The DSHEA Dilemma - At 20, are the regulations still relevant?The DSHEA Dilemma - At 20, are the regulations still relevant?

For our cover story two years ago in this very issue, NBJ asked thought leaders across the supplement space to consider a post-DSHEA world. What might that look like? In what ways could new thinking around supplement regulation advance or impede the industry? A number of targeted improvements to the law surfaced, as did a general disquiet among the respondents that the industry had strayed too far from its roots. Back in 1994, DSHEA felt like such an unqualified victory, but now, that victory carries with it at least a few shades of curse as well.

     As the landmark legislation governing supplements turns 20 years old—in an entirely new world of social media and globalized supply chains—NBJ again polls figures in and around the industry for an email roundtable to speak with candor about the best and worst of DSHEA, and what the industry might look and feel like in another twenty years. Here’s what they had to say.

Is the current regulatory environment helping or hurting the supplement industry?

Elan Sudberg, Alkemist Labs: Trust is unfortunately a thing of the past and today you must verify. It’s as simple as that. Not that all players in the industry are bad. Most are good. It’s the few bad ones out there that have given need for a constantly evolving regulatory environment. Viktor Frankl said this: ‘When we are no longer able to change a situation, we are challenged to change ourselves.’ Sometimes this change is painful to the bottom line, but this pain is helping the supplement industry on a global scale to move from a science-less and unsubstantiated perception to one of known government regulation, compliance and quality.

Robert Craven, FoodState: We believe that the current regulatory environment is driving product quality up and those who are not focused squarely on quality are slowly being forced out. However, we are still in the early stages of new regulations. It will take years to fully realize the benefits. The cGMP changes were needed, the industry is headed in the right direction, the science is strengthening, and consumer demand is growing.

Stephen Gardner, CSPI: It’s effectively an unregulated industry, which helps the companies but harms consumers. The problem is that DSHEA put the brakes on enforcement. After DSHEA, FDA kind of shrugged its shoulders and went away, which is understandable—the law really hamstrung them. It’s the Wild West right now.

David Pineda Ereño, EAS: It’s important to recognize that the US has been a pioneer in the development of regulations for dietary supplements. Many aspects of the US regulation are now among the key reference points for governments across the world.

Josef Brinckmann, Traditional Medicinals: While vitamins and minerals can be viewed as substances to supplement the diet, I have never actually considered herbal products to be supplements. Nonetheless, the US dietary supplement framework is the primary place where many orally ingested herbal products can find a home, albeit still a square peg in a round hole. In my view, the US presently lacks a rational framework for market access of herbal medicinal products. While DSHEA enabled a place for many herbal products to live, its scope is limited and thus does not offer a legal framework for a whole range of herbal products traditionally used to treat minor conditions.

Asa Siegel, Stamba Superfoods: Helping. The regulatory environment requires substantiating claims, verifying product safety through quality testing, and yet still allows for declaration of supplement benefits. It also strives to maintain a minimum level of quality standards that must be adhered to by supplement manufacturers. In terms of the industry itself, it is hard to argue with the consistent growth in the supplement sector over the past twenty years.

Courtney Nichols & Michael Cleary, SmartyPants: Responsible players in the dietary supplement industry had hoped that DSHEA would weed out the liars and cheats and the few products that actually endanger consumers. Twenty years later, the report card is somewhat mixed. FDA has written labeling rules that clarify what can and cannot appear on a supplement label. Products with really outrageous claims are off the shelf and largely unavailable. cGMPs have been established and codified for dietary supplements, following most industry recommendations and assuring safer products. Moreover, FDA has followed these rules with inspections, guidance and, less frequently, enforcement. But, true health & wellness claims for supplement efficacy are severely restricted and require a level of substantiation amounting to the level of scrutiny accorded a new drug application, a standard with a burden that few supplement companies can afford. And because label claims are so limited, consumers cannot distinguish between products built with premium ingredients and their lowest-cost competitors.

Jason Sapsin, Fox Rothschild: Thinking about DSHEA, the consumption of dietary supplements—according to both industry and government estimates—has increased, with half or more of the US adult population now taking them. Revenues have also dramatically increased in the last 20 years. The variety of supplements available and widely consumed has increased. These are good developments for the industry and, fairly or unfairly, the regulatory environment has provided the backdrop. Thinking in the near-term, the current regulatory environment may harm the supplement industry. I say this because I believe industry is helped when (a) the regulatory regime is predictable, and (b) consumers feel that the market for dietary supplements is ‘fair.’ Predictability requires clear rules and clear enforcement. I think fairness requires clear rules but also some degree of parity in the information buyers and sellers can bring to the market. The current regulatory environment may not offer either of these qualities particularly well. DSHEA—and FDA’s willingness and ability to enforce it—leaves open some important gaps for unscrupulous sellers while, simultaneously, maintaining consumers’ impressions that supplements are regulated comparably to pharma. I think this is a particularly dangerous combination for the long-term health of the industry.

What would you change?

