Before a supplement can hit the market, it must be tested according to FDA regulations. This makes sense; before consumers put anything into their bodies, they want to be confident the products they are using are safe, made with high-quality ingredients and do what they claim to do without unexpected side effects.
But the process of testing these products to ensure they meet those qualifications is complex. Many products contain multiple ingredients, many of which are altered to precise, often proprietary, specifications.
To ensure supplements meet these above-mentioned criteria, brands—and the manufacturers they team with to create them—often use contract labs (i.e., outside testing companies) to certify products are fully and validly tested.
This INSIDER Q&A with industry experts shines a light on how these companies navigate their complex relationships and obligations to each other to ensure all products hitting the market are safe and effective.
INSIDER: What’s the biggest issue facing contract labs that affects the credibility of finished health and nutrition products?
Tammy Blakemore, general manager, SORA Labs: The unknown.
Contract labs generally don’t know the ingredient interactions for the products they are testing and often, neither does the label owner or manufacturer.
Quality-control (QC)-based contract labs are expected to have fast turnaround times at competitive prices, but with the industry moving so fast and growing so quickly, marketing often outpaces science. Understanding the interactions between all the ingredients in a finished product is not being given the necessary time or resources.
When the industry is doing things accurately, there is ample time during formulation to test the products and determine the matrix effect with each ingredient. Once the product is blended and ready to ship, it’s too late to make adjustments and it can be a scramble to determine why results are out of specification.
Elan Sudberg, CEO, Alkemist Lab: The issue starts with the fact that most finished products are not getting tested by contract labs to confirm label claims. The second issue is that some clients are taken aback when they realize the cost to test finished products. There are no test methods for unique finished products unless and until someone commissions their development. While some companies work hard to make this investment, many finished products are not tested. There are plenty of testing points along the way, beginning with starting ingredients. What matters more than anything else is the final product; rarely is it actually tested to be sure it meets the label claim.
Tara Couch, senior consultant, EAS Consulting Group: The challenge for the contracting laboratory is that it is rarely provided material or product matrix information, any mitigating circumstances pertaining to the sample, or even specifications that are necessary to ensure that appropriate, scientifically valid test methodologies are used. Some of this lack of sharing is intentional due to proprietary concerns; unfortunately, it is far more common that the manufacturer does not have the scientific knowledge and is relying on the contract laboratory to have that understanding in a vacuum.
INSIDER: How can finished-product brands ensure their contract labs are using fit-for-purpose assays, given technological advancements and FDA’s requirement of “scientifically valid?”
Couch: A “scientifically valid” test method is described in the Preamble to 21 CFR 111, cGMP (Current Good Manufacturing Practice in Manufacturing), Packaging, Labeling, or Holding Operations for Dietary Supplements, as a method that is accurate, precise, specific, consistently does what it is intended to do (often referred to as rugged), and based on scientific data or published results.
The demonstration that a newly developed methodology, modified compendial test method or adopted compendial test method meets these criteria is a basic tenant of Good Laboratory Practices (GLPs) and GMPs prior to the use of any test and is referred to as a method validation or verification, as appropriate.
A brand owner can ensure its contracting laboratory uses only validated or verified test methods by requesting documentation of pertinent test-method validations and verifications and qualifying that lab through a Contract Laboratory Qualification program. Such a program should include an extensive qualification questionnaire to evaluate all the laboratory control processes, including method validation/verification. It should also include an on-site audit of the facility to determine whether the systems indicated on paper are actually adhered to in practice and follow-up periodic challenge testing of the results obtained from the laboratory.
Blakemore: Relationships are key here; the brand and contract testing lab should be considered an important partnership. Ensuring quality through testing is a financial decision, but the emphasis needs to be placed on working with a lab that has expertise for the products being tested, instead of cost-shopping and switching labs whenever a few dollars can be saved.
People don’t realize most methods are designed for raw material testing. So, when these same methods are used on blends and finished products, they may not report the same results anticipated for the finished product. Some potency claims may drive method adjustments or new method development using more sensitive instruments. These development steps should be addressed specifically for the unique ingredient blend of the finished product being tested. This research and method development is an investment of time and resources upfront, to ensure that the final QC testing is a successful, seamless part of the process.
John Atwater, Ph.D., senior director, Verification Programs and Edward P. Wyszumiala, director of customer engagement, United States Pharmacopeia: It is beneficial for a product brand owner to ensure that its contract laboratory is following all applicable GMP requirements. This requires a close and transparent working relationship with the contract lab. The product brand owner should not treat the contract lab as a “black box,” expecting to obtain reliable results by just sending in samples and requesting testing for a particular assay. It is the responsibility of both the product brand owner and its contract laboratory to ensure that properly validated and/or verified test methods are used for testing a particular substance in a product. Of course, the product brand owner should work with a reputable testing laboratory. When possible, the product brand owner should use an officially recognized test method (e.g., USP, AOAC) and verify that the validated test method is suitable for use for the product.
