The Participants Are:
• David Trosin, Director Of Global Business Development, Dietary Supplements, NSF International, Ann Arbor, MI
• Elan Sudberg, CEO, Alkemist Labs, Costa Mesa, CA
• Jennifer Cooper, Vice President R&D and Quality, Twinlab Consolidated Corporation, Boca Raton, FL
• Randal Kreienbrink, Vice President of Marketing, BI, Rancho Dominguez, CA
• Anna Lykkeberg, Research Associate, Beta Analytic, Miami, FL
The word “quality” is used (and abused) so frequently, to many consumers, it has lost its value of persuasion. Further, skepticism is at the forefront; consumers are hesitant to fully believe something is “high quality,” when they want to know exactly how the brand defines that term. What are the facts that support that opinion—and to consumers, “quality” is opinion-based. And this is what needs to change—quality as defined in scope should be transformed from marketing buzzword/opinion to facts about the processes that create that quality.
A lot of what creates and defines levels of quality is compliance to ever-tightening regulations, and the technological advances allowing for such attainment. Industry experts weigh in on what constitutes quality in the “natural” product world—how to attain it, and what challenges remain and are forthcoming.
NIE: What do you feel are the most significant strides in the past 10 years in regulations, philosophies and technologies that allow for more reliable quality and compliance?
Trosin: We are seeing more acceptance and compliance with good manufacturing practices (GMPs) in the dietary supplement industry. In recent years, the industry has come together to establish the Global Retailer and Manufacturer Alliance (GRMA) and focus its efforts on supply chain transparency and quality. It’s encouraging to see the dietary supplement industry moving in the right direction in both thought and action.
Sudberg: More reliable quality and compliance comes with an increased cost of doing business. The industry has accepted this idea, which can be seen by the growth in the lab sector. We have also done a great job of weeding out the bad players (from the standpoint of a lab that knows all the bad players). Transparency has become more than just another buzzword and we’re seeing it exemplified throughout the industry.
From a regulatory standpoint, unimpressive strides have been made toward clarifying “fit for purpose” test methods in response to the turbid vagueness for which cGMPs were forged. We’ve spent the last 10 years debating which methods we should all be using and for what samples based upon demonstrated scientific validity, and then from the sidelines, technologies such as Infrared spectroscopy (IR), Near-infrared spectroscopy (NIR), Fourier transform infrared spectroscopy (FTIR) and DNA have emerged as disruptors to the progress made in agreeing on best testing practices. All technologies might have a purpose in our industry once their strengths and weaknesses are understood and widely accepted. However, and unfortunately, premature application of technology, as we have seen with DNA and IR technology, has distracted industry from focusing on actual quality.
Cooper: The most important issue facing the industry today is a philosophical one. Is our quality strategy as an industry to get ahead of the regulators, or is “good enough” good enough for now? We have an unfortunate reputation as an industry of doing just enough to get by and waiting for the next shoe to drop. Some of that may be well deserved, and some of it is due to ambiguity in and the evolution of regulatory standards and enforcement activity. Shockingly, the industry waited with bated breath for more than a decade for the supplement GMPs. Among the next “shoes to drop” are NDIs (new dietary ingredients), raw material GMPs, SAERs (Security Access Eligibility Report) and finished product, market registrations. There are six key factors, as follows:
1. Advances in testing (eg, DNA) has very real limitations and has met with much controversy in the industry. We can accept that this tool, for better or worse, is coming. Regulators and watch groups are likely to use it, whether we embrace it or not. We can either keep bemoaning it, or we can participate in improving the technology and developing the standards for its use.
2. Claims challenges, class-action lawsuits involving claims or product descriptions are increasing in frequency. More worrisome, plaintiffs are winning huge settlements. The standard for “competent and reliable scientific evidence” has been a hot topic from the day DSHEA (Dietary Supplement Health and Education Act of 1994) was passed and continues to evolve based upon case law and consent decrees. While we may debate the definition of “competent and reliable science,” we should acknowledge that whatever the standard, the industry needs to be more committed to supporting scientific endeavors and to elevating science behind dietary supplements. We should not lose sight of the big picture while we debate the nuances.
3. The industry has taken a very proactive role in trying to shape the final guidance document on NDIs. If your company is not involved, you should be. Based upon the pending draft, the extremely broad definition of NDI will impact every company, and has the potential to create a quasi pre-market approval paradigm.
4. SAER reporting is actually dropping rather than increasing while sales are up. The industry is growing and social media makes it easier than ever for customers to voice their complaints, but reporting does not keep pace with these trends. SAER under-reporting is going to precipitate a cataclysmic event. Companies with a proactive, quality strategy should get ahead of the regulatory crisis that is looming.
