The Botanical Adulterants Prevention Program’s (BAPP) draft version of its Best Practices Standard Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles” has been seen as a landmark in the dietary supplement industry’s self regulation efforts.
BAPP, which is a joint effort of the American Botanical Council, the American Herbal Pharmacopoeia and the National Center for Natural Products Research at the University of Mississippi, has had the SOP under development for more than a year.
Speaking with NutraIngredients-USA at the recent SupplySide West show in Las Vegas, Blumenthal said: “There are problems with respect to adulterated, counterfeit, fraudulent materials coming into the market, and which herbs should manufacturers double or triple down on as far as their vigilance from a quality control perspective, and which analytical methods are or are not fit for purpose for detecting that adulteration.
“This is a global problem, this is not a US problem. There are global issues regarding the sale of these materials all over the world,” he added. “The good news is that companies are rejecting the material, but the not so good news is that it goes back to the supplier, which can often redirect that same material to another customer that may or may not be as diligent in detecting the defect, the adulteration or the contamination.
“Everybody knows this. This is not news,” said Blumenthal.
“Our purpose in developing this SOP is to give guidance to industry on what to do if they find a material that is adulterated or contaminated beyond lawful reconditioning – material that is irreparably defective – it should not be sent back to the supplier.
“Whoever is empowered at the company [purchasing the materials] to make this decision, we believe has the ethical responsibility and the legal responsibility not to send it back, but instead have that material disposed of by a properly qualified third party, or have it incinerated. We’ve come up with the “Burn it, don’t return it” slogan.”
Prior to its release to a broader constituency, the SOP was reviewed by members of BAPP’s Ad Hoc Legal Advisory Committee, members of ABC’s Advisory Board, and other regulatory and analytical experts. A version of the draft was shared with various herb and dietary supplement industry leaders at the annual NBJ Summit held in July 2018.
The public comment period on the SOP closed on October 30, 2018, and BAPP is now reviewing those comments and revising the document accordingly, said Blumenthal. A final version will be published along with the comments in a transparent way.
“We have received nothing but constructive and positive comments,” he said, before stressing that this is a voluntary SOP.
An important aspect of the document is the proposed boilerplate contract language, which was reviewed by seven leading industry attorneys, said Blumenthal.
“We’re saying that companies should put this contract language in their supply contracts that says, ‘from now on, if you want to do business with our company, we have a new stipulation. You have to a priori agree to this SOP. If you send us something that we have determined […] is adulterated or irreparably defective, you have to agree to abide by this SOP as a precondition of doing business with us. A) You are not going to get paid if this stuff turns out to be this way, B) you’re not going to get your stuff back because it’s going to be disposed of or destroyed, and C) you’re going to have to pay us for our extra testing and you’re going to have to pay for disposal or destruction’.”
“Interestingly, a number of leading supplier companies in this industry have agreed to and are supporting this SOP because frankly they have nothing to fear: A) They are providing good quality ingredients; B) they test the material before they ship it to their customer.
“What it’s going to do is help level the playing field so that the legitimate, responsible, ethical suppliers of ingredients in this industry will have less of an unfair disadvantage when they’re dealing with people at ridiculously low prices for materials because they’re adulterated they aren’t what they claim to be.”