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Medical Device/Consumer Product Protocol Workgroup

GRMA is in the process of developing a Medical Device/Consumer Product (MD/CP) Standard. Our goal is to utilize a group of key industry stakeholders that represent the MD/CP sector to develop the standard over the remainder of 2019 and into the first quarter of 2020. Our strategy is to create a standard based on product risk that would encompass consumer goods, making the potential for true global acceptance. The GRMA will then adapt this standard into its array of audit schemes. This process is known as the “protocol method”. This method allows for the rapid development of the standards so they can be brought to market in a timely fashion. Once the standard has been developed, the GRMA will then begin the formal process to become an ANSI Consensus Standard.

View our Membership Page to learn more about the benefits of becoming a GRMA Member. Join our Mailing List to stay current on future developments.

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Good Manufacturing Practices for Medical Devices
2019-09-09T16:34:39-04:00September 9th, 2019|News|

Panel Discussion: CBD Product Standard Development

Panel Discussion: CBD Product Standard Development: Alan Perlman (NSF) moderated a panel discussion of industry leaders at the GRMA Summit which centered around the complexities of the industry in relation to developing GMP Standards. Key discussion points included the need to connect GRMA with current GMP standard development activity by the industry. The question was raised as to the need to develop an entirely new standard or the potential to adopt the 455-2 Dietary Supplement Standard. Also discussed was the difficulty of working around the inclusion of hemp in the Farm Bill vs. the illegality of marijuana as a controlled substance, and the issue with state regulation and how it may impact this category. An exploratory group of GRMA members and stakeholders is in formation with plans to host a Stakeholder Roundtable meeting within the next 90 days. Stay tuned for more information on the stakeholder roundtable meeting and this topic as it moves forward.

Participants:
Alan Perlman, NSF Moderator
Duffy MacKay, CV Sciences
Robert Rhodes, NSF
Ben England, England Law Group
Hess Moallem, formerly of Charlotte’s Webb
Megan Olsen, Council for Responsible Nutrition

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2019-09-11T17:45:38-04:00September 9th, 2019|News|

China Tariffs

Senior Customs Attorney Jessica Rifkin and CEO & Founder Ben England greatly appreciated the opportunity to speak and make new connections at this year’s GRMA Summit.  View the presentations below to learn how the current (and future) tariffs are impacting the three categories of the 455-Standards.

China Tariffs Presentation – GRMA
The Intersection of Customs with FDA and OGAs
Strategies for Dealing with the Trade War

In light of recent news Benjamin L. England & Associates would like to share the latest information regarding the China Tariffs and the Trade War. Earlier this week, the USTR announced the next steps for the proposed 10 percent tariff on imports from China (what has been commonly known as List 4). The tariffs will be imposed by two separate lists, with List 4A beginning on September 1st and List 4B beginning on December 15th. Resources are listed below to help keep you abreast of the ongoing situation.

If you are ready to learn more about possible ways to reduce or eliminate the effect of the tariffs, please contact Benjamin L. England & Associates at contact@englandlawgroup.com. Their team of Customs attorneys is ready to discuss importer options.

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2019-09-09T16:37:11-04:00September 9th, 2019|Press Releases|

GRMA Invited to Benchmark Dietary Supplement GMP Audit Scheme Program

For Immediate Release:

Washington, DC, August 12, 2019: The Global Retailer and Manufacturer Alliance (GRMA) is excited to announce it has been invited by the Global Food Safety Initiative (GFSI) to have its Dietary Supplement (DS) GMP Audit Scheme program benchmarked as part of their safe foods initiative. This will be the first Dietary Supplement Audit Scheme that GFSI has invited to start the benchmarking application process.

The GFSI is composed of the world’s leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. “It was a pleasure to attend the recent GRMA Summit and present on the GFSI Benchmarking process,” stated Rishi Banerjee, Senior Manager, GFSI US/Canada. “I enjoyed meeting the GRMA members and seeing the commonalities with the origins of the GFSI. The GFSI is focused on delivering safe food to consumers everywhere, and I welcome GRMA’s commitment to the highest quality standards. The GFSI looks forward to GRMA’s continuous improvement and formally invites them to benchmark their Dietary Supplement Program based on NSF/ANSI 455-2 standards to the GFSI scope L benchmark requirements. We look forward to working together to build quality standards.”

