The ABC-AHP-NCNPR Botanical Adulterants Prevention Program’s “Best Practices SOP (SOP) for the Disposal/Destruction of Irreparably Defective Articles (IDAs)” can help suppliers reduce both harm and operating costs, according to panelists who recently adopted the guidelines speaking at a SupplySide West panel.
 
The BAPP SOP provides a simple strategy to incorporate directly into supply chain agreements, which is designed to protect all parties while ensuring the removal and destruction of adulterated materials from the supply chain if they cannot be remediated for lawful use.
 
Taneesha Routier-Rogers, director of regulatory affairs for Xymogen, and Tom Dubinski, vice president of quality systems for Arizona Nutritional Supplements (ANS), discussed the benefits and return on investment of implementing the BAPP SOP into existing agreements. They were joined by Stefan Gafner, PhD, chief science officer of the American Botanical Council (ABC) and director of BAPP, and Michael D. Levin, founder of consultancy Health Business Strategies LLC and principal author of the BAPP SOP.
 
Xymogen saw adulteration occurring in the marketplace and decided to incorporate the BAPP SOP guidelines, describing it as “a natural progression. It was the next step.”
 
“The SOP aligned with our values. It aligned with the fact that we not only want to put out a quality product that is good and effective, but it also does not harm. We want to be part of a community with other suppliers and manufacturers that are doing the same.”
 
Dubinski noted that ANS modified existing purchase agreements with one of its suppliers to include SOP language, and considers them more trustworthy.
 
“For us, it’s hundreds of thousands of dollars being saved in my lab testing, the amount of time to test, getting new samples in, purchasing items, having to source new materials, whatever it may be. It made a huge impact,” Dubinski said.
 
“The SOP has certainly saved us a lot of time and helped us financially because it provides a clear roadmap for what to do and when,” Routier-Rogers said. “Both you and the supplier are on notice as to what needs to happen and how we remedy if that’s even possible. While on the front end you have to do a bit of work so that you can make sure that you and your suppliers align and understand that you’re on the same page, in the end it saves so much time and so much effort.” 
 
Levin said that in implementing the SOP, purchase order specifications are the heart and soul of the program.
 
“It is up to the trading partners, the buyers and sellers, to say ‘these are your specs. Your representation to me is that it is not going to be adulterated. It’s going to be fit for use,’” Levin said. “This is a solution whereby we, all working together, can pull these irreparably defective articles out of the supply chain.”
 
Expert attorney fees to manage a regulatory action can start between $10,000 and $60,000, Levin noted. “The SOP is going to reduce adverse effects. It’s going to reduce product recalls. Putting this into place is basically reinforcing the rules and helping you do a better job for your customers, protecting your brand, and just doing the right thing.”