Regulatory matters to consider during botanical-led innovation

Ideally, product concept and marketing proposition should be considered side-by-side during front-end innovation before formal product development begins. At this stage, it’s easier to adapt the product and navigate regulatory hurdles, accelerating and streamlining the journey to market.

Three key matters to focus on are the specific requirements of target markets, substantiation of claims, and the wording of claims.

1. Specific requirements of target markets

Multi-market or global product launches can be challenging due to a lack of harmony in the requirements of different countries. There is great complexity surrounding which botanical ingredients or bioactives are permitted in different markets around the world. This is further complicated by the fact that the permitted dosage ranges may vary from market to market.

2. Substantiation of health claims

Scientific approaches to substantiation offer a strong foundation for the use of health claims related to botanicals and bioactives. Best practice dictates that the relationship between a bioactive compound and a health benefit is properly evidenced.

Substantiation generally involves desk-based scientific literature review and/or clinical studies or trials. Documentation or dossiers demonstrating substantiation should be available in readiness for any challenges posed by authorities, competitors, or consumers.

3. The wording of health claims

There are several factors to consider in the wording of health claims for products containing botanical ingredients, such as whether the scientific wording would be understood by an average consumer.

As companies look to take advantage of the rise of botanical ingredients and bioactives it’s important to give due consideration to regulatory requirements. Otherwise, health claims used to enhance consumer appeal could result in a negative backlash that seriously harms brand reputation. Any requirements surrounding ingredient permissibility must be fully understood and adhered to. High quality scientific evidence substantiating the relationship between the bioactive and the health benefit is also needed. Finally, health-related claims should be concise, factual, and not exaggerated.

Find out how we can help de-risk your innovation pipeline with a regulatory review of concepts and claims.