In April, the Council for Responsible Nutrition (CRN), working in conjunction with the Consumer Healthcare Products Association (CHPA) and the United Natural Products Alliance (UNPA) as the SIDI Work Group, released its new draft voluntary guideline, the Dietary Supplement Component Supplier Qualification Guideline. The document was created with the sole intention of offering recommendations to help ensure companies are meeting their obligations under Good Manufacturing Practices (GMPs). Among the many requirements included in the GMPs, manufacturers are responsible for qualifying their suppliers―a complex process that deserves a detailed and thorough approach.
 
The guideline is a voluntary tool that can assist dietary supplement manufacturers and ingredient or component suppliers with the supplier qualification process. This task is critical for maintaining the integrity of the supply chain and reducing or preventing issues such as adulteration. However, the complexities and scope of the GMP regulations may make it difficult for manufacturers, both large and small, to fully appreciate the intricacies involved in each step of the supplier qualification process. Moreover, while your company may have a robust understanding of the GMP regulation, the same may not be the case for your suppliers. Failure along the supply chain has led to problems for our industry and, if left unaddressed, has the potential to create a public health crisis. By utilizing this voluntary guideline and applying the suggested risk-based approach, a company should be able to improve GMP compliance and avoid a potentially problematic incident.
 
This is also a chance to reinforce to FDA that, as an industry, we are committed to holding ourselves accountable for the products we make and market. Self-regulation is a hallmark of the dietary supplement industry and the SIDI Works Group’s efforts are yet another example of industry proactively taking additional steps to demonstrate that companies are not only striving to be in compliance, but going beyond the minimum requirements under the law.
 
As a responsible industry, we must take additional steps to ensure the safety and quality of our products. This extra assurance will increase consumer trust in the safety of the products they rely on every day. By properly qualifying your suppliers and better protecting your supply chain, you can do your part to ensure that your products are of the highest quality.
 
While this guideline is voluntary, it presents an opportunity to improve your business model and further demonstrate responsibility in the area of GMP compliance, an area of increased FDA focus. The guideline was designed with flexibility in mind so that any company, regardless of size, could easily make the suggested models work for them. Because the SIDI Work Group wants every company to be able to implement the recommendations in the guideline, there is an open comment period during which companies can provide feedback before the guideline is finalized. If you would like to submit comments and contribute to the development of the guideline, I encourage you to visit the SIDI websitebefore June 18, when the comment period closes.
 
The dietary supplement industry faces a myriad of challenges. Compliance with complex regulations is one of those challenges, and the GMP regulation may be the most challenging component to understand. But there are tools available to help you improve and set your company up for success. It is our hope that this new supplier qualification guideline will prove to be such a tool.
 
About this blogger: Rend Al-Mondhiry is regulatory counsel for the Council for Responsible Nutrition, the dietary supplement industry’s leading trade association.