Wyard.

Pullulan: A Crucial Component in Organic Product Standards

Pullulan plays a pivotal role in the organic product sector, primarily due to its properties as a film-forming polysaccharide, which makes it ideal for use in manufacturing organic capsules. Bright Pharma Caps Inc.'s NOP Bright-Poly capsules made from organic pullulan not only rival traditional gelatin capsules in dissolution and functionality but also avoid common issues like cross-linking, making them suitable for accelerated stability studies. These capsules stand out for their attractive appearance, superior oxygen barrier—nine times more effective than gelatin—and flawless performance on high-speed encapsulation machines, which enhances manufacturing efficiency. They are also environmentally friendly, derived from naturally grown fungi on starch substrate. The exceptional oxygen barrier properties of pullulan protect sensitive ingredients from oxidation, extending shelf life, preserving nutrient potency and reducing production costs. Organic pullulan capsules offer a compelling story for manufacturers prioritizing quality, aesthetics and environmental responsibility.

"When pullulan was put onto the national list, it was placed there because there was a reclassification. Initially, reviewed as an agricultural ingredient, it was allowed in up to 30% of a made-with organic ingredients product. However, under new guidance from the USDA National Organic Program, it was deemed non-agricultural and thus required to be on the national list if it's to be used in a non-organic form," says Wyard.

Pullulan was officially added to the national list in 2021 following a rigorous petition process initiated in 2019. The NOSB critically evaluated this petition, acknowledging the scarcity of organic alternatives at the time, a crucial factor for approving non-organic materials in organic products. This year’s review and vote will have a huge impact on organic supplement opportunities.
As the organic industry faces the potential removal of non-organic pullulan from the national list, significant challenges and opportunities arise. The scarcity of alternative organic materials that match pullulan's functionalities could lead to increased costs and production delays for manufacturers who rely on this essential ingredient for encapsulated products. Amidst these challenges, Bright Pharma stands as a resilient solution, adapting to stringent organic standards and ensuring robust supply chain integrity amidst evolving regulatory frameworks. This commitment positions Bright Pharma to effectively navigate the uncertainties in regulatory changes and supply chain dynamics.

"We must carefully determine if pullulan, added to the national list in 2021, should remain for another sunset cycle to ensure that supply can keep up with demand without disrupting the market," emphasizes Wyard. Bright Pharma is keen to accept this challenge.

"We are well-prepared for the increasing market demand. Our production capabilities far exceed what we're currently utilizing, allowing us to scale up as needed," shares Barr.

Stakeholder Opinions and the Upcoming NOSB Vote

The perspectives of various stakeholders—from organic manufacturers to consumers and regulatory bodies—are crucial in shaping the future of pullulan in organic products. Manufacturers stress the necessity of maintaining a stable supply of certified organic ingredients to avoid market fluctuations and ensure product consistency. Consumers, increasingly vigilant about the ingredients in their supplements and the transparency of labeling, demand assurances that the products they purchase are genuinely organic and sustainably sourced. Regulatory bodies, tasked with upholding organic standards, focus on ensuring that all certified products meet stringent guidelines to protect consumer trust in the organic label.

"When discussing pricing with a competitor, they claimed to offer cheaper rates. I challenged them to show their organic certification, but they only provided their manufacturing plant's certification, which isn't sufficient. I emphasized that they lacked essential certifications for the raw materials and the final product, including the necessary transaction certificates for importing,” says Patrik Barr, co-founder Bright Pharma Caps. “This lack of proper certification could pose significant risks if they continue to market these as organic. It's crucial to verify these details thoroughly to avoid potential fraud."
In 2023, the NOP implemented the Strengthening Organic Enforcement (SOE) final rule to fortify oversight and enforcement of organic product production, handling and sales. This measure aims to reduce fraud by enhancing standards, organic integrity and supply chain transparency. As the industry adapts to these stringent regulations, companies like Bright Pharma are set to excel due to its expertise in organic certification complexities and company infrastructure. "The organic sector is expanding but also grappling with challenges like fraud," Patrik Barr notes. "Thorough certification is vital for safeguarding your business and maintaining the integrity of the organic label."