Lisa Olivo, Associate Editor07.18.16
Leaders in the dietary supplement industry have banded together in the face of federal enforcement action and consumer skepticism to reassure the public that supplements are being produced safely and responsibly.
A recent round table discussion conducted as part of the American Conference Institute’s fourth annual Legal, Regulatory and Compliance forum on Dietary Supplements outlined ways in which industry leaders are stepping up to increase the level of transparency and self-regulation within the sector, while reinforcing current good manufacturing practices (cGMPs).
Supplement Registry
In April of 2016 the Council for Responsible Nutrition (CRN), Washington, D.C., unveiled plans to develop an online product registry, scheduled to go live by the end of this year. The registry is designed for participation by finished product manufacturers, with the objective of increasing overall product transparency.
The database profiles will provide basic product information on a supplement and a copy of compiled product labels. The information would be voluntarily supplied by manufacturers, and if a company wishes it can expand upon product details in a paid-for profile, including information on ingredients, the company’s supply chain, or its manufacturing process.
Senior Vice President, Scientific & Regulatory Affairs for CRN Duffy MacKay, ND, said a key motivation behind the development of the database is to demonstrate the industry’s proactive approach to self-regulation, while also strengthening ties with the U.S. Food and Drug Administration (FDA). Further, this voluntary system may serve as a model for a mandatory registry in the future.
“The idea of registering products in the United States is not a new concept,” stated Dr. MacKay. “If you look around the world, we have other nations that require product registry. If you look at the Puerto Rico administrative order [which has since been dismissed] the focus of that is a product registry. Canada has it. Australia has it. For those who have read Josh Sharfstein’s proposal “Breaking the Gridlock,” a very important component of that is a product registry. In addition, in the infamous Durbin Bill—The Dietary Supplement Labeling Act—a key cornerstone of that is a product registry. So this idea that we would register our products, and make it publically transparent…when other public health officials and other governments look at new ideas and new structures for ways to regulate an industry, this seems to be a repeated theme.”
The platform is designed to support the regulator, explained Dr. MacKay, since as a trade organization CRN’s strength is communication with regulatory bodies rather than retailers and consumers. However, the registry will be accessible to all.
CRN stressed that this project is not being developed in a vacuum. The organization has been working with NSF International, as well as other trade organizations, to determine how this system can best serve the industry. When the registry is complete, it will be mandatory for CRN members to participate, and CRN is encouraging other trades to follow suit.
Following the conference, CRN revealed it has retained UL, a global independent safety science company, to develop and administer its dietary supplement product registry. The agreement between CRN and UL calls for the registry to go into an immediate development stage with beta testing to occur this summer and is expected to be up and running by the end of the year.
CRN President & CEO Steve Mister, commented “We spoke with a number of very capable companies for this important project, but UL best fit the bill because of its broad knowledge of the supplement industry, its technical prowess and its brand recognition for consumer safety.” Mr. Mister noted that UL is already well known by the dietary supplement industry and trusted by retailers who use the company’s Prospector database, a free service that provides manufacturers with technical data and safety information about the materials and ingredients used in consumer and industrial products, from food and personal care products to household cleaners, paints and adhesives. He added, “We were also impressed with UL’s flexibility in accommodating the range of data fields we want to include that address the important quality discussions taking place within the industry. We are confident that the dietary supplement product registry will provide a viable, adaptable product registry that will serve regulators, retailers, manufacturers, and ultimately consumers, over time.”
CRN said over the next few months about six companies will input their labels to a beta version of the database and provide feedback on the process and suggestions for improvements. CRN member companies will be required as a condition of membership to input all their product labels into the product registry by July 2017, and all dietary supplement companies will be strongly encouraged to do the same.
Auditing Initiative
The Global Retailer and Manufacturer Alliance, (GRMA) has launched a new initiative to streamline the auditing process for supplement manufacturers that are currently subject to multiple audits by different retailers and third parties.
Such audits can be “inconsistent in range, thoroughness and scope” according to David Trosin, director of business development—dietary supplements for NSF, Ann Arbor, MI, with manufacturers sometimes subject to multiple audits from different retailers and regulators weekly.
GRMA aims to solve this problem by establishing a consistent industry model for audits, based on existing regulations and accepted global standards. The unified audit system would provide better risk management programs and protect store brand integrity, while improving overall efficiency. Further, the system could reduce the number of yearly audits for manufacturers, while creating a more thorough and streamlined system to better protect consumer safety.
While this is an NSF-led initiative, other third-party certification organizations are participating, including U.S. Pharmacopeia, SGS, UL, AIB International, and Bureau Veritas.
The GRMA audit should be ready to launch within the next two years, according to Mr. Trosin.
Best Practices for Herbs
President Michael McGuffin of the Silver Spring, MD-based American Herbal Products Association (AHPA) outlined the development of good agricultural and collection practices (GACP) and current Good Manufacturing Practices (cGMP) in the herbal ingredient supply chain.
Mr. McGuffin noted that the GACP element of this guidance will detail best practices for seed-to-harvest and post-harvest handling operations, while the related GMP document will outline steps for operations engaged in activities from post-harvest handling to the point of receipt of herbal ingredients by finished product manufacturers.
"The herbal products industry continues to innovate practices and technology to meet the ever-increasing consumer demand for quality and transparency," Mr. McGuffin said. "Expanding global supply chains for herbal products present new opportunities and challenges for the industry and AHPA's initiatives will help members and the industry identify and meet emerging challenges and capitalize on opportunities."
AHPA is receiving input from companies directly involved in agriculture and wild crafting of herbal ingredients to provide expertise for development of the GACP guidance, and will gather comments from companies that distribute herbal raw materials and manufacture herbal extracts to develop the cGMP guidance.
