Nutritional Outlook asked a handful of supplement industry stakeholders about how DSHEA has aged-and what a DSHEA 2.0 should look like. What, if any, changes to the law are needed? What changes are needed in the way FDA polices the market?
October 15, 2019, marks the 25th anniversary of the Dietary Supplement Health and Education Act (DSHEA), the 1994 law that gave dietary supplements in the U.S. a regulatory category of their own. DSHEA opened the door to the $40 billion market that exists today.
The dietary supplement industry today looks very different from the industry that existed when DSHEA became law. More products enter the market each year-thousands more than existed in 1994-presenting new ingredients, formulations, delivery formats, and advertising claims. Consumers can purchase products from a multitude of retail channels, and supply chains grow more complex and global each year. All the while, emerging ingredients like hemp cannabidiol (CBD) are putting a spotlight on what happens when market demand for a supplement outpaces FDA’s regulatory oversight. And companies illegitimately selling misbranded or adulterated products masked as dietary supplements continue to operate under the radar.
FDA, the industry, consumers, and industry critics alike are aware of the need to maintain appropriate oversight of a market whose growth shows no sign of slowing, because one thing is for certain: consumers want access to dietary supplements. FDA is now actively looking into whether dietary supplement regulations need to be, in the agency’s words, “strengthened” and “modernized” so that FDA can effectively monitor the market. In May, FDA held a public meeting called “Responsible Innovation in Dietary Supplements,” with the mission of “giv[ing] interested parties an opportunity to present ideas for facilitating responsible innovation in the dietary supplement industry.” Industry stakeholders, advocates, and critics highlighted what’s needed, including from the agency itself. At the meeting, Steven Tave, director, Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition at FDA, estimated the number of products on the market today at 50,000 to 80,000, compared to the 4,000 products that existed when DSHEA passed.
Ahead, we asked a handful of supplement industry stakeholders about how DSHEA has aged-and what a DSHEA 2.0 should look like. What, if any, changes to the law are needed? What changes are needed in the way FDA polices the market?
At the end of the day, more consumers are turning to dietary supplements to proactively support their health and, crucially, to fill nutrient gaps they otherwise would have difficulty addressing. The hope is that the industry and its regulators can work together to address regulatory gaps, protect these consumers with a robust and well-regulated market, and ensure consumers can freely, confidently, and affordably access the products they need.
Photo © AdobeStock.com/Tanya
Scott BassHead of Global Life Sciences TeamSidley Austin LLP
There is no question that DSHEA needs to be fixed. It was a great law and one that we believed should be left alone for most of the past 25 years. But the industry has changed, revenues and the number of products have increased tenfold, and sophisticated science has yielded hitherto unknown substances now being introduced with little or no safety review. Dietary supplements are an essential part of addressing the crumbling healthcare regimes around the world. They help to keep people healthy, prevent disease in some cases, and contribute to well-being. But as regulatory lines among product categories blur, and as we see aggressive companies trying to slide by the DSHEA safety protections, loopholes have to be closed. The two biggest loopholes that need fixing are the New Dietary Ingredient (NDI) safety review process and the absence of a mandatory listing of all dietary supplements sold in the United States.
Christine Burdick-BellVice President and General CounselPharmavite
At Pharmavite, we believe the time is right for Congress to consider several important enhancements to DSHEA. This act created a framework to assist consumers in taking control of their own health through proper nutrition. It was first enacted 25 years ago, but times have changed since those pre-Internet days and we now have new challenges that were not anticipated back then. In particular, the rules concerning New Dietary Ingredients need to be updated and clarified to establish reasonable expectations for when NDI notifications are required, and to develop processes that will help stimulate innovation and promote compliance within the industry.
Pharmavite would also like to see DSHEA improved by updating the definition of allowable dietary ingredients to clearly create space for new strains of probiotics, as well as synthetic versions of botanical ingredients and other dietary constituents. Mandatory product listing would be another important step in moving the industry forward by creating greater transparency and consumer trust. That’s something the FDA has indicated it wants, but without proper enforcement it won’t benefit the FDA or the industry.
