The panel:
Cal Bewicke, CEO, Ethical Naturals Inc., Novato, CA, www.ethicalnaturals.com
Nena Dockery, Regulatory Affairs Manager, Stratum Nutrition, Carthage, MO, www.stratumnutrition.com
Wilson Lau, President, Nuherbs, San Leandro, CA, https://nuherbs.com
Jeff Lind, Director of B2B Ingredient Sales, MenaquinGold, Iselin, NJ, www.menaquingold.com
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA), Washington, D.C., https://chpa.org
Steve Mister, President & CEO, Council for Responsible Nutrition (CRN), Washington, D.C., https://crnusa.org
Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com
With certain ingredients, such as NAC (N-acetyl cysteine) and CBD (cannabidiol), in a state of regulatory limbo—combined with an extremely low level of regulatory enforcement, in general—it’s no wonder that this is both confusing and frustrating to the natural products industry, and that’s before we add pandemic-caused supply chain challenges and a labor shortage to the mix.
Here to help us sort much of it out is a distinguished panel of dietary supplement industry experts.
NIE: What is the biggest quality problem that the natural products industry has right now, and what immediate steps must be taken to address it?
Lind: The biggest quality problem is a lack of regulatory enforcement. The “bad actors” continue providing low quality products because there is very little chance of getting caught. The FDA (U.S. Food and Drug Administration) needs to have increased resources to be better able to enforce existing regulations. Until companies have a real fear of getting caught, they will continue to sacrifice quality for lower cost. Additionally, the brand marketers and contract manufacturers who buy solely on price and are not concerned with quality are undermining consumer confidence in our industry. Consumers have a right to receive the benefits they are promised when they use our industry’s products.
Mister: With the combination of stresses on supply chains as a result of the pandemic, along with the labor shortages as a result of The Great Resignation, the greatest threat is the temptation to “cut corners,” look the other way, or otherwise turn a blind eye to established quality procedures and requirements. The solution is simple—don’t do it. We must remind ourselves every day that our consumer depends on 100 percent quality and should know we won’t deliver anything less.
MacKay: The FDA is responsible for inspecting over 8,000 foreign and domestic dietary supplement facilities, but reports show that too few manufacturers are being inspected on an annual basis. Before COVID-19, FDA inspected just 10 percent of the facilities. Over the last two years, largely due to COVID-19, the number of facilities inspected has plummeted to just around 4 percent. This significant inspection gap has led to an unsustainable environment for manufacturers, and questions regarding the quality of products from consumers and health care providers alike.
To shrink the inspection gap, Congress should authorize third-party audits of dietary supplement manufacturers to FDA’s standards. A qualified inspector should visit all dietary supplement facilities on a regular basis to evaluate infrastructure, staff, ingredients and processes against legally required activities that are designed to ensure the identity, purity, quality, strength and composition of dietary supplements. These third-party inspections will benefit stakeholders across the industry.
Bewicke: The biggest problem that we see is in the supply end of the industry: the lack of U.S.-based potency and adulterant testing that’s done on botanical and other ingredients entering the country from overseas. This has always been a problem, with increasing numbers of suppliers importing and re-shipping out of warehouses with no testing facilities, or ability to administer a meaningful GMP (good manufacturing practice) program.
Today’s supply-chain delays, along with an increased demand for supplements, have only increased this problem: importing in this way is cheaper and quicker, because administering a meaningful testing program takes time and money.
Lau: I am going with an unexpected answer: the overtreatment of botanical raw materials to achieve unnecessarily low microbial levels. For example, does an extract manufacturer that uses alcohol for extraction truly need a really low total plate count? I think this impacts the quality of the herbal material.
Sudberg: The biggest quality problem the natural products industry has today is that we don’t talk enough about quality. If the consumers think we are not regulated, let’s address consumer perception and show them just how regulated we are. Show ‘em if you got ‘em … Brag about your excellent quality story or the money invested or the labs you use or … the actual independent lab data. The consumers want to know. You need them to know to further differentiate your brand.
NIE: What is the biggest compliance (legal or regulatory) issue in the natural products industry right now, and how can it be addressed?
Sudberg: Right now, there are two big compliance issues that must be addressed. First is the slow extinction of our dietary ingredients. NAC is a perfect example of a recent ingredient once sold legally then quickly stripped from our arsenal of ingredients to support health. Its timing, considering its usefulness around immune health, is very suspicious to me.
