The panel:
Gene Bruno, Vice President of Scientific & Regulatory Affairs, Twinlab, Boca Raton, FL, www.twinlab.com
Dieng Bui, Vice President of Quality & Regulatory Affairs, Lief Labs, Valencia, CA, https://lieflabs.com
Nena Dockery, Scientific and Regulatory Affairs Manager, Stratum Nutrition, Carthage, MO, www.stratumnutrition.com
Stefan Gafner, PhD, American Botanical Council, Austin, TX, http://herbalgram.org
Haley Gershon, Marketing Manager, Beta Lab Services, Miami, FL, www.betalabservices.com
Shaheen Majeed, President Worldwide, Sabinsa, East Windsor, NJ, https://sabinsa.com
Russ Michelson, Global Regulatory Director, VMS, Reckitt, Parsippany, NJ, www.reckitt.com
Kelly O’Connor, Sales Director – Key Accounts, Columbia Laboratories, Portland, OR, www.columbialaboratories.com
Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com
John Troup, Vice President, Scientific Affairs and Dietary Supplements, Consumer Healthcare Products Association (CHPA), Washington, D.C., https://chpa.org
William Rowe, President and CEO, Nutrasource, Guelph, ON, Canada, www.nutrasource.ca
Before the COVID-19 pandemic, arguably most companies in the natural products industry were already working hard to make sure that ingredients and finished products complied with (or exceeded) quality standards set by law and, in some cases, also abided by self-regulatory standards that can be stricter than cGMP (current good manufacturing practice) standards.
Some companies have been doing this for decades; others are new entrants into the marketplace. Firms that provide testing, regulatory guidance and market-access advice to natural products companies have been an important part of this equation, too.
Then the pandemic hit and, while we won’t say that “all bets are off,” we can safely say that the seams that stabilize parts of the industry were load-tested. In the meantime, consumers are asking more and more from companies whose products and ingredients they entrust with their wellness—in a time when health and wellness have taken on greater much importance than some can even remember.
So we decided to step back and ask industry experts to give us a reading of how strong are the industry’s vital signs now, and what’s the prognosis going forward?
NIE: What are the biggest compliance challenges the natural products industry face right now, and what should be done to address them?
Troup: There have been two key challenges over the last two years, including (1) rogue actors who make up a fraction of the industry continue to make disease-specific claims and overstatements supporting product use and (2) adulterated products continue to be in the supply chain, especially botanicals.
To address these issues, industry should educate consumers about the responsible use of supplements and support increased funding to improve the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) enforcement against adulterated products or misleading claims. Finally, industry should fully support retailer QA (quality assurance) efforts that can help address much of these adulteration concerns.
Michelson: I think there are two very unique and very costly new “compliance standards” in the industry. And, unfortunately, neither of them have anything to do with the FDA. One is the increase in class-action lawsuits in the food and supplement industry, the other is the increase in retailer quality and testing programs, which didn’t really exist four or five years ago, and now we have half a dozen or so. They are both seen as either extensions of current FDA regulations, or as filling gaps that some perceive exist in the regulations (aka lack of a pre-market approval process).
O’Connor: Today’s consumers are vetting their products before they purchase. The demand for transparency, compliance and traceable quality parameters goes beyond the FDA regulatory compliance. To stay relevant and competitive, it’s imperative to apply the latest technology, and best practices to the manufacturing process, including documentation for vendor vetting and ingredient sourcing.
Sudberg: Unlike the testing requirements for recreational cannabis in California, when the cGMPs (current good manufacturing practices) were forged by the FDA and released to the industry they failed to be specific around what test methods to use. This gave the industry too much freedom to make bad choices. “Scientifically valid” test methods (not validated—important distinction) was the basic requirement. This vague requirement means the unscrupulous among us can simply reach into their bag of fallacies and can choose their wiggle room option, such as commission testing using technology that is not fit for purpose, or skip lot testing, or rotational testing, or dry labbing. This and the lack of “cops on the ground” are the biggest compliance challenges to the natural products industry. To correct them the FDA should take a stance on appropriate testing methods with clear acceptance criteria. If there was such a working group, you know I’d lead it.
