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A Commitment to Quality

Meeting natural product stakeholder’s demands for ingredient quality is an ongoing task.

By Janet Poveromo, Nutrition Industry Executive magazine, July/August 2018

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, 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.

The Participants Are:

• 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, DC, wwww.crnusa.org

• Daniel Fabricant, PhD, CEO and President, Natural Products Association (NPA), Washington, DC, 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, 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: What are the biggest challenges to compliance, transparency and quality for finished product manufacturers and suppliers—claims, GMP (good manufacturing practice) standards, sourcing, or something else and why?

Davis:  Commitment to quality is always the foundation of good business. Challenges can be seen more positively as opportunities; the one constant with regards to both regulations and customer expectations is change. The “challenge” for the industry is to find the best way to anticipate these changes, while ensuring that the cost of quality is not increased in order to stay competitive.

Stakeholders’ expectations for compliance are simple; they want to ensure that they get it right [the] first time. Crucial to this is that manufacturers know their products, how they are used and identity upfront the requirements needed to meet both customer and regulatory expectations. Once the “Regulatory Design Space” has been developed, the focus is on a flexible approach to regulations based on science and quality risk management, with design, consistency and continuous improvement all key factors.

An additional opportunity for suppliers is in ensuring that regulations and expectations are met throughout the supply chain. Manufacturers of finished products need transparency across the supply chain, to ensure suppliers are meeting the standards required. If the operations and regulatory teams are aligned on expectations, delivering to a high and compliant standard in the first instance is seamless.

Fabricant:  Agency enforcement. People don’t realize that the industry wants more enforcement, and our members want more enforcement. Fly-by-night companies are not in for the long game or to build a reputation, and warning letters to them gives a black eye to the responsible industry that is in it for the long haul. Responsible industry invests in GMPs [good manufacturing practices] and compliance departments at their companies. Doing the wrong thing hurts their reputation.

Atkinson:  Dietary supplement cGMPs have been a mandatory compliance requirement for 10 years. However, the FDA (U.S. Food and Drug Administration) continues to report that the percentage of non-compliant companies is high when compared to other regulated industries like food. For example, FDA reports indicate that approximately 60 percent of cGMP inspections last year resulted in FDA having to issue a 483.

Responsible companies have a strong track record of compliance with cGMPs and often go above and beyond what is required. However, there are still a lot of the mid-size and smaller companies with less experience that continue to struggle with what is required by 21 CFR 111, and then unfortunately there are still some outliers that ignore the law altogether. Now that we are 10 years into this regulation, it seems that companies that are not able to comply have no place manufacturing dietary supplements.

CRN supports FDA enforcement actions against companies that are non-compliant. FDA needs to get these bad actors to come into compliance or face consequences. To further complicate things for the industry, there is a whole new set of complicated regulations, FSMA (Food Safety Modernization Act), so industry has to step it up and become compliant with FSMA because the expectation is that cGMP is the minimal standard.

Sudberg: From my experience serving finished product manufacturers, I observe that making a full and transparent commitment to quality can be the biggest challenge for some companies. It’s telling the board that you intend to spend X on quality while last year you spent less. It requires taking quality a step further and testing from seed to shelf, which means identity testing at each inflection point and, most importantly, testing the finished product. That is the biggest challenge since the regulatory guidance on how much testing the final product should actually receive is open to interpretation. To me it’s the most important last step, but the industry is slow to make that most important step universal. Of course you need to test the individual ingredients along the way, but if the label claims don’t match what’s in the bottle, you are liable to both consumers, FDA, class action attorneys and any state attorney general. The price for getting it wrong is just too high—far higher than testing properly.

Secrist: A main challenge is the complexity of the global supply chain. I see more and more botanical ingredients moving to China, which makes it harder for many companies to audit and verify that their suppliers are following good manufacturing practices.

The supply chain is continually changing, so just staying out in front of the issues is a full-time job. Natural products are especially vulnerable because geopolitical issues and increasingly unpredictable weather patterns around the world can suddenly disrupt the supply chain, which unethical players seize upon as opportunities. Fortunately, the company I work for recognizes that quality is synonymous with brand protection and provides all the resources my staff and I need to keep ahead of these relentlessly changing challenges.

