In recent years, however, increased scrutiny of the category in light of New York Attorney General (NY AG) Eric Schneiderman’s 2015 investigation of herbal supplements sold at GNC, Target, Walgreens and Walmart, has ignited a national debate over the quality and safety of such products. While independent, third-party testing ultimately confirmed the supplements sold by GNC were in fact safe and contained the proper ingredients, some believe the scandal has irrevocably damaged the reputation of the dietary supplement category as a whole.
From the perspective of Élan Sudberg, CEO and microscopist for Alkemist Labs, a Costa Mesa, CA-based leader in botanical identification services, consumer confidence has certainly been shaken by recent events. “From my own personal interactions, questions from friends and family and consumer inquiries to the lab over testing (consumers seeking testing services), I can say with certainty that consumer confidence has been impacted by recent controversies,” he said. “This industry and its products are intended to supplement a healthy regime of diet and exercise. We can’t market them to treat, prevent or cure disease. Right out of the gate dietary supplements lose credibility due to claim restrictions. Then add a scandal to question quality and it’s a perfect storm to further discredit the effectiveness of our beloved industry’s products.”
He believes it will take years without scandal to recover, followed by years of producing high quality products, to move beyond current negative perceptions.
Despite consumer concern, the category has still managed to maintain growth over the past year. According to SPINS data for the 52 weeks ending May 15, 2016, sales of herbal and homeopathic supplements grew 16.4%, earning nearly $1.7 billion. While the category has certainly made gains, some believe growth has stagnated in light of the category’s tarnished reputation.
“Although the industry has still grown, its growth rate has slowed in the past couple of years due to the recent controversy,” said Rikka Cornelia, product manager, BI Nutraceuticals, Long Beach, CA. “I do believe that consumer confidence is not completely lost and it can be regained; the industry needs to prove they have evolved into a quality-focused one.”
And many leaders in the industry have done just that. In an attempt to reclaim the public conversation, retailers, contract manufacturers, suppliers and trade organizations have stepped up to implement rigorous self-regulatory measures, partially in anticipation of increased government oversight in the future.
Industry Steps Up
Industry leaders are addressing safety concerns in a variety of ways, and are coming together to instill confidence in weary consumers.
Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), Austin, TX, and editor-in-chief of HerbalGram & HerbClip, said that more than ever before, “the responsible elements in the herb and dietary supplement industry have become increasingly concerned about potential problems with the quality of herbal raw materials and botanical extracts, and other ingredients.” He said these industry leaders are committed to increasing their diligence in reviewing the quality control measures for raw materials and extracts, while increasing vigilance for detecting potentially adulterated herbal materials.
Addressing the valuable role trade organizations play in helping suppliers and manufacturers stay up-to-date with the latest quality standards, Ms. Cornelia of BI Nutraceuticals suggested this was one way in which the industry is rallying in the face of adversity. “Industry associations provide updates on regulations and how to alter processes and procedures to adhere to them while ingredient suppliers, finished product manufacturers and contract manufacturers implement those changes.”
One leading program supporting quality control measures in the industry is the ABC-AHP-NCNPR Botanical Adulterants Program—a non-profit-based consortium led by the American Botanical Council, the American Herbal Pharmcopoeia, and the Center for Natural Products Research at the University of Mississippi. The program’s objective is to educate the industry on common adulterants of natural materials, and provide guidance on methods for testing.
Discussing the program, Mr. Blumenthal, the director of the ABC-AHP-NCNPR Botanical Adulterants Program, said, “This educational initiative has published over 20 extensively peer-reviewed documents that confirm the adulteration of some of the top-selling herbs in the U.S. and global marketplace and provides information on the most reliable laboratory methods to help detect adulteration and help ensure reliable consumer products.” Currently, he added, over 175 U.S. and international industry members, trade associations, professional research and healthcare societies, analytical labs, and others, have underwritten and/or otherwise endorsed the program.
The question of what tests to use to ensure safety and purity of herbal and botanical ingredients has also been a hot topic within the category. The NY AG investigation relied upon DNA barcode testing, which the industry protested against, saying it was a new technology that was misused in this instance.
While DNA testing holds great potential for the category, and can be used in valuable, specific tests for raw materials, it does have limitations. When it comes to testing the contents of finished products, results can be murky, and scientists are still learning how to harness this burgeoning technology.
In a March Nutraceuticals World webinar titled “Hot Topics In Supplement Safety,” Loren Israelsen, president of the United Natural Products Association (UNPA), Salt Lake City, UT, discussed the benefits and drawbacks of DNA testing. While he acknowledged the benefits DNA barcode testing can yield when used correctly, he cautioned that the technology could be used improperly and for the wrong reasons. “Bear in mind, DNA testing will not tell you the plant part, which is a requirement under DSHEA [The Dietary Supplement Health and Education Act of 1994] for your label,” stated Mr. Israelsen. “It’s also relatively easy to fool DNA testing.”
