Best Practices SOP to Prevent Resale of ‘Irreparably Defective Articles’ for Industry and Public Comment

Botanical Adulterants Prevention Program invites broad herb and dietary supplement industry stakeholder input

AUSTIN, Texas (October 10, 2018) — The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) has issued its draft “Best Practices Standard Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles.” The document, which is intended for members of the herb, dietary supplement, food, and cosmetic industries, is open for public comment until October 30, 2018.

The draft SOP can be downloaded after completing a brief survey on ABC’s website. After reviewing the SOP, all interested parties are invited to submit comments as instructed.

The document contains draft boilerplate legal language that buyers and suppliers of botanicals and other dietary ingredients can use in their supply contracts to implement the SOP. The document also includes flow-charts that describe five different supply chain scenarios illustrating the reception of dietary ingredients by an industry customer, such as a dietary supplement manufacturer.

Of particular importance is the fifth scenario, which describes a situation in which an article (e.g., an ingredient) is deemed to be “irreparably defective” after proper analytical testing by a qualified industry laboratory using one or more scientifically valid analytical methods. BAPP defines an irreparably defective ingredient as one that is adulterated and/or contaminated to an extent that the material cannot be effectively and lawfully remediated for use in a consumer product, thereby necessitating its disposal or destruction by a qualified third party.

The draft SOP was produced in collaboration with Health Business Strategies, LLC, an industry consulting firm, and it 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 draft SOP has been sent to ABC’s Sponsor and Small Business Members and BAPP Underwriters and Endorsers in the United States.

“It may be seen as curious that some of the best companies in the herb industry may never need to exercise the provisions contained in this SOP,” said Mark Blumenthal, founder and executive director of ABC and director of BAPP. “Many herbs and dietary supplement manufacturers both in the United States and internationally have developed long-term relationships with their suppliers, where the companies have fully qualified these suppliers and the ingredients obtained from them. Such suppliers consistently analyze their ingredients before shipping them to customers for further quality control testing and manufacturing into herbal preparations for consumer use. Though the risks of potential adulteration are real, there is an extremely low potential for such well-qualified ingredients’ having any defects that would make them ‘irreparably defective’ according to appropriate regulations and the BAPP SOP.”

“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 be made acceptable for any use in consumer products,” said Blumenthal. “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.”

Michael D. Levin, the founder of Health Business Strategies, LLC, noted: “Economic adulteration and low-level contamination represent very real supply chain concerns with all commodities, including botanical and other dietary ingredients regulated by FDA. Ingredient buyers are the ‘Guardians at the Gate,’ who is responsible for approving the use of ingredients for manufacturing. While manufacturers are prohibited under cGMPs [current Good Manufacturing Practices] from using ingredients that don’t meet their specifications, the cGMP regulations are generally silent on what to do with ingredients that are rejected, particularly if they cannot be lawfully reconditioned. Our work solves that gap, and provides the industry with contract language for buyer/seller and an SOP that can be used to bridge that gap and solve that problem.”

“In short,” said Stefan Gafner, Ph.D., chief science officer of ABC and technical director of BAPP, “we are helping the industry to prevent adulterated ingredients from being rejected by one company, only to be resold by an unethical supplier to another company.”

Blumenthal added: “We are deeply grateful to the many herbs and dietary supplement companies and organizations that have supported our efforts in BAPP over the past eight years since the program was founded, as well as those that have already shown their support for this draft SOP while it has been developed in the past year. There are many ethical and responsible members of the herb and dietary supplement industries in the United States and globally, and we salute their willingness to encourage and support this self-regulatory initiative.”

“The problem,” he continued, “may arise when a manufacturer purchases an ingredient in short supply on the ‘spot’ market where the supplier may not be adequately qualified by the customer and the ingredient might not be properly tested before it is shipped to the customer. Such situations, especially when a customer might be seeking the lowest-cost materials, might lead to quality problems that might require remedies contained in the newly-proposed SOP.”

“In sum, implementing this proposed Best Practices SOP represents a strong measure by responsible industry members to enhance their ability to more effectively control the ingredient supply chain,” Blumenthal said. “The SOP helps to ensure that consumers can purchase properly-labeled and lawful herbal products.”

ABC and BAPP are seeking input from all stakeholders to ensure all relevant concerns have been considered before the final SOP is issued later this year. BAPP encourages broad support for this voluntary program and, based on initial feedback, expects widespread acceptance from those stakeholders focused on superior quality practices.

About Health Business Strategies, LLC

Founded in 2004 by Michael D. Levin, Health Business Strategies, LLC in Clackamas, Oregon, provides expert consulting services in the natural products and integrative medicine industries, with a focus on regulatory compliance, quality assurance, and business development. After his 23 years of service in the pharmaceutical products/services industries, Levin served in executive positions since 1996 in both dietary supplement and dietary ingredients companies. Published in peer-reviewed medical journals, he has lectured internationally on quality and regulatory issues at medical universities, colleges of pharmacy, and hospitals, and he led the creation of the first dietary supplement natural products formulary in a hospital system. His clients include law firms for which he has served as a dietary supplement subject matter expert on cases involving low-level contamination in the supply chain. He can be reached on LinkedIn and at MDLHPS@earthlink.net.

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