Atwater: There are many challenges in the dietary supplement industry facing ingredient suppliers and product manufacturers in their goal to ensure quality compliance and transparency. Finished product manufacturers have a wide range of options when purchasing ingredients and are often faced with a need to use multiple suppliers to deliver on their product needs.

However, in an increasingly global marketplace with much variability in the quality of ingredients, finding consistent sources of high-quality ingredients can be a challenge. For this reason, finished product manufacturers seek to establish a sound supplier qualification process as part of their GMP quality systems to reduce risk in their ingredient supply chain.

For ingredient suppliers, they are not only faced with needing to differentiate their ingredients from their competitors—hopefully by demonstrating high quality—but also needing to meet different requirements for supplier qualification from multiple finished product manufacturers. This often means they are faced with multiple audits and compliance challenges to maintain a competitive edge.

Bath: If you look at compliance as a bare minimum of what the FDA requires, it can be like reading tealeaves. Companies find themselves trying to understand where the regulatory body is going to go, what type of compliance situations are going to come up over the next few years and trying to understand the dynamics of the different governing and regulatory bodies. Company leaders need to take a step back, do their homework, and consider what the real issues and concerns are that regulators are focusing on from a compliance standpoint and how should they adjust their programs, policies and procedures to be prepared and compliant with them. For example, the FDA has over the past several years been focused on making sure manufacturers understand and embrace cGMP practices, but going forward, regulators may be interested in focusing more on brand marketers. As such, it will be beholden on the contract manufacturers to educate its customers to help them get ready for increased scrutiny from the FDA because the brand marketers are the ultimate owner of the formulas and products that are being produced by contract manufacturers.

Most brands want to sell compliant goods, but not all of them care as much about quality, particularly if it impacts price. This provides challenges for contract manufacturers trying to win a bid, because during the quotation process, responsible contract manufacturers will work hard to be competitive with the bid while trying to balance the need for quality. This balance means that the bid may not be the lowest price, and it is a difficult conversation to have with potential customers who may have a propensity to choose the lowest bid. A good contract manufacturer must be concerned with pricing, but it is also focused on developing the highest quality standards available resulting in the highest quality goods on the market. This approach is ultimately good for the company and the industry, but there are costs associated with quality that are not always considered by the customer.

Transparency at its heart is being open and honest with customers, regulators and other stakeholders. During the manufacturing process, when challenges arise, it is important to be transparent with the customer regarding not only the problems, but also the choices and solutions available. It is a balance and an art, but it is the way trust is built among companies and within the industry [to have] open honest communication. The adage good news can wait but bad news is immediate is essential to developing a transparent and open dialogue with customers.

Rathi: I would say a combination of all of them, but particularly sourcing and identity testing.

As regulatory and compliance standards become more stringent, it’s more critical than ever to source from a supplier/manufacturer with a robust GMP program, one with strict process and documentation controls. Certain products pose bigger challenges than others. For example, plants or roots handled primarily by farms can have water or soil conditions that affect what is in them.

At Specialty Enzymes & Probiotics, we make custom formulas with unique ingredients. If a company requests a product with something like gingerols, derived from ginger root, or bromelain, an enzyme derived from pineapple, we pay even greater attention to where we are sourcing them from and how they are tested. If such ingredients are used in your finished product, it’s important to work with a manufacturer with strong process and testing controls.

Identification testing, an area of focus for regulatory agencies, is another step that can create a challenge. When multiple ingredients are combined in a supplement, they may overlap or interfere with identity testing. It’s important to use qualified labs and manufacturing facilities that have strict controls for testing. At times, test methods may not be specific enough to adequately identify single ingredients tested by themselves. In such cases, a combination of thorough testing, and process and documentation controls, are required for complete and accurate verification.

NIE: What efforts and initiatives do you think will improve the confidence of manufacturers, retailers and consumers in the quality and purity of these ingredients and suppliers?

Atkinson: There are a number of self-regulatory initiatives currently being developed and implemented that demonstrate a mature responsible industry and are aiming to improve transparency and stakeholder confidence. The Supplement OWL (Online Wellness Library) label registry is a perfect example of how industry is open to taking responsibility and being transparent to assist regulators, retailers and consumers understand the marketplace. Also, the Supplement OWL’s CDX (Commercial Data Exchange) platform (formerly referred to as Tier 2) is designed to assist marketers and retailers communicate and exchange additional information and support documents about quality practices for their products. Such documents can include supporting documentation to other industry self-regulatory initiatives such as AHPA’s (American Herbal Products Association) Guidance on Good Agricultural Collection Practices and GMPs for Botanical Materials and GRMA (Global Retailer and Manufacturer Alliance).