Majeed: On the domestic front, here in the U.S., the challenge of adulteration ranks pretty high, as does the rampant use of untested generic ingredients in the supplement marketplace. Price sensitivity is definitely on manufacturers’ minds, and with much less FDA on-site auditing in the last 1.5 years, a lot of things undoubtedly have slipped under the radar. Plenty of false and misleading claims on both ingredients and finished products also creates compliance issues. Take, for example, companies claiming high vitamin C content from sources that don’t actually contain a lot, such as amla. This is particularly alarming during this pandemic with so much concern about immune function and everyone taking more vitamins, particularly vitamin C. Prior to the pandemic, Sabinsa became vocal about natural vs synthetic in curcumin supplies. While we were recognized for that, it’s going to take an industry-wide effort to stamp it out, because if manufacturers choose to look the other way, consumers are the ones that are harmed.
Dockery: Quality continues to be a big compliance challenge for the industry, and this is an area that directly affects the end-consumer. In a free-market society, there can be a fine line between the rights of the business owner and the interests of consumers who expect a certain level of safety and efficacy in the products they purchase.
The natural products industry has done a reasonably good job at self-monitoring, but the sheer numbers of companies and products on the market make this almost impossible. It is a daunting task, but the best approach is probably to have more open communication between industry organizations and FDA/FTC with the goal of weeding out the companies that harm both the reputation of the industry and interests of consumers, while still allowing the consumer access to a broad range of natural health-supporting products.
Bui: Vendor qualification and verification are critical steps to addressing all of these issues. With vendor qualification, we can detect, early on, issues with supplier documentation and quality systems. With vendor verification, we are also testing to be able to confirm the quality of raw materials we are buying.
Gafner: One way the shortages impact quality is that in addition to low availability, prices for those ingredients that are in short supply are increasing, which provides an economic incentive to partially or fully adulterate high-demand ingredients with lower-cost materials. The most prominent example may be elderberry extracts, sales of which have skyrocketed in the early months of the pandemic, where excessively diluted and adulterated ingredients have appeared more frequently over the past year.
Gershon: With a large demand for naturally sourced products, the lack of standardized definition and regulation of the term “natural” creates challenges for the natural products industry. In addition, the industry lacks requirements for submitting products for testing prior to availability in the marketplace in several regions, such as the U.S. and Europe. Employing routine and standardized analyses by accredited third-party laboratories can ensure authenticity of natural claims and can identify adulterated or fraudulent “natural” products.
NIE: Briefly comment on the current and predicted impact of Amazon’s sweeping new specs for dietary supplements.
Sudberg: The loudest noises I am hearing are from those who should have always been doing the appropriate testing and if they had would now simply need to submit it to Amazon. It sounds kind of like a toddler whining, “but we’ve always done it like [enter substandard quality techniques].” I predict Amazon’s sweeping new specs (once ironed out) will reduce the bad players in the business.
Michelson: Firstly, while cumbersome to the good players, I think Amazon is doing the right thing to create some sort of bar for their shelf, given the variety of products and brands they sell, which includes an enormous number of start-up and small companies new to the supplement space.
In an ideal world, this new program will identify the bad players, and weed out companies with poor quality control, illegal ingredients and misleading claims.
However, my experience with Amazon over the years is that they don’t quite understand dietary supplement regulations, and frequently will flag compliant ingredients or claims made by reputable companies with large product volumes while continuing to permit small companies to sell products making blatant disease claims.
I would like to see more partnership between Amazon and the industry associations to educate on standards, align on priorities, identify significant risks within the industry, and smartly approach their enforcement of the new program. For now, they are just starting to receive thousands and thousands of letters of guarantee and certificates of analysis, so we will see how effectively they utilize this information.
Dockery: Amazon’s new requirements appear to be at least a step in the right direction. Products sold on Amazon, as well as other online sites, have long been vulnerable to adulteration and other business tactics practiced by less than reputable companies; and the new requirements for the most part simply state what most consumers assume.
