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Botanical Adulterants Prevention Program Releases SOP for Disposal of ‘Irreparably Defective Articles’

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The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) has announced the completion and public availability of its long-awaited bapp-logo-2022-2line-hiBest Practices Standardized Operating Procedure (SOP) for the Disposal/Destruction of Irreparably Defective Articles.

These best practices are a voluntary standards initiative designed to assist responsible buyers in the herb, dietary supplements, food, cosmetics and over-the-counter (OTC) drug industries to be able to remove ingredients from the supply chain if those ingredients (“articles”) are deemed by scientifically valid analytical laboratory testing to be an “irreparably defective article” (IDA)—a new regulatory term created by the SOP.

According to the SOP, an irreparably defective article, by definition, cannot be reconditioned or remediated for lawful use. Therefore, when laboratory testing approved by both buyer and seller concludes that an ingredient is irreparably defective, the buyer (e.g., a dietary supplement, food, cosmetic, or OTC drug manufacturer) should not simply return it to the seller (e.g., an ingredient supplier). Instead, as detailed in the SOP, it must be destroyed to prevent its resale into commerce. Notification of certified, lawful destruction shared between the parties is an essential part of this agreement; it evidences compliance with the objectives of this consumer protection initiative.

The SOP is applicable to botanical/herbal ingredients and non-botanical ingredients—any ingredient that might be subject to accidental or intentional adulteration or accidental contamination. In some cases of adulteration or contamination, the ingredient can be lawfully remediated or reconditioned to a level of quality that is deemed acceptable by relevant federal regulations. However, in other cases, due to the type of adulteration and/or the extent of contamination, some materials cannot be adequately reconditioned, thus requiring its being considered irreparable.

In the United States and many other countries, good manufacturing practices (GMPs) regulations require that ingredients must be tested for identity and purity — among other requirements — and, if they do not meet appropriate specifications, they generally cannot be released into manufacturing (for the production of consumer products). However, in the United States and elsewhere, GMPs do not include guidance regarding what the buyer should do with rejected material that does not qualify for reconditioning by either the buyer, the seller, or a third party. Such irreparably defective materials are the subject of this SOP.

The new SOP also contains contract language templates for the seller and buyer; a three-way confidentiality agreement among the buyer, seller, and contract analytical laboratory; and frequently asked questions that arose during two public comment periods. The public comment process included recommendations from various industry stakeholders, food and drug law attorneys, analytical chemists, and other botanical, supplement, and regulatory experts.

“Over the past 12 years, BAPP has published 75 extensively peer-reviewed documents that confirm the presence of adulterated, fraudulent ingredients (mis)labeled as herbal raw materials, extracts, and essential oils,” said Mark Blumenthal, founder and executive director of the American Botanical Council (ABC) and founder and director of BAPP. “These highly constructive BAPP publications are used by many responsible members of the herb industry, in the United States and internationally, to set appropriate quality specifications for their botanical ingredients.

“Now,” Blumenthal added, “BAPP has expanded its range of activity by providing responsible members of the food, supplement, cosmetic, and OTC drug industries with this SOP so that they can remove ingredients from the supply chain that should never have been offered for sale in the first place. Ultimately, this results in better quality products reaching consumers.”

Michael D. Levin, of Health Business Strategies (AHP), is the primary consultant and principal author of the SOP. After a successful 23-year career in the pharmaceutical and pharmacy services industries, Levin has served in executive leadership positions in the dietary supplements and dietary ingredients industries.

“Carefully constructed to fairly protect buyers, suppliers, and analytical laboratories, these best practices provide a cGMP-compliant framework to stop the resale of ‘irreparably defective, and potentially harmful articles’ (e.g., ingredients) from being resold into commerce,” said Levin. “Because of the extensive input from a variety of expert industry stakeholders during its development, we expect this SOP to be widely adopted.”

Loren Israelsen, president of the United Natural Products Alliance (UNPA), a leading industry trade group, and a principal architect of the Dietary Supplement Health and Education Act of 1994, the primary legislation that created the regulatory framework for dietary supplements, welcomed the new SOP:

“BAPP, in consultation with a host of industry leaders and experts, has meticulously developed a best practices SOP to address irreparably defective articles. As this is a new term, it bears repeating. The BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles should become a part of every manufacturer’s cGMP procedures. And while the title may be long, the goal is simple: Stop the resale of IDAs back into the stream of commerce. This is a first, and it is historic. Let us make the most of this tremendous effort to solve an important problem. Now it is up to responsible elements of the industry to adopt this SOP and to begin the important task of removing IDAs from commerce.”

Israelsen continued, “UNPA will be a leader in promoting the active adoption of this SOP, and we salute BAPP and all those who have worked to make the industry stronger and enhance consumer confidence in dietary supplements.”

The BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles will be formally introduced at an Expert Panel discussion at SupplySide West in Las Vegas, NV, on Wednesday, Nov. 2, from 2-3:30 p.m. Expert panelists include representatives from key ingredient suppliers, branded supplement companies, trade associations, certifying organizations, professional medical associations, analytical chemists, as well as industry attorneys and others.

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