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The State of Sourcing and Ingredient Purity, continued.

Sourcing Ingredient Purity Sourcing Ingredient Purity

Industry leaders discuss the recent challenges, as well as advances, to provide pure, safe and efficacious ingredients.

The participants are:

• Rikka Cornelia
Product Manager
BI Nutraceuticals
Rancho Dominguez, CA
(310) 669-2162

• Deanne Dolnick
Science Director
TR Nutritionals
Alpharetta, GA
(404) 935-5761

• Dr. Cheryl Luther
General Manager
Dietary Supplements and Beverage Quality
NSF International
Ann Arbor, MI
(734) 769-8010

• Shaheen Majeed
Marketing Director
Sabinsa Corp.
Payson, UT
(801) 465-8400

• Michael O’Hara
General Manager
UL Global Nutraceuticals
Northbrook, IL
(847) 664-2642

• Jon Peters
Morris Plains, NJ
(973) 867-2141

• Matt Stegenga
Olathe, KS

• Elan M. Sudberg
Alkemist Labs
Costa Mesa, CA
(714) 754-4372

• Sherry Wang
Founder and President
La Mirada, CA
(562) 207-9770

NIE: How does your company ensure quality sourcing?

Cornelia: In addition to our vendor quality management system, we employ a skilled procurement team with in-depth product knowledge as well as a quality team that includes trained/degreed botanists, chemists, microbiologists, technicians, and documentation specialists. These two teams work closely together to audit and mentor BI’s vendor base.

Dolnick: Quality sourcing has been a key component of TR Nutritionals’ success over the past 11 years. It is not a new or novel concept for us. We have always followed stringent SOPs regarding qualifying new manufacturers, and products from those manufacturers. We will continue to do so and our qualification processes will evolve with technology and regulatory requirements. TR Nutritionals maintains an office in Shanghai to ensure we know exactly what is going on with our manufacturers in China. We also use the most reputable independent labs in the U.S. to ensure the quality of our ingredients.

Majeed: The chemical composition of a natural product determines its bioactivity and, in turn, its application. Thus it is very important to maintain the quality of the raw material used to process a product. At Sabinsa, high yielding lines are maintained at our biotechnology facility, which serves as the explants for cultivation. Several hectares of agricultural land in different parts of the globe are under cultivation of high quality raw materials under conditions most suitable for quality natural products. Raw materials are analyzed and ensured to comply with the in-house specifications and vendor audit for that product. Sabinsa also believes it is the social responsibility of people in this industry to conserve our natural environment and invest more in optimum agricultural practices.

Stegenga: At Biova it starts with our corporate culture. It’s further supported by our vertical integration with the leading egg producers; close partner relationships, which afford and ensure not only unmatched quality, but similarly unmatched access to raw egg membrane supply— the right combination of access and relationship to drive opportunity and growth. From a process perspective, we don’t rest with cGMP (good manufacturing practice), GRAS (generally recognized as safe), kosher and halal; our comprehensive quality management system is 100 percent committed to consistent, high-quality ingredient production that extends beyond quality compliance.

Sudberg: Every botanical, even those we get from unquestioned experts like Roy Upton (AHP) or PhD botanists, go through a rigorous qualification process where we use organoleptic, macroscopic and microscopic techniques, based on compendia monographs where ever possible, to verify the identity before we begin to use it as a reference sample. This is all performed by appropriately trained staff and well documented.

Wang: We audit all factories with a list of 12 categories and 62 detailed evaluations. We perform third party testing on all new ingredients as well as in-house testing. Each shipment is inspected by our overseas QC (quality control) team and then again by our U.S. QC team. Our QC teams keep records of all factory origin and tracing for our customer’s cGMP compliance.

NIE: Are ingredient tests changing or expanding? What is being used?

Cornelia: As mentioned above, some manufacturers are now requiring DNA testing. It is very important for manufacturers to keep in mind that there are several different types of identification methods, each with their own advantages and limitations. Since every natural product is different, each requires specific test methods to optimally identify the species and plant part. Due to this, manufacturers and suppliers need to collaborate with one another to determine the correct test methods to be utilized for each ingredient.

