Introduction:
Welcome to our inaugural GRMA Digest.  We have kicked off 2020 with several changes and wanted to share our new address as well as a number of updates with our members and followers.  The GRMA views the Digest as a critical way of keeping our members informed with the organizations progress and available member benefits.  Additionally, the GRMA has hand selected a few key pieces of news articles/industry events and educational Webinars that are influencing the Health & Wellness category.

New Address & Phone # 
Global Retailer and Manufacturer Alliance, Inc.
1150 1st Avenue
Suite 501
King of Prussia, PA 19406
610-945-1797

ANSI National Accreditation Board (ANAB):
In December of 2019 the GRMA present our certification scheme/program using the following public standards to the ANAB accreditation committee for product/process/services bodies:

  • Dietary Supplements: NSF/ANSI 455-2-2018, Good Manufacturing Practices for Dietary Supplements.
  • Cosmetics: NSF/ANSI 455-3-2018, Good Manufacturing Practices for Cosmetics.
  • OTC Drugs: NSF/ANSI 455-4-2018, Good Manufacturing Practices for Over-the- Counter Drugs.
As an outcome of the meeting ANSI National Accreditation Board Opened Invitations to Certification Bodies (CBs) for Accreditation to GRMA Audit Program on February 12, 2020.  The GRMA is expecting multiple CBs to apply and become accredited. Read the full press release.

Additionally, the GRMA has formally requested ANAB to extend the invitation period to the maximum of 3 months. ANAB was in full support of our request and quickly confirmed the extension to May 12, 2020.  While this is a critical step for the GRMA in our path towards GFSI benchmarking for Dietary Supplements, we feel that it is a necessary step for the health and safety of our communities.

The following is an overview of key stage gates for the GRMA to submit our application to the GFSI benchmarking process:

Accreditation Program:

  1. ANSI National Accreditation Board Opens Invite to Certification Bodies (CBs) for Accreditation to GRMA Certification Scheme/Program – Complete February 2020
  2. ANAB Pilot Accreditation Kickoff Meeting – Target Q2 2020
  3. Certification Bodies that demonstrate conformance to the ANAB Accreditation program to GRMA Dietary Supplement Certification Scheme/Program, will be able to be accredited during 2020 – Target Completion Q4 2020 – Q1 2021
ANAB accreditation process see link:
Click Here

GRMA application to the GFSI Benchmark process:

  1. Receive Invitation to benchmark GRMA Dietary Supplement Certification scheme against GFSI requirements – Complete August 2019
  2. Complete 1 year of Accredited GRMA Dietary Supplement Certification scheme/program & Apply to GFSI Benchmarking – Target Completion Q4 2021 – Q1 2022
Certification Program Owners Undergoing Benchmarking:
Click Here

Temporary GRMA Conformity Assessment Guidance:
We wanted to take a moment to communicate GRMA conformity assessment activities (audit) changes related to the COVID-19 as this pandemic is having an unprecedented impact on our members, communities and families.  In response to the challenge, the GRMA is in full support of public health officials requests to practice social distancing and are providing this guidance to our members as we work through this challenging time.

We have requested that Certification Bodies (CBs) only perform remote audit, desktop Gap/Pre-Assessment audits during this time.  The following Audit descriptions within GRMAuditsphere would fall into the desktop GAP/Pre-Assessment audit activity listed above:

  • GRMA Dietary Supplements Pre-Assessment/Gap Audit Version 1.0.1
  • GRMA OTC Pre-Assessment/Gap Audit Version 1.0.1
  • GRMA Cosmetic Pre-Assessment/Gap Audit Version 1.0.1
Additionally, we have requested CBs to postpone conducting certification audits while health restrictions are in place.  The following Audit descriptions within GRMAuditsphere would fall into the certification audits that are being postponed due to COVID-19
  • GRMA – Dietary Supplements Version 1.0
  • GRMA – OTC Version 1.0
  • GRMA Cosmetics Version 1.0
This guidance enters into effect on the day of publication April 3, 2020 and is applicable until the GRMA revokes this guidance.

GRMAuditsphere Launch:
GRMAuditsphere is being launched the week of March 30th and is supported by of our technology partner, ReposiTrak.  Through ReposiTrak, the GRMAuditsphere utilizes an industry-leading Compliance Management solution that is trusted by retailers, wholesalers and manufacturers.  The ReposiTrak compliance management technology is considered the industry standard, is SOC 2 compliant (the highest standard for data security) and very friendly, which made it the obvious choice to keep member companies information safe & secure while providing efficient sharing of documents and item information.

Find out more about Out-of-Stock Reduction, Scan-based Trading and Sourcing solutions to leading retailers and their suppliers at ReposiTrak.com.

