Editor’s note: This article is part of a series from the American Botanical Council (ABC) that deals with various issues and self-regulatory initiatives in the global botanical supply chain that are related to the authentication and identity, adulteration, and/or contamination of botanical raw materials, extracts, and essential oils. Previously, we published an article on the National Animal Supplement Council (a trade association of manufacturers and suppliers of supplements for pets) and its self-regulatory program to monitor authenticity and quality of ingredients used in its members’ products.1
Procedures that help ensure quality in the supply chain have become increasingly important and relevant for the supplements industry in recent years. Standards for products in the practitioner channel have received particular scrutiny. As more and more integrative medicine practitioners turn to supplements to address common nutritional challenges and health issues, ensuring the safety, efficacy, and integrity of these products is critical.
Emerson Ecologics, a Manchester, New Hampshire-based wholesale distributor of professional-oriented nutritional supplements for the integrative health care community has been a leader in bolstering the standards for these products with its Emerson Quality Program (EQP). The program, launched in 2010, was the first program of its kind to assess and verify manufacturing practices of brands in the sector, according to Jaclyn Chasse, ND, vice president of science and regulatory affairs for Emerson (email, July 17, 2017). Born from conversations with integrative health practitioners, the program was designed to ensure that the brands Emerson distributes comply with the US Food and Drug Administration’s (FDA’s) current Good Manufacturing Practices (cGMPs) for dietary supplements, and to identify those brands that go above and beyond the baseline standards for compliance.
The launch of the EQP predated the full implementation of cGMPs in June 2010 under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Emerson was aware at the time of the challenges that practitioners faced with respect to the quality of supplements, said Chasse. “These practitioners were applying and using supplements as other practitioners apply medications. So they wanted to be sure they were not causing harm, that potencies were what they said on the label, and that they contained the correct plant to have the right effect,” she said (oral communication, July 3, 2017).
Currently, the EQP requires all companies (also referred to as “brands” by Emerson) whose products are distributed by Emerson to complete a three-phase process.2 The first phase is cGMP compliance verification, which is reviewed and summarized by the Emerson Quality Department. The second phase of the program is a verification process in which Emerson conducts a document audit, requiring the brand to provide all requested manufacturing standard operating procedures (SOPs), as well as master manufacturing records, batch/lot-specific manufacturing records, and analytical testing documentation for selected products. The document audit is followed by verification product testing, in which certain potency or contamination tests for selected products are conducted by an Emerson-qualified independent analytical laboratory. The results must be consistent with the brand’s product specifications and standards, which must also meet EQP standards. The final phase is a full-day, onsite audit conducted by Emerson quality personnel with a review and audit report. Program participants must correct any findings from the audit.
The current Emerson Partner standard is required for all distributed brands and ensures practices that are consistent with high-quality, safe, and reliable dietary supplements.3
Getting Companies on Board
There have been changes to the program over the years. When it first rolled out, the basic certification was called a Green Partnership, which verified that brands met cGMP standards. Silver and Gold Partnerships, which required additional verifications and onsite audits, identified companies that went beyond the baseline level.
Early on, it was difficult to get every company to embrace the program, Chasse recalled. Many company executives were excited about the program, but others were more cautious, so Emerson worked to anticipate any objections. “We took ownership of the cost, because in the beginning we wanted to be sure that EQP was not a ‘pay-to-play’ program,” she said. “We wanted to eliminate hurdles for small brands and any perception that you could throw money at the program and get the seal.”
Emerson found that the program struck a chord for practitioners in particular. “What we saw over time was that the majority of Emerson’s sales are in the brands that are current Gold and Silver Partners,” Chasse wrote (email, August 3, 2017).
The EQP faced other challenges in the beginning. For example, as it laid out testing parameters, Emerson quickly realized that companies have many different ways of testing and verifying products at various stages of manufacturing. “We wanted to make sure we were using valid methods and set parameters around how often companies were verifying potency and testing for relevant contaminants,” Chasse said.