The other big compliance issue is [California] AB 1341 that bars the sales of weight loss supplements to minors without a prescription. While the bill reads well, it treats our ingredients like they are tobacco and is a slippery slope for the removal of other categories that offer alternatives to pharmaceutical drugs. They can both be addressed by supporting our trade associations who fight to protect access to important ingredients. Thanks to Dan Fabricant and the NPA (Natural Products Association) for taking a lead on opposing this bill and the damages it will do to our industry.
Lind: Don’t know that it is the biggest, but perhaps the ability to make statements not supported by legitimate data and studies. The “borrowed science” problem the industry used to have has evolved into benefit claims by some that are not necessarily supported by research. Another concern is branded ingredients not made by the seller which may not always be the same if the actual manufacturer of the material changes.
Lau: I think the biggest regulatory issue in the natural products industry is the Foreign Supplier Verification Program that is part of the Food Safety Modernization Program. COVID has impacted that process greatly, especially with the in-person audits, if you don’t have feet on the ground like Nuherbs. I am interested to see what happens with this as our pandemic becomes an endemic, whenever that will be.
Regarding NAC, according to the GAO (U.S. Government Accountability Office), although the FDA could issue a regulation allowing NAC to be used as or in a dietary supplement, to date the agency has never issued such a regulation for any article. This exclusion was intended, at least in part, to maintain incentives for pharmaceutical companies to invest in clinical trials needed to obtain FDA approval of new drugs. What about providing incentives to dietary supplement and ingredient manufacturers?
Mister: Your question exposes the imbalance at FDA. Great efforts are taken by the agency to create and protect incentives for pharmaceutical research and innovation. The agency does not create similar priorities for protecting supplement innovation and Intellectual property.
One example is the proposal for master files associated with new dietary ingredients which FDA has declined to implement. Another is its reluctance to enforce the NDI (new dietary ingredient) requirements for “me too” imported ingredients that do not have their own NDI notification.
When the agency does not impose consequences on firms that violate the intellectual property of others, it essentially signals that it does not value innovation in this industry.
MacKay: The most dramatic step industry can take against adulteration is through DSHEA (Dietary Supplement Health and Safety Act of 1994) modernization. With modernized policies, such as a mandatory product listing and authorizing third parties to inspect manufacturers, along with more dedicated resources, FDA will be able conduct more effective enforcement against bad actors selling adulterated products.
The current regulatory framework lacks transparency because it allows ingredients to enter the market without FDA’s knowledge. Increased FDA visibility into the market with mandatory product listing would make it easier for FDA to identify and more quickly remove illegitimate and illegal products from the market. In the event of a quality issue with an ingredient, an up-to-date database allows FDA to identify which products and manufacturers are affected so they can take action.
The current regulatory framework is not optimized to inhibit bad actors or inexperienced companies from being non-compliant without consequences. This leads to poor quality products with potential safety implications for consumers. Authorizing third parties to inspect manufacturing facilities would increase the number of inspections each year, ensuring that companies are abiding by cGMPs and are manufacturing products that are safe for consumers.
Dockery: Providing incentives for dietary supplement and ingredient manufacturers to investigate new ingredients for use in the supplement market would seem to be an equitable way to introduce new ingredients that are safe and effective.
However, since FDA is not bound to any type of evaluation of the research supporting an ingredient in the supplement market, it would be difficult to provide incentives without some level of FDA scrutiny of the ingredient, including its safety and research support for the intended application. That is not likely to happen under the parameters of DSHEA. At present, FDA’s attention to a particular ingredient or product is limited to potential disease claim violations.
NIE: Currently, there is no authoritative list of dietary ingredients that were on the market prior to Oct. 15, 1994, although FDA has announced its intent to develop such a list. How well is the industry cooperating on coming up with some comprehensive list, with documentation, and when will this be presented to the agency?
Dockery: Developing an authoritative list of ingredients on the market prior to Oct. 15, 1994 is not an easy task as there are numerous complications. FDA requires substantial documentation to support the marketing of such ingredients prior to the 1994 date. Much of the documentation is in the form of old catalogs, magazine advertisements and paper manufacturing files. Finding these, especially if the companies marketing the products are no longer in existence, can be daunting. In many cases the records of manufacture and/or sale of these ingredients have been destroyed.
This lack of records has made some within the industry skeptical of the value of a grandfathered list. If adequate records can’t be found, then FDA will assume the ingredient was not marketed prior to the 1994 cutoff, even if there is a consensus within the industry that the ingredient was in use. Open discussion with FDA to resolve this obstacle will be necessary for any headway to be made in finalizing a comprehensive list that will be useful to the industry and pave the way for the introduction of new ingredients.
