Personal ResponsibilityQuality control.When NY Attorney General Eric Schneiderman used DNA barcoding to determine that botanical extracts sold by GNC, Walgreens, Target and Walmart were mislabeled, it cast doubt on the contents of finished products throughout the natural products industry. In reality, however, respected manufacturers and suppliers of raw materials have long tested their ingredients to ensure quality, employing methods beyond DNA barcoding.
“DNA testing is useful but has limited practical value,” says Joe Veilleux, general manager of Euromed USA, Inc., Presto, PA. “When the fresh plant material undergoes processing from drying and then extraction, the original plant DNA undergoes increasing fragmentation and breakdown.”
Rod Benjamin, research and development director of Bergstrom Nutrition, Vancouver, WA, concurs, explaining that, “While DNA barcoding helps identify botanical species...DNA testing usually won’t distinguish the specific part of the plant (such as root, leaf, flower or fruit) the material came from...Most ingredients require a combination of DNA barcoding, botanical taxonomy and/or chromatography to properly identify, characterize and quantitate ingredients.”
However, despite the limitations of this method, distrust had already been sowed. This means that responsible suppliers and manufacturers will either have to better communicate their efforts to customers or enhance their current methods to meet the demands of consumers. Benjamin makes an apt point when he says, “Mr. Schneiderman’s actions showed that if the industry doesn’t step up and establish proper means for demonstrating that our products are safe, healthy and of high quality, then they will come up with the means for us. Self-regulation is the best way to ensure that our systems are realistic, informative and economically feasible, while fulfilling the desired goals.”
Since dietary supplements are not regulated like pharmaceuticals, they are not held to those same standards, but some firms manufacture raw materials for multiple product categories, making them better equipped to meet higher standards. Medley, FL-based Unique Biotech, for example, is a pharmaceutical-grade WHO facility that manufactures raw materials for pharmaceutical, nutraceutical and food applications. “We use our pharmaceutical standards for the manufacturing of our ingredients regardless if it goes to pharma, nutra, or food applications,” says Luis Echeverria, executive vice president for the firm. “We use our highest standards all the time and keep the integrity of our raw materials in terms of assay, micros, and all of our quality specs.”
Others take a more hands-on approach. “The quality challenges are starting way before the test of the finished product and are the results of traceability issues and a major gap between the source of the ingredient and the finished product manufacturer,” explains Golan Raz, vice president of health and nutrition at Lycored, Orange, NJ. That is why his firm is vertically integrated, meaning that it supervises every step in the production of its ingredients, starting from the farm and ending when it ships the product to its customers.
To highlight these efforts, Lycored initiated a program called LycoSelect, which aims to make its label as clean as possible by “getting all production stages from the farming, harvesting, initial processing, extraction and packaging under very strict supervision with additional check points and restrictions,” says Raz. The company’s intention is to produce a standardized product that is natural, as close as possible to the original whole-food source as well as safe and effective.
Not all raw materials for dietary ingredients come from agriculture. Ingredients such as collagen are derived from animals, as the collagen protein is found abundantly in their hide and connective tissues. Gelita, for example, “sources its raw materials according to strict and stringent veterinary inspection and always in accordance with the specific country regulations,” the company says. “Only raw materials that are designated for human consumption [are used].”
However, field-to-pill supervision of the entire supply chain is just not realistic for everyone, so other methods must be employed to test quality once materials are brought in house. “Raw materials that do not meet InterHealth’s rigorous quality standards are rejected,” explains Paul Dijkstra, CEO of InterHealth Nutraceuticals, Benicia, CA. “All of our suppliers and vendors go through an extensive qualification program for approval and they are audited annually for compliance.” Vetting one’s suppliers and vendors is just as important of a control method as overseeing the source itself.
