BAPP issues revised SOP for irreparably defective articles, opens public comment

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The American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program (BAPP; Austin) issued its revised draft of "Best Practices Contract Language and Standard Operating Procedure (SOP) Templates for the Disposal/Destruction of Irreparably Defective Articles," intended for members of the herb, dietary supplement, food, and cosmetic industries. The documents are open for public comment until Dec. 14, 2020.

According to BAPP, an irreparably defective ingredient is “adulterated and/or contaminated to an extent that the material cannot be effectively and lawfully remediated for use for oral or topical consumption in a consumer product, thereby necessitating its pre-authorized disposal or destruction by a qualified third party.” 

The new documents were sent to all qualified stakeholders and include expanded and clarified sections on definitions and dispute resolution, a FAQs that addresses many of the comments received during and after the first public comment round, and a three-party non-disclosure agreement (NDA) for use by the buyer, seller, and analytical lab to facilitate dispute resolutions. 

Additionally, BAPP obtained comments from current and former members of FDA, the National Institutes of Health, dietary supplement companies, dietary ingredient supply companies, analytical laboratories, and GMP (good manufacturing practices) consultants. 

This revised round of comments is meant to give stakeholders another opportunity to review and comment before the documents are finalized and proposed for acceptance by industry members.

“We are inviting input from a wide array of stakeholders to shape these final tools for widespread industry adoption to help solve a known supply chain issue that sometimes occurs,” said Mark Blumenthal, founder and executive director of ABC and director of BAPP, in a press release. “Implementing these proposed best practices contract and SOP templates represents a strong measure by responsible industry members to enhance their ability to more effectively control the ingredient supply chain. The SOP helps to ensure that consumers can purchase properly labeled herbal products with authentic ingredients.

“Though the risks of potential adulteration are real, there is a relatively low potential for such well-qualified ingredients’ having any defects that would make them ‘irreparably defective’ according to appropriate regulations and the BAPP SOP,” Blumenthal continued. “However, there are documented cases where unscrupulous sellers of adulterated ingredients offer their fraudulent materials to the market. In such cases, industry buyers must maintain appropriate vigilance in their quality control systems and have the ability to protect themselves.

“This voluntary industry self-regulatory initiative is intended to empower dietary supplement manufacturers to prevent the resale of defective ingredients that are irreparable; that is, they cannot lawfully be made acceptable for any use in consumer products,” added Blumenthal. “For ten years we’ve been alerting industry members about specific botanical materials that we have confirmed as being subject to adulteration and also which analytical methods are most robust and fit for purpose to detect such adulteration. Now we are counseling industry members on the best practices to prevent irreparably defective materials from remaining in the supply chain.”