Dolnick: We will continue to evolve to ensure the purity of ingredients. Just one example of improved testing is with chondroitin sulfate. TR assays every batch of Chondroitin Sulfate by two test methods to ensure the proper amount of active ingredient. The first test performed is CPC (cetyl pyridinium chloride). This is a validated USP assay; however, results can be skewed higher if adulterants have been added to the raw material. To verify that TR Nutritionals supplies only pure chondroitin sulfate, a second assay is performed—enzymatic HPLC (eHPLC). The eHPLC test uses enzymes to digest the Chondroitin, which is made up of organic glycosaminoglycans. An HPLC analysis is then conducted on the digested product. Enzymatic HPLC is used by the AOAC and the FDA (U.S. Food and Drug Administration).

Luther: NSF International recently acquired AuthenTechnologies, now called NSF AuthenTechnologies, offering next-generation DNA testing as part of the identity testing process for dietary supplements furthering NSF International’s capabilities of the testing and certification program for dietary supplements and NSF Certified for Sport. In fact, DNA-based testing coupled with advanced chemical analysis can identify the plant part and quantify its chemical constituents and/or contaminants down to trace levels. This testing is important to identify supplement ingredient fraud which NSF’s own research has shown can occur in the market when harmful ingredients and contaminants including drugs and untested compounds, not always listed on the label, appear in dietary supplement products. NSF’s research has revealed a pattern of untested compounds such as DMAA, DEPEA and DMBA cropping up under the deceptive guise of botanical extracts. These harmful ingredients have not been proven safe for human consumption and appear on the label as botanical names. This gives consumers the false impression that the ingredient is derived from plants.

Majeed: Along with innovation in testing methodologies and analytical instrumentation, ingredient tests evolve over time. Simple gravimetric estimations or UV spectral methods that were previously followed to standardize an herbal extract have been replaced by more precise HPLC or LC-MS techniques. With limits being more stringent to match regulatory guidelines as well, sensitive instrumentation that detects compounds even at ppm and ppb levels have come to be used for natural products. The authentication of natural extracts is also being pursued with more aggression, with modern techniques involving increasingly sophisticated instrumentation.

O’Hara: We have seen an increase demand for ingredient testing and more discussion around what is the right methodology as this was a big topic post NYAG (New York attorney general). Our customers want to make sure the methodology used is the best possible science available to deliver accurate results.

Peters: Yes, in the world of quality assurance, testing methods are continuously being improved to guarantee optimal quality. All BENEO production sites regularly undergo quality audits such as IFS where we have achieved the highest marks in 2015.

Sudberg: Ingredient testing is changing as technology advances. As we all know, the new kid on the block is DNA testing. While it’s been around for decades in crime labs, it recently showed up in our industry unannounced, essentially forced upon us by excited AGs and frightened brand holders. It’s important to understand that DNA testing stands a chance to mess up this industry if not utilized correctly. To make it a useful addition to this industry’s testing world, open dialogue and transparency over methods and data must be the standard. Until we have agreed upon reference standards and primers that everyone can access, using this method with proprietary references is the opposite of transparent. As it stands now, the labs performing this analysis protect their data as if it’s proprietary. Just tell that to the judge and see how proprietary it really is. All testing should be ‘open access,’ and that is how we are approaching it as we ramp up next generation DNA sequencing at Alkemist Labs.

Stegenga: Yes, and they should because safety, ensuring purity is ongoing; technology will always improve to offer better methods of testing. Biova’s QC is always evaluating methods that will improve our ability to maintain our cutting edge lead. And, as per above, we work closely with our USDA (U.S. Department of Agriculture)- and FDA-regulated egg producers to ensure the same—an added benefit to these changes is the added protection for legitimate manufacturers like Biova by making it harder for substituted or altered products from unscrupulous suppliers to survive the scrutiny.

NIE: Would natural finished product databases be practical and beneficial for consumers and the industry?

Majeed: It is better to have the finished product database, however all manufacturers should help in disclosing their product information on the website. Consumers should have the choice of ingredients and hence relevant information needs to be provided in such a way that the products are authentic and backed with science. The supplier industry should be able to approach the manufacturer for their product promotion. The drawback to this database may be the price disclosure, unlike in the drug database. The price of raw materials may vary from time to time, and hence price fixation may be a constraint. Thus the content of the database should be thoughtful, practical, informed and collaborative.