Combined with greater overall FDA enforcement of the rules that govern our industry, we believe a strengthened DSHEA would benefit both consumers and the industry for years to come. However, any modernization of DSHEA will be meaningless if the FDA doesn’t have the will or desire to enforce it, as demonstrated by its lack of meaningful enforcement against CBD supplements it has clearly declared illegal. We remain hopeful that an enhanced DSHEA can give consumers access to more safe options to help address gaps in their nutrition.
Daniel Fabricant, PhDCEO and PresidentNatural Products Association
DSHEA has been monumental in allowing growth for the natural products industry. But gaps remain in enforcement and structure of the current law, such as the apparent conundrum created by the influx of CBD products without an effective regulatory framework. Additionally, enforcement and communication from the FDA, such as import alerts, could more practically encourage New Dietary Ingredient notifications and lead to better industry-wide data. There’s much work to be done. We as supplement manufacturers, suppliers, and retailers must stay engaged with all branches of government-legislative, administrative, and judicial-and fight to advance DSHEA so it can provide a commonsense framework for our industry as we look toward its next 25 years.
Dr. Vasilios (Bill) FrankosSenior Corporate Advisor; Product Science, Safety, and ComplianceHerbalife Nutrition
After 25 years, DSHEA definitely needs some tweaking in order to improve consumer confidence in the supplement industry. The FDA should consider the following updates:
1) Mandatory label notification process: FDA and the public need to see what dietary supplement products are being marketed. By implementing simple changes to DSHEA, the mandatory 30-day structure/function claim notification can be expanded to include submission of the supplement’s label. Furthermore, this 30-day notification process would apply to all dietary supplements and not just those that make structure/function claims. The new legislation would require the notifications be posted in a consumer-accessible database that includes a unique identifier that would be placed on the label so a consumer can check if the product is complying with FDA notification requirements. If there is no unique identifier on the label, or the identifier doesn’t correspond to the product in the FDA Dietary Supplement Label Database, the consumer should be suspicious of the product.
2) Better enforcement of the New Dietary Ingredient provisions of DSHEA: [Companies selling] “me-too” NDI ingredients [but that] never submitted an NDI [notification] or don’t have the permission of the non-objected-NDI holder to market the ingredient should be blocked by the FDA from selling the ingredient. This will give more incentive to reputable companies to invest in submitting an NDI notice to FDA. Protecting the intellectual property of the NDI could also be improved through a Master File process for NDIs, such as already exists and is used for other FDA-regulated products (e.g., drugs). Of course, all this will only work effectively if FDA finalizes the long overdue NDI notification guidance, so industry can submit better notifications and decrease the high number of rejections.
3) Improve the NDI process: The process could be improved if the industry can tell whether they are using a new or old dietary ingredient. Until FDA publishes a list of old dietary ingredients, even if it is only a partial list, industry will continue to be uncertain about whether an ingredient requires an NDI notification.
Mark LeDouxCEO and Chairman of the Board of DirectorsNatural Alternatives International
DSHEA needs to be enforced by the agency tasked with oversight-namely, the FDA. Failure to use the tools given to the agency (FDA) is not a legislative shortcoming, but rather one of potentially inadequate resources, misdirected priorities, or lack of motivation by partners inside government (think the Department of Justice) to take appropriate and timely action.
If this statute is amended, it should only be done in a way that extends the legal responsibilities for safety and purity of products throughout the supply chain. At the moment, the onus for providing safety and purity assurances falls on the dietary supplement product producer and own-label purveyors, and does not fall to the actual producers of the raw materials utilized in finished products. That is utter nonsense. Enforce the law through seizure and prosecution when appropriate. Nothing gets attention faster than seizure of assets and resources in a public way.