Mister: CRN has expressed great interest in assisting FDA with the development of an authoritative grandfathered list of ingredients, but FDA has repeatedly signaled its disinterest in creating such a list.
As more time goes by, it will become harder and harder to obtain the evidence that particular ingredients were in the marketplace prior to Oct. 1994.
The longer FDA waits to get started, the less likely it is that an authoritative list will actually be helpful to the industry.
Lind: Although a list may be comprehensive, it should not be static, as it should have the ability to be added to upon the uncovering of commercial sales pre-DSHEA of a dietary ingredient. FDA’s delay in developing this list has made it more difficult provide that data, so that flexibility is needed and appropriate.
Sudberg: The industry is split on this topic. CRN has been promoting its Supplement OWL (online wellness library) as a dietary supplement product registry to serve as a resource for businesses, consumers and regulators to identify products, their ingredients and the companies that market them, and permit registry users to examine and evaluate labels and other product information. Much of the opposition of this comes from small companies who are averse to the added operational expenses the owl will induce. As a testing lab I see it as a terrific list of clients who may need our help.
NIE: One analysis of FDA data reported that 776 adulterated dietary supplements were identified by the agency from 2007 through 2016, of which 619 were found to contain one unapproved drug ingredient, and 157 products were found to contain more than one pharmaceutical ingredient. What dramatic step can the industry take to try to eliminate the scourge of economic adulteration?
MacKay: The most dramatic step industry can take against adulteration is through DSHEA modernization. With modernized policies, such as a mandatory product listing and authorizing third parties to inspect manufacturers, along with more dedicated resources, FDA will be able conduct more effective enforcement against bad actors selling adulterated products.
The current regulatory framework lacks transparency because it allows ingredients to enter the market without FDA’s knowledge. Increased FDA visibility into the market with mandatory product listing would make it easier for FDA to identify and more quickly remove illegitimate and illegal products from the market. In the event of a quality issue with an ingredient, an up-to-date database allows FDA to identify which products and manufacturers are affected so they can take action.
Mister: Responsible industry can only do so much to address this problem—the solution lies with a strong enforcement stance from FDA. While responsible companies police themselves and take precautions to assure the quality of their own products, it takes a commitment and resources from FDA to identify and prosecute the outlier firms.
Only the regulators can enforce the law on companies who intentionally or recklessly ignore their obligations. To be clear, intentional spiking. This is not economic adulteration—economic adulteration is using inferior quality ingredients to reduce costs and raise profit. This issue of intentional spiking of products with prescription drugs and illicit substances is just criminal behavior.
Lau: Those are instances of trading in illegal substances and trying to masquerade them as “dietary supplements.” That’s clearly illegal and actionable by FDA. Economic adulteration does happen in our industry, for example someone using vanillin to enhance vanilla and then label it as pure, selling a synthetic labeled as natural, or spiking low quality green tea with caffeine. Working with reputable, vetted suppliers and testing the material proficiently will catch this kind of sub-par material. The quality brands reject such material.
Bewicke: Economic adulteration has always been a part of the supplement industry, just as there are shady operators in almost every segment of our economy. Unfortunately, there doesn’t seem to be one dramatic step to eliminate the problem, because it’s really a moving target: the specific issues are always changing.
Sudberg: It’s one of my favorite four-letter words…test. We can very easily test out adulterated ingredients and API if we just tested every ingredient and finished product. No skip lot testing. No testing by input. Just test the ingredients before manufacturing and test the final product.
In fall of 2021, a supplement manufacturer obtained 22 samples of NMN (nicotinamide mononucleotide) products being sold on Amazon; of these, 14 claimed to contain 500 mg of NMN. Sadly, 64 percent of the products tested contained less than 1 percent of the active ingredient. Is this representative of the products being sold on Amazon, or is this a larger problem for the industry?
Lau: That is a great question. The industry as whole has a lot of great companies that make wonderful products, however there are some bad apples. Prior to Amazon implementing their vendor qualification rules for dietary supplements, there wasn’t a traditional gatekeeper, a role the retailer usually plays. If it’s a pure marketplace, then anyone with product can sell it on that platform, so it brings all sorts of interesting issues and circumstances such as the case you referred to. I always looked at Amazon’s seller marketplace and such platforms as caveat emptor because there is no gate keeping function to assure the quality of a product versus the items sold directly by Amazon.
