From Field To Extract
Industry leaders Weigh in on the Current state of Botanical Adulteration
It is no surprise that there is a problem in the global herb and dietary supplements industry—the persistent availability of adulterated herbs, herbal extracts, essential oils and other plant-derived dietary ingredients. Nutrition Industry Executive (NIE ) asked those schooled on the subject to discuss this topic, and offer their thoughts on how botanical adulteration can best be tackled.
The participants are:
Mark Blumenthal
Founder & Executive Director,
American Botanical Council
Editor-in-Chief,
HerbalGram & HerbClip
Austin, TX
(512) 926-4900 x102
Roy Upton, RH,
DipAyu
American Herbal
Pharmacopoeia
Scotts Valley, CA
(831) 461-6317
Dr. Ikhlas Khan
Director, FDA Center of
Excellence
Assistant. Director NCNPR,
University of Mississippi
(662) 915-7821
John Travis
Senior Research Scientist,
NSF International
Ann Arbor, MI
(734)-769-8010
Mollie Kober
Senior Auditor,
NSF International
Ann Arbor, MI
734-769-8010
Antoine Bily
R&D Director,
Naturex Inc.
South Hackensack, NJ
(201) 440-5000
Alice Chin
Quality Control Director,
GWI
La Mirada, CA
(877) 550-3600
Wilson Lau
Vice President,
Nuherbs Co.
San Leandro, CA
(800) 233-4307
Amanda Lu
Sales Manager,
Chenguang BIOTECH GROUP
CO., LTD.
China
+86-31-088-51319
George Pontiakos
President & CEO,
BI Nutraceuticals
Long Beach, CA
(310) 669-2100
Brien Quirk
Director of R&D,
Draco Natural Products
San Jose, CA
(408) 287-7871
NIE: Are botanical adulterations accidental or deliberate?
Upton: Both; historically and currently adulterants have always occurred both deliberately and unintentionally. For example, recently one testing company suggested that 100 percent of the muira puama on the market is adulterated based on the fact that originally the common name muira puama was assigned to the botanical with the Latin name Ptychopetalum olacoides. Presumably, this species went extinct more than 100 years ago and the common name muira puama was presumably reassigned to Croton echioides, a species presumed to possess similar activity. If this turns out to be accurate, it is clear that the majority of manufacturers of muira puama products were not aware of this species switch. If this is correct, technically, if assigning the name Ptychopetalum olacoides to muira puama, the product would be adulterated. However, in the world of herbalism, there are no absolute guidelines for how common names are assigned to botanicals. Thus, if all this bears out to be accurate, muira puama can now be considered to refer to the Latin binomial Croton echioides. This would be an example of an unintentional adulteration that perhaps should not be regarded as an adulteration.
Additionally, a segment of adulterations can be considered intentional or unintentional depending on one’s perspective. Many manufacturers outsource manufacturing to contract labs expecting the contract lab to set the specifications and perform the appropriate tests without ever auditing the company. The manufacturers feel they have done their due diligence; FDA (U.S. Food and Drug Administration) has made it abundantly clear to everyone listening that this is not acceptable. It is the direct marketer that is responsible for ensuring their products are manufactured in a GMP (good manufacturing practices) compliant manner.
Intentional adulterations are clear; unscrupulous manufacturers spike sex performance and athletic products with steroids; extract manufacturers spike ginkgo and bilberry extracts with pure flavonoids or dyes, respectively; others mix cheap berberine-containing herbs (e.g., Oregon grape root) into goldenseal, the latter being very expensive; or cut ginseng root powder with dicalcium phosphate to increase the weight. When this is done consciously it is intentional. However, a manufacturer may purchase a lot of ginseng root powder that is cut with 20 percent dicalcium phosphate, perform all the necessary identity tests and even quantify ginsenoside content and the material may pass. In this case, though the adulteration was intentional by the original supplier, it becomes an unintentional adulterant once used by whoever bought it to use in a marketed product.
Blumenthal: Both. Adulteration can occur if a plant collector accidentally collects the wrong plant and no party in the subsequent supply chain identifies the error. An herb can be adulterated if a different herb is accidentally mixed in with another herb in a warehousing or processing facility. These types of accidents can be avoided by ensuring that personnel along all areas of the supply chain are properly trained, and that appropriate good collection practices and GMPs are adhered to. And, an herb can be accidentally adulterated, at least theoretically, if the grower of a commercially cultivated herb plants the wrong seeds of a plant, even one in the same genus, and, again, no one detects the error up the supply chain.