Experts in the field have suggested DNA testing could possibly be used as a tool to cheat and possibly spike low quality products with just trace amounts of a desired active botanical, according to Mr. Israelsen, so the technology should not be viewed as the ultimate solution to fixing the herb and botanical category’s problems.“Understanding how to use the analytical arts and sciences as the starting place is essential as we go down this journey of how we budget, plan and staff for quality,” he said.
Regardless, companies such as GNC, Herbalife and Nature’s Way have all publicly announced that they will require DNA testing for their ingredient suppliers as a condition of doing business. However, Mr. Israelsen pointed out that all three companies are approaching testing differently. “That means suppliers are going to have to think through and adjust to three separate systems of DNA testing. The real problem is that we don’t have recognized standards for DNA testing.”
Ms. Cornelia also noted the varying and changing safety and purity specifications demanded by retailers and contract manufacturers. “Our customer base already had stringent quality requirements in place and we are seeing more of the market embrace our quality focus. We have experienced a rise in audits, document requests and testing requirements, most notably DNA testing,” she explained. “All these combined are in effort to increase transparency.”
However, Ms. Cornelia noted it is very important for manufacturers to keep in mind that there are numerous identification methods out there—not just DNA testing—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.”
At the February 2016 Raw Materials and Supply Chain Summit hosted by UNPA, GNC unveiled a draft of its new Good Manufacturing Practice (GMP) program for raw materials, which included detailed instructions for its suppliers across the harvesting, manufacturing and processing supply chain. As a company at the center of the NY AG controversy, as well as one of the largest dietary supplement retailers in the U.S., GNC has taken the investigation as an opportunity to get out in front of the negative perceptions of the category, and help create what it hopes will become a new standard for the industry.
In the absence of official government sanctioned GMPs for raw materials and the herb and botanical supply chain, many in the industry saw GNC’s draft GMPs as an important first step toward harmonization of standards.
“Given that raw material GMPs are still technically voluntary, the smart companies are going above and beyond to source the best ingredients and use amounts that give consumers the benefits they expect to get when they buy and use a product to support good health,” said Shaheen Majeed, marketing director for Sabinsa Corporation, East Windsor, NJ.
Since raw material GMPs are relatively new and are driven by the trade, not FDA, Will Ji, group director of the bioactive ingredients division at TSI Health Sciences, Missoula, MT, said they have had little impact on the industry overall. However, he noted, “they have been embraced by one of the largest companies in the industry and if this momentum continues with other leaders, these GMPs will have a large, positive impact on the industry overall.”
Ms. Cornelia believes raw material GMPs are setting the category’s standards higher, especially with regard to establishing a complete chain of custody and increasing vendor surveillance, both domestically and internationally. “This will result in an improved, more sophisticated supply chain.”
Quality Control 2.0
Suppliers within the industry play an integral role in ensuring the safety and purity of raw materials. For manufacturers looking to avoid media controversy like that seen in recent years, turning to a reliable herb and botanical supplier is the first step in protecting their brand, as well as their end users.
“Supply chain management is of the utmost importance with all raw materials,” stated Deanne Dolnick, science director, TR Nutritionals, Alpharetta, GA. This, she said, is why TR Nutritionals develops strong relationships with its manufacturers. “It is also the responsibility of the finished goods manufacturers and contract manufacturers to know their suppliers. Companies work hard to get the best price on all products, but if a manufacturer is purchasing a botanical for $100 less than market value, that should be a red flag that the product is probably adulterated.”
Steve Siegel, vice president of Belleville, NJ-based Ecuadorian Rainforest, LLC, similarly stressed the importance of proper supply chain supervision, as he cautioned that there are numerous opportunities for botanicals to become contaminated if no proper quality control practices are in place. “While it is difficult to keep an eye on botanicals every step of the way, doing so ensures a low risk of adulteration,” he said. “This is a win for suppliers, manufacturers and consumers alike.”
Noting an upside to the controversy within the category, Mr. Majeed with Sabinsa believes the industry is now far more focused on both the ingredient supply chain and testing than it has been in the past. “At the risk of saying ‘we told you so,’ companies like ours who have focused upon quality ingredients backed by research and intellectual property that is defended, are in the strongest position, and are a safer bet for manufacturers. Vetting suppliers, choosing ingredients from reputable manufacturers rather than by price, rigorous testing, scientific research, knowledgeable formulating and strict GMP compliance, along with responsible marketing, are best practices that companies wishing to be in business long term should abide by.”