For Long Beach, CA-based BI Nutraceuticals, vendor qualification includes providing vendors clear guidelines on specifications, test methods and product quality; regularly auditing manufacturing and lab facilities to ensure GMP and GLP compliance; conducting random audits of traceability; performing random sampling and testing to ensure compliance with specifications; overseeing the vendor’s quality assurance/quality control program; and testing materials before, during and after production, says Rikka Cornelia, product manager for the firm.
BI Nutraceuticals performs this testing with its Identilok botanical testing program, which was introduced in 1996 and continues to improve. The program authenticates raw materials on the Genus Species level from multiple angles, including macroscopic taxonomy, microscopic taxonomy, organoleptic tests, TLC fingerprint, Fourier-transform infrared fingerprint, high-performance liquid chromatography and high-performance thin-layer chromatography. “As of right now, BI’s Identilok program is 98% correlated to DNA testing and in the third quarter, we plan to further strengthen our identity authentication and testing efforts as well as meet customer demand by installing DNA testing technology in our new Reno, NV, facility,” Cornelia adds.
Increased efforts by suppliers to further control their supply chain and verify the safety and efficacy of their products helps improve consumer confidence in dietary supplements. As Veilleux explains it, “We are communicating our botanical GMP program to retailers as part of our Phyto-Proof promotional campaign...Herbal supplements displaying the Phyto-Proof logo on the label provide assurance to retailers that the ingredient has been produced in our Barcelona extraction facility possessing seven industrial certifications and each and every batch undergoes a minimum of 20 laboratory tests.”
This is part of a larger trend of suppliers trying to connect with consumers through transparency. Other such efforts include the PLT360 program from PLT Health Solutions of Morristown, NJ, which is based on ingredient integrity, quality, sustainability and efficacy. Finished product makers can then communicate this quality to consumers on product labels and marketing collateral similarly to third-party certifications such as USDA Organic or Non-GMO Project Verified.
Ensuring quality and safety has a deep intrinsic value, but as business owners, suppliers must also be aware of the cost involved in implementing such initiatives. “We should be honest with ourselves and understand that quality affects cost and when low cost is a core objective, it will in most cases affect quality,” says Raz. “At the end of the day, regulating the industry will help raise the quality bar, but will also make sourcing, production and marketing more challenging.”Being Non-GMO Project Verified not only assures customers that our oil is completely free of genetically modified organisms, but, more importantly, it also demonstrates the traceability and transparency of our supply chain. —Becky Wright, Aker BioMarine
This expense is not only experienced by the supplier or ingredient manufacturer, but also throughout the supply chain, starting with the farmer and very likely reaching the wallets of your customers. East Windsor, NJ-based Sabinsa Corporation, for example, understands that the support from government institutions for farmers of medicinal plants is lacking compared with those farming crops for food. That is why Sabinsa created incentives for farmers in the form of social welfare programs under Dr. Majeed’s Foundation. These programs include ensuring education for children, housing loans as well as buyback programs to ensure payment to farmers. Sabinsa’s efforts help maintain a sufficient supply of quality raw material to produce its extracts.
Organic/non-GMO.The consumer demand for products that are organic and/or non-GMO has spurred manufacturers to reformulate organic or non-GMO versions of their products. This, however, is not an easy undertaking, considering that it demands either finding an organic or non-GMO source for ingredients or transitioning the current source to organic agriculture, which is both time consuming and costly.
“Our production programs are non-GMO and being so was a pillar for us before non-GMO became a ‘hot trend,’” says Raz. “As far as organic programs, our LycoSelect is a major step toward being more and more organic and we are passionate about moving in that direction. At the same time, we are the largest manufacturers of natural tomato lycopene and the quantities we process make organic a challenge.”
Veilleux echoes this sentiment. While the firm produces a line of organic botanical extracts such as black cohosh, St. John’s wort and saw palmetto berry, as well as the only organic milk thistle seed extract, due in part to its dominance over European milk thistle seed cultivation, it is not without challenges. Veilleux explains that the challenge comes from the limited cultivation of organic botanicals, which the company hopes to overcome by “establishing new global botanical cultivations to meet our crop requirements for organic certified extracts.”