Most of us purchasing products on Amazon would expect that the label is accurate regarding the list of ingredients and their potency. This will now need to be verified, as will substantiation that the ingredients are safe and lawful for the intended use. Though documents and labels can be falsified to appear to accurately depict the contents and manufacturing processes of the product being sold, it will now take more effort to deceive the consumer—and that is a good thing.
Amazon does need to increase their support resources for sellers who want to comply so documentation can be provided accurately and as efficiently as possible.
Majeed: The phrase “better late than never” comes to mind when we think of Amazon’s new requirements. Many will simply consider this as additional paperwork, and nothing more, because they are already doing things correctly. Many of those documents are assurances of that, so the real question is the fall out: what’s the punishment from Amazon for those who provide false documentation or none at all?
We have seen supplement companies on Amazon change their company name, brand name, product name, etc., all to elude negative feedback from customers for shoddy products. Will these new requirements halt those practices? We think not. As a supplier of branded and patented ingredients, we have seen our trademarks on finished products sold on Amazon that was never purchased or licensed from Sabinsa. The task of removing such products is daunting, and we don’t see that changing anytime soon either. Since sellers now have to provide more comprehensive label photos, it would be helpful if Amazon had a mechanism for companies like Sabinsa to flag products falsely claiming they contain branded ingredients.
Bruno: Many see it as onerous, expensive to follow and not consistent with industry cGMP standards. However, UNPA has developed a good working relationship and established good communication with Amazon on this issue, advising them on industry cGMP standards. Hopefully this communication will yield positive results where Amazon’s requirements are concerned.
O’Connor: The specifications are certainly a step in the right direction to limit liability for manufacturers and the retailer (Amazon), also to increase consumer confidence, which ultimately leads to more sales and safer products on the market. Many box stores, such as Natural Grocers, Whole Food and Market of Choice, require their supplement vendors to verify supply chain management by checking products’ testing and production records. These box stores have control to enact an “any and all” recall, while online retailers do not have as much control over their supply. As such, online sales rarely include such high level of scrutiny, so Amazon setting standards will likely cause other online retailers to follow suit.
Rowe: Amazon is simply asking for confirmation that the brand is in compliance with U.S. Federal Government dietary supplement regulations, this should not be a stretch or huge business interruption for brands that are otherwise in compliance.
NIE: Some industry leaders have said that they believe that there are “two industries:” (1) the companies that have always worked very hard to comply, and (2) new players, almost exclusively online, who are in it to make a killing. What specific self-regulatory steps can the industry take to reduce the “two industries” problem, if there is a way?
Bruno: This has been an ongoing problem for decades. There is no simple answer for this. In my opinion, educating consumers and retailers on what to look for is a good way to help create awareness. Of course there is also the option of reporting the bad players to the FDA, but that is a slippery slope to some extent. Another possibility is to try and bring the new players “into the fold,” befriending them and advising them on how to do things right—but this will have limited appeal for those that are only in it for the short term to make a killing.
Sudberg: First let me share that some of the folks in category No. 2 are not new to the industry and have been flying under the radar for years doing substandard testing. Their marketing is strong and followers loyal but the quality has always undercut those in category No. 1. The solution is more boots on the ground, more better trained FDA officials auditing and challenging the quality of the industry. That’s from the regulatory side. From within the industry, brands can shout their quality stories from the mountain tops because they are proud to use the industry’s best labs and have no reason to hide what it takes to stay in category No. 1.
Troup: While they only make up a small portion of the market, the industry can take steps to help minimize the “bad actors” contributing to the compliance problems we see. There needs to be recognition and execution on compliance, as many of the regulatory issues are due to lack of understanding or poor intent. For the former, we should help by better educating companies and developing programs that facilitate compliance (retailer programs, certification of cGMP, etc.). For the truly bad actors, we need robust FDA enforcement targeting those who knowingly violate the law.