Mr. Sudberg of Alkemist Labs said that with supply chain management, quality can be made paramount to all other considerations, but that is often not the case. “If we have full control over ethical supply chain management decisions beginning to end, this industry would be very different,” he said. “Unfortunately, only a handful of companies are paying close attention to the process of supply chain management, from seed to shelf, while their lower-priced competitors employ only trust, willful ignorance, inferior test methods and skip lot testing.”
Management of the entire supply chain, starting from the raw materials—rather than just focusing on final product testing—is crucial, according to Mr. Ji of TSI Health Sciences. “In many cases, raw materials for botanical ingredient manufacturing are sourced on the open market, and these markets typically act as a co-op where multiple farms feed fragmented raw material harvests into one regional selling location. Ingredient manufacturers buy bulk raw materials strictly on price, and this environment of supplier fragmentation coupled with low-cost incentives creates the environment for farmers to adulterate the raw material with cost-effective adulterants.” He noted that TSI has created a vertically integrated supply chain for its ginkgo that is supported by comprehensive transparency and traceability with total chain-of-custody “farm-to-product” assurances.
Regardless of the splashy headlines attacking the category, herb and botanical supplements still attract a large audience, especially among consumers looking for natural alternatives to the traditional approaches of western medicine.
Perceptions of herbal and botanical supplements being natural, safe, effective and low-cost bolster the category, according to Mr. Blumenthal of ABC. Furthermore, he said a concern about the toxicity of conventional pharmaceutical drugs is motivating consumers to look for alternative solutions. He also cited a “preference for self-medication when deemed appropriate,” as well as “a sense of empowerment in using self-selected natural products” as reasons why users of herbs and botanicals keep coming back.
Mr. Ji of TSI Health Sciences attributed the appeal of botanical and plant therapies to the fact that they are “safe and effective alternatives to pharmaceutical products that typically carry significant side effects.” He said typical consumers tend to be young to middle age women who are “in tune with their health, are educated and want to use preventive natural products to maintain a healthy lifestyle.”
Ms. Cornelia of BI Nutraceuticals also reported “consumers are straying away from pharma, taking the ‘back to the basics’ approach and preferring prevention over treatment.” She observed a diverse array of demographics interested in such products. “As of right now, the elderly (>60 years old) are the most interested in herb/botanical supplements, then Baby Boomers and so on. However, there has been an increase in appeal among younger generations as they seek out more natural and organic products.”
Consumers today are well aware that herbs can support their health, and ready access to resources for information on the Internet gives them the tools they need to be more educated consumers, explained Mr. Majeed of Sabinsa. Furthermore, he pointed to rising healthcare costs, particularly in the U.S., as a motivator for consumers to turn to supplements to maintain their health at various stages of life. Discussing the category’s consumer base, he said, “Seniors grew up in a culture that began to embrace alternative ways of thinking, and their children and grandchildren just take for granted that they have options.”
According to sales data from SPINS, the top-selling ingredient in the herb and homeopathic category was the anti-inflammatory wonder turmeric, which earned about $42.2 million in the natural channel, up 36.7% from 2015.
Sales figures from ABC’s HerbalGram confirmed turmeric’s dominance in the natural channel. “It has been the #1-selling herbal dietary supplement in the natural food market channel for three years (2012-2014), while it ranked #26 in sales in 2014 in the mainstream channel (food stores, drug store, et al.),” Mr. Blumenthal reported.
Sabinsa’s Mr. Majeed attributed turmeric/curcumin’s exponential growth to “the body of science having both solidified credibility of the herb, as well as expanded understanding of the range of the benefits it provides, beyond inflammation.”
After specialty homeopathic remedies ($38.2 million), milk thistle was the next highest earner in the natural channel ($10.5 million), according to SPINS, followed by elderberry ($10.2 million), maca ($8.7 million), echinacea ($8.4 million), oregano ($7.5 million) and saw palmetto ($7.3 million).
As the category continues to expand Mr. Blumenthal said herbs such as saffron (Crocus sativus), and yaupon holly (Ilex vomitoria) are ingredients to watch.
Examining saffron’s potential, Mr. Blumenthal referred to recent clinical trials using extracts made from saffron flower parts (either the more expensive and traditionally-used stigmas, or the less expensive flower petals), which have shown preliminary benefits for people with mild-to-moderate depression. “What’s more, the lower-cost extract made from the flower petals appears to have similar efficacy as the extract made from the higher-priced stigmas,” he said.
