12.01.20
The Botanical Adulterants Prevention Program, a group of nonprofits including the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the National Center for Natural Products Research (NCNPR), has issued its second draft of a document detailing the best practices for disposing of raw materials which are adulterated, contaminated, or otherwise unfit for human consumption.
The “Best Practices Contract Language and Standard Operating Procedure (SOP) Templates for the Disposal/Destruction of Irreparably Defective Articles,” intended for members of the various nutraceutical and cosmetic industries, will be available for public comment until Dec. 14. The draft of best practices documents was made in collaboration with Health Business Strategies, LLC, a consulting firm for natural products companies.
It defines an irreparably defective ingredient as one that is adulterated or contaminated to the extent that the material cannot be effectively and lawfully remediated for use of oral or topical consumption in a consumer product, thereby necessitating its pre-authorized disposal or destruction by a qualified third party.
In 2019, BAPP reports that it received 106 substantive comments in 2019 from industry stakeholders, which were used to revise the most recent draft. The revisions also included comments from the current and former members of the U.S. Food and Drug Administration, the National Institutes of health, dietary supplement companies, ingredient suppliers, analytical labs, and GMP consultants. Additionally, BAPP added an FAQs document which addresses many of the comments received during the first public comment round. The documents also include a new three-party non-disclosure agreement for use by the buyer, seller, and analytical lab which can be used for dispute resolutions.
“Just as the contract language fairly and carefully protects the interests of both buyer and supplier, the NDA protects the economic interests of the buyer, supplier, and laboratory,” BAPP said in an announcement. “All document revisions were reviewed and approved by the BAPP legal advisory team.”
The revised documents have been sent to all qualified stakeholders who previously commented, BAPP said, and other qualified stakeholders can download them after completing a brief survey on ABC’s website. After reviewing the package of documents, those representing buyers, suppliers, analytical labs, expert consultants, attorneys, regulators, or industry associations are invited to submit comments. To be clear, BAPP is not accepting comments from non-stakeholder consumers on these highly technical legal templates.
The second round of comments is intended to give all stakeholders another opportunity to review and comment before these 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,” Mark Blumenthal, founder and executive director of ABC and director of BAPP, said. “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.”
Blumenthal mentioned that most manufacturers have developed long-term relationships with suppliers and consistently use best practices in full compliance with current GMPs to analyze ingredients before releasing them for manufacturing, packaging, or commerce.
“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. 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.”
“Economic adulteration and low-level contamination represent very real supply chain concerns with all commodities, including botanical and other dietary ingredients regulated by FDA,” Michael D. Levin, founder of Health Business Strategies, LLC, said. “Ingredient buyers are the ‘guardians at the gate,’ who are responsible for approving the use of ingredients for manufacturing. Though this problem is believed to be infrequent, it does happen. Our proposed solution empowers all responsible buyers and suppliers to unite in support of this effort to stop the potential for resale of irreparably defective ingredients through contractual obligations that fairly protect the economic interests of both parties.”
“In short, 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,” Stefan Gafner, PhD, chief science officer for ABC and technical director of BAPP, said.
“We are deeply grateful to the many herb and dietary supplement companies and organizations that have supported our efforts in BAPP over the past ten years since the program was founded, as well as those that have already shown their support for this new project, some of whom are already including it in their supply agreements. 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.”
Those seeking to support BAPP and this project may do so by contacting ABC Development Director Denise Meikel.
The “Best Practices Contract Language and Standard Operating Procedure (SOP) Templates for the Disposal/Destruction of Irreparably Defective Articles,” intended for members of the various nutraceutical and cosmetic industries, will be available for public comment until Dec. 14. The draft of best practices documents was made in collaboration with Health Business Strategies, LLC, a consulting firm for natural products companies.
It defines an irreparably defective ingredient as one that is adulterated or contaminated to the extent that the material cannot be effectively and lawfully remediated for use of oral or topical consumption in a consumer product, thereby necessitating its pre-authorized disposal or destruction by a qualified third party.
In 2019, BAPP reports that it received 106 substantive comments in 2019 from industry stakeholders, which were used to revise the most recent draft. The revisions also included comments from the current and former members of the U.S. Food and Drug Administration, the National Institutes of health, dietary supplement companies, ingredient suppliers, analytical labs, and GMP consultants. Additionally, BAPP added an FAQs document which addresses many of the comments received during the first public comment round. The documents also include a new three-party non-disclosure agreement for use by the buyer, seller, and analytical lab which can be used for dispute resolutions.
“Just as the contract language fairly and carefully protects the interests of both buyer and supplier, the NDA protects the economic interests of the buyer, supplier, and laboratory,” BAPP said in an announcement. “All document revisions were reviewed and approved by the BAPP legal advisory team.”
The revised documents have been sent to all qualified stakeholders who previously commented, BAPP said, and other qualified stakeholders can download them after completing a brief survey on ABC’s website. After reviewing the package of documents, those representing buyers, suppliers, analytical labs, expert consultants, attorneys, regulators, or industry associations are invited to submit comments. To be clear, BAPP is not accepting comments from non-stakeholder consumers on these highly technical legal templates.
The second round of comments is intended to give all stakeholders another opportunity to review and comment before these 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,” Mark Blumenthal, founder and executive director of ABC and director of BAPP, said. “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.”
Blumenthal mentioned that most manufacturers have developed long-term relationships with suppliers and consistently use best practices in full compliance with current GMPs to analyze ingredients before releasing them for manufacturing, packaging, or commerce.
“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. 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.”
“Economic adulteration and low-level contamination represent very real supply chain concerns with all commodities, including botanical and other dietary ingredients regulated by FDA,” Michael D. Levin, founder of Health Business Strategies, LLC, said. “Ingredient buyers are the ‘guardians at the gate,’ who are responsible for approving the use of ingredients for manufacturing. Though this problem is believed to be infrequent, it does happen. Our proposed solution empowers all responsible buyers and suppliers to unite in support of this effort to stop the potential for resale of irreparably defective ingredients through contractual obligations that fairly protect the economic interests of both parties.”
“In short, 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,” Stefan Gafner, PhD, chief science officer for ABC and technical director of BAPP, said.
“We are deeply grateful to the many herb and dietary supplement companies and organizations that have supported our efforts in BAPP over the past ten years since the program was founded, as well as those that have already shown their support for this new project, some of whom are already including it in their supply agreements. 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.”
Those seeking to support BAPP and this project may do so by contacting ABC Development Director Denise Meikel.