Fabricant:  The Supplement Safety and Compliance Initiative (SSCI) is driving that train for consumer confidence, transparency and supply chain quality. GNC and Walmart spearheaded it and it parallels the global food safety initiative (GFSI). GFSI never took supplements in so SSCI was created to fill a gap and need to hold everyone accountable, create best class practices everyone would adopt. The fact that it is retailer-led is especially important. SSCI will benchmark standards in the supplement industry to hold them to the highest level, so that third party auditing bodies will all be on the same page. Many companies have auditors in their facilities 30 to 40 weeks out of the year. Not all of them are of the same caliber. SSCI will address that issue as well. It will seek to harmonize with global standards as well.

Davis:   Meeting recognized compliance standards and the appropriate certifications needed are crucial to increasing transparency and building manufacturers’ confidence in the rigor of systems. Testing to recognized standards and ensuring certifications, not only improve quality systems and processes, but it ensures a consistently high-quality end product for our customers.

At Lonza Consumer Health & Nutrition (CH&N), we comply with industry standards and regulations across our ingredient and dosage form portfolio. For instance, thanks to rigorous testing in line with regional standards, Lonza’s Carnipure L-Carnitine has been approved in a number of countries globally, including in the US, where it has a self-affirmed GRAS (generally recognized as safe) status. This certification has also enabled Carnipure L-Carnitine to be used in infant nutrition formulas in the U.S.

Sudberg: The only sure way to improve the confidence of manufacturers, retailers and consumers in the quality and purity of these ingredients and suppliers is transparent lab testing. Proudly tell the world what you have tested, by what methods, what the tests were looking for and who did the testing. Proudly share every single lab test. Show the world your quality. For too long, the expense of quality, spent either internally or externally, has been hidden. It’s high time to be transparent, because consumers want to hear about it. Amazon.com dedicated more “real-estate” on their website to detailed product information when they sold their turmeric product than another company in this industry. They clearly believe that there is a story to be told, and consumers want to hear it.

Secrist: I think that supply chain transparency initiatives help to improve the confidence of consumers, retailers and manufacturers alike. Over the past several years, NOW Foods has been very involved with the Supplement Safety and Compliance Initiative (SSCI). SSCI is an industry-driven initiative led by retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain. SSCI is a bold step forward in providing quality assurance from harvest to retailer shelf. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers, all with the goal of providing quality products and increasing consumer confidence. A lot of progress has been made recently to introduce blockchain technology to create an unbroken chain or history of everything that has happened to the raw material, all the way from the seeds going into the ground to the powdered material that shows up at a manufacturer’s door. This has the potential to be a game changer for the industry!

Additionally, other organizations have contributed greatly to the quality assurance professional’s toolbox, such as AHPA with their good agricultural collection practices and good manufacturing practices (GACP-GMP) for botanical materials. This helps give growers, harvesters and processors the tools they need to be able to supply unadulterated, high-quality ingredients, and the tools that manufacturers need to be able to evaluate the practices of their suppliers. The American Botanical Council (ABC) has also been very involved in making sure that the industry is aware of potential adulteration threats/issues and making sure that responsible companies have the tools they need to keep these adulterated materials out of the marketplace.

All of these things help bring supply chain GACP/GMP practices into the light of day where it can be examined and scrutinized, and what can be examined and scrutinized, can be improved!

Atwater: Third-party scientific verification services such as USP’s (U.S. Pharmacopeia) Ingredient Verification Program (IVP) and Dietary Supplement Verification Program (DSVP) are a comprehensive and independent way for both ingredient suppliers and dietary supplements manufacturers to establish the quality of their ingredients and finished products.

For suppliers, it is a great way to provide quality assurance to manufacturers and stand out from other suppliers. For manufacturers, it can strengthen their brand recognition and build consumer confidence when choosing a quality product through clear transparency, such as the USP Verified mark awarded to those products that meet the program quality requirements.