Dockery: There are several reasons why there are more inferior products sold on Amazon. Amazon is the biggest online retailer in the world. The sheer volume of products makes them more vulnerable. Many of the unscrupulous companies selling on Amazon found an easy way to sell under the radar of regulatory scrutiny. This is an area that Amazon must deal with in a better way than they have thus far. They have made changes in their document requirements for supplements sold through Amazon, but this may not be enough to keep the bad players out of the market.
But to put this issue into perspective, before the days of online shopping, many people purchased their supplements from discount stores across the country. Many of these products were of exceptionally poor quality. The whole market has expanded tremendously, including the number of inferior, unsafe and poor-quality supplements.
At some point there needs to be a dedicated and coordinated effort at the top levels within the industry and the FDA to keep these products off the market. It hurts the entire industry when consumers can’t trust the products they want to buy.
Sudberg: Between the best legacy brands in the industry to outstanding newcomers, Amazon sells a lot of good products. I know that because we test many of them. To extrapolate that the results of this study are representative of all product sold on Amazon is illogical. I am sure I can find a category and test the bottom of the barrel and reproduce this data. In my experience the quality of materials we test is increasing with each and every test.
Lind: Because the volume of dietary supplement product sold on the Amazon platform is so immense, and until relatively recently the bar to entry was so low, this has been a hotbed of sub-par products. Industry self-policing initiatives have found time and time again a shockingly bad quality track record with high-cost category products by little-known brands that are only sold online.
Amazon’s recently initiative requirements are a start in addressing the problem of products not meeting label claims but does nothing to address low quality starting material.
NIE: In many ways, quality is—or should be—about the science. Given FDA constraints, how can manufacturers get the word out about the science behind their proprietary ingredients and finished products?
Sudberg: While there are a few ways to define and measure quality, the FDA has given us only vague guidelines on how to correctly identify ingredients and be sure they are safe from harmful pesticides, heavy metals, micro/mold and residual solvents. Remaining, are the phyto/fungal chemicals that can and should be measured as an additional indication of quality. Low quantities of phyto/fungal chemicals may render an ingredient ineffective. In most cases we are not allowed to attribute a benefit to said measurements, however a growing number of brands have successfully conducted appropriate studies and can now connect quality and science.
MacKay: Manufacturers should publish studies in peer-reviewed scientific journals, share credible research at scientific conferences and meetings, and train staff on appropriate ways the law allows companies to share published science as an education tool.
Bewicke: Publishing the science behind our product innovations in the industry, while remaining within FDA constraints, is generally not that difficult. Most of our industry’s innovations are designed to support good health rather than cure specific diseases. For example, we’ve been able to talk freely about the published studies on our VinCare grape extract, that found significant cardiovascular support benefits, and our AphaWave L-Theanine that showed increases in alpha brainwave activity that resulted in benefits of relaxation and stress-relief. These health support claims clearly pointed to the benefits of the products, without stepping over any legal boundaries.
Dockery: It helps the reputation of the natural products industry for there to be ready access to the research on ingredients. Though this takes extra effort by the suppliers of these ingredients, publishing human clinicals and in-vitro studies lends more credibility to the research support.
Many companies choose not to publish research to protect their methodology and dissuade competitors. However, this can also be a way of hiding substandard research; and even if the research is of high quality, failure to publish can leave the impression that the research isn’t of high enough quality to pass peer review.
Getting the word out about the science also requires a lot of communication and coordination between a company’s R&D and marketing departments to develop the best ways to get the message across regarding an ingredient’s benefits to the end-consumer supported by the research findings. Effectively getting the message across also requires a lot of tiptoeing around research findings that could be interpreted by FDA as disease treatment, prevention or any other type of mitigation.
NIE: What are the top one to two technological advancements that have improved the quality of dietary supplements?
MacKay: The first advancement is supercritical CO2 extraction, which has been around for years, but is essential because it allows companies to move away from using solvents for extraction, helping reduce solvent use and advancing environmental improvement efforts.
The second development is advanced product testing. Amazon started actively testing products marketed in high-risk categories, like sexual enhancement or dramatic weight loss, for the presence of undeclared drugs. This protects consumers against adulterated products on one of the most popular markets to purchase products.
Dockery: One of the top technological advancements has been improved data management. The learning curve has come down sharply for managing electronic data allowing organizations to create and maintain databases of production and quality data. Insights gained from the greater access to data is leading to better decisions.
Sudberg: Most of the tech in this industry utilizes was invented around 80 years ago and has advanced upon itself. Over my 25 years of testing plants for identity and purity I have seen numerous technological advancements, promising improved quality, come and go.
