What is the top thing companies can do to make the pathway to market easier?

Companies need to understand that biostimulants are still an evolving regulatory area in the US. This means claims that are allowed in other countries may prove to be problematic for companies looking to register a product in the states. Understanding the regulatory pathways that are available and which claims are allowable can help companies make an informed choice on the best option for their product.

What makes registering a biostimulant product so challenging?

Because there is no defined pathway to market for this type of product in the US, manufacturers attempt to fit biostimulants into an existing product category, such as fertilizers, amending materials or pesticides. In addition, fertilizers and amending materials have specific labelling and data requirements that may vary by state. Not surprisingly, companies have limited flexibility when making label claims because biostimulant products don’t align with any existing categories.

What are the key struggles for a company when trying to comply with various regulations?

Since there is no federal oversight for fertilizers and amending materials, states have developed their registration requirements independently. Consequently, this can make access to market a slow, lengthy process. TSG has experience handling unique state regulations and can help your company to better understand the varying state requirements when developing claims and product labels.

What market trends do you anticipate over the next 12 months for the biostimulant industry?

Industry groups and regulatory bodies are working hard to create a regulatory process for biostimulant products. Nonetheless, it will take more than a year for data requirements to be finalized in each state. In some instances, a regulatory process will require legislative changes at the state level. We will likely see an increase in guidance documents that provide insight into the types of data and study requirements necessary for future biostimulant registrations, so manufacturers are ready to bring their product to market when a regulatory process does exist.

In addition, state regulators are also attempting to achieve greater harmonization for labelling requirements in the existing registration categories; however, this will be a lengthy exercise and it will take time before states implement harmonized requirements.

Shannon will be participating in this year’s Biostimulants World Congress, taking place in Hollywood, Florida from 29 November to 2 December. If you’re interested in more information and would like to arrange a meeting with Shannon, contact [email protected] and we will happily make that happen. If you plan to attend the Biostimulants World Congress, stop by and say hello to TSG at booth 80!