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Quality Assurance Q&A

Compliance & Quality Compliance & Quality

Embarking upon a dietary supplement launch (whether a signature singular product or a line) is a laudatory event, especially given the mass consumer acceptance of, desire for and trust in our products; a goal a long time in the making.

So, you have an idea and the talented team to turn it into products for consumers. But it is no longer enough to assemble the research, development, contract manufacturer and marketing team. Quality is more than a buzzword that you need to know all about.

Industry experts discuss what the best questions are you to ask, and what you need to know to launch your product with confidence in its authenticity, safety and efficacy.

David Trosin, director of global business development, dietary Supplements at NSF International, Michigan, observed, “It’s surprising how often quality agreements are not part of overall business agreements. Many brand marketers are not familiar with current regulations nor aware of their requirements. Having good guidance and an equitable agreement in place will be helpful if and when issues arise.”

Ingredient sourcing is imperative to gain a handle on, said sources. “We all know how wide the range of ingredient quality is, from truly stellar to absolute crap,” emphasized Elan Sudberg, CEO, Alkemist Labs, California. When buying ingredients as commodities, they were more than likely aggregated from numerous sources, therefore it is difficult to know what it really is and how it was handled.

He advised to always have an experienced industry lab test for identity, potency and purity, notably for commodity ingredients. For branded ingredients and generic ingredients from reputable suppliers, “you don’t need to be quite as relentlessly suspicious,” but testing for identity is still required. He added to ensure that the supplier works with several experienced labs in training them to test their novel ingredients. “I say several because if it’s just one, that’s like drylabbing. Testing novel ingredients is a bigger issue than most of the industry realizes; lack of transparency on how to test novel ingredients causes a lot of consternation because of failed samples that could be avoided.”

When working with contract manufacturers, he advised, you need to be specific about the ingredients and confirm these are ingredients are indeed being used; plus, you need to ensure that the testing being performed is done by labs proficient in those testing methodologies. “The FDA (U.S. Food and Drug Administration) expects the brand owner to have written cGMP (current good manufacturing practice) documents, and that includes testing to confirm ingredient identity,” he said, warning: “Make sure the contract manufacture is doing the testing and doing it right, because the CM won’t pay your legal bills if the FDA finds they are not.”

According to Jennifer Cooper, vice president R&D and quality, Twinlab Consolidated Corporation, Florida, processes including method development, safety validation, stability testing, claims substantiation, procuring standards, vetting suppliers, determining appropriate packaging, collecting a wide range of samples, refining specifications, and preliminary testing are all necessary and all take time, which needs to be built into the R&D blueprint—and the quality should be constantly monitored throughout the entire development of a product. “Too often, a wonderful, unique product idea is modified, compromised, and tweaked along the path to market every time it encounters a technical, scientific or quality hurdle,” she commented. The resulting product does not reflect at all what was originally designed or indeed what the customer wanted.” And because the final version is so different than what was originally conceived, no company department – sales, marketing, R&D and QA (quality assurance)—is quite happy.

If you intend to use the word “natural” on your products, Anna Lykkeberg, research associate, Beta Analytic, Florida, has a checklist of questions for which you should obtain responses.

• What controls/tests are in place to verify that a “natural” ingredient is plant-derived and actually natural?

• What controls/tests are in place to verify how “natural’ the composition of the final product is? “Depending on the processes used, this may not necessarily be the same as the raw ingredients,” she emphasized.

• Who carries out these tests – in-house or third-party testing facilities (or both)?

• Are they ISO 17025 accredited?

• Are they using standardized techniques and professional technicians?

• What are the QA controls and tests specifically testing for?

“The delicate relationship between marketing, quality and R&D must be a collaborative process which is dedicated to incorporating quality from the earliest stages, concluded Cooper. “Quality should be involved from the very beginning to prevent a cascade of ‘surprises’ at the end of the process that force companies to make difficult decisions and sometimes compromises.”