The Global Retailer and Manufacturer Alliance (GRMA) is a global nonprofit with members of major retailers, manufacturers, trade associations and certification bodies. The alliance was formed to develop an auditing program that utilized consensus-based, ANSI accredited quality system standards for Good Manufacturing Practices (GMPs) in the Health and Wellness product categories, including Dietary Supplements, Cosmetics and Over the Counter Drugs.

“This is a giant step forward for our industry and helping to advance consumer confidence,” stated GRMA Board President Mike Finamore, who is also the CEO of Gemini Pharmaceuticals. “It is one more brick in the foundation of strong supply chain accountability.”

GRMA, which uses the NSF/ANSI 455-2 Standard as the base of its audit scheme, has been working diligently to build capacity as it rolls out the DS GMP Audit alongside several partner Certification Bodies (CBs). These CBs are also working toward ANSI accreditation for the GRMA DS Audit Program. “The GRMA has been putting forth significant resources toward the submission of our GFSI application,” stated Finamore. “Our retail and manufacturing partners are very excited to have our audit scheme globally benchmarked, gaining worldwide recognition.”

To learn more about the GRMA, visit www.grmalliance.org, or contact Randy Slikkers at rslikkers@grmalliance.org.

To learn more about GFSI, visit https://www.mygfsi.com/

GRMA
Randall G. Slikkers, CEO
1775 I St NW, Suite 1150
Washington, DC 20006
202-587-5647

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2019-09-09T16:32:53-04:00August 13th, 2019|News, Press Releases|

2019 GRMA Summit

For Immediate Release:

Washington, DC, July 19, 2019: The Global Retailer and Manufacturer Alliance (GRMA) is excited to announce its Annual Summit in Chicago from August 5 – 7 at the Sheraton Suites Chicago O’Hare. The GRMA is a global nonprofit with members from most major retailers, manufacturers, trade associations and certification bodies. The alliance was formed to develop an auditing scheme that utilized consensus-based quality system standards for Good Manufacturing Practices (GMP’s) through the American National Standards process in several Non-Food related industries. Each year, the GRMA Annual Summit brings together this broad group of industry stakeholders to focus on the continual improvement of quality and safety.

This year, the list of conference attendee’s includes, among others: Alkemist Labs, Amazon, ANSI, Brandless, Consumer Goods Forum, Costco Wholesale, Council for Responsible Nutrition, County of San Mateo, CV Sciences, Inc., Diesch Law Group, APC, First Quality, Gemini Pharmaceuticals, GRMA Board and Staff, H-E-B, International Vitamin Corporation, NSF International, Pharmavite LLC, Ranir, Retail Business Services (Ahold Delhaize USA), Rockline, SAI Global, Topco Associates LLC, Tracegains, VNI Inc., Walgreens Boots Alliance, Wegmans Food Markets, Inc., and Whole Foods Market.

Included in this year’s agenda are critical topics facing the industry today, such as the rapidly evolving issues around the development of Good Manufacturing Practices (GMP) standards for CBD products. The GRMA has put together a panel of experts who can help shine a light on this important issue. Other critical issues include Social and Ethical Accountability Standards, the impact of the trade war and tariffs with China, emerging regulatory issues, a message from the Consumer Goods Forum, updates on the Global Food and Safety Initiative, and many other important topics.

The GRMA welcomes all stakeholders and the public to attend its Summit. You can register for the Summit by going to https://grmalliance.org/grma-summit/ or contact Kathy King at kathyking@grmalliance.org

GRMA
Randall G. Slikkers, CEO
1775 I St NW, Suite 1150
Washington, DC 20006
202-587-5647
rslikkers@grmalliance.org

2019-07-24T15:19:56-04:00July 19th, 2019|News, Press Releases|

Dietary Supplements Standardization – How ANSI is Striving for Safety and Quality

by Brad Kelechava

Many Americans depend upon dietary supplements to fortify their nutritional intake. According to the U.S. Food & Drug Administration (FDA), “3 out of every 4 American consumers take a dietary supplement on a regular basis.” Unfortunately, the connection between the consumer and the benefits of dietary supplements isn’t always clear. In some cases, supplements have been found to contain ingredients that are harmful to consumers and in others unsubstantiated claims have been made about their ability to treat health conditions. All of this erodes consumer confidence in the dietary supplements market.

