This is a voluntary standards initiative is designed to assist responsible buyers to remove ingredients from the supply chain if those ingredients are deemed by scientifically valid analytical laboratory testing to be an "irreparably defective article."
The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP; Austin, TX) has completed and published its long-awaited “Best Practices Standardized Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles.” This is a voluntary standards initiative is designed to assist responsible buyers to remove ingredients from the supply chain if those ingredients ("articles") are deemed by scientifically valid analytical laboratory testing to be an "irreparably defective article" (IDA).IDA is a regulatory term created by the SOP, and by definition IDAs cannot be reconditioned or remediated for lawful use. As a result, the buyer cannot simply return the article to the seller, but must instead destroy the article to prevent its resale into commerce. An essential part of this agreement is the notification of certified, lawful destruction of the article shared between parties as evidence of compliance.
While good manufacturing practices (GMPs) regulations require testing ingredients for identity and purity, there is no guidance regarding what buyers should do with rejected materials that do not meet qualifications for reconditioning by either the buyer, seller, or a third party. The new SOP also contains contract language templates for the seller and buyer; a three-way confidentiality agreement among the buyer, seller, and contract analytical laboratory; and frequently asked questions that arose during two public comment periods. These comment periods included recommendations from industry stakeholders, food and drug law attorneys, analytical chemists, and other botanical, supplement, and regulatory experts.
"Over the past 12 years, BAPP has published 75 extensively peer-reviewed documents that confirm the presence of adulterated, fraudulent ingredients (mis)labeled as herbal raw materials, extracts, and essential oils," said Mark Blumenthal, founder and executive director of the American Botanical Council (Austin, TX) and founder and director of BAPP, in a press release. "These highly constructive BAPP publications are used by many responsible members of the herb industry, in the United States and internationally, to set appropriate quality specifications for their botanical ingredients.Now, BAPP has expanded its range of activity by providing responsible members of the food, supplement, cosmetic, and OTC drug industries with this SOP so that they can remove ingredients from the supply chain that should never have been offered for sale in the first place. Ultimately, this results in better quality products reaching consumers."
"BAPP, in consultation with a host of industry leaders and experts, has meticulously developed a best practices SOP to address irreparably defective articles. As this is a new term, it bears repeating. The BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles should become a part of every manufacturer's cGMP procedures,” said Loren Israelsen, president of the United Natural Products Alliance (UNPA; Salt Lake City, UT). “And while the title may be long, the goal is simple: Stop the resale of IDAs back into the stream of commerce. This is a first, and it is historic. Let us make the most of this tremendous effort to solve an important problem. Now it is up to responsible elements of the industry to adopt this SOP and to begin the important task of removing IDAs from commerce."
The SOP will be formally introduced at an expert panel discussion at the SupplySide West in Las Vegas, Wednesday, Nov. 2, from 2 - 3:30 p.m. If you are interested in attending, RSVP here.