O’Hara: UL believes 100 percent that a product registry database would be practical and beneficial for both the industry and consumers. Based on consumer studies that UL has conducted, consumers are very interesting in understanding more about the supplements they purchase but don’t know where to go for this information. An industry sponsored and supported database could fill that need and show that the industry is dedicated to driving more voluntary transparency into the market place.

Luther: There is still debate within the industry on the need or use of natural finished product databases and their practicality and use by consumers and the industry.

Peters: In principle the idea of a database is not a bad one. However, what would be the criteria? Which ‘committee’ would be qualified enough to set-up and maintain such information? Even a reflection on what is the value of having a definition of ‘natural’ may be needed as first step. Either way, if there are developments in this direction, BENEO as a corporation can make valuable contributions with ingredients that can be referenced as ‘made by nature’ and help to widen healthy, tasty food choices.

Stegenga: They might be … especially if they’re managed by impartial entities, and open to the same critical audit control as the ingredients themselves. The market tends to be “self-regulating” in that deceptive companies tend to be “found out.” Reputable brands source from reputable suppliers. Should “good deals” compromise this pattern, it is unfortunate, that this market-driven self-regulation typically requires time to self correct, which means consumers can be duped, and then the market suffers as a whole. Biova will always take the high road—it’s who we are.

Sudberg: I currently don’t see how natural finished product databases will fix any immediate problems. Sure it will make our industry seem more organized and more regulated, which is in contrast to popular belief. Just like having driver’s licenses doesn’t help drivers drive well or keep drunks off the road, a product registration will not improve quality. Here’s an idea … stop buying the cheapest of ingredients, stop using second-rate labs to qualify that ingredient and include a therapeutic does of the ingredients, and the quality of this industry will rise.

NIE: What trends and consumer demands should product manufacturers be prepared to meet in 2016?

Cornelia: Along with transparency, the clean label trend is here to stay. Clean label is an ambiguous term, but it is often described as few, free-from, and minimally processed ingredients as well as natural alternatives to artificial colors, flavors, preservatives, etc. In regards to the first half of this definition, non-GMO, plant-based, and whole food nutrition are top trends. While for the latter half, natural colors and sweeteners are top trends.

Luther: New FSMA requirements (Subpart L- Food Safety and Subpart O – Analysis of Good Manufacturing Practices) will impact supply chain management for manufacturers this year.

Majeed: The growing desire to take preventive measures in maintaining general health and wellness has led to the rise in demand for natural standardized phytoextracts. Individuals are more likely to seek nutrition and health benefits from every meal they consume throughout the day. Manufacturers should be aware of this and introduce natural products that find a place in functional foods that serve as easy and safe delivery techniques.

O’Hara: Data has shown that consumer confidence in the supplement industry has begun to slide and we fully expect the industry to respond with positive actions. For example, GNC is leading four different working groups with a common goal of improving consumer perception of the industry.

Peters: In general there is a major trend in improving the health profile of food items. Consumers are increasingly aware of the ingredients that are contained in foods and beverages. They are focused on making healthy choices by seeking more natural, less processed, non-GMO options, and are carefully checking labels before making purchase decisions. This also includes more balanced and improved nutritional profiles of final products. Particularly formulations with less sugar are on trend.

For example, research commissioned by BENEO in early 2015 quantified insights that directly link to consumer focus on eating healthier foods made with natural and non-GMO ingredients. 65 percent of the 1,000 consumers interviewed said that they consider natural products as better and 45 percent considering non-GMO products as “better.” Forty-seven percent actively look for natural products.

In terms of concern about sugar content in food and drinks, 63 percent of respondents indicated that they try to avoid or limit sugar and particularly avoid artificial sweeteners. We appreciate the fact that consumers are looking for products with less sugar and thus try to follow a healthier nutrition. In the long run, however, we believe that a nutritionally balanced diet that supports a good metabolic set up is even more decisive for a healthy life. This is why we also recommend looking behind the curtain to see how the reduction is made. Sugar reduction by fiber enrichment, e.g. with chicory root fiber is improving the physiological response of the final product. Chicory root fiber allows sugar reduction, calorie reduction, a better blood glucose management and fiber enrichment at the same time.

BENEO has responded to these natural health and wellness demands from consumers by providing manufacturers with natural non-GMO ingredients that focus on improved and balanced nutritional profiles and that contribute to healthier lifestyle as well as general overall well being. We offer various solutions for manufacturers to improve the nutritional profile of their final products including sugar and fat reduction, fiber enrichment as well as blood sugar management, etc. We offer chicory root fibers, functional carbohydrates from beet sugar, rice specialties and functional proteins from wheat.

