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Industry Leaders and Former FDA Official Express Support for BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles

AUSTIN, Texas (December 7, 2022) — Dietary supplement industry leaders and a former Food and Drug Administration (FDA) official have expressed strong support for the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) Best Practices SOP (Standard Operating Procedure) for the Disposal/Destruction of Irreparably Defective Articles.

Four years in development, the BAPP SOP was formally introduced during a 90-minute, four-panel session at the recent SupplySide West (SSW) tradeshow and conference in Las Vegas in November, with a sole objective to remove from commerce “irreparably defective articles” (IDAs), a new term developed in the SOP. IDAs include ingredients and finished products, on which both buyer and seller agree that they cannot be lawfully remediated for any use anywhere and therefore must be destroyed to prevent resale into international commerce.

At the expert panel session, leaders representing dietary supplement brand owners, contract manufacturers, botanical ingredient suppliers, analytical laboratories, and a major natural foods retailer expressed support for the program. Additionally, a former chief legal counsel for FDA weighed in on the significance of the BAPP SOP.

“It's a very good sign that three nonprofit, science-based organizations have come together to agree that it's time to have a voluntary program to prevent the continued use in commerce of any type of botanical or other ingredient that does not meet statutory obligations under the federal Food, Drug, and Cosmetic Act, but also contractual obligations on agreements between suppliers and those who purchase the items,” said Peter Barton Hutt, an attorney at Covington & Burling and former FDA chief counsel, in a pre-recorded video testimonial.

“We've had many of those best practices in our documents before. But what we've not had was the ability to remove articles from the market, to say, ‘This is irreparably defective; we're not going to send it back.’ And that is a key piece,” said Christine Burdick-Bell, executive vice-president, general counsel, and corporate secretary for Pharmavite.

“We [Pharmavite] started rolling the SOP out in advance of the [public release of the final] program,” she added. “We've rolled it out to our contract manufacturers, and I've had no pushback. They've accepted it, without question….What I'm really asking is for the rest of industry to do the same thing. Because if we all adopt it, then the ingredient suppliers will have no ability to push back.”

“We’re a proud part of this program,” said Tom Dubinski, vice president of quality systems for contract manufacturer Arizona Nutritional Supplements. “We are updating agreements, terms, and conditions with our purchasing teams on our supplier agreements, where we are putting in the BAPP SOP verbiage. We are working with new suppliers, saying, ‘This is our standard. If you want to be a partner with us, you're going to have to meet the standards.’ We will not take lower-level-quality product; we will not take adulterated product. We support this effort and want to help demonstrate that there is good going in the marketplace.”

“Whole Foods Market is in the early stages of reviewing the details to assess where and how we can support this work,” noted Kathy Wickenden, senior technical advisor, dietary supplements, for Whole Foods Market, in a pre-recorded video testimonial. “We look forward to sharing this critical information with our business partners in the near future. And we encourage everyone involved in the botanical ingredients supply chain to do their part to ensure the integrity of the industry.”

The SOP provides an audit trail to document certified destruction and a dispute resolution provision that buyers and sellers can agree to use in the event of dispute. Panelists at the SSW session universally believe this provision fairly protects both buyer and supplier.

“We have a very diverse group of stakeholders in our industry. In creating these templates for contract language and the SOP, our top priority was to make it flexible for firms of all sizes and expertise to use, make it inexpensive to adopt, and embed the essential basics into quality systems,” said Michael D. Levin, founder of Health Business Strategies LLC and principal author of the SOP. “This is a consumer safety initiative, first and foremost. I am pleased by the enormous support received by BAPP stakeholders for defect-free natural products.”

For more information about the BAPP SOP, including access to the complete document, visit http://herbalgram.org/resources/botanical-adulterants-prevention-program/.