By David Trosin, Managing Director, Health Sciences Certification, NSF07.06.23
It’s never been a better time to be in the natural botanical and herbal supplement market. According to the Centers for Disease Control (CDC), 57.6% of U.S. adults aged 20 and older reported using dietary supplements in the past 30 days. The usage rate is only growing as global consumers look to improve their health and fitness levels.
However, the increase in demand has also led to concerns about the quality and authenticity of these products. I was proud to be a part of the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP), which last year unveiled its Best Practices Standardized Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles, or IDAs.
In the U.S. and other countries, good manufacturing practice (GMP) regulations require that ingredients be tested for identity and purity, among other requirements. If they do not meet appropriate specifications, they generally cannot be released back into the global supply chain. However, GMPs do not include guidance regarding what the buyer should do with rejected material that does not qualify for reconditioning. The BAPP SOP and the IDA terminology identifies the potential health hazard and provides next steps and framework about what should happen if an IDA is identified.
It took us a long time to create the IDA definition. In total, we spent four years and two rounds of public commentary getting it right.
Since it was made publicly available in December of 2022, we’ve seen 500+ downloads of the SOP itself and heard stories from early adopters who have challenged their suppliers. Some have even changed suppliers who would not comply with the SOP, which shows us this has huge potential to be a differentiator for businesses.
NSF is reviewing the BAPP SOP for possible inclusion in our standards and is strongly encouraging our clients to begin using it.
About the Author: David Trosin is the Managing Director of NSF International’s health sciences certification program, which includes Certified for Sport. He has nearly 30 years of industry experience, including over a decade of expertise in dietary and sports supplements. Trosin leads a team whose focus is providing companies the most current and credible auditing, testing, certification and, separately, training services available to the dietary supplement, functional food, beverage, cosmetics, and OTC drug industries. Through his work at NSF he has helped hundreds of companies achieve their safety and quality goals, gain access to retailers and professional sports organizations, and cultivate trust among consumers.
However, the increase in demand has also led to concerns about the quality and authenticity of these products. I was proud to be a part of the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP), which last year unveiled its Best Practices Standardized Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles, or IDAs.
Identifying a Potential Hazard & Removing it from Commerce
“Irreparably defective article” is a new regulatory group created by the SOP’s consortium of industry experts to identify adulterated or contaminated ingredients and remove them from the global supply chain. Its definition is “material that cannot be lawfully remediated.”In the U.S. and other countries, good manufacturing practice (GMP) regulations require that ingredients be tested for identity and purity, among other requirements. If they do not meet appropriate specifications, they generally cannot be released back into the global supply chain. However, GMPs do not include guidance regarding what the buyer should do with rejected material that does not qualify for reconditioning. The BAPP SOP and the IDA terminology identifies the potential health hazard and provides next steps and framework about what should happen if an IDA is identified.
Bridging the Guidance Gap
Ultimately, this SOP was created to protect people. Currently, there is no guidance for a company that receives an IDA; each company decides for itself what to do with the material. Often the path of least resistance is to give the material back to the supplier, who then sells it to someone else. This material eventually makes its way to less scrupulous companies that sell the product illegally or try to evade federal regulations. Consumers who purchase these products may experience adverse health reactions.It took us a long time to create the IDA definition. In total, we spent four years and two rounds of public commentary getting it right.
Since it was made publicly available in December of 2022, we’ve seen 500+ downloads of the SOP itself and heard stories from early adopters who have challenged their suppliers. Some have even changed suppliers who would not comply with the SOP, which shows us this has huge potential to be a differentiator for businesses.
NSF is reviewing the BAPP SOP for possible inclusion in our standards and is strongly encouraging our clients to begin using it.
About the Author: David Trosin is the Managing Director of NSF International’s health sciences certification program, which includes Certified for Sport. He has nearly 30 years of industry experience, including over a decade of expertise in dietary and sports supplements. Trosin leads a team whose focus is providing companies the most current and credible auditing, testing, certification and, separately, training services available to the dietary supplement, functional food, beverage, cosmetics, and OTC drug industries. Through his work at NSF he has helped hundreds of companies achieve their safety and quality goals, gain access to retailers and professional sports organizations, and cultivate trust among consumers.
