The State of Sourcing and Ingredient Purity

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Industry leaders discuss the recent advances, as well as the challenges, to meet the demand for pure, safe and efficacious natural 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
President
BENEO, Inc.
Morris Plains, NJ
(973) 867-2141

• Matt Stegenga
President
Biova
Olathe, KS
(877) OVACORE

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

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

NIE: The biggest challenges facing the natural products industry last year were actions by New York and state attorneys generals regarding ingredient purity. How have suppliers and manufacturers responded?

Cornelia: For most of our existing clients, transparency has always been highly valued and not much has changed. For some, its priority has increased and we have experienced a rise in document requests. However, the most notable change since the actions by the New York attorney general (NYAG) is the requirement of DNA testing from some of our customers.

Identity authentication and testing has always been on the forefront of BI’s quality efforts. In 1996, we introduced our Identilok program in order to guarantee the highest levels of purity, authenticity, and cleanliness. It encompasses identity authentication and testing on the Genus Species level from all angles: macroscopic taxonomy, microscopic taxonomy, organoleptic tests, TLC fingerprint, FTIR fingerprint, HPLC chromatogram, HPTLC chromatogram. As of right now, BI’s Identilok program is 95 percent correlated to DNA testing and in April, 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.

Dolnick: TR Nutritionals has made a number of changes to accommodate our customers’ responses to NYAG actions. Several customers are now requiring samples of raw biomass to be included with shipments of ingredients or for the biomass to undergo additional ID testing at U.S. labs with reports supplied prior to order delivery. It requires some extra legwork on the part of TR and our manufacturers, but we are happy to facilitate and promote our quality ingredients. TR Nutritionals has been working with most of our key manufacturers for over a decade and without reservation stand behind our ingredients.

Luther: As a result of the NYAG’s actions this past year, dietary supplement companies are striving to restore and maintain brand integrity by demonstrating their commitment to producing safer products for their customers. Because of this action, retailers and consumers want to know that they can trust the safety and quality of their supplements. One important role that NSF International plays in this industry is helping to educate consumers about how they can find supplements that have been analytically tested to confirm the contents in the supplement match the label claims. Suppliers and manufacturers who understand the importance of brand integrity invest in quality control and risk management, many choosing third-party certification of their ingredients and products.

NSF International has seen an increase in certification of dietary supplements which may come from consumer demands that manufacturers and suppliers have a responsibility to demonstrate the contents of their products are true to their label claims and not harmful to consumers.

We have also seen an increase in supply chain management integrity. The GMP (good manufacturing practice) audit is a critical step in providing and proving quality within the manufacturing process.

Majeed: As an ingredient supplier, we have not seen anything in particular that all or most of our customers (from contract manufacturing to marketing companies) are asking, but that may be because with our ingredients there is never a question as to identity or fear of adulteration. If anything, they now repeatedly ask if they can come audit us, but other than asking this question, very few are spending the money to do this.

The focal point today seems to be on ingredient purity, but let’s not forget where this started—from tainted products to products that did not contain the adequate amounts that were stated on their labels. Very little had to do with the legitimate ingredient suppliers. However, now this seems to the target of the industry because it is a deficiency in industry GMP compliance. Part of the problem is commoditization of ingredients, that is ingredients aggregated by brokers, making the source murky and adulteration more likely.

With increasing knowledge and awareness of the benefits of natural products, there is exponential increase in their demand. To meet this demand, there are a few foul players in the industry who indulge in adulteration of authentic natural extracts. With continuous innovation by the genuine suppliers in the industry, several techniques have evolved to identify adulterants.

Right from the first step of raw material sourcing, adulteration is a concern. Parts of plants are normally supplied in dried form and hence until authenticated, tend to pose a challenge. Since the chemical profile and in turn activity of the plant extract is dependent on the authentic raw material, identity screening is critical. Simple and quick techniques such as anatomical sectioning of plant parts, microscopic techniques to study the sections and powdered material, are popular and accepted methods of identification of raw materials, and perhaps in the near future high-end DNA finger printing could be something suppliers can look into. Chemical fingerprints of raw materials are also a preferred method of authentication.

A common form of adulteration of natural extracts is by addition of synthetic versions of the same. Radiolabelling techniques are able to analyze and curb this practice. A very common example in the industry is the adulteration of natural curcuminoids with synthetic curcumin, which has on several occasions been identified using this technology.

Another form of adulteration is fortification of natural extracts with other plant extracts. However, using chemical fingerprints using HPLC and LC-MS chromatographic techniques, this form of adulteration can also be effectively identified.

