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As consumer preferences fluctuate, food and beverage companies typically strive to develop new products that will meet these shifting demands. For example, today’s consumers increasingly look for products that are healthier and more sustainable. But products making claims like “supports digestive health” or “made with recycled materials” must meet specific compliance regulations—and those regulations can vary by market.

Rather than spending time and resources to develop products that may not qualify to make desired claims, many companies are opting to test their product ideas in advance through regulatory concept reviews. This audit framework helps businesses determine, early on, whether their product ideas will be permissible in their target markets and whether they can make the nutrition and health claims they wish to make. 

“A regulatory concept review at the early innovation stage is a process where innovators engage with regulatory experts to consider and align on key regulatory requirements and expectations for new products or technologies,” explains Mariko Kubo, head of global regulatory at Leatherhead Food Research, which helps clients in more than 150 countries navigate regulatory challenges. “This early interaction helps ensure that the development process adheres to necessary regulations, potentially avoiding costly delays or redesigns later on.”

Below, Kubo discusses how concept reviews can help food and beverage companies excel with production innovation by reducing risk and avoiding wasted resources.

What are the biggest risks involved in developing new food and beverage products?

Development of new food and beverage products comes with several risks. Regulatory risks can come from various angles leading to potentially significant cost, delays, or redesigns later on, including:

  • New license requirements: Companies must understand licensing requirements to produce food products. For example, a soft drink product moving into the alcoholic beverage category may need to comply with additional licensing regulations, which can be costly.
  • Authorization: Some ingredients and claims need authorization before they can be marketed. In some cases, this requires a comprehensive and costly dossier to prove the safety and efficacy of the product. This process can be expensive and may take years to gain approval.
  • Registration requirements: Certain products may require registration. Some fortified food products, for example, need to be registered in specific markets, while the same product without vitamins and minerals does not. In some markets, the timeline for how long before the product can be marketed in the country is specified, adding to the complexity and potential costs.

These risks could be mitigated if a regulatory review is carried out at the point of ideation. This is the key principle of our front-end innovation regulatory concept philosophy.

What are the benefits of an early concept review?

Food and beverage companies experience several benefits from a concept review at the early stages of innovation:

  • Innovators receive initial feedback on their development plans, which can help shape the direction of their projects to meet regulatory standards.
  • Potential regulatory risks are identified early, allowing developers to address these issues proactively.
  • This process fosters collaboration between innovators and regulators, promoting a better understanding of regulatory expectations and facilitating smoother approval processes.
  • Regulatory experts provide support and advice on leveraging new technologies and methodologies, which can enhance the innovation process.>

Talk about Leatherhead’s front-end innovation principle. 

This approach applies a regulatory lens at the very beginning of the product development process to reduce risks of failure later on. Opportunities are identified, reviewed, and validated before the first prototype is made. Our process involves several steps: 

  • Checking ideas, theoretical recipes, and emerging technologies against global regulatory frameworks.
  • Ensuring sufficient substantiation of desired claims through preparation of unbiased dossiers.
  • Recommending alternatives to reinforce regulatory compliance.
  • Conducting risk assessments to show target markets where the products are ready to go, stop, or proceed with caution.
  • De-risking product concepts where possible by, for example, scanning competitors’ products.

Can you share an example of how an early concept review made a difference? 

Leatherhead Food Research showcased the effectiveness of regulatory concept reviews while working with a global company on a food product for healthy aging. This case study highlights the importance of early regulatory engagement and a comprehensive strategy to ensure compliance across various regions. The company aimed to develop a product that could be classified as a food, food supplement, or Food for Special Medical Purposes, depending on regulatory constraints. The primary goal was to conduct a regulatory assessment to inform the business about the product’s possibilities and limitations, providing recommendations for classification and ensuring compliance.

The assessment covered product classifications, labeling requirements, health claims, ingredient authorizations, and other considerations like marketing and advertising implications, sales channels and factory licensing. This proactive approach helped the company navigate the complex regulatory landscape, ensuring their innovative product could reach the market smoothly and compliantly.

Learn more about Leatherhead Food Research and its regulatory concept review services.

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