Bath: The only way to improve confidence in manufacturers and brands is to develop more progressive standards. The industry has to be honest with its consumer base regarding what the products can and cannot provide. That is where regulations can come into play—they can shape how labeling is handled, which can be a very good thing for companies and consumers alike. The best approach would be for the industry to come together to develop a standards body to manage the key testing that is required by the FDA (purity, potency, strength and composition) and ensure that the transparency created by those testing methodologies is also something that is consistently being practiced across the industry. This will empower manufacturers and brands to be transparent and honest about how they are testing and how they are coming to conclusions. This will also allow for responsible, fact-based marketing.

Third-party audits help engender consumer and industry confidence, but it is important to choose an independent auditor that will be rigorous and stringent such as the NPA, NSF and others that have reputations for excellence.

Rathi: I would highlight a couple of efforts and initiatives: certifications from reputable third-party vendors; and periodic supplier audits go a long way toward improving confidence in the quality and purity of ingredients and suppliers.

As a purchaser, you must establish quality systems in place to track and approve documentation, and test raw materials and finished products. The buck stops with your quality program.

That being said, for even greater confidence in your suppliers or manufacturers, more peace of mind, find ones that are already being checked out by reputable third-party agencies. This means instead of presenting you with a statement stating they follow GMPs, or are kosher or halal, or their products are non-GMO (genetically modified organism), they provide you with certification from an outside agency who rigorously audits their facility and program annually, at minimum. It takes time to establish a strong quality program, so look for established companies who seek outside certification. For example, we have received GMP and non-GMO certification from NSF International, kosher certification from OK Kosher and halal certification from Islamic Services of America.

And lastly, audit your vendors at regular intervals. Walking through the facility, and learning about their documentation and process controls first hand, will improve your confidence in the quality and purity of the goods you purchase.

NIE: What do you think are the most significant strides in the past several years in regulations, philosophies and technologies that allow for more reliable quality and compliance?

Atkinson:  One of the most significant strides in the past several years has been the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires reports of serious adverse events to be submitted to the FDA by manufacturers of dietary supplements and nonprescription drugs. Improving both the dietary supplement and OTC (over-the-counter) industry’s post-market surveillance is valuable for consumer safety.

Fabricant:  Passage of the AER (Adverse Event Reporting) bill made supplements the only commodity of food to have mandatory reporting for serious adverse events. I think that was critical. It enables the agency to take action much quicker on ingredients found to cause harm to humans. FSMA also gave mandatory recall authority to the agency to remove immediate harms and it held the ingredient supply chain accountable. The GMP final rule was also a driver for change. It separated the wheat from the chaff. FDA’s dietary supplement inspection program does 600 annually in the U.S. and another 50 or more internationally. It continues to highlight companies that are having difficulties with the basics, such as setting and meeting specifications.

Davis:   More than ever, consumers are demanding greater transparency and understanding of how products are produced. A recent study of supplement users in the U.S. commissioned by Lonza Consumer Health & Nutrition (CH&N), and conducted by the Natural Marketing Institute (NMI), found that 61 percent of consumers surveyed rate “unquestionable safety” as a priority when purchasing supplements, with 40 percent of respondents citing knowing the source of ingredients as important. This purchasing dynamic has put the spotlight firmly on the supply chain.

Suppliers partnering together for an integrated supply chain from end to end also allows quality expectations to be aligned, with the added benefit of potential savings due to reduced redundancy. As an integrated solutions provider, Lonza CH&N offers supplement manufacturers a unique end-to-end approach—from ingredients sourcing and processing, to dosage form innovation, to manufacturing and branding commercially ready end-products.

Sudberg: I’m extremely happy to report that the industry’s tolerance for secret sauce and proprietary test methods is at an all-time low. In fact, the main purveyor of such poor practices as being unwilling to share data and or collaborate with others to resolve conflicting test results has left the industry and her successor vows to take a different approach. I feel like the testing lab segment of this industry had a dark isolationist period that is now warming up to better collaboration and transparency, which ultimately serves all parties better. Importunely, skip lot testing has been given the thumbs up by some in the industry recently for a particularly uniform product and operation, but some of us see that as a slippery slope that may give others producing in a less controlled environment encouragement to try the same thing. “Gee, I am so glad that company deployed skip lot testing!” said no consumer ever. My hopes are that such poor practices are short lived, and quality wins over quick profit. The best quality assurance people in the industry are committed to testing every lot of every ingredient, testing again during production, and testing yet again at the finished product stage. That’s where the whole industry should be, and I believe it will get there.