5. We have better testing methods and more agreement on their standardization, lower detection limits, increased specificity, expanded reference libraries, more precise standards and the “school of hard knocks” to thank for smarter, faster and more accurate testing of ingredients and products. We still have more we can do here, and as new ingredients or forms of ingredients come into the market, we need to invest in the best practices for ensuring their quality. The ability to test the identity of most ingredients using various LC and GC technologies (including MS and MS-MS strengths) has facilitated a different level of detail available to us for monitoring purity, potency and identity. (Both TLC and HPTLC technologies are still heavily used.)
6. Philosophies and practices such as SQF (Safe Quality Food) and HACCP (hazard analysis and critical control points) have guided cleanliness and practices in manufacturing that help protect the quality of the products being sold to the customer and ensure safety. They can help in designing processes as well as redesigning them when failures occur in formulation, production or testing.
Kreienbrink: Both FSMA (Food Safety Modernization Act) and GFSI (Global Food Safety Inititative) have made strides on food safety quality and standards. FSMA has shifted food safety measures from responsive to preventative, while GFSI has created consistent food safety standards across the industry. Trade organizations—ABC (American Botanical Council), AHPA (American Herbal Products Association), CRN (Council for Responsible Nutrition), NPA (Natural Products Association)—have also had great impacts on quality and standards as well as safe, unadulterated products.
Lykkeberg: While Carbon-14 natural source testing is not a recent development, it has been gaining traction in the supplement industry, in line with the changes in consumer perceptions and priorities, and businesses implementing stricter quality controls for natural ingredients and rising demand for botanical extracts.
NIE: What are the most significant challenges brand marketers now face for compliance when formulating new products?
Cooper: Claims, claims, claims. The substantiation standard for claims is one that continually plays out in the court system. Natural product claims are on the radar of the National Advertising Division, FTC (Federal Trade Comission), FDA (U.S. Food and Drug Administration), CRN, state attorneys and others.
It is marketing’s job to create the most compelling story for a product and its ingredients. Label claims are so much more than just the front panel structure function claims. Claims also come in the form of how we describe the ingredients in the supplement facts panel and any additional language about their sourcing, origin or certifications. It’s Quality’s and R&D’s job to make sure that we haven’t created an ingredient mythology where all the bells and whistles have limited our ability to source this magical ingredient to less than 2 percent of all the material available on the planet. I like to refer to this as sourcing from the dark side of the moon. Basically, we have over spec-ed the ingredient to where it is not realistically, commercially available on a consistent basis, or where its sourcing will have dire environmental consequences.
Kreienbrink: Label claims, health and wellness claims, ingredients that match specifications and certifications all pose challenges when formulating with new products, but the new Nutrition Facts label regulations, though postponed, are proving to be especially difficult due to the lack of clarity in some of the provisions. The lack of clarity applies to areas such as fiber, for example: will the FDA allow other fibers besides the seven designated fibers to make claims? Fibers such as inulin aren’t currently on the list.
Another area that is murky is added sugars. Fruit concentrates are currently labeled as added sugars but fruit pumices are not. Will this change? And finally, there are questions regarding portion sizes. Who will define what constitutes a reasonable amount? Will this be the FDA, consumer or manufacturer?
Lykkeberg: When formulating new natural products, a big challenge is becoming familiar with the supply chain and QA (quality assurance) of any new ingredients. With the ever-burgeoning variety of natural ingredients on the market, and the corresponding adulteration techniques, it is important to understand how the natural raw material is sourced and what measures are in place to assure its authenticity throughout the increasingly complex supply chains.
There are no specific regulations on the use of the term “natural” in many industries including dietary supplements; however, claims must not mislead consumers. Understanding natural ingredient sources and ensuring their authenticity when formulating new natural products is crucial to prevent any legal ramifications from any claims used. The cosmetics industry also sees similar issues with natural product claims, and the U.S. Federal Trade Commission has acted on misleading natural labels. There have been settlements with several companies that used “100 percent natural” or “all-natural” claims on products containing synthetic material.
An additional concern here is the complexity of regulatory restrictions. For example, raspberry ketones are permitted in small amounts as flavoring in the E.U. However, for use as a dietary supplement it is classified as a “Novel Food,” meaning its use as a supplement was unauthorized in the E.U. until a review later permitted the use of a specific extract sourced from raspberries. In this case, the above considerations of the supply chain and QA have added regulatory implications. Extracting them from raspberries is expensive and gives a low yield, whereas the synthetic version manufactured from petrochemicals is a much cheaper option.
Trosin: You might think qualifying a contract manufacturer is a challenge, but NSF International’s GMP Registration lists hundreds of manufacturing facilities, packagers and distributors that are verified to comply with the FDA’s GMP requirements. NSF International evaluates thousands of dietary supplement products and we’ve found that contamination, adulteration and a lack of claimed ingredients or stated level of ingredients are the biggest challenges for brand marketers.
