GRMA close to finalizing consensus-based GMP standard for dietary supplements

By Stephen Daniells contact

- Last updated on GMT

© iStock / YiuCheung
© iStock / YiuCheung

Related tags: Dietary supplements, Audit

The Global Retailer and Manufacturer Alliance (GRMA) expects to finalize and publish a consensus-based GMP standard for dietary supplements before the end of Q1 2017.

The GRMA initiative currently includes over 20 major retailers in the grocery, drug, mass merchandiser and club store channels, representing US-based and international operations. The alliance also includes manufacturers, trade associations, certification bodies, academia, government agencies and other stakeholders seeking to improve quality, safety and regulatory compliance to ultimately benefit the consumer.

Manufacturers of dietary supplements must comply with Good Manufacturing Practices (CFR 111), while retailers may also have a number of additional requirements for manufacturers, which can lead to variety of standards. The GRMA aims to “tie” all these additional auditing requirements into one industry audit.

“Combining regulatory GMP requirements and retailer requirements into a single standard and auditing program for dietary supplements will help ensure consistency and proper training of auditors while also reducing the number of audits and strengthening safety, quality and trust throughout the supply chain. A single standard and auditing program will also reduce financial costs associated with multiple audits,” ​Casey Coy, a member of the GRMA and Cosmetics & Personal Care program manager at NSF International, told NutraIngredients-USA.

Work on a single, industry accepted standard and auditing program for dietary supplements using the ANSI consensus-based standard development process started in 2014, and draft language for the standard is expect to be finalized for approval by the Joint Committee before the end of 2016, said Coy. The standard would then go for review by the Council of Public Health Consultants and public comment during Q1 2017, with the final standard expected to be published before the end of March 2017.

“That’s an amazingly fast time-frame given how far they’ve come,” ​said Steve Mister, president and CEO of the Council for Responsible Nutrition. “What industry can do is engage in the comment period, and then companies need to adopt and drive this once it’s out.”

The need is high

“The need for the standard is high, for sure,” ​said Loren Israelsen, president of the United Natural Products Alliance (UNPA), which has been working with GRMA for over 18 months. “We’ve seen that need when polling attendees at our conferences over the last 12 months, with 90-95% expressing an interest in a common system for auditing.”

Israelsen said there is perhaps more urgency to spread the word of GRMA now that the Supplement Safety & Compliance Initiative (SSCI) has, “popped up on the radar, and the question is whether we need two of these systems. The whole point was to get down to one system and that should incentivize GRMA,”​ he said.  

SSCI was unveiled at SupplySide West in October​ and described as the Global Food Safety Initiative (GFSI) for supplements.

Dr Daniel Fabricant, Executive Director and CEO of the Natural Products Association, which is leading the SSCI, explained that the initiative is complementary to GRMA and the two schemes can work synergistically. “GRMA is focused on CFR 111 compliance, whereas SSCI is benchmarking multiple quality standards, including, for example, fair trade or DNA barcoding or process controls for wild crafted herbs. We’re looking to take every important regulatory problem and benchmark all of these. The scope of SSCI is much broader than just GMP compliance, and SSCI and GRMA can work synergistically.”

Building awareness

CRN’s Mister and UNPA’s Israelsen agree that awareness of GRMA could be better. “Awareness is low and some of that is attributable to the process, which is a very deliberate ANSI process,” ​said Israelsen. “Creating and managing accreditations and certifications is a slow process.”

“Many people don’t understand why ANSI is so important,” ​added Mister. “An ANSI standard means consensus based on input from all stakeholders, including industry, government and consumers.”

“It’s not easy to meet the ANSI Essential Requirements, but this effort assures that the standards define expectations of all stakeholders,”​ explained Joe Bhatia, President of ANSI, in a statement​. “Lesser documents rushed to market may not hold up to requirements demanded by industry.  The ANSI process is a proven benchmark providing confidence and managing risk, and we are proud to continue to work with NSF International as it leads development of crucial standards for health and safety.”

According to GRMA's Coy, the new ANSI-approved, consensus-based American National Standard for Dietary Supplements is designed to:

- Protect consumer health and safety
- Provide better risk management programs and protect store brand integrity
- Improve the efficiency of retailer/manufacturer interactions
- Create a single audit report per regulatory classification that is acceptable by all participating retailers
- Create consistency in audit results due to auditor qualification, training and calibration requirements
- Reduce the number of audits required by retailers
- Reduce manufacturer audit costs (both time and money)
- Give manufacturers time to address continuous improvement

Members

The GRMA Governance Board includes members from retailers (Costco, HEB, Walgreens and Wegmans) and manufacturers (First Quality Products, Perrigo, United Exchange Corp (UEC) and Vi-Jon) to provide oversight for the entire GRMA membership.

“The GRMA has filled a long-time unmet need for independent, consensus-based standards for retailers and manufacturers, and we are thrilled to be a part of the solution,” ​said Betsy Crater, Wegmans Non-Foods QA Manager.

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