This is a problem faced by many, as organic agriculture is limited, making it difficult to reach the necessary quantities in a sustainable way. Some, on the other hand, corner the market in organic agriculture. Irvine, CA-based Algae Health Sciences, a subsidiary of BGG is one of them. “We’re the world’s first (and so far only) producer of organic astaxanthin,” says Bob Capelli, executive vice president of global marketing for the firm. “We’ve also improved cultivation techniques that have allowed us to get the purest product and most concentrated algae biomass around.”
People are attracted to organic and non-GMO designations because they offer traceability and transparency, says, Becky Wright, marketing and communications director at Aker BioMarine, Issaqua, WA. “These are the reasons we sought out Non-GMO Project Verification,” she explains. “Being Non-GMO Project Verified not only assures customers that our oil is completely free of genetically modified organisms, but more importantly, it also demonstrates the traceability and transparency of our supply chain.”
And shoppers are willing to open their wallets for this level of trust. As Dijkstra points out, “Retail sales of non-GMO verified products exceed billions per year, indicating the demand is huge. Although the process for obtaining these verifications can be lengthy and costly for manufacturers, the resulted opportunities tend to exceed the challenges...by producing quality products; and as a result, establish brand loyalty.”
Achieving several “clean” certifications simultaneously is a strategy some companies are using to make brands as clean as possible. Ganeden is one example. “GanedenBC30 is a safe, sustainable, naturally occurring probiotic strain that is organic compliant, kosher, halal, non-GMO, gluten free and allergen free, so it can easily be formulated into these products,” says Mike Bush, president of the Mayfield Heights, OH-based firm and executive board president of the International Probiotics Association. “We have many partners with organic and Non-GMO Project Verified products and the use of GanedenBC30 in their products has never hindered them in getting their certifications.”
Something to consider when approaching organic and non-GMO ingredients is the lack of a standard definition for non-GMO and some gray areas within the organic label. While organic has the advantage of having a federal certification program, the U.S. Department of Agriculture (USDA) does not enforce a non-GMO standard, although USDA Organic ingredients cannot knowingly be GMO.
Within the United States and among various countries, different certification agencies disagree about what makes a product organic or non-GMO, explains Veilleux. Cornelia agrees with this, adding that identifying a GMO is not black and white, resulting in many gray areas that need addressing. “For instance, enzymes are standardized with corn starch; extracts utilize corn-based solvents; yeast grows on sugar beets; and so on,” she explains. “If the USDA determines these processing aids have to be non-GMO verified in order to receive the label, then suppliers are faced with the challenge of proving they are since the true test for GMOs happens at seed level.”
Despite its value, Cornelia believes non-GMO certification should only apply to those ingredients at risk of being made from or contaminated with GMOs, in order for this to remain relevant. “If a raw material is inherently non-GMO, then testing and convoluted documentation is unwarranted,” Cornelia explains. “For instance, a vast amount of botanicals are still wild crafted. There is zero incentive to gene splice a one-off ingredient only grown deep in the Andes.” This constitutes a waste of time and resources.
People may be looking for products that are clean, natural and organic, but they are also looking for products that work, which is where research plays an important role. Structure/function claims. Achieving desired results is key to the success of a product and therefore is an important part of selling an ingredient (and finished products) with appropriate structure/function claims. “When a supplier is looking to develop structure/function claims for their ingredient, they need to ensure the claims can be substantiated by at least two properly conducted randomized controlled trials,” explains Michael De Cicco, scientific and regulatory affairs specialist for Neptune Wellness Solutions, Laval, QC, Canada.
Providing evidence for structure/function claims is a responsibility many suppliers take seriously. “We continually invest in clinical research supporting three key areas: safety, mechanism of action and dose-response efficacy,” says Annie Eng, CEO of HP Ingredients, Bradenton, FL. “Brand marketers need to know first and foremost that an ingredient they are interested in has the portfolio of research demonstrating all three factors.”