Yaupon holly, he noted, is closely related to yerba mate, which has become a popular source of natural caffeine in recent years. “Mate’s leaves have about the same level of caffeine in them as do yaupon leaves—the only plant north of the Rio Grande that contains naturally-occurring levels of caffeine. Numerous small, startup businesses are producing yaupon teas (dry or roasted leaf) and some are marketing ready-to-drink yaupon tea, “ Mr. Blumenthal explained.
Ms. Cornelia with BI Nutraceuticals pointed to the rise in demand for Ayurvedic herbs and botanicals, which she explained is a system of holistic medicine that originated in India over 5,000 years ago. Ayurvedic herbs and botanicals such as ashwagandha, ginger and turmeric are continuing to gain public favor, while adaptogenic herbs and botanicals like ginseng, maca and schisandra are gaining ground. “Adaptogenic herbs/botanicals, traditionally referred to as tonics or rejuvenators, have been used for thousands of years to enable the body to adapt to stress, both mentally and physically.”
Sabinsa’s Mr. Majeed also predicted a strong future for ashwagandha, which he anticipated is about to “break into the mainstream.” He added, “Sabinsa has experienced a very robust 35% growth from 2014 to date for our ashwagandha sales, which we expect to increase as we develop the market based on the quality and the scientific rigor inherent in Sabinsa’s products.”
Mr. Siegel of Ecuadorian Rainforest sees Chanca piedra as a breakthrough botanical in 2016. Another Ayurvedic herb, Chanca piedra is found mainly in coastal areas, and has “resurfaced on the radars of consumers because of its historical use against several stomach ailments.”
He added that American ginseng is also in demand within the category. “In the last year, manufacturers have taken an interest in American ginseng due to its historical use against the common cold.” Similarly, goldenseal root has also surged in popularity as of late. “Like American ginseng, it is believed to combat the common cold but others have used it for several maladies, including stomach disorders.”
TSI Health Sciences noted Ginkgo biloba is an important ingredient in the category, because it has been used widely in both dietary supplement and pharmaceutical industries, mainly for cognitive function and memory support. However, ginkgo’s well-known struggle with adulteration makes partnering with a trusted supplier especially important when formulating with the ingredient.
“Historically, ginkgo has been heavily adulterated in the worldwide supply chain; this cost-driven adulteration, or ‘economic adulteration,’ and the cost gap between authentic and adulterated ginkgo is significant,” explained Mr. Ji. “At the moment the industry is focusing on improved testing to determine the extract’s authenticity.” However, he said market leaders are moving to increase supply chain transparency, with the ultimate goal of complete control over the product’s chain of custody.
Eric Zhang, PhD, R&D director for KEB Nutraceutical USA, Inc., Ontario, CA, said that milk thistle and St. John’s wort are leading the company’s herbal extract portfolio. “The medical efficacy of these two items has been investigated and supported in a lot of medical research reports,” he said. “In some EU countries, these two items are even being used as drugs.”
To ensure product quality and improve product fulfillment rates, KEB has been managing its own farmlands for milk thistle. “To keep up with the needs of the market, KEB has been continuously doing research and launching products with new specs, such as Silymarin 80% by HPLC and St. John’s wort extract (Hypericins 0.3% by HPLC),” said Dr. Zhang. “All these efforts have contributed to the success of these two products.”
Horphag Research, Geneva, Switzerland, suggested that ingredients providing effective, science-backed benefits that are under the strictest quality control would continue to see growth in the herb/botanical category. Vice President of Global Sales & Marketing Sébastien Bornet suggested the company’s ingredient Pycnogenol, an extract from the bark of the French maritime pine tree, meets such standards. “Pycnogenol…is produced from a sustainable botanical source under pharmaceutical GMPs in a facility that exceeds the highest quality standards. Pycnogenol is viewed by the industry as the ‘gold standard ingredient’ because of its commitment to science and innovation,” he said. To date, Pycnogenol has been included in more than 700 dietary supplements, cosmetic products and functional foods and beverages worldwide and has a research portfolio including more than 340 scientific publications over the last 40 years.
The post-NY AG world may look different for the herb and botanical category, but many are optimistic that the resulting increased safety and quality standards will benefit the industry in the long run.
“Considering the age of herb trade itself, this is only a small inconvenient blip in the grand scheme of dietary supplements,” said Mr. Sudberg with Alkemist Labs. “As we collectively improve quality control, it’s only going to get better.” That said, he believes future scandals, recalls and industry upsets are somewhat of an inevitability. “It’s natural for an industry only recently seriously regulated to take some time to mature, but we are making great progress.”