Updated Member Portal – Click Here:
The Member Portal has been updated to be more resource and tool oriented.  Please signup to receive communication on our website and add generalinquiries@grmalliance.org to your company email’s safe email sender list, otherwise you might not receive future communications. The new page now contains the following sections and will continue to evolve for our members:

  • Documents:
    • Normative GAP Assessment – Provides a summary of the approach used to create the NSF/ANSI 455 standards, standard orientation, the reference standards used in each category and a quick reference guide to the clauses that deviate from the normative reference standards.
    • Featured Article – Top Five Quality Gaps in the Contractor-Brand Owner Relationship, Provided by EAS Consulting.  This is inclusive of 5 webinar links.
    • Featured Whitepaper – What you don’t know about label claims is as important as what you do, Provided by NSF Health Sciences, LLC a division of NSF International. There is a webinar training teaser link for more detailed learning on claims.
  • Trusted Partner: The GRMA has been listening and we wanted to share a short list of consulting, testing, legal, educational service providers for our members reference.  The vendors on the short list have an established reputation within the Health & Wellness Industry and manufacturers may find their services useful as they look to advance their quality system capabilities.  The new program is expected to launch in the 2nd calendar quarter of 2020, and we will likely be adding partners to the list thereafter.  Additionally, we will be publishing requirements for this program to help our members understand our initial evaluation requirements.
  • Webinars: The GRMA will look to provide members with webinars both from the GRMA as well as our trusted partners on learning topics for the Health and Wellness category.  The GRMA will be kicking off webinars by offering free webinars to walk manufacturers through the key steps to achieve a GRMA Certification.  The webinar dates are below:
  • April 30th
  • May 12th
  • May 27th
Please sign up to receive GRMA communication on our website to receive the meeting detail on these webinars.
  • Learning – GRMAuditsphere Training is available for download.  The training documents will walk you through company set up, user set up, factory set up, audit requests and the audit process.  This is a simple 2 step training called:
    • Step 1: GRMAuditsphere Instructions: Supplier/Manufacturer Account Creation
    • Step 2: GRMAuditsphere Instructions: Suppliers/Manufacturers – Company/Facility Details & Audit Process
  • Certification Bodies (CB’s) with an active Partner level GRMA Membership are listed at the bottom of the member portal page.  The current list includes NSF International, Perry Johnson Registrars Food Safety Inc, SAI Global, and UL.  If you click each of their logo’s you will get specific contact information for each.
2020 GRMA Summit – Strategic Partnerships
The 2020 Summit theme will be Strategic Partnerships.  The dates will be November 18th-20th and will directly follow the PLMA trade show in Chicago, IL. We will be putting a summit tab on the GRMA website by May 15th, 2020 where you can get details on the following:
  • Agenda
  • Summit Registration
  • Training Registration
  • Hotel Accommodations
  • Sign up to receive communication leading into the summit
  • Sponsorship
Health & Wellness Industry News:

  • Supplement contract manufacturing recall ‘unprecedented’ – Jan 31, 2020 A contract manufacturer of dietary supplements for years fell short of regulations intended to ensure products are safe and made to quality standards. Read more https://www.naturalproductsinsider.com/regulatory/supplement-contract-manufacturing-recall-unprecedented
  • Talc – On March 9, 2020, FDA issued a new Constituent Update and FDA In Brief on the release of results from FDA’s sampling assignment with AMA Analytical Services, Inc.  (AMA) testing talc-containing cosmetic products for the presence of asbestos.  On February 4, 2020, FDA held a public meeting on testing methods for asbestos in talc and cosmetic products containing talc. Read more https://www.fda.gov/cosmetics/cosmetic-ingredients/talc
  • FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) – There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD).  FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. Read more https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
  • FDA FDA Requests Removal of All Ranitidine Products (Zantac) from the Market – The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. Read more https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

Featured Whitepaper:

  • What you don’t know about label claims is as important as what you do – Provided by NSF Health Sciences LLC, a Division of NSF International. When it comes to claims, there is more than meets the eye – A Lot More. Manufacturers don’t always grasp the complexity, technicality or scope of information for substantiating claims. There are numerous categories of claims, and each category can have its own individualized requirements, and requirement latitude. The requirements around claims are varied and depend on the type of claim. Read more https://go.pardot.com/l/129231/2020-03-24/36vj86

Featured Health & Wellness Industry Webinars:

Top Five Quality Gaps in the Contractor-Brand Owner Relationship – Provided by EAS Consulting Group, LLC

More and more dietary supplement companies are contracting out their manufacturing, packaging, laboratory testing, and distribution services, enjoying great efficiencies and enhancement of capabilities while getting their products to consumers more quickly.

The brand owner, or Own Label Distributor (OLD), is ultimately responsible for all this regulatory compliance and liable for ensuring product safety, no matter where or whom performs operations.  Let’s take a look at the OLD – contractor relationship, with specific attention to the top areas where a lack of OLD processes and communications, as well as oversights, can become catastrophic.

#5: Not understanding the role of GMPs as part of product development
Watch: Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success

#4: Lack of proactive participation in the contractor relationship
Watch: Own Label Distributors Responsibilities

#3: Not paying attention to FDA enforcement actions
Watch: Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters

#2: Failure to Qualify your Contract Laboratory
Watch: How to Select and Qualify a Contract Laboratory

#1:  Failure to establish a quality agreement
Watch: Quality Agreements in the Complex World of Dietary Supplements

A note: We will be illustrating these challenges and some solutions through links to on-demand webinars found on the EAS website. These regulatory rich tools are meant to be a learning opportunity that allows you to strengthen your knowledge of GMP compliance. Whether you use these one-hour courses as a check on your GMP programs, or choose to partner with an outside consulting firm to assist with development and implementation, we encourage you to learn as much as you can about 21 CFR 111 and other applicable FDA regulations. The better your knowledge, the better your ability to protect yourself from FDA enforcement action and protect your brand’s reputation.