Processing Purity

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Manufacturers, suppliers and labs shed light on how transparency has made its mark at this juncture of the supplement pipeline, in ensuring and demonstrating ingredient purity.

Through actions both pre-emptive and reactive, dietary supplement makers have answered the consumer cry for transparency in many ways, from verification symbols to GPS traceability and labeling redesigns. Further up the supply chain, dietary ingredient suppliers fill a role typically less visible to consumers, but just as vital to industry’s transparency aims, as they manage how raw materials are sourced and transformed into powders, oils and extracts fit for use in supplements.

Brand Views
According to industry rules set by the U.S. Food and Drug Administration’s (FDA) current good manufacturing practices (GMPs), accountability for ingredient purity lies with the makers of a finished supplement. As outlined by Vasilios Frankos, former director of the Division of Dietary Supplement Programs at FDA’s Center for Food Safety and Applied Nutrition, in 2007, it “shifts the burden for ensuring the quality of dietary ingredients used in dietary supplement to the manufacturer of the final product“(1).

This “burden” is one taken in stride at supplement brand NOW Foods, Bloomingdale, IL. “Nothing has really changed for us here at NOW Foods because we have a long track record of being as transparent as possible,” says Aaron Secrist, director of quality assurance/quality control and research and development at NOW Health Group. Identity testing for raw materials is achieved at in-house laboratories outfitted with multiple testing apparatus, including inductively coupled plasma mass spectrometers (ICP-MS), high-performance liquid chromatographs (HPLC), a Fourier transform infrared spectrophotometer (FTIR) and an ultraviolet/visible spectrometer (UV/VIS) (2). The company also conducts extensive audits of potential and existing ingredient suppliers (3).

Traveling as far as China and Sri Lanka, for instance, isn’t too far to determine supplier qualification for companies like NOW Foods. Quality systems are firmly under the microscope during these visits, such as the facility design and the way products flow through the facility, says Secrist, who calls this principle “quality by design.” He explains, “For top-notch suppliers it is clear that quality is not an afterthought, but is built or designed into the process throughout.”NOW Foods

While visiting facilities, Secrist believes having in-house laboratories demonstrates a level of commitment to quality.  “Having the ability to test and make improvements based on that testing is really critical to a facility,” he states. “Relying only on third-party labs leaves many suppliers not knowing much about their products and sometimes making decisions on faulty data.”

Secrist notes public attention on transparency has had some impact on the upstream segments of supplement industry. “We are beginning to see a change in the attitudes of some suppliers that we deal with,” he states. In instances when NOW does work directly with a supplier, Secrist says brokers and distributors used to be reluctant to give details about the actual ingredient sourcing company or manufacturer. “Now, most are seeing the writing on the wall and realize that they must share this information or they will lose the business.”
 
Testing, Testing
As a supplier carrying hundreds of dietary supplement ingredients, such as botanical powders, extracts, vitamins, minerals and amino acids, BI Nutraceuticals, Rancho Dominguez, CA, holds its own in seeing to ingredient purity and communicating results with clients. BI product manager Rikka Cornelia says the company has long-devoted technologies and initiatives on this front.

“Transparency has always played a role in the development of our company’s in-house procedures and is part of the foundation of our quality department,” Cornelia says. “It starts before the raw materials enter our facility with our strict vendor quality management system. Once raw materials enter our facility, the product is tested before, during and after production.”

BI favors a steam sterilization method to preserve ingredient purity. According to Cornelia, BI developed Protexx HP Green Steam in-house in 2002, and “found that steam sterilization delivered maximum reduction in potential contaminants; preserved the color, flavor, and bioactive components; and left no residue so no additional label declarations are required.” The device also has settings for over 1,000 product-specific validated protocols, which she notes, “provides the maximum kill and minimum deterioration of the desired attributes through evidence of process validations and product stability studies.” BI also implements ingredient testing. The company introduced Identilok in 1996, which guarantees raw materials have undergone thorough genus species testing, including macroscopic and microscopic taxonomy, organoleptic tests, thin-layer chromatography fingerprint, FTIR fingerprint, HPLC and high-performance thin-layer chromatography (HPTLC). Parallel to NOW’s procedures, audits also play a large role, from regular audits of the manufacturing and lab facilities for GMP and Good Laboratory Practices (GLP) compliance, to audits of traceability “to assure usage of correct raw materials,” Cornelia says.