Sudberg: We have evolved as an industry to where the increased cost of identity testing is no longer “that new liability” on the balance sheet getting people fired. Most of the industry has taken that big gulp and swallowed it down: identity testing is essential. The industry’s next big challenge that must be addressed sooner than later is new product method development. Once a formulation has more than just a single ingredient there is a need for fit-for-purpose methodology. Test methods simply don’t exist for blends of ingredients until they are developed by a lab. Ginger in ginger powder testing is quite routine. Testing Gingerols in ginger is also quite routine. Gingerols from ginger in a ginger blend with all of ginger’s close colleagues is not routine; it requires specifically developed test protocols. Some companies choose not to spend the money, but that’s foolish: the FDA has been hunting for labels that make constituent claims without scientifically valid methods to back up the data. The resulting fallout is far, far more expensive than doing it right in the first place. We see this as the next major challenge for the dietary supplement industry, which is why we’re strongly recommending dealing with it now.
NIE: There are hundreds of thousands of natural ingredients/sources for dietary supplements—and still a high potential for adulteration or use of the wrong material. How do you believe adulteration prevention has potentially improved—and what needs to be done to make it even more foolproof?
Cooper: One of the best, and worst, things about the natural products industry is that there is literally an infinite number of possibilities when it comes to raw materials. The same ingredient could be grown in multiple regions of the world, fluctuating seed stock, sprayed with different kinds of herbacides and pesticides, exposed to varying weather patterns, pests and pollution, picked during different seasons and at different times during the plant life cycle. It can be harvested and processed immediately or languish in silos or bales. It might be sterilized, extracted, dried, granulated and stored under diverse conditions. The same mega lot might be sub-lotted and sold under different lot numbers for many months or longer. Even with all this uncertainty, legally this could all be the same ingredient—and we haven’t even discussed how it might be adulterated, contaminated or misidentified.
It is not the same thing to do quality control for a pure substance, like ascorbic acid, as it is for an agricultural commodity. Just like there are fat, juicy brightly colored oranges, there are also green, hard, stubby oranges. They are all still oranges, but not really the same thing. Certainly, if you ask the consumer what he wants, his expectation is definitive.
There is also an endless number of things that can go wrong in the global, complex supply chains that are now prevalent. It is impossible to spec your way to quality. The first step to getting high quality ingredients is having a rigorous specification, but unless your specification is a doctoral dissertation for each ingredient, you can’t define or anticipate everything that could go wrong. Specifications are constantly evolving to consider new threats, better sourcing options and improved testing techniques. Even when you have great relationships and solid specifications, nothing can take the place of testing. So many different grades of materials are available, and the bottom line is that you get what you tolerate. Every time I reject a lot, I know the likelihood that it will be sold to someone else is very high, someone who didn’t do as aggressive testing and whose tolerance is higher than ours for accepting variation and risk.
Trosin: Adulteration prevention starts with raw material and finished product testing. It’s also important to know the likely adulterants for different ingredients and product categories. NSF offers two levels of certification for dietary supplement and functional foods. NSF product certification verifies regular GMP compliance and product content while also making sure the product is free of common contaminants. At a higher level of certification, products that are NSF Certified for Sport are tested on a lot-by-lot basis for over 270 athletic banned substances. That’s why NSF Certified for Sport is recognized by major professional sports leagues, including the NFL, NHL, MLB, PGA and LPGA.
Lykkeberg: One form of adulteration in the industry arises from the fact that many natural raw ingredients can be expensive to extract and low in supply, with prices fluctuating significantly depending on harvests, while petrochemicals are plentiful and cheap with comparatively stable supply chains. This difference means that many natural products are subject to economic adulteration with a variety of cheaper additives including petrochemical sourced synthetics. A prominent example of this in the supplement industry is curcumin. There have been legal cases brought against suppliers selling petrochemical-derived synthetic curcumin as natural, indicative of businesses taking the problem of adulteration increasingly seriously.
A Euromonitor survey found that consumers associated products labeled as “natural” with being plant-based and free of artificial additives. Businesses with verified natural claims and stringent quality controls for natural ingredients can use this to their advantage in marketing their products. There have also been issues with suppliers providing falsified testing certificates. Using a third-party ISO 17025 accredited laboratory to confirm any in-house testing can detect any fraudulent claims along the supply chain. Carbon-14 testing offers a definitive answer to whether any natural products have been adulterated with any petroleum-derived synthetic ingredients, and is able to detect adulteration of curcumin as described above, providing assurances to consumers that the product is 100 percent plant based.