The biggest challenges [the dietary supplement industry faces today] come from self-inflicted wounds in the industry-e.g., allowing companies to exist that have no idea what current Good Manufacturing Practices (cGMPs) are or why they are necessary. In order for these companies to exist, they must have customers willing to procure products made under illegal or shoddy conditions. This has to stop, and it can once the FDA decides to seize products, padlock facilities, and criminally or civilly prosecute serial offenders. Perhaps the product liability insurance industry may be interested in providing significant preferred-rate discounts to companies with a clean history of DSHEA compliance.
Having a license plate on a vehicle or a driving license to operate a vehicle on public highways seems like an accepted factor of modern life. Our firm does business in over 40 countries. Most other countries outside the USA require some form of registration, documentation, and notification to their government agencies tasked with consumer health and welfare, in order to provide us and our clients the legal right to make products available to consumers in those jurisdictions. Why is this such a difficult subject for the FDA to grasp? Premarket registration is not the same thing as premarket approval. Registration with essential data points allows the agency to exercise enforcement and traceability in the event of a necessary recall for human safety concerns. The argument that ‘outliers’ and ‘criminals’ will not comply [with a mandatory product registry] lends even more credence to the wisdom of requiring some form of licensure, because failure to demonstrate one in an investigation would be prima facie evidence of guilt, and when combined with stiff fines and penalties for non-compliance, should prompt appropriate behavior. Failure to know the law does not exculpate offenders.
Failure to enforce current provisions against Internet sellers and resellers of finished products with clear content and/or labeling issues of non-compliance with the statute will continue to erode consumer confidence in this industry. Either the FDA does what it is tasked to do, or perhaps the entire function should be reassigned to another agency such as the U.S. Department of Agriculture, which has a robust Food Safety Inspection Service and is not unknown for swift regulatory action, including product seizure, destruction, and asset forfeiture in the case of proven malfeasance.
Claudia A. LewisPartnerVenable LLP
Many in the dietary supplement industry agree that it is time for a review and adjustment of how such products are regulated. It is a fact that the dietary supplement industry has matured and evolved. Indeed, with such a swiftly growing industry, it has been difficult for FDA’s policy and existing regulatory approach to keep up. A good example is how FDA recently handled the ingredients phenibut and vinpocetine. Those ingredients have been included in supplements for many years without agency comment or objection. FDA is now taking the position that the ingredients are New Dietary Ingredients and/or may not qualify as dietary ingredients and therefore cannot be sold as supplements. As we all know, the New Dietary Ingredient notification process is underutilized. Initially, that was due to lack of enforcement action. Now, that is largely due to the lack of clear guidance on the process and the unpredictability of the agency’s response. In my view, DSHEA was drafted to be a low barrier of entry for supplement products. And the New Dietary Ingredient [provision] was implemented to be sure that ingredients that did not have a market history were safe. Rather than using the process to limit ingredient innovation, it should be used as it was intended, to confirm the safe intended use of an ingredient. This can be accomplished with a policy change and perspective within the agency.
The challenges associated with applying DSHEA to the current market are further evident with the issue of dietary supplement products resembling functional foods. Everyone wants a convenient superfood/dietary supplement. At the time DSHEA was drafted, it did not contemplate that there would be so many supplements in the form of gummies, drinks, and chews. Yet, that is what the market is demanding. Since supplements are a subcategory of foods, it seems that expanding the purview of the appropriate form of supplements could be easily accommodated via a painless regulatory fix.
Though the challenges in applying the existing DSHEA framework to the current market are impactful for industry, FDA plays an important role. We all want our food and supplements to be safe. However, it is imperative for FDA to develop a reasoned, practical approach to a regulatory pathway for dietary and food ingredients. This is very evident with the explosion of the CBD market. The juxtaposition of the federal and state regulation of CBD has proven to be very complicated. It is even more so because FDA has been clear that it questions whether CBD can lawfully be included in foods and/or dietary supplements. I am optimistic. FDA has a good history of developing its position through guidance documents and the use of regulatory procedures. I am hopeful that FDA will soon address CBD and other issues relevant to the food industry through notice-and-comment rulemaking to allow for stakeholder participation and the most fulsome record for the agency’s consideration.
