When a supplement brand is considering working with a contract manufacturer, a critical question is: Will the brand take care of ingredient sourcing or let the contract manufacturer take care of it? Key points to consider before making the decision:
- Quality assurance
- Regulatory awareness
- Financial consideration
- Availability of specialty ingredients
Regardless of the path, at the end of the day, product owners need to take full responsibility of products; it can’t be left to the contract manufacturer.
If ingredients are supplied by the contract manufacturer, the brand needs to conduct a site audit or ingredient supplier evaluation report to approve the suppliers. The manufacturer must inform the brand of supplier changes and provide the documentation of the new supplier. For each batch other than finished product certificate of analysis (CoA), a set of ingredients CoAs would help the traceability of the ingredients.
Quality is the key point of ingredient sourcing, especially for botanical ingredients. Sometimes, an ingredient’s CoA doesn’t ensure the quality of the ingredient. Botanical ingredients need documentation for plant identification, including the extract solvent, extract method and plant part used for extraction. Active ingredients must be tested with a validated method. A third-party testing report will help ensure the content of active ingredients.
If possible, ask for bioavailability data. High bioavailability could reduce the ingredient usage while maintaining or enhancing the product final efficiency. Microbial testing is a basic requirement. Storage conditions must be considered for some ingredients.
Pesticide testing needs to be considered if the ingredient source has any possibility of contact with a pesticide during growth, including contaminated soil. Heavy metal should be considered, as well.
The Food Safety Modernization Act (FSMA) has forced brands to consider ingredient sourcing. Brands need to know FSMA and understand its role when sourcing ingredients, especially the importance of foreign supplier verification.
Financial consideration often is the most considerable fact for ingredient sourcing. However, for the same ingredients, the price may differ widely from different suppliers. Price is important, but brands that only consider price may be ignoring quality and regulatory issues. The benefit of the contract manufacturer sourcing ingredients is it can purchase in large quantities for economy of scale. A best practice is letting the buyer work with QC/legal personnel during the ingredient sourcing process to balance the budget with the quality and regulatory requirements.
Specialty ingredient sourcing is challenging. Products need to be innovative, however, it can be difficult to find innovative ingredients in the current market. The best solution is to work with an ingredient manufacturer with research and development (R&D) resources to customize ingredients. The benefits of using a custom ingredient is the ingredient is specialized for a specific brand, not for its competitors; brands can sign an exclusive agreement with the ingredient supplier so the ingredient isn’t available to other supplement brands.
When brands use a contract manufacturer to create a product, whether the ingredient is sourced by the brand or the contract manufacturer, brands need to ensure the ingredient is traced, quality, meets regulatory requirement and fits the company’s budget.
Hua Deng, Ph.D., is the president and the founder of Davidia Healthtech LLC, a professional service company for food, dietary supplement and cosmetics. Deng holds a doctorate from Lanzhou University in China with a major in analytical chemistry. She has extensive experience of global regulatory affairs in the food, dietary supplement and cosmetic industries.