Unfortunately, an herb or a botanical extract, and/or an essential oil can be adulterated (either substituted or diluted by an undisclosed lower-cost material) intentionally by parties that are seeking to maximize their economic gain at the expense of the customer. The term for this is economically motivated adulteration (EMA), and it is fraud.
Khan: Since prehistoric times, substitution and adulteration has been detected in herbs and spices. Now, from the FDA website it looks like products can be adulterated with synthetic drugs, which cannot be considered unintentional.
NIE: Which botanicals are at risk and why?
Upton: On the intentional adulteration side of the conversations, ingredients that are expensive (e.g., goldenseal, ginseng, etc.) and products marketed to deliver a powerfully experiential action (weight loss, athletic, sex performance, energy products, etc.) are most at risk of adulteration as there is a significant economic incentive to do so. This principle has not changed historically to current times. On the unintentional adulteration side, species that are closely related and freely traded are subject to adulteration (e.g., mixing up Echinacea angustifolia root with Echinacea pallida or Echinacea atrorubens, for example.
Travis: Ingredients that are costly as well as ingredients in short supply are at risk for deliberate, economically motivated adulteration. Botanical ingredients that have similar morphology and characteristics can be at risk of misidentification, resulting in accidental adulteration. Adulteration has been present in industry possibly since its inception. As the industry revenue has grown, so has the propensity for adulteration, which is economically motivated.
Quirk: Adulteration can be twofold with the FDA—in one type it can be the wrong botanical, and in another it can be contamination with something like an unauthorized or undeclared pesticide, drug, toxin or heavy metal. Botanical extract ingredients and blended formulas are particularly at risk to test for the botanical identity because the plant part morphological characteristics are no longer present after extraction and it is more difficult when there is a larger and more diverse matrix of phytocompounds with multiple botanical sources in a multi-herbal formula. The matrix can interfere with the detection of a characteristic phytocompound that would identify a particular plant. It is also quite difficult to know if other plant parts have been used to manufacture an herbal extract since its visible detection is no longer possible. Voucher samples of the raw material used to make a lab extract sample should be obtained to see if it matches the HPTLC (high performance thin layer chromatography) or IR (infrared) of the bulk extract purchased.
Also, plant species such as hawthorn experience interhybdrization, meaning that the species can cross-pollinate, making it difficult to properly identify which species is present.
Bily: The adulteration risk is correlated with the scarcity and price of a feedstock. The adulteration appears as the price increases (e.g. turmeric extract adulterated with synthetic curcumin, high fructose corn syrup or cane sugar being used to adulterate honey, etc.). We are seeing a higher risk of adulteration on ingredients such as black cohosh, curcumin, ginseng, bilberry and saw palmetto.
Lu: Grape seed extract and Ginkgo biloba extract, for example [are at risk], but there have been improvements in the industry due to higher awareness. However, there are still manufacturers who provide fake extracts and there is still demand for them as some customers only care about low prices. I am assuming, though, that the situation will continue to change and manufacturers will have to provide more transparent information. Because of distributors such as GWI, suppliers need to be transparent about all their products and there is additional quality control.
Lau: All ingredients are at risk because when there is an economic incentive for people to cheat, some people will be lured by the allure of the extra money. Additionally, there is a cost associated with properly and thoroughly identifying the botanical, so people may try to save money and not properly qualify the material. However, most of the people in our industry do a great job combating these two major risk sources.
Pontiakos: Trending ingredients are especially susceptible to adulteration. The markets for “overnight success” ingredients usually witness a flood of new players looking to make a quick buck, even at the cost of the consumer’s health. A perfect example of such an event playing out is green coffee bean extract. The drastic increase in popularity of green coffee bean extract late 2012/early 2013 can be accredited to “The Dr. Oz Show.” Because of the rapid increase in demand, the quality of the product was jeopardized in just a few months following Dr. Oz’s promotion. Several suppliers were caught claiming more chlorogenic acid than what is actually in their material, possibly supporting that claim with differing test methods––several samples BI tested could not pass our chlorogenic acid test. There is no standard chlorogenic acid test method so it is easier to utilize a fallacious test method.