Shaheen MajeedPresident WorldwideSabinsa
Change is inevitable. Our world has changed dramatically in 25 years-the global population boom, its health (or lack thereof), technology, and significant gains in the knowledge of the universe and its contents, too. The sheer magnitude of growth our industry has seen since 1994 isn’t something that could ever have been anticipated back in 1994.
There were not many good published clinical studies on products regulated under DSHEA 25 years ago, but today there is an enormous amount of good research. It does not serve consumers that we are not legally allowed to talk about much of it, especially if [an ingredient] prevents, cures, or mitigates a disease. I think we need to revisit that.
People’s ways of accessing information were comparatively rudimentary back then, but today people research everything right from their phones. It would serve them better if we could link the research to the actual ingredients or formulas that were studied.
Steve MisterPresident and CEOCouncil for Responsible Nutrition
It’s time for DSHEA to create a little more transparency around dietary supplements.
In the 25 years since DSHEA was enacted, the law has served consumers and industry well, balancing protection of consumer safety with assurance of access to a wide range of supplement ingredients. However, one missing component that has vexed FDA is its inability to see clearly into the market-to know which product brands are offered for sale, what ingredients are contained in those products, and what manufacturers are producing which supplements. It’s difficult to properly enforce other aspects of the law: compliance with the NDI notifications, or adverse event reporting, or proper ingredient labeling, if the agency doesn’t know which products are being sold. FDA has commented recently that it estimates there are between 50,000 and 80,000 supplements in the market, and the fact that the margin for error is 30,000 demonstrates there’s a problem with oversight. FDA can’t regulate what it doesn’t know is there.
Fortunately, there is a solution in the proposal for mandatory product listing for dietary supplements. Any product carrying the Supplement Facts label would be required to provide to FDA a copy of the label and some basic information about the product before it could be marketed in the U.S. And the database could be publicly available for consumers, healthcare practitioners, retailers, or regulators.
Skeptics worry that mandatory listing could be the first step down the slope toward premarket approval, but this concern can be addressed with strong assurances that listing, although required for all products, could not be used to prevent or slow down market entry. Like the difference between a birth certificate and a driver’s license, inclusion in FDA’s database of products could not be denied, even if the agency has reservations about a product’s legal compliance. But it would help alert the agency to the existence of safety concerns for separate follow-up investigation. In this age of corporate accountability, it’s time DSHEA caught up and shed a little light on the dietary supplement marketplace.
Irfan QureshiVice President, Product Development and Quality AssuranceHealthy Directions
As we reach the 25th anniversary of DSHEA, it’s clear that in many ways the dietary supplement industry in general has flourished under it, as DSHEA finally provided a framework for the development of the industry that was sorely missing. This allowed for significant innovation on the ingredient side and has certainly stimulated the amount of research performed on natural products. Unfortunately, over the years, the implementation of the statute has certainly left much to be desired. Two examples that stand out are the much-delayed enactment of dietary supplement cGMP guidelines as well as the lack of clear guidance and enforcement of the New Dietary Ingredient notification requirement. Had there been clear guidance from FDA from the start on both issues, many of the challenges that have been faced by the industry could have been mitigated. Of course, from FDA’s perspective, a major stumbling block in enforcement has always been a lack of resources. Increased funding would have led to more robust enforcement and is still an issue that needs to be addressed.