Michelson: Well, I think the “two industries” thinking is an oversimplification. There are good and bad players, but also a lot of in between. The most established “good” companies can still get a 483 or a warning letter or a lawsuit on an off chance. And not all new players are “bad,” meaning intentionally doing the wrong thing to make a buck. There will always be a subset of players who jump into the category quickly and with no cares to comply; they are unlikely to be moved off of their approach or willing to participate in trade associations or lean into best practices. But many new entries are trying to do the right thing and just need opportunities to interact with the good players, find adequate resources to educate themselves, and build up that reputation as they build their brands. Any new entry into any new category is going to stumble a bit, but if we build an environment where they have access to broader industry, trade associations, industry events, training, etc., you can raise that floor so that even the small online players are given the tools to be both successful and compliant.
Rowe: Lobby and push to have dietary supplement SKUs pre-approved much like the Health Canada model. That model has assisted in cleaning up the natural health product industry in Canada tremendously.
NIE: Speak to specifically what ways the continuing supply-chain disruptions caused by the COVID-19 pandemic are hurting inventories or endangering quality.
Troup: Unprecedented growth in the category has resulted in manufacturing and supply that cannot keep up with demand of the most common ingredients used in the most popular consumer products. As long as companies maintain adherence to strict quality control procedures, product quality should not be affected. Many suppliers and third party manufacturers are taking the responsible step of not over-committing themselves for the sake of business, which is the best way to manage the process and doesn’t mean that quality has to be compromised.
Bruno: One of the biggest issues is obtaining packaging components in a timely manner. Getting the correct size and color of bottles and caps has been surprisingly challenging. It’s also been a challenge to obtain sufficient quantities of veggie caps. In one case, I had a supplier tell me that the lead time to obtain a specific natural color of a veggie cap was 41 weeks. Clearly, these delays are not conducive to avoiding out-of-stocks. It sometimes puts supplement companies in the position of having to decide whether it is better to deviate from packaging specifications.
NIE: Ingredients being substituted with cheap alternatives is a problem of economic adulteration. How widespread is this problem, and briefly, how can manufacturers avoid being duped?
Gafner: There are a number of ways to prevent purchasing adulterated herbal ingredients. It starts with a thorough supplier qualification process, but also by having a robust quality control program at your company. Being aware of the risks for a given ingredient is also crucial, which is why the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) publishes and documents known cases of adulteration. And then each companies needs to test, test, test.
Gershon: Economically motivated adulteration is a serious problem across several industries including the nutraceuticals and dietary supplement, flavors and fragrance, food and beverage, and essential oil sectors. This problem is especially widespread with products composed of expensive raw materials. For example, products formulated with turmeric, garlic oil or lavender face ingredient substitution challenges where petrochemical-derived synthetic ingredients may be produced at a significantly lower cost than the natural plant-based source. As a result, the natural product market is vulnerable to adulteration. To ensure authentic, high-quality products, manufacturers need to employ a robust quality control program. By adding routine natural product testing using analyses like carbon-14 testing, manufacturers can verify their suppliers to confirm ingredients have not been adulterated with cheaper synthetic alternatives.
Sudberg: In our experience the problem is widespread and hitting even the best of companies in this industry. The solution is to test test test test test test and be sure it’s by a lab you are proud to lean on and not one who has a list of FDA warning letters and 483s that is simply rebranded to avoid their history. Proficient testing is the only sure way to confirm identity and quality.
Bruno: I don’t know how widespread it is. As far as avoiding being duped, the answer is the same as its always been. Complete your due diligence with raw material suppliers, require comprehensive documentation (COA [certificate of analysis], specifications, etc.), and make sure to test raw materials once they’ve arrived.
NIE: Adulterated and illicit products were the subject of a paper published March 23 in the journal, Clinical Toxicology, whose authors found nine potentially dangerous stimulants in 17 supplement products sold in the U.S. Does this indicate a much larger problem than we realized, or something else? Please explain.
Gafner: The sale of conventional drugs masquerading as dietary supplements is one of the most egregious forms of adulteration, since it often puts the consumer at risk for serious adverse events. It seems that this type of adulteration is especially prevalent in certain dietary supplement categories, especially weight loss, sexual dysfunction and bodybuilding. Findings as those published in the paper are unfortunately nothing new, but enforcement against the fraudsters really challenging since it’s often very difficult to track down the manufacturer and to take regulatory action as these adulterated products often come in from outside the USA. But this is not only an U.S. problem, but a global issue, and therefore will need a global solution.