A recent round table discussion conducted as part of the American Conference Institute’s fourth annual Legal, Regulatory and Compliance forum on Dietary Supplements outlined ways in which industry leaders are stepping up to increase the level of transparency and self-regulation within the sector, while reinforcing current good manufacturing practices (cGMPs).
Supplement Registry
In April of 2016 the Council for Responsible Nutrition (CRN), Washington, D.C., unveiled plans to develop an online product registry, scheduled to go live by the end of this year. The registry is designed for participation by finished product manufacturers, with the objective of increasing overall product transparency.
The database profiles will provide basic product information on a supplement and a copy of compiled product labels. The information would be voluntarily supplied by manufacturers, and if a company wishes it can expand upon product details in a paid-for profile, including information on ingredients, the company’s supply chain, or its manufacturing process.
Senior Vice President, Scientific & Regulatory Affairs for CRN Duffy MacKay, ND, said a key motivation behind the development of the database is to demonstrate the industry’s proactive approach to self-regulation, while also strengthening ties with the U.S. Food and Drug Administration (FDA). Further, this voluntary system may serve as a model for a mandatory registry in the future.
“The idea of registering products in the United States is not a new concept,” stated Dr. MacKay. “If you look around the world, we have other nations that require product registry. If you look at the Puerto Rico administrative order [which has since been dismissed] the focus of that is a product registry. Canada has it. Australia has it. For those who have read Josh Sharfstein’s proposal “Breaking the Gridlock,” a very important component of that is a product registry. In addition, in the infamous Durbin Bill—The Dietary Supplement Labeling Act—a key cornerstone of that is a product registry. So this idea that we would register our products, and make it publically transparent…when other public health officials and other governments look at new ideas and new structures for ways to regulate an industry, this seems to be a repeated theme.”
The platform is designed to support the regulator, explained Dr. MacKay, since as a trade organization CRN’s strength is communication with regulatory bodies rather than retailers and consumers. However, the registry will be accessible to all.
CRN stressed that this project is not being developed in a vacuum. The organization has been working with NSF International, as well as other trade organizations, to determine how this system can best serve the industry. When the registry is complete, it will be mandatory for CRN members to participate, and CRN is encouraging other trades to follow suit.
Following the conference, CRN revealed it has retained UL, a global independent safety science company, to develop and administer its dietary supplement product registry. The agreement between CRN and UL calls for the registry to go into an immediate development stage with beta testing to occur this summer and is expected to be up and running by the end of the year.
CRN President & CEO Steve Mister, commented “We spoke with a number of very capable companies for this important project, but UL best fit the bill because of its broad knowledge of the supplement industry, its technical prowess and its brand recognition for consumer safety.” Mr. Mister noted that UL is already well known by the dietary supplement industry and trusted by retailers who use the company’s Prospector database, a free service that provides manufacturers with technical data and safety information about the materials and ingredients used in consumer and industrial products, from food and personal care products to household cleaners, paints and adhesives. He added, “We were also impressed with UL’s flexibility in accommodating the range of data fields we want to include that address the important quality discussions taking place within the industry. We are confident that the dietary supplement product registry will provide a viable, adaptable product registry that will serve regulators, retailers, manufacturers, and ultimately consumers, over time.”
CRN said over the next few months about six companies will input their labels to a beta version of the database and provide feedback on the process and suggestions for improvements. CRN member companies will be required as a condition of membership to input all their product labels into the product registry by July 2017, and all dietary supplement companies will be strongly encouraged to do the same.
Auditing Initiative
The Global Retailer and Manufacturer Alliance, (GRMA) has launched a new initiative to streamline the auditing process for supplement manufacturers that are currently subject to multiple audits by different retailers and third parties.
Such audits can be “inconsistent in range, thoroughness and scope” according to David Trosin, director of business development—dietary supplements for NSF, Ann Arbor, MI, with manufacturers sometimes subject to multiple audits from different retailers and regulators weekly.
GRMA aims to solve this problem by establishing a consistent industry model for audits, based on existing regulations and accepted global standards. The unified audit system would provide better risk management programs and protect store brand integrity, while improving overall efficiency. Further, the system could reduce the number of yearly audits for manufacturers, while creating a more thorough and streamlined system to better protect consumer safety.
While this is an NSF-led initiative, other third-party certification organizations are participating, including U.S. Pharmacopeia, SGS, UL, AIB International, and Bureau Veritas.
The GRMA audit should be ready to launch within the next two years, according to Mr. Trosin.
Best Practices for Herbs
President Michael McGuffin of the Silver Spring, MD-based American Herbal Products Association (AHPA) outlined the development of good agricultural and collection practices (GACP) and current Good Manufacturing Practices (cGMP) in the herbal ingredient supply chain.
Mr. McGuffin noted that the GACP element of this guidance will detail best practices for seed-to-harvest and post-harvest handling operations, while the related GMP document will outline steps for operations engaged in activities from post-harvest handling to the point of receipt of herbal ingredients by finished product manufacturers.
"The herbal products industry continues to innovate practices and technology to meet the ever-increasing consumer demand for quality and transparency," Mr. McGuffin said. "Expanding global supply chains for herbal products present new opportunities and challenges for the industry and AHPA's initiatives will help members and the industry identify and meet emerging challenges and capitalize on opportunities."
AHPA is receiving input from companies directly involved in agriculture and wild crafting of herbal ingredients to provide expertise for development of the GACP guidance, and will gather comments from companies that distribute herbal raw materials and manufacture herbal extracts to develop the cGMP guidance.