While DSHEA is far from perfect, I believe that, on balance, it is a statute that the industry and regulators can work with. Enforcing the existing provisions of DSHEA to the extent possible-including more clarity around the NDI notification procedure-would go a long way in ensuring that industry stakeholders play by the rules. I don’t believe blowing up DSHEA is the answer, as that could portend additional and unnecessary restrictions on the industry and would stifle innovation. Maintaining a separate category for dietary supplements under the regulations, much like DSHEA does, is in the best interest of industry as well as consumers. These products aren’t drugs and therefore shouldn’t be regulated as such. Industry associations and self-regulatory bodies should continue to work with FDA and their own membership to ensure that the structure of DSHEA is maintained while compliance and enforcement efforts are enhanced. Ensuring that ingredient suppliers, manufacturers, and brand holders play by the rules and are held to account will go a long way in maintaining the confidence of consumers, researchers, and regulators in the industry.
Alexander G. Schauss, PhD, FACH, CFSCEOAIBMR Life Sciences Inc.
Between 1989 and 1992, the natural products industry was under siege. Health food stores were being visited by FDA inspectors who, without warning, removed hundreds of dietary supplements from store shelves around the country. The agency alleged these products were drugs due to label claims. Imported supplement ingredients needed by manufacturers entering through our borders experienced seizures. The media argued that supplements should meet the same standards for cGMPs and supportive evidence of safety and efficacy required of pharmaceutical products. It was in this environment that the stage was set in 1992 to introduce in Congress a separate category for ingestible products labeled as dietary supplements to differentiate them regulatorily from that of foods or drugs.
It was grassroots organizations that helped to urge members of Congress to protect the right of consumers to continue to have access to supplements without burdensome and unjustified costs. After three years of debates in Congress, DSHEA finally passed by unanimous consent of both houses and was signed into law by President Bill Clinton.
This legislation gave FDA the authority to regulate the industry according to Congress’s intent as spelled out in the colloquy and language of DSHEA. Unfortunately, on the day DSHEA finally came to the House floor for a vote, a trade association successfully convinced the chair of the House Subcommittee on Health to remove the provision that would have required registration of dietary supplement products. Many who were surprised the language had been removed from the final House version of DSHEA, and that it was not reinserted in the Senate version, have regretted that this last-minute action ever took place without first consulting with the very grassroots group, Citizens For Health, that played such an important role in urging Congressional support.
Twenty-five years after the passage of DSHEA, many are now raising the question of whether the perception of this industry would be different today had the registration provision of this legislation been retained. The United States remains the only country that does not require mandatory registration of supplement products. Would registration of supplement products have stifled attempts by individuals and companies to market products that failed to meet cGMP requirements and other provisions of DSHEA? Would urging the FDA to require registration of all supplements have avoided the stigma heard so often ad nauseam that supplements “are not regulated”? These are timely questions the industry must ask itself today.
Suzanne SheltonManaging PartnerThe Shelton Group
What could we do to make DSHEA better? My scope of work is exclusively with products regulated under DSHEA, so I think about this a lot. Most laws reveal, over time, their strengths and weaknesses, and DSHEA is no exception. One of the main things I observe is the lack of clarity in several areas:
Testing: Essentially, manufacturers have to use something that is “fit for purpose” but that is just so vague. More specific guidelines would raise the quality bar. And ingredient companies are exempt, which is kind of ridiculous, because experience demonstrates that supplement products should be tested as they move through the supply chain.
The NDI guidelines process is ridiculous with the next incarnation of guidelines in limbo and suppliers just going the Generally Recognized as Safe (GRAS) route so they can at least demonstrate safety. I see it as an abject failure on the FDA’s part to have created this situation.
DSHEA put the same requirements and limitations on all the substances under the law’s umbrella, but it doesn’t really make sense. Herbs have a very long history of use for medicinal purposes, and a lot of very good research on prevention and cure of disease, but we can’t talk about that. This doesn’t serve the consumer well. Michael McGuffin, president of the American Herbal Products Association, has some really good ideas about this.