There were also hurdles getting companies to share their processes. “Many companies are very proud of their manufacturing practices and were open to bringing us in to audit and take a look at their practices,” Chasse explained. However, she added, some brands were more hesitant to disclose what they were doing or share trade secrets, especially if they used a contract manufacturer. (A contract manufacturer [CM] produces finished consumer products for many brand holders; the contract manufacturer usually procures the raw materials [although often the brand holder actually sets the specifications and purchases raw materials to be processed by the CM], checks the quality of these materials, mixes them, and processes them into capsules, tablets, liquids, etc., and into the packaging of the brand holder.)
“The communication hurdles have gotten better over time,” she noted, but added that disclosing information about contract manufacturers can still be difficult for some companies. “If we don’t know who the contract manufacturer is, we cannot ensure it is cGMP compliant.”
In 2014, with cGMP compliance having been a legal requirement for all dietary supplement companies since 2010, Emerson believed that being cGMP verified should no longer be a special distinction, but should be the standard. They therefore eliminated the Green Partnership. “When we eliminated the Green Partner level and made those standards the base requirement for distribution, the existing Green Partners either moved up (by enhancing their quality practices because they wanted to retain a special seal) or they simply lost the seal. We now have 41 EQP brands. The majority of the sales still go through these brands,” she said. But Emerson also distributes several hundred other smaller brands that must at least meet the baseline requirements.
The Silver and Gold Partner standards remain for brands that want to certify above and beyond the basic Emerson Partner level. (Companies that meet the Gold and Silver Partner standards still are considered EQP Partners.) In addition to adhering to the basic Emerson Partner certification program, Silver Partners must meet the following requirements:
- Acceptable supplier and contract brand qualifications, such as cGMP compliance, and regular onsite audits. (In addition, certificates of analysis for raw materials and finished products are initially validated by conducting full confirmation testing);
- SOP demonstration of controlled manufacturing processes for all finished products and cGMP operations;
- Specifications for all raw materials and finished products with documented use of standards;
- Use of appropriate testing methodologies when testing for identity, microbiological contamination, heavy metals, pesticides/herbicides (for botanicals), aflatoxins (when applicable), melamine (when applicable), and residual solvents;
- Raw material testing on each batch/lot or raw material testing at a frequency justified by a written rationale, which will include a certificate of analysis for each ingredient, batch/lot testing for identity, as well as analytical testing on at least every fifth batch/lot to determine microbiological load, heavy metals, pesticides/herbicides (for ingredients that are not certified organic; US Department of Agriculture organic certification would be an acceptable alternative test for pesticides and herbicides), solvents (used in extracts), and adulterants. Each ingredient or product must be tested according to an established risk-based testing program;
- Potency testing procedures to ensure that finished products meet label claims in place and in use;
- Demonstrated industry knowledge of common adulterants and contaminants and sufficient testing to guarantee the absence of these adulterants and contaminants in finished products, (with suppliers of adulterated ingredients being disqualified); and
- Re-qualification for the program through a questionnaire or onsite audit at least every three years.2
In addition to adhering to all Silver Partner qualifications, Gold Partners must also demonstrate the following additional requirements:
- Analytical testing on each batch/lot of raw material or finished product for identity, potency (label claims), microbiological contaminants, as well as other analytical tests on ingredients at risk for certain impurities, such as residual solvents (for extracts and concentrates), pesticides (for non-organically grown botanicals), melamine (for animal proteins), aflatoxin (for high-risk herbs and foods), and adulterants;
- A real-time stability program to ensure that all finished products meet label claims for their entire shelf life;
- Products contain adequate active ingredients for clinical efficacy (as evaluated by the Emerson clinical team), and clinical trials are conducted whenever possible; and
- Evidence of total quality, including research and product development, sustainable environmental practices, support of efficacy and safety with data from clinical trials when possible, and good business practices.2
The primary difference between the Gold and Silver Partner programs, according to Chasse, is that Gold Partners are required to have real-time stability programs, while Silver Partners may employ accelerated stability testing. “Real-time [means] measurement of product stability/potency/contaminants (like microbes), through the shelf life of the product,” Chasse wrote (email, July 17, 2017). She noted that because the FDA allows skip-lot testing as an acceptable practice (e.g., for heavy metals in herbs purchased from the same supplier), Silver Partners can test for contaminants in up to every third batch/lot. “But they have to have a rationale as to why this is low risk,” Chasse said. Gold Partners test each batch/lot by EQP standards.