Voluntary consensus standards and related conformance systems help to assure safety and quality in dietary supplements as a component of industry self-regulation and an adjunct to the regulatory framework. As the voice of the US voluntary consensus standards system, the American National Standards Institute (ANSI) is playing a key role in bringing together stakeholders to dialogue on this issue. In December 2018, ANSI and the Global Retailer and Manufacturer Alliance (GRMA) hosted a Dietary Supplements Stakeholder Meeting in Washington, D.C. on how to advance the quality and safety of products marketed in the United States.

ANSI is convening a follow-up Dietary Supplements Standardization Coordination Meeting to continue this discussion on May 13, 2019. Any interested stakeholder (e.g., manufacturers, retailers, government agencies, trade and professional associations, and consumer advocates) can attend. Read more at the ANSI Blog: Dietary Supplements Standardization – How ANSI is Striving for Safety and Quality

2019-05-28T18:06:03-04:00March 25th, 2019|News|

Global Retailer and Manufacturing Alliance Announces ANSI-Accredited Auditing Standards 

Contact:  Randall G. Slikkers, MBA
202-587-5647
rslikkers@grmalliance.org 

  

Newly-developed audit integrity program aims to help eliminate “audit fatigue,” redundancy and associated costs in the areas of Cosmetics/Personal Care, Dietary Supplements and Over-the-Counter Drugs 

WASHINGTON D.C. – The Global Retailer and Manufacturer Alliance (GRMA) received notification of ANSI-accreditation (American National Standards Institute) on the newly-developed 455 standards for Cosmetics/Personal Care, Dietary Supplements and Over-the-Counter Drugs.    

“These standards are an integral part of a ground-breaking audit system. They are the first of their kind in the industry,” stated Randy Slikkers, CEO of GRMA. “It is our intention that the standards adoption in these three key high-risk product categories will advance product quality and safety for consumers while improving the audit process.”   

Established in 2014 by a robust group of retailers, manufacturers and certifying bodies, the GRMA membership collaborated on the creation of the standards for the audit process.   

“The inherent credibility of an ANSI standard and related audit scheme will provide for the elimination of the expense, time and interruption caused by redundant audits faced by all manufacturers. This will allow manufacturers to redirect those efforts into improving quality systems,” explained Mike Finamore, CEO, Gemini Pharmaceuticals, Inc and GRMA Board Chair. “This needed adjustment to a broken system promises to provide efficiencies and improvements to all parts of the manufacturer/retailer relationship.”   

Christine Summers, Assistant General Manager over product safety and quality and environmental compliance for Costco and GRMA Board Vice President, believes that ANSI accreditation was a critical part of the process. “Having NSF and GRMA utilize the ANSI open and transparent consensus-building process ensured that all stakeholders were a part of building the standard. Everyone had buy-in and as a result the standard is very robust and will appeal to consumers, manufacturers, and retailers looking to ensure the highest product safety and quality.”    

Several pilot audits were completed in Q4, 2018 and the first certification audits will begin in February 2019. “The feedback and contributions of the certifying bodies, retailers and manufacturers who participated in the training and pilots were invaluable to this initiative,” commented Slikkers.   

The GRMA is in the process of identifying future consumer product categories for standards development.    

Retailers, manufacturers and other industry stakeholders interested in learning more about GRMA membership may contact: kathyking@grmalliance.org   

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The Global Retailer and Manufacturer Alliance (GRMA) is a 501 (c)(6) nonprofit collaboration led by major retailers, manufacturers, certification bodies and industry stakeholders. The alliance was formed in 2014 to develop consensus-based auditing standards for cosmetics/personal care, dietary supplements, over-the-counter drugs and other consumer products.

2019-05-20T20:00:59-04:00January 8th, 2019|Press Releases|