Sudberg: A finished-product brand can ensure its contract labs are using fit-for-purpose assays by auditing them. It’s also smart to get a second opinion in certain cases, which is why it’s helpful to have a relationship with a consulting firm.
INSIDER: What are the best ways for brands to know their contract lab uses correctly calibrated equipment and qualified personnel?
Daniel Sliva, PhD, chief science officer and founder, DSTest Laboratories, Purdue Research Park: The brands should ask if the contract labs are ISO 17025 certified. ISO 17025 is a valid certification that ensures calibrated equipment. In addition, it is important to ask about the qualification and experience of the lab director and lab technicians.
Blakemore: Relationships are important here, too. Know what questions to ask—and when—to make sure you are getting quality service. Testing relationships are built on trust and proven by competency. Ask questions and get to know the company you’re putting your trust in. Paper or on-site audits are also effective ways to get the answers you’re looking for. When you partner with an ISO 17025-accredited testing lab, it shows you have quality top of mind, as they have been through the rigorous audit process that ISO requires.
The bottom line: Get to know your partner in quality because it will give you peace of mind in the potency and quality of your products.
Sudberg: Audit them. There is no other way.
INSIDER: What are the top things a brand should look for during an on-site audit of a contract lab?
Sliva: On-site audits should focus on several important signs that the contract lab is performing its analyses according to the GLP. Is the QC/QA (quality assurance) in place? Specifically, laboratory instruments should be calibrated and certified; tested samples should be properly documented and stored; laboratory notebooks or electronically stored information should contain proper description of performed analyses and results.
Atwater and Wyszumiala: The product brand owner should begin reviewing the laboratory staff’s level of knowledge, experience and expertise, and should ensure that the lab has the appropriate analytical instrumentation with which to perform the desired testing. Most contract labs specialize in certain types of analyses, so the brand owner should make sure to use the right lab for the job.
Couch: The purpose of using a contract laboratory is to have access to their scientific expertise, both in terms of their personnel and testing methodology, so these must be critical factors assessed during an audit. However, none of that matters if the data generated from the laboratory is not generated with integrity. The use of GLPs and GMPs will ensure data integrity.
It is also important that the laboratory have robust quality systems in place to address quality incidents such as deviations and out-of-specification investigations. Vital to all these evaluations is the auditor. The auditor of a laboratory must be experienced and well-versed in laboratory operations.
INSIDER: Like many categories in the health and nutrition industry, there’s been a high level of Merger and Acquisition (M&A) in contract labs. What implications does this have for brands who use contract labs to test their ingredients/finished products?
Sliva: The most reliable laboratory results are the data from an independent laboratory which are confirmed by another independent laboratory. With a high level of M&A, the independent confirmation of results by other independent laboratories will be difficult.
Blakemore: For brands using labs that are merging, it’s important to keep the line of communication wide open with the lab staff. Make sure the quality of testing is not being impacted by the structural changes. If you notice changes that cause delays in results reporting, slower communication or indications that the quality of testing may be declining, a follow-up or on-site audit is a good idea.
Couch: The high volume of M&A of contract laboratories has limited the number of “named” laboratories that are available to support the health and nutrition industry. These labs use the consolidation as a marketing tool to say that they’re a “one-stop shop” for all testing needs. However, the fact is there are still, and will always be, many different laboratories that must be used for all the various scientific expertise needed for testing health and nutrition material and product samples. This means the level of scientific expertise, GLP and GMP compliance, and quality system robustness therein also varies, and that manufacturers and own-label distributors contracting with these laboratories must ensure they are auditing the actual facility where the testing of their materials and products are performed.
Sudberg: It means the industry has fewer choices and less freedom to find the best lab to fit specific needs. Imagine you once went to the farmers market for your organic produce, Whole Foods Market for your animal protein, Amazon for your paper goods and Trader Joe’s for your dried snacks (because that’s what my family does). While it does take more time, we end up with the best and exactly what we want in all the categories.
Now imagine you can only go to Walmart for all those things.
That’s a fitting analogy for the lab arena today. There is only a handful of reliable small labs that have their specific areas of expertise, and a few big ones who are going to try to undercut the little specialty labs while claiming to be able to test everything proficiently.
At the end of the interviews, the respondents were asked if they had any parting words. Dr. Atwater and Mr. Wyszumiala summed up everybody’s thoughts well:
“Contract laboratories play an important role in the health and nutrition industry. They can support a manufacturer’s research-and-development (R&D) efforts and can provide QC testing for GMP compliance. A clear and detailed quality agreement and strong partnership between the brand owner and contract laboratory are keys to a successful working relationship.”