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A Commitment to Quality … Continued

Complaince & Quality Complaince & Quality

The Participants:

Elan Mikel Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com Justin Bath, President, Biovation Labs, Salt Lake City, UT, www.biovationlabs.com

Gisele Atkinson, Vice President, Quality & Technical Affairs, Council for Responsible Nutrition (CRN), Washington, D.C., www.crnusa.org

Daniel Fabricant, PhD, CEO and President, Natural Products Association (NPA), www.npanational.org

Christen Davis, Director of Quality, North and South America, Lonza Consumer Health & Nutrition, Greenwood, SC, www.lonza.com

Aaron Secrist, Vice President of Quality and Regulatory Affairs, NOW, Bloomingdale, IL, www.nowfoods.com

Ankit Rathi, QA Manager, Specialty Enzymes & Probiotics, Chino, CA, www.specialtyenzymes.com

John Atwater, Senior Director, USP Verification Services, Rockville, MD, www.usp.org

Compliance, quality and price are in the balance for the natural products industry’s unique mission-driven business model of promoting health and wellness from seed to shelf. But achieving the goals that come with that demands ongoing diligence. Here is the continuation of the feature article where industry experts offer their take on what constitutes quality in the natural products world—how to attain and maintain it, and what obstacles may lie ahead.

NIE: There are hundreds of thousands of natural ingredients/sources for dietary supplements—and still a high potential for adulteration or use of the wrong material. How do you believe adulteration prevention has potentially improved—and what needs to be done to make it even more foolproof?

Davis: Adulteration prevention is a key focus area for manufacturers and suppliers alike. While a deep understanding of required testing is vital, end-product manufacturers are increasingly demanding that suppliers’ quality systems go beyond these minimum requirements. It’s also critical to ensure that the test methods used are based on relevant global, regional and industry-specific regulations, and that these processes are validated to ensure consistency and accuracy.

Fabricant: Enforcement has been a deterrent or band aid, but full implementation and adoption of SSCI (The Supplement Safety and Compliance Initiative) by the industry will certainly be a major driving factor for change in the industry over the next decade.

Sudberg: Adulteration prevention has improved as a result of raised awareness by both consumers and B-to-B. A lowered industry tolerance for substandard labs has also helped, because experienced labs know what to look for. We’ve seen some manufacturers or suppliers identify new forms of adulteration and share that information with the industry, which we applaud, huge proponents of collaboration that we are. There are also groups of experts collaborating on high-risk material, and testing experts identifying best methods for specific types of risks. For example, adulteration of ginkgo from China is extremely common, but we devised a method of analysis using two different HPTLC (high-performance thin-layer chromatography) methods to screen out the most common tricks. One of the methods we use is the recommended Pharmacopoeial method, which is inadequate to see the adulteration by itself unless one knows what to look for, and the other is an alternate HPTLC method that clearly demonstrates the difference between adulterated and non-adulterated ginkgo. Now we routinely run both methods for any ginkgo samples we receive for identity testing. So relying on a lab with extensive testing experience is the best line of defense catching adulteration, particularly in botanicals.

An issue that needs far more attention than it gets is testing lab competency. No lab is proficient at testing everything for everything, that’s just a fact. And since the vast majority of manufacturers are not equipped to handle every kind of testing they would need to do for true compliance and assured quality, manufacturers need to know which labs they can trust to give them results that are supportable using fit for purpose testing methods applied with expertise. Vetting a testing lab prior to using them is essential. Some of the questions to ask include: What do we need tested, and what for? Which labs do that well? What kinds of certifications do they have? Have they been assessed by an outside organization like American Association for Laboratory Accreditation (A2LA)? If they have ISO accreditation, does it apply to what you are having tested, or something unrelated? How transparent are they about the methods they used to test your material (which you need to know so the tests can be duplicated if challenges arise)? What is their process for handling it when testing results in failed material (the answer should be collaborative to find answers)?

While some substances are relatively straightforward to test, botanicals are the most complicated category of dietary supplements to test, requiring true experts to be sure of the results and work through any complications that go with the territory. I can confirm that even manufacturers with decent in-house labs regularly seek out highly specialized testing for herbs because they come to us.

FDA (U.S. Food and Drug Administration) told me they don’t audit labs unless bad data leads to a health hazard, so relying on them to tell you if your testing lab is inadequate is foolhardy. I’ve actually issued an invitation to them to our facility for a training session in botanical identity testing, and hope they will take me up on it.

Secrist: Opportunities for adulteration are certainly not decreasing. The continued, ever-expanding global supply chain requires constant vigilance. There are many tools and strategies available, but they require commitment and have to be consistently utilized. These include on site auditing, commitment to ethical and sustainable sourcing policies and the willingness to invest in quality and maintain the standards that are set.

The knowledge regarding the ways that these ingredients are adulterated and the tools to discover them have never been more prolific than they are today. That being said, it takes a high degree of expertise to wield this knowledge and these tools in an efficient and effective way, along with absolute commitment to quality to avoid the many pitfalls and snares of the supply chain and ensure that high quality ingredients are used to make high quality finished products. Many companies are not willing to do the following three things to ensure this happens:

1. Invest in the expertise of someone that can build a high functioning quality system. It isn’t cheap to hire someone with the appropriate skill set and experience to build a quality system from scratch or to overhaul one that is not what it should be. There aren’t a lot of people with this skill set in the industry and the ones that have it are in high demand.