We need companies to test, audit, and learn about how to do them smartly and effectively. While a positive trend has been observed in the innovation of such techniques, it is primarily the ethical responsibility of manufacturers to curb such practices; that would be the most ideal way to bring to a halt the practice of adulteration.

O’Hara: UL has seen a big push for greater visibility and transparency in the industry. Our customers want greater and greater assurance that the products they are receiving and/or producing have the purity and potency as advertised. Also, testing methodology and validation of protocols is a question we receive from our customers as well. They want to make sure the analytical chemistry methods UL uses in our FDA (U.S Food and Drug Administration) registered lab will produce the correct results. The industry has worked very hard to ensure finished product manufacturing facilities meet the cGMP requirements set by the FDA, but we have seen more and more focus on the ingredient or raw material supplier. Manufacturers want more information and assurance about the ingredients they are receiving.

Peters: Organic, natural, non-GMO (genetically modified organism), and clean label are very important trends in food innovation. We do see a strong consumer demand for products that, in their perspective, contain easy-to-recognize natural ingredients, no unwanted chemical additives, label transparency and ingredients that provide natural or intrinsic health benefits. Still, BENEO feels that consumers are making purchase decisions based on their own personal definitions when it comes to clean label, natural, etc.

Consumer research commissioned by BENEO in the U.S. and announced in January 2015 showed that 65 percent of respondents consider that natural products are better and 47 percent are actively seeking natural products, including foods and beverages that contain the healthy benefit of fiber.

BENEO is seeing a number of trends with clean-label foods and beverages. However, there is a challenge to make sure that products with fewer additives are still pleasing to consumers when it comes to taste. They also need to appeal to consumers visually and in terms of texture. By carefully selecting natural ingredient combinations and working with an experienced partner, manufacturers can master the art of balancing technological issues with a cleaner label, taste and texture.

For example, there is a trend in meat production of replacing modified cornstarch in the U.S. with clean label, non-GMO rice starch for poultry.

Stegenga: Truthfully, the vast majority of our customers, and prospects that inquire about our ingredients, don’t appear to have changed much; they’ve always been concerned with ingredient quality and safety. It’s just sound business. That said, if we’ve noticed anything is a greater industry “awareness” that ingredient sourcing matters … while there is a heightened awareness as to formulator accountability, there is also clear demand for high integrity ingredient sourcing. And we welcome this level of scrutiny.

Sudberg: In my experience, suppliers and manufacturers are paying closer attention to ingredient purity now than ever before. Quality has never been a choice, but rather an obligation that is enforced more and more each day. So now where suppliers might have trusted a C of A (certificate of analysis) yesterday, today they verify, and where manufacturers might have trusted and then sometimes verified, they are now verifying first and then trusting.

NIE: There are other issues that now impact the industry—FSMA (FDA Food Safety & Modernization Act), defining natural, GMO labeling, etc. Are they affecting your company?

Cornelia: I wouldn’t call them “issues.” All of the above will have a positive impact on the industry as well as BI. Our products and procedures already address them—our ingredients are plant-based, non-GMO, and minimally processed and our global supplier qualification program is one of the industry’s most stringent quality programs that verifies and validates all stages of the supply chain from the farm to our shipping docks. In the past year, we have experienced an increase in new clients looking for a more transparent, quality focused supplier base. Transparency has always played a role in the development of our company’s in-house procedures and we are experiencing the benefits of it now more than ever. As manufacturers start implementing much stricter requirements, we will see supplier bases become smaller as those without the infrastructure to support the new requirements are weeded out. The above are elements professional suppliers have in place to protect their customers, not issues.

Dolnick: Documenting non-GMO compliance continues to be a growing concern. Just a short time ago, a simple statement that material was non-GMO was sufficient. Today, many of our customers are requiring analysis to document and/or more detailed surveys about individual products, solvents etc. FSMA compliance dates are coming up later this year for large companies and we are getting increased inquiries from customers regarding steps TR is taking to comply. Our compliance date will be August 2017, but we are already working to ensure complete compliance ahead of schedule.

Luther: Many of these issues have made a positive impact on the industry. To assist the industry with these issues NSF International has developed several new services this year including: • FSMA Training—NSF International will begin offering training courses in May for the dietary supplement industry around the new FSMA rules. NSF International is also working to incorporate FSMA rules into the NSF GMP audits.

• GMO Labeling—NSF International is updating Non-GMO True North to include an additional criteria for dietary supplements in mid-2016. NSF is currently working with the industry for feedback on this new annex that defines the requirements for testing and auditing in this area.

• DNA Testing—NSF International offers both chemical and DNA testing for both dietary ingredients as well as finished products.