Aparna Kalidindi, Pharm.D, BCPS, technical sales and marketing manager at Natreon, Inc., New Brunswick, NJ, using her company as an example, explains that when developing its Ayurvedic herbal extracts, multiple safety and efficacy studies are used to back up its brands with structure function claims, which can then be used to market finished products containing the ingredients. It doesn’t end there however. “Manufacturers that we supply to request certificates/statements to prove we are providing safe ingredients,” she says. “We provide manufacturers with our analytical methodology, safety/toxicity studies, and efficacy studies. Manufacturers can also do audits to ensure safety.”
Many structure/function claims can exist for a single ingredient, allowing manufacturers to tailor product marketing to the specific claim or design a specific formulation. “BGG and its subsidiary AlgaeHealth proudly announced recently that we had submitted 241 structure/function claims to FDA and only two in the area of inflammation were rejected,” explains Capelli. “Many of the 239 claims that were not rejected can serve as extremely good marketing tools for our customers’ labels and in their messaging.”
Aker BioMarine, for its part, also believes that suppliers should substantiate ingredients. “This is why we compiled a comprehensive claims dossier that covers everything from sustainability/environmental and omega-3 uptake claims to nutrient content claims and structure/function claims,” says Wright. She adds, however, “Each brand owner should do their own due diligence on claims so that all bases are covered and risk is substantially reduced.”
This is important, because while suppliers are willing to take responsibility by using time and resources to substantiate products, this does not absolve finished products manufacturers from making sure everything is right on their end. For this reason, Benjamin believes that the supplier’s main responsibility should be to assess safety, but “Structure/function claims based on efficacy and substantiation should rest on the finished product company.” Elaborating, he says, “That doesn’t necessarily mean they would have to perform clinical trials on all of their finished formulations. Sufficient substantiation may come from an ingredient manufacturer, or they may be able to enter into a collaborative research project.”
One factor to be wary of says Raz, is how claims are used. A structure/function claim should be a simple explanation of the functionality of an ingredient, such as “calcium supports bone health.” However, “the challenge starts when the claim becomes a marketing tool,” he explains. “When this is the case, there is the possibility that the claim will be designed to target specific conditions and not to describe the product in a simple way.”
Lynda Doyle, senior vice president of global marketing, Omniactive Health Technologies, Inc., Morristown, NJ agrees. “It’s important that the claims be truthful and reflect the science on which they are based and in an appropriate population,” he explains. “Any claims based on science in ‘diseased’ populations are considered drug claims and, therefore, not allowed under current FDA regulation.”
This, of course, depends on where the product is being sold. Anurag Pande, Ph.D., vice president of scientific affairs at Sabinsa, explains that requirements for claims substantiation differ throughout the global market. So, while, two randomized, placebo-controlled trials featuring healthy populations may not be appropriate in the United States, in places like Canada, where premarket approval is required, different standards apply. For that matter, how research is interpreted and what verbiage is used, is important. “A fair amount of the research on our products looks at conditions that are considered diseases under DSHEA, but of course any responsible manufacturer knows not to say their joint health formula treats arthritis, even though the science says it does,” says Pande.
Another thing Raz says can be problematic when an ingredient gets into a finished product is the difference between the individual substantiated ingredients and the final formulation. “The fact that four ingredients tested separately will have a specific biological or bio-chemical effect isn’t saying anything about the effect of all four ingredients mixed together,” he explains. “Many finished products today will carry a claim that is based on the ingredients that were used to formulate the product and, in most cases, the finished product wasn’t tested for the claim that it carries.”
InnovationTechnology in the dietary supplements industry is advancing quickly, as ingredient manufacturers continue to find innovative ways to process raw materials to create potent, clean and efficacious ingredients as well as overcome challenges. One of the most recent technological innovations comes from Aker BioMarine, which developed a new patented technology called Flexitech. According to Wright, it “has the ability to up-concentrate krill oil’s various beneficial components (such as phospholipids and omega-3s) while removing the salts in krill oil, which can lead to off odors and taste.”