Ms. Dolnick of TR Nutritionals anticipated continued success for those botanicals with strong scientific support. “Scrutiny is good if it weeds out those suppliers that are selling adulterated products,” she said.
TSI Health Sciences’ Mr. Ji has observed more interest from peers in the industry for advancing analytical methods to identify poor quality and adulterated products. “It’s likely there will be new regulatory pressures stemming from FSMA [Food Safety Modernization Act] that could significantly impact botanical ingredient producers.”
ABC’s Mr. Blumenthal is optimistic looking ahead. “As has been the general trend for the past 30 years or more, consumer interest in and demand for herbal products will continue to increase,” he said. “This is true whether the products are sold as teas, dietary supplements, natural cosmetics, or even non-prescription drugs, natural health products, etc. A growing body of consumers are interested in safe, relatively low-cost, natural health products, especially when these consumers are constantly exposed to media stories regarding the inherent toxicity of many conventional pharmaceutical drugs and the high number of deaths associated with conventional medical practices. The use of herbal healthcare products is not a fad; it is a strong inexorable trend in consumer self-education, awareness and lifestyle shifts.”
Cranberry Quality Assurance program aims to ensure quality, safety and efficacy.
Cranberries are well-known as a potent berry, offering benefits for urinary tract health and beyond. To ensure the highest quality standards for users, cranberry suppliers have implemented a testing program designed to ensure safe, pure and effective ingredients for the natural products marketplace.
This year the Cranberry Quality Assurance (CQA) was structured to develop higher quality standards for suppliers of cranberries.
“I am concerned over adulteration, counterfeit ingredients and contamination in the supply chain,” stated Stephen Lukawski, director of sales and business development for Fruit d’Or Nutraceuticals, Quebec, Canada, a cranberry grower, processor and supplier. “It’s bad enough that the cranberry industry for natural cranberry powders offers no standardization, but when it comes to health and safety of consumers, adulteration and purity of cranberry ingredients should be a priority in the supply chain.”
The CQA pointed to two significant factors that imposed the need to create standards for cranberry powder through a quantitative and qualitative testing protocol. First, offshore suppliers entered the U.S. supplement market with adulterated cranberry (often blended with other high-proanthocyanidins (PAC) materials such as grape and peanut skins, plum and black beans), which did not provide the same benefits as cranberry. Secondly, the 2015 New York Attorney General’s investigation claimed there were adulterated and mislabeled cranberry products in the marketplace, suggesting a need for increased regulatory standards.
Ultimately, Mr. Lukawski believes cranberry suppliers need to be held more accountable in the supply chain. “Transparency and traceability are important but higher testing standards are needed to protect consumers’ long-term future of the cranberry industry. Therefore, Fruit d’Or promotes the CQA supplier testing program. We need to raise the bar of quality by introducing higher testing standards and start to debunk the junk within the supply chain in order to achieve quality and efficacy.”
Prior to CQA’s establishment, there was no specific standardization of the berry, which resulted in disparity of efficacy. Furthermore, there were no sufficient testing procedures and methodology, reference standards or availability of sophisticated analytical equipment, such as MALTI-DOF.
Rigorous testing is essential in order to achieve CQA’s safety and quality objectives. Independent, third-party laboratories such as Complete Phytochemical Solutions LLC and NSF-AuthenTechnologies have performed the specific testing measures called for by CQA to determine the ingredient’s safety and efficacy.
In order to be CQA approved, RS Specialty Ingredients or Complete Phytochemical Solutions receives a supplier’s cranberry powder and it becomes registered. The powder gets tested and the supplier receives all documentation so there is traceability and transparency. Once material is tested, manufacturers send back the retained sample and finished product, which will be held at Complete Phytochemical Solutions.
Under the program, cranberry materials submitted undergo the following tests: Polyphenol Fingerprinting analysis for identification of bioactive ingredients; DNA sequential bar coding for botanical species authenticity; analysis for adulteration via MALDI-TOF mass spectrometry standardization; standardization of biomarkers such as PACs; and anti-adhesion testing to establish efficacy. CQA refers to this as the “5 Star Supplier Testing Program,” designed to verify raw materials and finished cranberry products.
For those who purchase the cranberry material or have their current material tested through the program, a certification seal is available. The seal can be used on product labels, consumer brochures and advertising, and on social media.
“It is important to protect the health and safety of consumers by introducing cranberry powders and products that provide quality and efficacy. Not all cranberry products are of the same quality,” concluded Mr. Lukawski. “Therefore, the cranberry supplier program generates more credibility and trust within the nutraceuticals industry to win the respect and confidence of both consumers and the media. The industry is under pressure by government and media to improve the quality of dietary supplements and ensure there is no adulteration.”