The advancement most notable is of course DNA whose timeline and value have been challenged as of late. Our industry was force fed DNA testing simultaneously by three independent sets of experts, two now considered disgraced and the other sold and split up.
What we know now about advancements in testing technology is that they usually work best when combined with legacy techniques in an orthogonal manner.
NIE: We now have qualified health claims (QHC) for magnesium and reduced risk of high blood pressure. Comment?
Mister: CRN is proud to have helped support the efforts to establish a qualified health claim for magnesium. However, given the QHC process, the resulting claims are tedious and cumbersome.
Many consumers will still find structure/function claims more accessible for communicating the benefits of magnesium supplements.
The creation of these QHCs are, however, useful for demonstrating to healthcare practitioners the benefits of these products in their practices. And QHCs illustrate the emerging science behinds these products, even if FDA weighs down the usable claims with so many qualifiers.
Perhaps the real value of QHCs is their public demonstration of the growing body of science rather than their verbatim use on product labels.
Dockery: It is an achievement that a qualified health claim now exists that addresses the benefits of magnesium in reducing high blood pressure. However, the required claim wording is so onerous that most companies will not want to put it on their label. Not only is it full of disclaimers, but it is also very wordy and would take up substantial space on a label.
MacKay: From an academic point of view, the FDA announcement helps validate the extensive science published on magnesium for blood pressure.
However, from a marketing standpoint, the qualified health claim language is clunky and is not very useful for supplement companies. None of the following approved statements makes a very good advertising claim.
NIE: In what ways does sustainability support quality?
MacKay: Improving sustainability requires an internal evaluation of supply chain practices, packaging and waste generation. These evaluations are intertwined with a company’s quality systems, so the evaluation and any changes that are made require attention to overall cGMPs. It’s similar to when a doctor asks a patient to write down what they eat—it can lead to improvements in their overall diet through careful evaluation of the entire system.
Lau: With herbs, sustainability has to be built into the business. Our commitment to sustainability is an integral part of the company because we practice geo-authenticity, which in TCM is sometimes called Di Dao—meaning “authentic source.”
This is the principle that potency and authenticity of herbs harvested from where they naturally grow will be superior to that of plants cultivated in non-native locations. The soil, temperature, humidity, terrain and micro-climate all contribute to the potency of the plant. Through the years we have established lasting relationships with growers and wildcrafters in specific regions, which ensures our supply.
Because we buy our herbs directly from our long-term partners, we know exactly where they were grown and how they were harvested. Our practices prevent over-harvesting. Specifically, each herb is assessed to confirm it can be harvested sustainably. We’re a third-generation company so we think long term, and our practices are designed to ensure future generations will have access to these herbs.
Bewicke: Verified sustainability is the first step in the development of product integrity. It takes the kind of care and attention that’s necessary at every step in the supply chain to end-up with a quality product. This is one reason why a core description of our work at Ethical Naturals has always been “From Field to Finished Product.”
Dockery: Part of defining quality in a natural product ingredient should include the concept of sustainability. Attention to sustainability implies a greater degree of caring about the processes used to generate ingredients, whether it be farming practices that protect the soil and environment, selective harvesting to ensure future harvests and protection of animal and plant species, or environmentally sensitive ingredient production procedures.
Companies that value sustainability are more likely to look beyond the quick monetary gain into other areas as well, and this includes the quality of the end product. Most consumers who select natural health care products as a way of improving their overall wellbeing, also value the health of the planet we live on. Emphasizing sustainability, traceability and other areas of planet responsibility should be a hallmark of the natural products industry.
NIE: What would you like to add about compliance, quality or both?
MacKay: Plain and simple—the biggest need to improve quality and compliance is through regular inspections of every manufacturing facility against cGMPs. The significant inspection gap leaves a lot of questions and uncertainty for consumers, retailers, industry and regulators. Increased inspection of manufacturers and enforcement against bad actors will ensure companies are complying with cGMPs and improve the overall safety and product integrity of dietary supplements.
Lau: There’s a myth that products from China or India are not high quality, but the reality is it’s not where it’s made but who is making it.
Some of the best ingredients in the world come from China, and I count the materials Nuherbs sells among them. Having established relationships with suppliers who have demonstrated dependable quality, followed by proficient testing to confirm the identity and quality of the material, is a crucial part of both quality and compliance.
An added bonus from established supplier relationships is that in times of disruption, such as what we have all experienced these last two years, buying from people you know and trust removes an element of risk that brands buying whatever’s cheapest from a large pool of suppliers undertake. NIE