Majeed: Right from the introduction of natural products in the market, there have been challenges that the industry has had to face. At Sabinsa, there is always a conscious effort to abide by regulatory guidelines that are both valid and relevant, including evaluating and analyzing our products to adhere to the guidelines laid by the various regulatory bodies. Most of the raw materials used by Sabinsa are cultivated either on our own lands or through contract farming to prevent and control any contamination.

A hot issue for us is non-GMO ingredients because of the pressure our customers face from consumers on their finished products. Also, while there is no official definition of “natural” we’ve come out strongly against substituting synthetic versions of botanical products without labeling them as such. Since we control the harvesting of our major crops, we know exactly what the materials are and how they are handled from the seed to extraction, and beyond.

O’Hara: As a certification, audit and testing company, our customers come to UL to better understand how these changes affect them and their products. FSMA’s impact on supplement ingredient suppliers is very significant. Based on all the questions from our customers, UL has developed a program that helps customers understand the changes that FSMA will introduce. Regarding GMO evaluation and labeling, UL has recently been approved as a testing vendor for the Non-GMO Project and chose to do this as GMO and GMO labeling is and will continue to be an important topic for the industry. UL is able to conduct qualitative screening and quantitative testing using real-time PCR, which is a highly sensitive and reliable method for the detection and quantification of nucleic acids in our ISO 17025 Certified lab.

Sudberg: Identity and potency are the major concerns our customers have. As of now I don’t see any major affects of FSMA or GMO labeling in my lab but won’t be surprised if we see more business as a result.

Stegenga: We don’t see these as “issues” so much as standard operating procedure; principles we’ve embraced from day one. Biova has always considered issues of safety and quality as paramount—everything we do is tied to creating efficacious, safe ingredients of exceptional, unmatched quality. By definition, our natural egg membrane based ingredients come from very regulated, highly scrutinized producers—all of our raw material comes from egg production facilities that meet or exceed all USDA (U.S. Department of Agriculture), FDA regulations. We have further proprietary internal operational standards that must be met; these are continuously monitored and 100 percent compliance ensured.

NIE: How does your company define “transparency?” What are the best methods to achieve it?

Cornelia: Transparency is receiving the exact product requested with a complete chain of custody. Transparency starts before the raw materials enter our facility with our strict vendor quality management system. The program provides clear guidelines on specifications, test methods, and product quality to suppliers; regular audits of the manufacturing and lab facilities to assure compliance with GMP and GLP (good laboratory practice); random audits of traceability to assure usage of correct raw materials; random sampling and testing to ensure compliance with specifications; and oversight of the suppliers’ entire QA/QC program. Once raw materials enter our facility, the product is tested before, during and after production.

Dolnick: Transparency has become one of those industry buzz words, but when every company uses it, it loses its meaning. At TR Nutritionals “transparency” is simply the way we have always worked to ensure that our customers are buying the highest quality raw materials available. We work with manufacturers with whom we have long-established relationships. We supply samples for all of our products. For our botanical extracts, we offer raw biomass, as needed. We supply requested documents. We do all of this with full disclosure, never trying to obfuscate the manufacturers from whom we purchase our ingredients.

Luther: NSF International’s dietary supplement certification program offers assurance of transparency to consumers in a three–step process:

1. Manufacturers seeking certification of dietary supplements first must demonstrate compliance with good manufacturing practices (GMP) of the manufacturing facility as specified by the FDA in 21 CFR Part 111. Compliance to GMP begins with twice annual audits and only after any findings that do not comply are addressed will the facility become NSF GMP registered.

2. The next step in the process is NSF Dietary Supplement Certification. Fourteen years ago, NSF developed the only American National Standard for dietary supplements (NSF/ANSI 173). This certification produces transparency of label claims and content verification, including contaminant testing, which verifies there are no harmful levels of specific contaminants in the product. As part of the demand for transparency and safer products by consumers the number of NSF certified products has doubled in the past year to over 800 certified dietary supplements.

3. Transparency of a dietary supplement product can go an additional step via the NSF Certified for Sport Certification. Certification to this program means that the product has been screened for more than 200 athletic banned substances from the World Anti-Doping Agency (WADA), NSF Annex B, NFL and MLB prohibited substance lists. NSF Certified for Sport dietary supplements are the only recognized supplements allowed for use by the NFL, NHL, MLB, PGA, LPGA, Canadian Center for Ethics in Sport (CCES) and the New York City Police Department.