NIE: How have GMPs affected botanical adulteration?
Upton: GMPs have forced every responsible manufacturer to review their internal specifications and identify where they had deficiencies, either in terms of specification development or verification/testing protocols. It has raised the bar of accountability greatly. It has also showed the industry that, especially in the area of extract quality, there are severe deficiencies in accountability regarding identity as the identity profile of extracts varies greatly, both due to the inherent variability that is in nature and different extraction procedures. For example, a water extract of Echinacea angustifolia will give a very different analytical profile than a solvent (e.g. alcohol) extract; a 20:1 extract may give a very different profile than a 5:1 extract. If the specifications are not specific enough it can be very difficult to interpret analytical findings; on the other hand if there is too must specificity, then the inherent variability seen in many analytical techniques—and that is common to natural products—cannot be interpreted properly.
Travis: GMPs require at least one scientifically valid test to determine the identity of any dietary ingredient. Before GMPs, many manufacturers relied upon a supplier’s certificate of analysis in lieu of testing for identity. An unscrupulous supplier may have provided false documentation, which would not be uncovered without identity testing.
Pontiakos: GMPs have had a positive effect on botanical adulteration. They provide clear, concise requirements, which details both process and responsibility across our ecosystem. In the past year, the FDA has become more stringent with enforcing GMPs, which have caused finished product manufacturers to enhance their manufacturing, testing, and most significantly, documentation procedures as well as ramp up their surveillance and understanding of their supply chain. Although we are seeing injunctions, seizures, and what seems like countless warning letters, this only means GMPs are doing its intended function: to provide safe product to consumers. We are going to witness the removal of companies uncommitted to quality from the playing field and increased consumer confidence in an industry that was lacking it.
NIE: What have industry groups and associations done to address the issue?
Travis: The American Herbal Products Association (AHPA) has developed their Botanical Authentication Program, which provides tools to help identify botanicals, including training in analytical techniques and developing analytical methods for identity, and listing known adulterants in the marketplace.
The American Botanical Council (ABC), American Herbal Pharmacopoeia (AHP), and University of Mississippi’s National Center for Natural Products Research are collaborating on a Botanical Adulterants Program.
Upton: In my opinion, American Botanical Council, American Herbal Pharmacopoeia, and the American Herbal Products Association have done the most to address these issues. ABC has a long history of publishing articles on herbal adulterations in HerbalGram. Then, in 2013, ABC developed a collaborative project of ABC, AHP and AHPA to underscore issues of adulteration and to propose solutions. AHP was founded in 1995 specifically to help establish a model of ensuring identity, quality and testing for botanical ingredients through its publication of monographs.
Additionally, AHP provides the industry with authenticated botanical reference materials that can be used in testing so a manufacturer has an authenticated reference to compare their test samples to. AHPA has a long history of identifying botanicals that are subject to adulteration and are listed on their website. AHPA also developed an online forum for botanical ingredient identification that one day may be the go-to site for botanical identification. Other groups, such as NSF International, have led the way in independent GMP certification. United Natural Products Association (UNPA) has held numerous seminars on what FDA expects when they perform inspections. And independent businesses such as Alkemists Laboratories, Botanical Liaisons, Chromadex, Flora Research Laboratories and others have led the way in providing testing and botanical ingredient authentication services.
NIE: What are suppliers and manufacturers doing to address the issue? What are their biggest challenges in this area?
Kober: The supply chain continues to be driven towards lowest cost. Many companies have not yet been able to lock in quality sources and suppliers of ingredients. In fact, the majority of dietary supplement manufacturers generally shop for ingredients and use multiple sources. These factors put price pressure on the ingredient supply chain and when that happens, adulteration is generally not far behind. This has happened time and again with various ingredients and the end result being a finished product that does not deliver the quantity or quality of ingredients listed on label. Supplier qualification testing beyond just identity is one of the least implemented aspects of the new GMP regulation, but one of the most critical in stopping ingredient adulteration.
