In a video interview at SupplySide West, Mark Blumenthal, ABC’s founder, laid out the genesis of and the reasons for the SOP for the disposal or destruction of irreparably defective articles. The document was developed under the aegis of the Botanical Adulterants Prevention Program (BAPP), which is a cooperative venture of ABC and the American Herbal Pharmacopoeia and the National Center for Natural Products Research at the University of Mississippi.
Identifying adulteration only half the battle
Blumenthal said the need for the procedure became apparent as BAPP started publishing its adulteration reports, lab guidances and other documents more than a decade ago. BAPP has to date published more than 75 missives to the industry.
As BAPP outlined the scope of the problem the question started to be raised: What becomes of all of those materials that have been found to be adulterated using the information that BAPP makes public? The dirty little secret within the industry is that defective materials that have been rejected and returned to a supplier or broker all too often are shopped around looking for a less sophisticated buyer or one who is willing to look the other way. And, all too often, such buyers have been found.
The SOP provides a framework to prevent this practice, Blumenthal said. Buyers and sellers enter into a contract by which the supplier agrees that if the buyer finds the material to be defective or adulterated, and that can’t be fixed (or ‘lawfully remediated’), the material will be disposed of and won’t be returned.
Lengthy review results in robust procedure
Blumenthal said the document went through a very thorough (some might say, ‘tortuous’) process of review and revision before entering its final form. The procedure places significant burdens on both parties and definitions and responsibilities needed to be made crystal clear before companies could feel comfortable using it. If buyers couldn’t feel as if they were protected from a lawsuit for not returning rejected material to a supplier, the whole idea would be stillborn.
“Our primary focus at BAPP up to now has been helping people do proper analysis and what analytical methods can be fooled by some of the adulteration techniques where they modify the chemistry of various extracts,” he said.
Blumenthal said that there is something of a hole in the GMP regulations on what to do when such adulteration is found. Federal rules are silent about what to do with lots of adulterated materials.
“Now, we’re telling the customer don’t send it back,” Blumenthal said. “It should be picked by a third party, certified company that deals with disposal and destruction.”