An Ongoing Investment
Providing testing for EQP brands requires Emerson to make a significant investment to keep the EQP going and evolving, as the industry changes and advances — so much so, Chasse said, that Emerson is considering an application fee for the brands, which will cover some of the initial certification costs.
Emerson would also like to get more leverage from some of the testing data it collects and best practices it monitors, which could be of value in the broader industry, she noted. But because Emerson has a non-disclosure agreement (NDA) with every client, there are limits on information sharing.
Emerson would also like to share more information about the lab testing of products. Four times a year, Emerson sends products from its warehouse shelves to independent labs to be tested for heavy metals or some other issue of current industry concern. For example, Emerson recently tested grapefruit (Citrus paradisi, Rutaceae) seed extract for benzalkonium chloride and related compounds, which are used in hand sanitizers and other household products and that have been reported as known adulterants of grapefruit seed extract.4 The ABC-AHP-NCNPR Botanical Adulterants Program (BAP) is a prime resource for Emerson Ecologics as it determines what adulterants to test for.
“Because we have NDAs with all our partners, the only action we can take if we see a failed result is to discontinue the product or brand,” Chasse explained. She added that Emerson is talking with potential partners, such as the nonprofit American Botanical Council (ABC) and the ABC-AHP-NCNPR Botanical Adulterants Program, about how to get permission from EQP brands to anonymously publish or make use of such test results.
Looking ahead, Emerson hopes to continue to use the EQP to help drive improvements in supplement quality through testing methods, transparency, and sharing best practices. “The herbal identification world is rapidly changing with many partners trying DNA testing,” Chasse said. “We have had a lot of brand audits in the last year [and] we are seeing brands explore new analytical methods, including DNA testing. DNA testing is not ready to be an EQP standard yet, but this is an area we are paying attention to.”
Emerson also wants to keep things relevant for its clinician customers. “Practitioners don’t necessarily want to do the research themselves or review the [certificates of analysis], but they do appreciate full transparency, which guides their trust,” Chasse said.
The EQP strives to stay on top of changes and advances in the industry, and Emerson thinks there is an opportunity to bring partners together in a communication forum to share best practices and innovative ideas. “Some companies are reluctant to share these things because it gives them an industry advantage,” Chasse said, “but for us, we also care about the practitioners and their patients, and this is where information sharing is so valuable.”
- Yearsley C. NASC Preferred supplier program focuses on quality standards in animal supplement industry. HerbalGram. 2017;113:62-69. Available at: http://cms.herbalgram.org/herbalgram/issue113/HG113-qc-nasc.html. Accessed July 12, 2017.
- About the EQP. Emerson Ecologics website. Available at: www.emersonecologics.com/Quality/AboutTheEmersonQualityProgram/. Accessed June 15, 2017.
- EQP Partner Standards. Emerson Ecologics website. Available at: www.emersonecologics.com/Quality/EmersonQualityProgramPartnerStandards/. Accessed June 30, 2017.
- Cardellina JH. The adulteration of commercial ‘grapefruit seed extract’ with synthetic antimicrobial and disinfectant compounds. HerbalGram. 2012;94:62-66. Available at: http://cms.herbalgram.org/herbalgram/issue94/QUALCONTROL_gfse.html. Accessed July 10, 2017.