Secrist: I would cite the supply chain initiatives I talked about above as some of the most significant strides for the industry in the areas of quality and compliance.

I would also say that some of the most significant strides have been technological advancements in the area of analytical instrument sensitivity. This is both a blessing and a curse! A blessing in that knowledge is power and can help us to make improvements where we find potential issues that have been hiding behind the limitations of the sensitivity of past instrumentation. It can be a curse because marketers are very fond of saying things like, “zero pesticides” or “free from harmful contaminants” or “100 percent pure.” Scientists know that these types of statements are based on the analytical sensitivity at the time, which eventually will continue to become more and more sensitive, driving the limit of detection (LOD) lower and lower. These types of statements open companies up to plaintiff’s lawyers looking for a quick payday.

It is the incredible sensitivity of our LC-MS/MS and GC-MS/MS that have made it possible for our sports line to be certified by LGC for their Informed Sport/Informed Choice. This sensitivity gives collegiate, Olympic and professional athletes everywhere the assurance that they can safely take our sports products without fear of failing a banned substances test, putting their career and future in jeopardy.

Other technology advances in the field of genetics has made whole genome sequencing affordable. NOW Foods has invested in the latest technology related to the genetic identification of bacterial strains used in our probiotic products. In the past, many of the probiotics in use in the industry had, at best, been identified to the species level. The science has shown that the various beneficial properties associated with probiotic bacteria are strain specific, enabling probiotic products formulation to provide specific health benefits. Probiotic Strain Verified products are NOW probiotic supplements in which the probiotic strains have been analyzed and their identity verified using the cutting-edge RiboPrinter microbial characterization system.

Atwater: There has been continued progress on quality in the industry. With initiatives such as the Dietary Supplements Quality Collaborative (DSQC) in place, members are able to work in concert to advance the quality and safety of products marketed as dietary supplements in the U.S.

In addition, recent updates by the FDA to help global, domestic, and international customers ensure compliance with the new FSMA regulations should help to establish more consistency in quality around the world.

Furthermore, new technologies continue to emerge, such as rapid ID techniques for botanical products. This is an area where USP is doing significant work to help support the use of quality standards for botanical ingredients and products. In support of these efforts, USP has updated all of its relevant programs to be reflective of these changes and to be of greater value to ingredient suppliers and finished product manufacturers.

Bath: Implementation of the CFRs, specifically 21 CFR Part 111, has helped provide some structure to the overall manufacturing and supplement space. That said, philosophical shifts will be more impactful on the industry, leading to more trustworthy and compliant companies, rather than just adherence to the CFRs alone. Major global brands are entering the space and these companies and investors who back them do not want to bank on “junk science—” they want to invest in something that will stand the test of time and provide real growth. This will force the entrepreneurs in this space to step up and strive for the highest, most stringent levels of quality to not only compete, but to evolve themselves into attractive targets for venture capital investments or acquisitions.

Rathi: In terms of regulations, the FSMA is a significant step for both food and dietary supplement industries. It’s the biggest piece of regulation that’s been passed in more than half a century, and for dietary supplements, decades. The FSMA builds on 21 CFR Parts 110 & 111, requiring companies to add a food safety plan that includes a hazards analysis, and a foreign supplier verification program.

FSMA regulations, combined with closer monitoring of companies in the dietary supplement industry, support more reliable quality and compliance. The industry continues to move toward stricter documentation practices, stronger testing programs, and increased verification of quality controls in the forms of certifications for GMP and GFSI—providing for greater transparency and confidence in the products being manufactured.

In terms of technology, both in production and testing, there are many advancements. Advancements in testing allow for lower detection limits and faster turnaround times. Our lab, for example, in addition to activity, identity and microbiological testing, now has ICP capability to test every raw material and finished product for heavy metals. It also tests for gluten in house.

NIE: What are the most significant challenges brand marketers now face for compliance when formulating new products?

Atkinson:  There was a period of time when brand marketers did not fully understand their obligations under GMP. A few years ago, a series of FDA warning letters made it clear that although you may be contracting out the manufacturing process, your name is on the product and therefore you are responsible for ensuring your product has been manufactured in compliance with cGMP requirements. FDA warning letters clearly indicate FDA’s position: “Although your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.” Over the years many brand marketers have had to figure out how to be more engaged in their supply chain and understanding details about where ingredients are sourced, how they are identified, and details about manufacturing.