Scott SteinfordManaging PartnerTrust Transparency Center
The question is not one of if but when DSHEA needs to be revisited. Every law and policy written before Y2K needs to be reviewed. From our Constitution to our communication laws, regulations were written without fathom of the impact of the Internet on our commerce and safety. DSHEA placed the most significant onus of responsibility on the brand owner with the belief the brand owner would have the greatest reason to oversee the process and the most to lose if they failed to do so. However, with almost no barrier to entry for brand owners today, the risk of not following DSHEA’s cGMP requirements is almost equally nonexistent. There are thousands more brands and tens of thousands more products than existed at the onset of DSHEA. This burgeoning population of commerce needs more attention than the writers of this Act counted on DSHEA providing.
FDA [does not have the ability] to enforce the cGMPs that have been provided. The dietary supplement industry will have to self-police if cGMPs are expected to be respected. Additionally, DSHEA took for granted that the brand owner knew more about the products they provide than they do today. While the major brands are intelligent and responsible, many smaller, strictly e-commerce brands create a product suggested by a contract manufacturer with little to no understanding of what DSHEA and cGMPs are required. We, as an industry, must work diligently to ensure the actions of a few do not hinder or harm the opportunities and trust hard-earned to date. We should remain committed to the spirit of DSHEA but realize the world has evolved to require more than what DSHEA was designed to deliver.
Elan SudbergCEOAlkemist Labs
DSHEA was and still is great, but it’s time to revamp it to further protect the supplements we take and love. This is not a reflection on the quality of its first rendition, but rather an adaptation to the current times where willful ignorance is prevalent and skip lot testing is recklessly promoted by misaligned leaders. It’s time to tighten, and make more specific, the laws that gave birth to cGMPs. The only folks who are not for more enforcement are the ones fearing more enforcement, as it leans on their bottom line. Enforcement makes our products safer and more effective. The biggest change I’d like to see is towards method-specific testing. cGMPs mandated by DSHEA failed to list specific methods for analysis of our products when FDA developed them and as a result have left a gaping hole for interpretation that the unscrupulous exploit. Updated DSHEA should ban plug-and-play chemistry sets bouncing virtual libraries around or “save the day” magic boxes using cell phones as poor substitutes for analytical lab equipment. Let’s require and enforce real chemistry with fit-for-purpose foundations.
With adequate testing, adulteration will go extinct, like some inadaptable lizard no one remembers even existed. I’ve said it before and I’ll say it again: Test test test test test test and then test some more. If the FDA made the top-level determination to enforce specific test methods and protocols, appeal to ignorance would no longer promote poor-quality products in our industry.
The FDA has never had a better relationship with the dietary supplement industry than it does now. I invite them to tour my lab at least twice a year. More dialogue between industry stakeholders and FDA officials is an obvious improvement in transparency from both sides.
Peter ZambettiGlobal Business Development and Regulatory StrategyLonza Consumer Health & Nutrition
The dietary supplements industry has evolved significantly in the 25 years since the DSHEA regulations were first enacted. These changes not only include the advent of new technologies, but also new processes and numerous new ingredients and combinations thereof, as well as the globalization of supply chains and distribution. With a prolific number of new products coming onto the market all the time, DSHEA is still important to ensure consumer safety is prioritized by everyone in the industry.
Both Lonza and Capsugel have been at the forefront of supporting regulatory bodies and industry associations, in the U.S. and globally, for many years. Open dialogue between industry and regulators is key to evolving regulations to make sure they remain fit-for-purpose and in line with market changes. At Lonza, we play an active part in this process.
Our experience through serving on many trade associations in the U.S. and globally [has led us to believe that] FDA and supplement companies are aiming for the same goal: access to safe products that are marketed within the laws of that country. Understanding the regulatory requirements is key-being proactive to know exactly what’s required of you, whether you’re a supplier or manufacturer, and being ready and receptive to FDA inspections. Plus, open dialogue between industry and regulators should continue to be encouraged to make sure all challenges and requirements from both sides are put on the table and discussed.
Preserving consumer access to dietary supplements is crucial, but only for those supplements and manufacturers that operate safely and within the regulations required by DSHEA. Modernizing DSHEA, through industry consultation, and strengthening FDA enforcement will enable the continued access of safe supplements for consumers.