Michelson: We, as responsible industry, don’t want unsafe and unproven ingredients on the market and harming consumers. And while regulations are in place to prevent this from happening, it’s not hard to break the rules and it’s nice to see some punishment on occasion when consumers and our industry PR are at risk. The hardest part is separating that these are the exception to the industry, and just because the negative news gets the greatest reach doesn’t mean that this represents the majority of responsible industry that you find in respectable retail establishments.
Bruno: The paper you speak of investigated adulteration in sports nutrition and weight loss supplements containing deterenol. Likewise, in the past I’ve seen the same thing occur with sildenafil adulteration of male sexual health products. Certainly such adulteration is a problem—although I don’t know how frequent it really is. The authors of the cited study stated that the “sample size is small and therefore the quantitative findings are not necessarily representative of all deterenol-containing products.” In any case, this issue underscores the importance of complete your due diligence with raw material suppliers.
NIE: Quality is also about the science. In what tangible way is having relevant science behind ingredients so important? And how can this science be better communicated to the public at large?
Gafner: There are regulatory limits to what a company can say about their scientific data, so communicating results from a study to a consumer is very challenging. However, products that are made with a/several herbal ingredient[s] that have been extensively studied and clinically tested, tend to have a much better chance to be relevant in the herbal dietary supplement market than those where sales are raising because of a celebrity endorsement or a strong marketing campaign. As an example, there are several very successful ingredients, e.g., ashwagandha, boswellia or turmeric on the U.S. dietary supplement market that came out of the ayurvedic system of medicine. Those ingredients all have solid clinical data in support of their benefits.
O’Connor: Reliable third-party testing is the cornerstone of transparent supply chain management, from ingredient sourcing and vendor vetting to achieving compliance and meeting specifications. When a new ingredient or vendor comes in, test it. When you formulate, test it. [Test] at each level of the supply chain-test for contaminants.
This science can be communicated to the public at large, but it requires companies to maintain batch-specific testing and keep documentation in order. That’s the hard part. The easy part is sharing that with consumers through marketing and consumer education available at the click of a button.
Bruno: Not to overstate the issue, but science is everything when it comes to formulating effective dietary supplements. I have great appreciation for raw material suppliers who have conducted or sponsored efficacy studies on their raw materials. In our industry, products based on marketing science rather than real science has always been a problem and hurts the credibility of our industry. I think it is important to continue writing articles to educate the public on this issue, and to create advertisements that let the public know that certain products are, in fact, based upon real science.
NIE: Along these lines, a percentage of consumers and media outlets continue to believe that the supplement industry is an unregulated Wild West filled with crazy companies and dangerous products. What can be done to change this paradigm?
Troup: The narrative that the supplement category is unregulated is categorically false. DSHEA (Dietary Supplement Health and Education Act of 1994) continues to provide a strong regulatory framework for dietary supplements, including cGMP (current good manufacturing practice) requirements for manufacturing, packaging, labeling and other quality system procedures.
We can and must do better through self-policing and greater enforcement by FDA and FTC. Through modernizing DSHEA and introducing mandatory product listing, we can provide the FDA and FTC with a needed tool to help keep rogue actors accountable. Industry must also continue to educate consumers on dietary supplements to help them understand the benefits and what to consider when purchasing a product.
Consumers both expect and deserve safe products and the threshold of entry into the category as a business owner is the commitment to use and support certifiable quality assurance processes.
Sudberg: Unfortunately there are companies that behave as if the industry is the Wild West, as the recent uncovering of all the bad actors on Amazon demonstrates. The companies doing all the right things need to keep doing them, and be more transparent about their processes and safeguards. As I keep saying, companies should make test results public to show that what is on the label is in the bottle. Spending a lot of money for results that sit in a drawer until FDA or Amazon wants to see them is a lost opportunity. Show consumers how careful you are. Shout transparency and quality from the mountain tops.
NIE: In what ways does sustainability support quality?
