The ABC-AHP-NCNPR Botanical Adulterant Prevention Program (BAPP; Austin, TX) has completed and released its long-awaited “Best Practices Standardized Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles.” This is a voluntary standardization initiative designed to help responsible buyers remove ingredients from the supply chain if those ingredients (“articles”) are judged by scientifically valid analytical laboratory tests to be a “irreparably defective item” (IDA). IDA is a regulatory term created by the SOP and, by definition, IDAs cannot be repackaged or patched for legal use. Accordingly, the buyer cannot simply return the item to the seller, but rather must destroy the item to prevent its resale in commerce. An essential part of this agreement is notification of certified and lawful destruction of the shared item between the parties as proof of compliance.
While Good Manufacturing Practices (GMP) regulations require testing for the identity and purity of ingredients, there is no guidance on what buyers should do with rejected materials that do not meet GMP criteria. repackaging by the buyer, the seller or a third party. The new SOP also contains contract language templates for seller and buyer; a three-party confidentiality agreement between the buyer, the seller and the contracted analytical laboratory; and frequently asked questions during two public comment periods. These comment periods included recommendations from industry stakeholders, food and drug lawyers, analytical chemists and other botanical, supplement and regulatory experts.
“Over the past 12 years, the BAPP has published 75 extensively peer-reviewed documents that confirm the presence of adulterated and fraudulent (mis)labeled ingredients 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 the BAPP, in a press release. “These highly constructive BAPP publications are used by many responsible members of the herbal industry, in the United States and around the world, to establish appropriate quality specifications for their botanical ingredients. Today, BAPP has expanded its line of activities by providing responsible members of the food industry, supplements, cosmetics and over-the-counter drugs 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 translates into better quality products reaching consumers.
“BAPP, in consultation with a host of industry leaders and experts, has meticulously developed a best practice SOP for dealing with irreparably defective items. As this is a new term, it bears repeating. The BAPP Best Practices SOP for disposal/destruction of defective items should be part of each manufacturer’s cGMP procedures,” said Loren Israelsen, President of United Natural Products Alliance (UNPA; Salt Lake City, UT). “And while the title may be long, the goal is simple: to stop the resale of IDAs in the mainstream of commerce. This is a first, and it is historic. important problem. It is now up to the responsible elements of the industry to adopt this SOP and to begin the important task of removing IDAs from commerce.”
The SOP will be officially presented at an expert roundtable at SupplySide West in Las Vegas on Wednesday, November 2, from 2-3:30 p.m. If you would like to attend, RSVP here.