Sudberg: Cheaters will cheat. They have since the beginning of trade—there is clear evidence that olive oil adulteration was a major problem in ancient Rome. The industry has resources available that can help, such as AHPA’s tireless efforts to guide the industry toward quality products and ABC’s Botanical Adulterants Program. By deploying a testing regimen that strategically uses these resources, to engineer an internal or external testing program that will minimize adulteration risk and optimize product efficacy, a company can make something we shouldn’t have to worry about foolproof. If testing is not part of a company’s internal operations, incorporating high quality standards into their buying power, such as only buying from the top providers with demonstrated quality standards, will do its part.
NIE: “Clean label” has rocketed to the forefront of consumer demand—what types of challenges does this place on the brand marketer and its supplier/contract sources? What are more recent developments in achieving this as expediently and effectively as possible?
Sudberg: “Clean label” is a fancy way of saying that consumers increasingly opt for products with simple ingredients, are ethically produced, and with nothing to hide. Many supplements have complex production that isn’t easy to describe, and some products can’t honestly make such a claim. To claim “clean label” for supplements requires demonstrating ethical sourcing, conscientious manufacturing and robust fit-for-purpose testing to both retailers and consumers. For legitimately high-quality ingredients, marketers are telling the stories behind their products, but are missing the boat in an important way. One way of demonstrating quality that the industry has not yet caught onto is being transparent about testing. Testing is crucial to product quality, and good testing labs are quality gatekeepers, so why are we kept secret?
Cooper: Clean label ingredient options are now more commercially available than ever, making “clean label” more the rule than an exception for many brands that are willing to pay a premium. Organic, non-GMO (genetically modified organism), allergen free, animal product-free actives and excipients are commercially available and more functional than ever. The challenge of changing a traditionally formulated product to clean label product is always how to mitigate the cost increases and how to decide what the consumer is willing to pay for such a change.
Lykkeberg: The push for “clean label” has seen a rise in demand for plant-derived ingredients and phasing out of artificial additives and flavors. Making clear and verifiable claims is a key aspect of “clean labels” and with the term “natural” not being regulated or having a harmonized definition across the industry, authenticating natural claims is one of the key considerations.
The aforementioned Euromonitor survey noted that while many consumers seek natural products and trust the “natural” label, the majority are also aware that the term is not regulated. Being plant-based and free of artificial additives are attributes that consumers associated with the label. The use of the “natural” claim for vitamins that contain more synthetically sourced ingredients than natural ones is an example of an instance where this label has caused concern and left consumers feeling misled.
Being able to verify natural claims is an important step for a “clean label,” and the Carbon-14 method provides an easily communicable result for consumers and QA. By distinguishing between biomass-derived and petrochemical-derived material, Carbon-14 testing substantiates claims that natural products are free of petrochemical-derived synthetics, in line with consumer perceptions of the “natural” claim.
NIE: What is on the horizon in the area of compliance and quality control, eg., regulations and technology?
Trosin: FSMA compliance requirements for dietary supplements are on the horizon. Shortly after that, we hope to see finalization of the GRMA dietary supplements standard. With that said, it is not about what is new, but about perfecting what we have.
Lykkeberg: Many natural product industry stakeholders and consumer segments are calling for a more defined and restrictive definition for use of the term “natural,” and we are beginning to see regulatory bodies respond to this. Other industries have been facing similar challenges to nutraceuticals and supplements with “natural” claims and the “clean label” trend.
In the personal care industry, the FTC has taken action against several businesses using “all-natural” or “100 percent natural” claims for products that also contained synthetic ingredients. Additionally, the E.U. has recognized the problems of misleading marketing that the lack of a regulated and harmonized definition for “natural” has on the cosmetics industry. And the FDA has also shown an interest in the use of the “natural” label in foods, and requested comments on the topic. As supply chains become increasingly complex and consumers demand more clarity, the use of more standardized tests to substantiate claims verifiable by third-party laboratories is a logical step toward increased accountability of any natural claims. Along with QA for the ingredients themselves, any third-party laboratories used should themselves also hold accreditation confirming their technical competence; ISO 17025 is the recognized benchmark for testing and calibration laboratories.
Sudberg: Expectation that regulatory scrutiny would decrease with Republicans winning Congress and the White House was silly, because it’s not like industry critics such as state AGs (attorneys general), the media and other fault finders were abducted by aliens. With the administration so chaotic, anything can happen. Your best plan is to focus on quality and genuine regulatory compliance, so whatever happens, your business should be on solid quality and regulatory ground.
While there are always people drawn to the latest shiny ball of new technology, when it comes to testing, new technology often gets dilettantes in trouble. Experts spend years being nerdy together to agree on what methods work best, and you don’t throw that over lightly. The fact is that if it isn’t fit for purpose and reproducible, it’s not good science. There is no single technique to be utilized for plant identity (extract or not). DNA, HPTLC, microscopy and good old-fashioned organoleptic techniques can’t be beat when combined. As you remove one from that mix you add risk to your quality. NIE