A second challenge in this area is the fragmented supply chain. The majority of botanicals come from overseas markets. The supply chain is multilayered and a true relationship at the factory level is rare. The ingredient may easily change hands four to six times prior to being sold to its final destination. Each layer clouds the traceability of the ingredient. There are economic incentives along the way to provide “higher quality” documentation while delivering a substandard ingredient.
Bily: To avoid adulteration, manufacturers need to work on several aspects all at the same time. First, they need to make sure the botanical that enters their factory is safe and corresponds to the right botanical. At Naturex, we believe that providing the right ingredient starts by selecting a reliable partner in the field who watches carefully over the raw material and respects the environment. Our eight local purchasing offices employ agronomists whose job is to exchange with local people about their good agricultural and collection practices (GACP) and to share technical advice to achieve the best yields. In the meantime, we have developed a full traceability system in the field by assessing and auditing our suppliers on a regular basis.
We also need to make sure that when the botanical arrives at the factory, it is the right botanical. Naturex is able to perform more than 350 different methods of analysis from macro/micro authentication based on assessment at macroscopic levels by botanists to phytochemical levels involving sophisticated methods like HPTLC, HPLC, and gas chromatography (GC). The core expertise of Naturex’s scientists is knowing exactly which type of test is suitable for each botanical.
Lu: Chenguang, as a leading herbal extract producer, we are always advocating for producing superior materials, as anything else would affect our reputation and relationship to our U.S. customers. We are committed to be an industry leader in the way we grow our herbal ingredients and manage our production process. We are also very conscious about every regulation.
The most challenging problem for U.S. customers is that the market information is oftentimes blurry and not transparent. There is a lot of competition from [suppliers of] adulterated materials and the prices of genuine articles are threatened significantly because of it.
Lau: Based on my experiences, suppliers and manufacturers are proactively addressing this issue by investing substantial resources in their QA (quality assurance) and QC (quality control) departments. I would venture a guess that this is a fast-growing line budget item in most companies. The biggest challenge is finding qualified individuals to do the work and secondly, following and complying with the everchanging regulations. Remember cGMP is not a fixed endpoint but one that is ever-evolving and changing based on new technology, regulations and products.
NIE: What can the industry do to put consumers at ease when buying products that contain botanicals?
Upton: Unfortunately, nothing. Clearly there is a responsible segment of the industry that believes wholeheartedly in the health benefits of plants and there is that segment that jumped on the herbal boom bandwagon for a paycheck; these two segments cannot be differentiated by the consumer; or often by FDA; these products sit side by side each other on the shelf. Individual companies must make their case to their distribution chain; to their practitioners, retailers, and consumer base and tell a story that is good enough to believe and hopefully with the GMP documentation and clinical experience to back it up.
Blumenthal: This is a big challenge. In general, many experts suggest that consumers purchase brands with which they are familiar and brands that they trust, but this may not be responsible guidance, as many consumers are confused by the dizzying array of brands in the marketplace, new product proliferation from new companies, etc. It may be appropriate for consumers to rely on seals showing third-party verification, but many of these seals relate to an audit by a third party of a company’s manufacturing facility, and does not necessarily mean that the actual product or its ingredients have been tested for accurate identity by the third-party certifier.
The two most respected third party verification programs are conducted by NSF International and the United States Pharmacopeia Dietary Supplement Verification program, respectively, but to the best of my knowledge, the USP’s DSVP has not yet certified any botanical products (the USP program is based mainly on letter vitamins, e.g., vitamins A, B, C, D, E, etc.). And, it must be emphasized that some very ethically responsible companies that make high quality products do not subscribe to either the NSF or the USP programs, so the absence of such a third-party seal on a label should not necessarily be misinterpreted as a lack of adequate GMP, quality, or proper identity of that product.
Chin: Consumers won’t be at ease unless there is no more adulteration of extracts. As a supplier, GWI is making an extra effort in regard to quality control to ensure that our customers are at ease, and we strongly encourage our U.S. customers to share this transparent information with their end consumers. There are a lot of improvements in the industry, and the best thing to do is to enhance the progress and the steps suppliers are taking to be transparent.
Education is key! By educating U.S. customers about the consequences of using fake materials and how to test it, we can help to prevent further damages. At the same time, we need to be aware that there would be no market for herbal adulterations without a continuous push for the lowest price.
Khan: Overall, a lot of progress has been made and we hope that in the future we will see more development in this area.