Gafner: The concept of sustainability does not only involve where and how the plant is grown, harvested and processed, but also how the humans who work for the dietary supplement industry are treated and compensated. Treating humans more fairly and equitably will get them more invested in the success of the organization, which is certainly correlated to better quality products. With regard to cultivation and processing of the plants, the harvesting practices have a big impact on the quality—for example, the content in ginsenosides in American ginseng root has been positively correlated to the age of the roots. In cases of overharvesting, including 1- to 2-year old roots, the amount of ginsenosides, and hence the quality of the roots is lower. Another problem is the dwindling resources—I use the case of rhodiola (Rhodiola rosea) roots, where the availability is more and more limited, leading to cases of adulteration and fraud.
O’Connor: Sustainability and quality go hand in hand; they support each other, as both are the mechanisms and the goals for any successful company. Sustainability can be applied to ecology, business practices, partnerships and even packaging. It is sustainable for a business to engage in best practices that then create quality products. Quality means consistency and efficacy. If you create sustainable growth based on sustainable practices, consistency and quality will be evident in the final product.
Gershon: In many ways, sustainability and quality go hand in hand. With a growing interest in sustainable and plant-based products, many companies are shifting product formulations to include high-quality ingredients to benefit both consumers and the environment. By opting for raw ingredients that are grown sustainably, this allows manufacturers to formulate with authentic natural-sourced ingredients. In contrast, companies may cut corners by formulating products with less expensive synthetic adulterants that are not naturally and sustainably sourced while fraudulently claiming the product to be natural, resulting in lower quality products.
NIE: Related to hemp and CBD, has the regulatory misalignment between the USDA (U.S. Department of Agriculture) and FDA become any less foggy? If so, specifically why; if not, what concrete steps do Congress, the FDA and industry need to take?
Bruno: Despite Congress instructing the FDA to find a path for legalization of CBD as a dietary ingredient, it simply has not yet happened. Industry—especially organizations like UNPA—has been active in trying to more the process forward. However, there is still no clear regulatory position on CBD. Furthermore, the FDA has made it clear that when such a pathway does exist, such materials will have to be submitted as an NDI (new dietary ingredient), indicating that GRAS (generally recognized as safe) status may not be acceptable in this instance. But it’s difficult to know what will ultimately happen.
Troup: A contributing factor to the perceived disconnect between agencies is due to the difference in their focus and paradigm. USDA has been more concerned on farming opportunities and methods and FDA has been concerned with ensuring products entering the market are safe. These issues are intertwined, so consolidated processes where farmers, manufacturers and brand owners work together to develop and invest in the processes and services that the entire industry—from the farm to shelf—should meet.
O’Connor: If anything it has become more convoluted by the introduction of cannabis ISOMERS into the market. There is still no clear supply chain regulation and a ton of dangerous products are reaching the open market. Canada, the U.K. and E.U. are leading examples of regulatory pathways. The FDA, DEA (Drug Enforcement Agency) and USDA have a laundry list of things to do … they could start with collaborating to establish a standardized nomenclature for hemp/cannabis.
NIE: Also related to hemp, how do the values of diligence, ethics and transparency fit into testing, standards and compliance for hemp extracts and products, and what are the most common challenges the hemp industry faces in these areas?
O’Connor: Without standardized regulations for testing through the supply chain, the bad players are rewarded. It costs money to adhere to ethical, diligent practices that ensure quality and safety. Without enforcement and checkpoints for these best practices, transparency is optional. Many companies are cutting corners. Products are out onto the market that are not represented accurately or tested for contaminants or quality. And to top it off—the testing labs are also not testing to the same standards. Consumers beware—cheap products are, well, cheap.
NIE: What would you briefly like to add?
Troup: As a health care category, the dietary supplement industry must continue to demonstrate a commitment to meeting or exceeding standards impacting safety and quality. This includes having scientific support for all product claims. The vast majority of the industry is committed to marketing quality products. With more robust regulatory processes and pathways, including mandatory product listing, and use of fully transparent, standardized certification processes, the industry can further demonstrate its commitment to improving the lives of consumers. NIE
