Speaking with us via video, Mark Blumenthal, Executive Director and Founder of the American Botanical Council and Founder of BAPP, said: “The basis of what we’re doing here is when people have material in quarantine in their facility, and through this SOP it is determined that the material they have cannot be legally, lawfully remediated, that it is irreparably defective, rather than return it, they have a moral responsibility to ensure it does not re-enter into the supply chain.”
Michael Levin of Health Business Strategies, and the primary consultant and principal author of the SOP, added: “This SOP is not only about the economic adulteration of botanicals, it includes all articles, all ingredients, all products that are adulterated by virtue of residual solvents, toxic chemicals, drug spiking. That all comes under the whole umbrella of adulteration.”
Burn it, don’t return it
The Standardized Operating Procedure (SOP) is an industry self-regulatory tool to assist responsible botanical industry companies in removing ingredients from the global botanical supply chains if deemed to be an “irreparably defective article” (IDA) by scientifically valid analytical laboratory testing.
The SOP is applicable to botanical/herbal ingredients and non-botanical ingredients — any ingredient that might be subject to accidental or intentional adulteration or accidental contamination, according to a release.
In some cases of adulteration or contamination, the ingredient can be lawfully remediated or reconditioned to a level of quality that is deemed acceptable by relevant federal regulations. However, in other cases, due to the type of adulteration and/or the extent of contamination, some materials cannot be adequately reconditioned, thus requiring its being considered irreparable.
In the US and many other countries, good manufacturing practices (GMPs) regulations require that ingredients must be tested for identity and purity — among other requirements — and, if they do not meet appropriate specifications, they generally cannot be released into manufacturing (for the production of consumer products).
However, there’s a gap in the GMPs: They don’t include guidance regarding what the buyer should do with rejected material that does not qualify for reconditioning by either the buyer, the seller, or a third party. Such irreparably defective materials are the subject of this SOP.
When laboratory testing approved by both buyer and seller concludes that an ingredient is irreparably defective, the buyer (e.g., a dietary supplement, food, cosmetic, or OTC drug manufacturer) should not simply return it to the seller (e.g., an ingredient supplier). Instead, as detailed in the SOP, it must be destroyed to prevent its resale into commerce.
Notification of certified, lawful destruction shared between the parties is an essential part of this agreement; it evidences compliance with the objectives of this consumer protection initiative.
Work on the SOP was announced in 2018 and underwent an extensive process of public comment that included recommendations from various industry stakeholders, food and drug law attorneys, analytical chemists, and other botanical, supplement, and regulatory experts.
In announcing the Award for Industry Initiative of the Year, the NutraIngredients-USA Editor stated: “The term "game changing" gets used too often, but the BAPP SOP truly does change the game. This is a momentous achievement that will have wide-ranging benefits for the dietary supplements supply chain - botanicals and others.
“We salute the BAPP team for their years of work to make this SOP a reality, and this truly does stand out as THE industry initiative of the past 12 months.”
To access all of the information about the BAPP, including the SOP, please click HERE.