Fabricant:  Ingredient innovation. The patent rulings on “products of nature” are not consistent, and the U.S. Patent and Trademark Office issued guidance to its examiners that products of nature are not patentable subject matter under 35 U.S.C> 101. This should be a huge concern for dietary supplement, food, and drug manufacturers and ingredient suppliers.

Davis:   Operating on a global scale is a significant challenge for brand marketers when formulating new products. With global sourcing expected to grow over the next decade, it is imperative that manufacturers and suppliers understand the global regulatory market and lifestyle expectations and adapt to the evolving requirements in each region.

Sudberg: I see the most significant challenge brand marketers face for compliance when formulating new products is verifying label claims since no off the shelf test methods exist for unique formulas, they have to be developed. Finished products are complicated beasts and no method exists to make sure what is on the label is in the bottle until a lab is tasked with such work. It may not be scientifically possible for all products and for such, a letter from the lab explaining why can do the trick. For all else, finished product testing must be developed. We’re hearing reports of FDA asking about this specific step in verifying label claims during their inspections more frequently.

Secrist: I am going to sound like a broken record, but one of the biggest challenges that brand marketers face when formulating new products for compliance is traceability. There has been a [trend] by many in the industry to move away from brokers and try to establish direct relationships with the growers and processors of the ingredients. This is a good thing for the consumer, and technology is poised to provide this to the end consumer in some exciting and new ways.

Although this is not a compliance issue, I would also say that sourcing ingredients that are sustainable, are non-GMO and are naturally derived also continues to be a challenge. Consumers expect these things and we as a company are committed to delivering them. Non-GMO ingredients can be very difficult to verify back to the source (traceability). We have publicly stated our position on our website which is that we do not believe that GMO ingredients fit the definition of natural and we believe that consumers have the right to know the status of these ingredients so they can make informed decisions related to the products they take to support their health. This becomes very difficult for animal derived ingredients such as gelatin or vitamin D where we cannot certify the GM status of the feed used for these animals. We have been very transparent about where we are at in our journey to completely remove GMO ingredients from our supply. Sometimes we may take longer to come to market than other companies because we will not compromise our quality standards, including insisting on the non-GMO status of ingredients. Sourcing for some ingredients can literally take years.

Atwater: Some of the ongoing quality challenges for brand marketers are related to new products that require new and unique ingredients emerging in the dietary supplement category. Responding to new consumer demands and market trends with products like gummies and probiotics introduce new territory for many manufacturers and suppliers, which can require new technologies to ensure quality control within the supply chain.

Bath: One of the biggest challenges today is protecting intellectual property, including developing a novel formulation that is hard to steal or replicate. This includes having the studies to back their novel formulation and then be able to make claims based on the type of scrutiny that would be present in peer-reviewed journals (scientifically proven, double-blind, placebos.)

Working to ensure that the products they are producing do not get adulterated. This adulteration can come from contamination or on purpose. Marketers may be tempted to adulterate their products with synthetic rather than natural ingredients that may or may not be banned by the FDA in natural products.

Another big challenge is that they ensure they don’t make health-based claims that are problematic when aligning with the FDA’s drug statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The challenge is that the FDA changes its stance on what is constituted or classified as disease. For example, the FDA is constantly changing their view on what is a disease and it can get brands in hot water because what was a safe statement can morph overnight to be a claim to treat a disease.

Rathi: Two of the most significant challenges brand marketers face in terms of compliance is qualifying their vendors and contract manufacturers, and making sure their labels and marketing materials meet claims.

To do both well, partnering with companies that have technical expertise and strong quality programs can make all the difference. The demand for products manufactured and packaged in GMP-certified facilities, non-GMO, gluten free, certified organic, etc. is growing.

Brand marketers must qualify their partners’ documentation and testing, and possibly visit their facilities. New products need to be verified via testing and controls.

Partners with technical expertise, like Specialty Enzymes & Probiotics, can help brand marketers not only create an efficacious and marketable product, but also help with labels and testing. Our company frequently walks brand marketers through their label claims, any testing issues they encounter (even reputable third-party labs sometimes have trouble with enzyme activity and probiotics identity), and a host of other matters. NIE

Reference:

NMI SORD Proprietary Report for Lonza Consumer Health & Nutrition – US – 2,000 participants on-line, 2017.

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.