“For most of our existing clients, transparency has always been highly valued,” Cornelia says. “For some, its priority has increased due to the new Food Safety Modernization Act (FSMA) amendments and most significantly, the actions taken by the NYAG.”

transparency

On Camera
For vertically integrated companies like FoodState (maker of MegaFood), Manchester, NH, the work of the supplier is an added responsibility to the overall production process, which involves everything as promised in MegaFood’s slogan “Fresh From Farm to Tablet.” Consequently, transparency promises, including those of the supplier variety, are directed to consumers. In addition to facilities maintained to established quality standards–GMP-registered with NSF and ISO (International Organization for Standardization) 9001-certified (4), MegaFood launched a “Big T Transparency” initiative in July 2015.

“We have not necessarily adjusted any of our procedures,” says Bethany Davis, director of regulatory affairs at MegaFood. “What we have done is made sure we’re doing a better job about educating people about how we do what we do.”

The program includes 24/7 livestream feeds from cameras throughout their facilities, a reveal of their new product pipeline and a plan to share audit results (5). “These are all relatively minimal investments but they bring a lot of value in terms of transparency,” Davis says.

The supplement brand is also focusing on HPTLC enhancement, “sending team members to technology training and sending employees out into the field to meet with other industry experts to make sure we’re operating to the highest standards we can,” Bethany explains. “Ingredient and product identification measures are critical to building trust with consumers, and we want consumers to feel secure in the knowledge that our products are what we say they are.”

Lab Support
Though it is valuable for suppliers and manufacturers to invest in in-house testing facilities, Alkemist Labs, Costa Mesa, CA, provides third-party natural product testing expertise and lab services.
“Internal labs can be wonderful, and we work with a lot of great ones,” says Alkemist Labs CEO Élan Sudberg. “Alkemist Labs acts as extension of internal labs, functioning as a partner in the quality assurance process. We don’t care about pass or fail—only the highest quality, reproducible and transparent data.”

Even for an independent contract testing laboratory, far removed from consumer views, transparency can and does play an important role. Alkemist reports include “100% of the method and data—essentially giving away the farm,” Sudberg says. “When you pay us for testing, you get the full package of results and how we got them. Now that we are entering the DNA testing category, !we plan to do the same, in our true and time-tested way, contrary to the practices of other labs.”

Sudberg says he’s seen a rise in testing in recent years, with companies spending “more than the usual 2–5% on quality control,” but has not seen this focus translate into transparency, at least in terms of external marketing.

“If I were in their shoes I’d make available all tests for all ingredients for all products, including the specific testing lab and that lab’s qualifications,” Sudberg says. “Transparency is a window into how a company operates. If you are proud of your quality program, pull up the shade!” WF

References
1. U.S. Food and Drug Administration, “Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry,” www.fda.gov/Food/GuidanceRegulation/CGMP/ucm173996.htm,
accessed Feb. 17, 2016.
2. NOW Foods, “Our World Class Labs Ensure You Get Pure, Safe Natural Products That Work,” www.nowfoods.com/Quality/Are-Supplements-Safe/world_class_labs2.htm, accessed Feb. 17, 2016.
3. NOW Foods, “My Trip to China,” www.nowfoods.com/Quality/Are-Supplements-Safe/104633.htm, Accessed Feb. 17, 2016.
4. MegaFood, “Sweet Certifications,” https://megafood.com//our-approach/certifications, accessed Feb. 17, 2016.
5. MegaFood, “Transparency with a Big T,” https://megafood.com/transparency-with-a-big-t, accessed Feb. 18, 2016.

Published in WholeFoods Magazine April 2016