Another company boasting its advances is Metuchen, NJ-based NattoPharma USA, Inc., which manufactures vitamin K2 menaquinone-7 (MenaQ7). “The most substantial technological development in the new generation of MenaQ7 products is a proprietary multi-step process of purification, condensation and crystallization of naturally derived vitamin K2,” says Eric Anderson, senior vice president of global sales and marketing for the firm. “This innovative process leads to an end product that is more than 96% pure natural menaquinone-7 (MK-7). Further, as it is manufactured using Bacillus licheniformis in a non-soy based medium, MenaQ7 Crystals is free of soy products and all known allergens.” Another patent-pending, multi-step synthesis used to produce an ingredient called MenaQ7 PURE offers the benefits of vitamin K2 at a more competitive price, giving it a broader reach, says Anderson.
The probiotics category has seen immense popularity recently and these beneficial bacteria are therefore incorporated into many products across categories. With this popularity, however, comes a good deal of competition between different suppliers of probiotic strains. Picking the right one is important because “the benefits of any probiotic are strain-specific, so it is important for manufacturers to choose a high-quality, science-backed probiotic ingredient,” says Bush. Ganeden’s patented strain (GanedenBC30) has been incorporated into many products, most notably foods and beverages, making the strain itself an innovation because of its proven viability in products that previously could not support probiotics. These and other companies have long been innovating in order to consistently push the quality and purity of their products. Bergstrom, for example, pioneered the manufacturing of MSM, with its unique multi-stage distillation process that “purifies the product, resulting in a single molecular entity with an extremely high level of purity,” says Benjamin.
BI Nutraceuticals utilizes its patented Protexx HP Green Steam Sterilization process developed in 2002. “BI pioneered the use of dry steam sterilization in the United States for botanicals in 2002, before EtO and Irradiation were not permitted,” says Cornelia. “BI’s Protexx HP Green Steam sterilization utilizes more than 40 settings, which control heat, moisture, time, and pressure parameters, tailored for each individual ingredient.” This has made it possible for the company to fine-tune more than 1,000 product-specific validated protocols, she adds.
RegulationThe U.S. Food and Drug Administration (FDA) recently announced that it would be proceeding with implementing the Food Safety and Modernization Act and released a new draft guidance for New Dietary Ingredient notifications. Regulations tend to complicate things for suppliers and manufacturers of dietary supplements, which can be costly and time consuming. WholeFoods’ Legal Tips columnist Scott Tips in this month’s column is particularly unhappy with FDA’s actions, considering them to be overreach (see page 55).
However, the companies contacted for this article have a more positive spin on these recent events, considering them good for the industry and consumer welfare. “The continued efforts of regulators to work with the industry is a positive sign for manufacturers and consumers,” says Dijkstra. “Consumer demand for safe and effective products is being met, and manufacturers can meet this demand by partnering with trusted suppliers following the guidelines.”
It appears that resourceful and responsible suppliers are well prepared to meet the demands of FDA’s new rules. This means unscrupulous suppliers will be hurt, but so will smaller operations that simply don’t have the resources to keep up with stricter regulatory and consumer demands. “In the past year, we have experienced an increase in new clients looking for a more transparent, quality-focused supplier base,” says Cornelia. “As these regulations are fully implemented and manufacturers become stricter, the supply base will become smaller as those without the infrastructure to support the new requirements are weeded out.”
One of the few concerns expressed was by Pande, who wants to see a change in policies related to new technologies on the revised draft guidance for NDI notification. “This may discourage supplement manufacturers from using the newer extraction technology for fear of going through a long NDI review and approval process for the same ingredient which they can sell in the market using old technologies,” he says. “There has to be some incentive for new technology to grow.”
Raz notes that while regulations may help the industry take more responsibility, we “can’t replace the commitment from the industry itself” to produce high-quality efficacious ingredients.WF
Published in WholeFoods Magazine October 2016