2. Invest in the instrumentation and equipment to do what needs to be done. Primarily marketing companies that aren’t willing to lay out the capital needed to equip and staff a proficient quality control laboratory. Developing methods is time consuming and expensive, standards are expensive, but there is no substitute for reliable in house laboratories. They provide a level of control over and insight into products that can’t be attained with any contract laboratory.

3. Commit to adhering to the standards, specifications, values and tenants even when nobody else is aware or watching. This is known as instilling a culture of quality. It is easy to run a quality system when everything is going well, but you can tell a lot about a company by how they handle the problem situations. Sometimes there are mistakes made during the manufacturing process that require rework or in some cases, discarding the product, or recalls. This is what responsible companies do when there is a problem; they do the right thing regardless of the consequences.

Atwater: New analytical technologies are being employed to identify and counter adulteration and minimize the potential use of wrong ingredients. Some examples include the use of qNMR and DNA-based test methods.

By working with industry and academia, USP has been and continues to be actively involved in exploring and developing public quality standards that employ these new analytical techniques. Continued vigilance and greater participation from industry stakeholders working with USP is needed to help identify cases of adulterated ingredients or misidentified ingredients so that new test procedures can be developed and employed to identify and prevent such occurrences.

Bath: The key to ensuring that adulteration doesn’t happen is adherence to testing. Consistent testing will track and prove that raw ingredients and finished goods are not adulterated. If manufacturers are not testing on a regular and consistent basis, there is a high likelihood that some adulteration can come in. A strong and proactive supply chain management process is also key to preventing adulteration, through vendor validation, and working with raw material suppliers who are known to provide consistently high quality materials.

Rathi: Adulteration prevention has improved as monitoring of dietary supplement manufacturers and suppliers becomes more frequent and stringent. Companies recognize the importance of strong GMP (good manufacturing practice) programs, which not only have strong standards and procedures set up, but also consistently implement them.

Process and documentation controls are critical in making sure the correct materials are used. Robust testing programs improve adulteration prevention. Rigorous identity testing is a greater area of focus to make it more foolproof.

Allergan-control is more critical than ever, as consumers are becoming more aware of their allergies. Allergan testing has made great strides, but needs to become even more scientifically and technically capable.

No company can test for everything, so once again, it’s important to find suppliers with strong experience, certifications from reputable agencies, and a strong combination of testing, quality controls, and hazard analysis to maximize adulteration prevention.

NIE: What is on the horizon in the area of compliance and quality control, e.g. regulations and technology?

Atkinson: The recent restructuring underway in FDA’s Office of Regulatory Affairs, Program Alignment, will have inspectors grouped and assigned by product type rather than assigned by geographical location. Therefore industry can expect more knowledgeable inspectors taking a deeper dive during inspections, resulting in a more detailed and exhaustive look into a company’s policies and programs, which could result in findings that may have previously gone unnoticed. For example, the first phase of cGMP inspections that have occurred over the past ten years may verify that you are performing identity testing of incoming raw materials. Now the inspector may go one step further and evaluate whether the identity test that you are doing is ‘scientifically valid’. However, these changes are expected to result in the agency attaining a better understanding of dietary supplements, ultimately improving the relationship between industry and FDA.

Fabricant: Technology front, it is definitely CRISPR-Cas9 and its use to silence genes in crops rather than inserting DNA into them. Quality control, as I mentioned before SSCI.

Davis: As technology makes our lives more convenient and data-rich, it also increases risk around data accuracy and integrity. At Lonza CH&N, we continue to implement training for colleagues on data integrity and design systems, to ensure both compliance and complete peace of mind for our customers. With products designed and manufactured for commercial success, we need to apply these same principles to the quality systems in place, to ensure that products are regulatory compliant and in line with manufacturers’ expectations.

Sudberg: On the horizon is an arena where products have substantiated claims, and not only efficacy but quality. Branded ingredients are increasingly the predominant material in our products and the need to develop methods to prove their inclusion and label claim will be in high demand as the FDA starts pulling the string on that old sweater.

Secrist: I believe that technology will continue to increase our ability to continuously improve the quality of the raw materials and products. Knowledge is power and now more than ever data is becoming more accessible, and data in the hands of an able and experienced quality professional is like gold! It provides the opportunity to, in a very methodical way, improve everything in the supply chain and throughout the manufacturing process.

I believe that if the industry as a whole can get better at continuous improvement we will effectively be able to regulate ourselves, which will remove the need for future government regulations.

Bath: More testing will come into play. For instance, DNA technology will allow for more accuracy in testing. Technology will also provide quicker results in assay and identity testing. (DNA will not always be applicable, such as in the case of extracts). The timeframe and costs will reduce over time as well, making it more viable to conduct advanced tests that would currently be cost prohibitive. Testing will also become more sensitive and expansive. For instance, today we test for lead and other heavy metals. In the future, tests for impurities will include items such as GMOs (genetically modified organisms), pesticides and other containments that are outside of today’s normal tests.

Rathi: FSMA (Food Safety Modernization Act) and GFSI (global food safety initiative) are hot topics in compliance, as companies look to meet regulations, and strengthen their quality programs. Having more oversight or access to your supply chain is becoming more important.

In terms of technology, stronger identity testing in herbs and probiotics, as well as improvements in allergen testing are critical areas in need of technological development. Testing methodologies are being widely studied and I think we’ll see rapid development in these areas.

NIE: Other comments?

Rathi: Strong quality requires constant and consistent vigilance. We sometimes hear from the end users of our products, who say our enzymes and probiotics offer support for everything from minor digestive issues to chronic conditions. Like our counterparts in the industry, our focus is on them, and the safety, efficacy and purity of the products they receive.