Editor’s Note:
This article is part of a series from the American Botanical Council that deals
with 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 for the supplement 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 chronic, or even
acute, health issues, the safety, efficacy, and integrity of these products are
critical.
Emerson Ecologics, a leading wholesale distributor
of professional-oriented nutritional supplements for the integrative health care
community that is based in Manchester, New Hampshire, 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 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 (275 as of July 2017) 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
when 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.
The Silver and Gold Partner Standards
remain for brands that want to certify above and beyond the basic Emerson
Partner level, and companies that meet the Gold and Silver standards 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 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, even in pharmaceutical cGMP
regulations, for example, 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 the company 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, the
company 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.”
—Karen Raterman
References
- 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.
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