Majeed: Sabinsa believes in complete transparency in terms of educating the consumer about details of products and we provide quite a bit of information to our customers to help them do that. Details provided in the specification of individual products encompass physical and chemical parameters along with 26-32 other parameters. For each product the customer is also provided with a set of documents that include manufacturing process details, “free from” statements, a certificate of composition, technical data sheet and, most importantly, a safety data sheet. The company is also audited and certified by several bodies such as NSF and inspected by US-FDA. Individual company audits are also not unusual although we’d like to see more customers audit us in person. Product related websites, brochures, white papers and both scientific and popular articles from the Sami—Sabinsa Group gives information regarding the source, chemistry, and preclinical and clinical studies conducted for individual products in order to educate the formulator and consumer.

O’Hara: We believe information management and availability of information drive “transparency.” This is the main reason UL developed ClearView and are now working with industry stakeholders like Natural Products Association (NPA), GNC, Council for Responsible Nutrition (CRN) and others to evolve ClearView into the product registry. It may be easy to say you want more transparency but there has to be commitment and focus to develop the tools necessary to truly deliver transparency. We believe a common industry platform can offer manufacturers a new mechanism to differentiate themselves from other branded firms that may not be building in the same level of quality into their products. The goal is to have a platform where manufacturers can increase their visibility in the industry to ultimately ensure only the highest quality products are available to consumers. UL firmly believes in transparency and that is a main driver into why we have the UL and NPA GMP Certification program accredited by ANAB.

Peters: BENEO is keenly aware of its nutritional responsibility to constantly ensure top quality. This occurs through a laser focus on selected natural sources, state-of-the-art production facilities and comprehensive services to meet very high standards along the entire supply chain. Additionally, we provide valuable up-to-date insights on nutrition, legislation, markets and application technology. Our supply chain is consistently evaluated to ensure delivery of the highest quality ingredients. As a 100 percent subsidiary of the German company Südzucker, an organization deeply rooted for more than 100 years in the highest agricultural quality, it is in the genes of BENEO and part of its policy to be constantly committed to natural raw material sources of highest quality.

Sudberg: We have defined transparency since the day we sold our first test in the terms of full method disclosure at no extra cost. Our C of A’s have always shown the entire method, which is not standard in the industry but we feel is what makes an Alkemist Labs C of A the gold standard. You can essentially come to Alkemist Labs for as long as it takes to test each botanical you sell, set up an HPTLC lab, hire some chemists and reproduce the work we do. The fact is, only a few of our customers have done that in the 20 years we have been testing in this industry. It’s actually a lot harder than one might think to replicate what we do, however it is possible and with our full disclosure C of A’s you will never wonder, “how did they come to that conclusion?” To take the transparency definition further it means that our customers have everything they need to demonstrate to FDA auditors that they know what is in their products.

Stegenga: Complete and open exchange of information. We’re seeing more requests tied to ingredient specificity from our customers, and we welcome it. Biova is uniquely qualified among egg membrane ingredient suppliers to be transparent—our vertical integration with some of the world’s largest egg producers gives us unmatched control over our raw source material. While we have patents and other proprietary intellectual property that are not open to the public, all data concerning ingredient quality and safety is shared with our mfg./formulator CPG customers; and they’re free to share with their customers.

Wang: Transparency should mean, honest and open, easy to see through and easy to understand. Suppliers must be able to provide transparency on price, factory of origin, inventory and QA/QC documentation—just to name a few. Ingredientsonline.com is an online platform providing raw materials for the dietary supplement, food, beverage, cosmetic and pharmaceutical industries. The cutting-edge technology equips buyers with knowledge and information that is just a click away. Knowing the factory of origin is critical in today’s environment. Ingredientsonline.com provides factory information on all ingredients. Having QA/QC documentation at your fingertips for any ingredient you are sourcing is critical. Online technology provides a fast and efficient method to download documentations and it’s very transparent. Seeing the price for each and every ingredient and seeing tiered pricing for volume discounts can save a huge amount of time for purchasing agents. Inventory levels are also clearly displayed on ingredientsonline.com for both our California and New Jersey warehouse locations empowers purchasing agents with the information needed to keep their production schedules on track.

NIE: Other comments?

Majeed: We’re pleased to see so much industry focus on ingredient quality in the past year, because we have been talking about this literally for years. Buying by price alone has contributed to the industry’s vulnerabilities, with identity, potency and scientific verification of safety and efficacy an afterthought. Consumers expect and deserve to get the benefits of safe and effective products, and we are optimistic that the industry will improve on delivering that.

Stegenga: Ensuring ingredient purity isn’t an activity that’s “done once” and considered achieved. Providing pure, safe, efficacious ingredients (and making sure one formulates with these types of ingredients) is more a mindset, an ongoing commitment to SOPs that address changes in the market space and stay one step ahead, one level above expectation, requirement or regulation. Safe. Pure. Natural. This is how Biova approaches the production of our ingredients, every day, all the time. Our families consume our ingredients. We are committed to quality. NIE

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