Stegenga: Understanding that sourcing ingredient purity is the just the basis of a larger consumer expectation … that the ingredients are not only safe, natural and pure, but that the science behind the claims ensures that these ingredients are efficacious; that ingredients perform consistently and in the manner they should. Which means that research behind any ingredient/formula claims must also be held to a high level of accountability—is a research study relevant? Are the study constructs valid? Consumer trust can only occur when all levels of expectation are honestly met throughout the supply chain.

Sudberg: Transparency is becoming an obligation. Do things right and demonstrate it. Take quality out of the closet and wear it on your sleeve. This will be the never-ending trend pushed by the finished product retailers and demanded by consumers.

Wang: The demand for plant-based proteins continues and more and more manufacturers are looking to replace chemical colors and flavors with natural and organic choices. We are working with our customers and factories to continue to supply these consumer-demanded ingredients.

NIE: How do you advise manufacturers as they look to explore new products and opportunities going forward?

Cornelia: In terms of natural alternatives, keep in mind that it is not a simple 1:1 replacement. Each ingredient, especially artificial ingredients, plays a functional role in a finished product. Not only do they play a functional role but also they play it well, whether it is improving structure, adding color, or providing a nutrient. Hence, the reason companies utilize them over their natural alternatives. For instance, you cannot completely replace sodium benzoate with a natural preservative and receive the same degree of effectiveness. Also keep in mind that artificial ingredients not only play a functional role but they do so cost effectively. Natural alternatives will be more expensive. However, as consumers become more aware of health and wellness, the more they are willing to pay a premium price for clean label products. Education is key.

Dolnick: The first thing that a manufacturer must do is confirm that there is solid science behind an ingredient. Without the science, it is impossible to determine if a product is efficacious. Once a manufacturer or contract manufacturer is ready to purchase a new product, they need to be open to looking into new suppliers. Manufacturers and contract manufacturers get into a supplier “slump.” They have been using the same suppliers for years and are averse to exploring new options. It is advantageous when sourcing new ingredients to find suppliers that offer the highest quality ingredients along with making customer service a top priority. At TR Nutritionals, we are aware that it is difficult to qualify a new supplier, but it is often well worth the effort.

Luther: NSF International advises manufacturers to listen to their customers and understand the importance of third-party certification of dietary supplements. This assurance can go a long way to help the manufacturer demonstrate to their clients that they are producing safer dietary supplement products through the certification program. It also provides the consumer the assurance and transparency that the dietary supplement they are taking has been tested to the label claims.

Majeed: With the knowledge that value addition to functional foods holds great opportunities, ensuring compatibility and palatability of natural extracts should be taken up as priority. In addition, manufacturers need also to ensure quality of plant based extracts and not indulge in any form of adulteration. The world trusts and believes that the natural product industry has goodness to offer in its purest natural form and it is the responsibility of the industry to reciprocate appropriately.

O’Hara: They have to ensure they have the data to back up all their label claims and ensure the production sites meet the cGMP requirements.

Peters: BENEO’s integrated chain of expertise accompanies customers along the entire product development process. This includes the team for Market Intelligence and Consumer Insights that systematically observes market and consumer trends throughout the world. Only very recently consumer research in the U.S. has been commissioned showing very clearly that U.S. consumers are watching particularly the sugar content, the naturalness as well as the fiber content of products for their children.

Our technical experts at the BENEO-Technology Center are working on recipes how such a product targeted at kids (e.g. a gummy or cereals) with less sugar but more fiber could be formulated in a tasty and appealing with our natural chicory root fibers. Due to their characteristics they can replace sugar, reducing calories and adding fiber without affecting taste or texture of the product.

The team at the BENEO-Institute gives advice on the labeling of the product and which claims might be possible to be put on pack. Also in terms of health benefits such as digestive health, weight management as well as blood sugar management they have access to the latest scientific research, which supports the added value of the finished product.

Stegenga: Manufacturers need to carefully consider where the ingredients they formulate with come from and whether that source is safe and sustainable in today’s changing world. Biova has rigorous operational standards, and we process hundreds of millions of eggshells. All our raw source material comes from USDA-inspected facilities, part of our vertically integrated, domestic supply chain.