“Transparency” is a hot term in the natural products industry. Manufacturers know that health-conscious people want to know as much as possible about the foods and supplements they buy. Consequently, many brands now make claims about their transparency and their products’ traceability.
Few, however, publish complete, regularly updated data from their quality analysis testing for all the world to see.
This year, Metagenics—one of the top three practitioner-channel brands—has taken that step, with its new TruQuality program.
The initiative provides practitioners, patients, and basically anyone with an internet connection, full access to the data from all analytical tests performed on every lot of Metagenics’ products going back for 2 years.
“This is 100% transparency,” says Brent Eck, Metagenics CEO.
Any interested party will be able to see all tests and all parameters for all of the company’s roughly 300 different products. For each formula, the TruQuality website lists results for every quality assurance measurement, along with reference standards for each test, allowing viewers to see how Metagenics’ results stack up against accepted and validated standards.
The analytic data are fed directly from Metagenics’ in-house quality control laboratory, without filtering from the executive or marketing departments, and the list is exhaustive. Each product lot is put through literally dozens of tests, including a thorough microbial analysis, tests for various heavy metals, pesticides, solvent residues, environmental contaminants, and common allergens including gluten.
Trust, But Verify
“We test every product extensively, and we’ve always done everything we could do. I believe we do all the appropriate and validated tests. If there’s something we’re not doing that we should be doing, please tell us,” Eck told Holistic Primary Care.
“If you’re going to say that your products are better than mine, that your products are made to higher quality levels, then prove it by putting all your test data out there.”--Brent Eck, CEO, Metagenics
Metagenics employs 33 people in its Quality Assurance and Quality Control teams. The motto, “Trust But Verify” is the team’s guiding principle, says Steve Sheppard, Senior Manager of QA/QC.
Sheppard, who has been with the company for 18 years and previously worked in the medical device industry, says Metagenics is extremely diligent in vetting raw materials.
“We put a ton of effort up front, working with raw materials suppliers, so we have a really strong understanding of what they’re providing us. We don’t just approve a supplier by itself. We approve a supplier and their manufacturing method in combination. We want full documentation on how they manufacture, so we understand how the raw materials are processed, and all the sub ingredients, processing aids….. any info on allergenicity, or possible contaminants.
“Then, once we gather all this info---which includes GMO status and gluten contamination--we begin a full testing regime on the samples that they submit. And that’s before we bring anything into our doors.”
Reflecting on the Metagenics’ exacting standards for its ingredients, Eck added: “We are not easy to work with. We test a lot. We require three batch samples for testing before we’ll even consider buying an ingredient.”
But he believes such diligence is absolutely necessary to ensure the quality of the company’s output.
In addition to its own in-house testing, Metagenics also has its finished products independently tested by 3rd party labs.
“We send the products—without labels—to 3rd party labs for analysis. They report back to us what they see in the products, and we label based on what these 3rd party analyses tell us, not on what we tell them,” Eck explained.
The company leaders are also great believers in 3rd party certifications—such as GMO-Free and Gluten-Free--from independent organizations.
It’s a substantial investment. Eck said it took more than two years to obtain a Certified Gluten-Free seal because the certifying agency—the Gluten-Free Certification Organization, run by the Gluten Intolerance Group of North America—had to audit not only all of Metagenics’ final products, but all of the company’s raw materials suppliers as well, at Metagenics’ expense.
Beyond that, says Sheppard, Metagenics is constantly doing in-house testing for gluten content using ELISA tests.
“I think that the FDA says it has to be less than 20 ppm to be called gluten free. GFCO says 10 ppm and that’s what we aim for.”
Sheppard says going several steps beyond federal safety standards is the norm at Metagenics. “From an FDA regulatory standpoint, companies are supposed to manufacture to a certain standard, but the FDA doesn’t give you a “thumbs up” seal. So you don’t know when was the last time FDA visited a company. With multiple third party certifications, we are being reviewed all the time. They tell us where we perform well, and where we can improve. It really drives this culture of continued process improvement.”
He added that Metagenics meets or exceeds standards set by the NSF, the US Pharmacopeia, and Australia’s notoriously stringent Therapeutic Goods Association.
“We put a ton of effort up front, working with raw materials suppliers, so we have a really strong understanding of what they’re providing us. We don’t just approve a supplier by itself. We approve a supplier and their manufacturing method in combination. We want full documentation on how they manufacture, so we understand how the raw materials are processed." --Steve Sheppard, Sr. Manager of Quality Assurance, Metagenics
The company’s products are currently under review for certification by the Non-GMO Project. Sheppard says it is a very rigorous assessment, and it is all the more challenging because for some supplement ingredients, the bulk of what’s in the supply chain is genetically modified in some way.
“We have to go all the way to the source of the material, even if it is an animal derived ingredient. We have to look at the animals’ feed. Several of our products have been reviewed. We have a calcium-based product that comes from a microcrystalline hydroxylapetite. It is animal-derived, and we were able to get that non-GMO certified. We’re fairly proud of that, because it is a hard thing to find.
We continue to focus on that, and we will bring out more and more products that are certified non-GMO.”
Continuous Process Improvement
The production of probiotics is another key concern for Sheppard and his QA/QC team.
“We put quite a bit of effort into evaluating our probiotics, and making sure the viable count is maintained throughout the shelf life of the product. We make sure during the entire process that we keep the probiotics under as friendly environmental conditions as possible. They’re manufactured under low humidity, low temperature conditions, to make sure we don’t impact the viability of the organisms. We test for the activity, the viable counts on receipt of the materials at our facility, then we monitor the conditions during mfg, and then we test them prior to release of final products, to ensure that will sustain the label claim over time.”
It’s a complex process, Sheppard explained. Some species are inherently hardier than others, and long-term viability is influenced by delivery form (capsules versus tablets versus liquid suspensions). Further, interactions between different organisms in a multi-strain formula can also affect shelf-life. There are many variables, and they all need to be measured and controlled.
As the supplement industry grows and matures, so do the analytical testing technologies and methodologies. Sheppard says his company routinely invests in increasing its internal testing capabilities. A recent focus is on liquid chromatography coupled with mass spectrometry (LC/MS), “to test microquantities of different actives within formulas.”
Like many supplement companies, the Metagenics team is also evaluating the potential of DNA-based methods for verifying the identity of botanical ingredients. Sheppard believes that ultimately, the combination of high-performance thin-layer chromatography (HPTLC) and DNA analysis will prove to be the best method for herbal verification.
A Challenge to the Industry
In baring all of its analytical data, Metagenics is, no doubt, opening itself to criticism. Some people might take issue with the minute barely-detectable amounts of lead or other metals—all at levels far below federal safety standards—that show up on testing.
Eck says this is inevitable, especially with botanical ingredients grown outdoors. “No herbs are going to be 100% free of metals. You simply cannot get all of it out 100%. Anybody who says they can is lying. The key is to ensure your ingredients are well below the safety limits.”
With the TruQuality program, Eck says he’s throwing down the gauntlet to other leading supplement makers, challenging them to be equally transparent about their analytics and their product quality.
As much as the TruQuality information is intended to be useful to practitioners and patients, he also sees it as a step toward ending the rancorous infighting that occurs within the industry; each brand trumpeting its claims about quality and transparency while offering little meaningful data to support the assertions.
“If you’re going to say that your products are better than mine, that your products are made to higher quality levels, then prove it by putting all your test data out there.”
He and his colleagues hope that 100% transparency on analytic testing and quality validation will eventually become the norm across the industry, and especially among practitioner-focused brands.