Sudberg: To give all players in the supplement industry a better chance, I would start by putting together an industry task force to write a ‘cGMPs for dummies’ take on current regulations. I hear from so many customers and industry regulars that the laws are unclear. They are either profit-obstructing and ultra-compliant, or unsure of what to do, waiting for the legal hammer to drop and force their compliance. Each and every cGMP consultant I have ever worked with has a different take on levels of compliance, depending on their background.

Craven: We would give FDA more authority to remove ridiculous radio ads from the air quickly. Many radio ads make claims that have no place in our space.

Gardner: Either repeal DSHEA entirely, or amend FDCA to make supplements regulated as drugs.

Brinckmann: First of all, I would trade the DSHEA framework, wherein herbal products are not intended to diagnose, treat, cure or prevent any disease, for the Canadian Natural Health Product (NHP) framework. I think the Canadians have this right and the US policy makers should consider following their lead. I also do not inherently trust all companies and therefore, as a consumer, I would prefer a marketplace where companies are required to submit pre-marketing evidence of product quality, safety and efficacy—for the intended uses—to a competent authority, and post-marketing are subject to periodic GMP inspections.

Siegal: I’d like to see a declaration of synthetic vs. natural materials in supplements. Consumers still don’t fully understand that vitamins and minerals that are not derived from nature are not natural. To go one step further, an ingredient from nature should further be categorized as a whole food or processed food. Also, USDA and FDA should work together. Currently, FDA standards and organic certification standards are completely independent from one another. For example, if a supplement company states on their supplement label that an ingredient is ‘organic’ and their supplement label meets all FDA requirements, according to the FDA that product is legitimate. Yet, who is verifying the authenticity of the ‘organic’ claim? The answer is—nobody.

Gould & Cleary: We are much more concerned with safety, transparency and making consumers comfortable that the industry is not filled with folks just trying to make a fast buck than we are with being able to make more and more claims, but there is a balance. The fact that we can’t share content in a blog or on Facebook that in any way addresses disease impact—even about nutrients our own products don’t contain—is absurd. The media is free to misreport corollary studies as causal, but we aren’t permitted to share counter evidence. It’s frustrating to see so many of our competitors breaking the rules.

What would you think about pre-market registration of products?

Sudberg: A good idea overall, but cumbersome and logistically challenging for the industry to comply with unless FDA creates a simple path and meaningful final product from this idea.

Craven: We don’t see what is gained by this practice. What would the benefit be? The idea doesn’t worry us, since we already perform a version of this exercise in Canada and other countries, but we truly don’t see the point. We have a strong, credible retailer community in the US, and they do a good job of making sure that the credible brands are on the shelf. Solve the direct-to-consumer problem, and this will take care of the big issues.

Gardner: It’s not a bad idea, but neither is it particularly helpful in addressing the widespread consumer deception and safety risks inherent in supplements.

Brinckmann: In principle, I am in favor of pre-marketing authorization of products so long as the governmental agency charged with reviewing product applications is competent and the costs of doing so are not exorbitant. I think that the Canadian system for licensing of NHPs is reasonable and affordable, as is the Australian system for listing of Complementary Medicine products. The EU system for the registration of herbal medicinal products—whether traditional or well-established-use products—is presently far too costly for most small- to medium-sized companies.

What would you think about stronger permissible claims tied to stronger science?

Sudberg: This worries me a little. Over the years, the supplement industry has begun to mimic the pharmaceutical industry in everything from sexy novel ingredients—and marketing of such with pharmaceutical-like ad campaigns—to structure/function disease claims. Stronger permissible claims tied to stronger science may infer more scientific substantiation, which will strengthen the supplement industry, however I fear this will be only valuable to those companies who are, at heart, marketing companies donning the cloak of natural products.

Gardner: Companies have abused the regimen of health claims for regular foods already, so I would argue that imposing more work on FDA is not a worthwhile idea. Also, supplements are now being marketed as though they are drugs, but they don’t have the oversights that drugs get, thanks to DSHEA. It’s a twisted form of unfair competition with the drug companies.

Siegal: We already have very lenient claims guidelines as compared to other nations throughout the world. I am very hesitant about the ability for manipulation by major supplement manufacturers if there are further allowances linked to science. If all companies are able to make stronger claims, consumers will become more confused than they already are. These claims would also become less and less meaningful if they become more ubiquitous.

Sapsin: From my viewpoint, one of DSHEA’s weakest features is its handling of claims. From a public health standpoint—which may not always align with industry’s standpoint—supplements were never really ‘supposed to’ be about treating or preventing disease. The reality, however, is that consumers either want or have been trained to seek these effects from their supplements, and the barriers to claiming them are sufficiently low that unscrupulous marketers can work around them. I think this results in a ‘race to the bottom,’ in which the less-scrupulous potentially reap greater rewards. A regime under which the lines are much brighter, in which industry agreed systematically to accept defined and significantly more stringent burdens of proof in exchange for the creation of a wider safe harbor for claims, could help to redress this problem.

What would you think about pre-market safety assessments?

Craven: We believe that the NDI program adequately allows for pre-market safety assessments. The greater issues might be ‘post-market.’ As more data flows to FDA through AER reporting, we are likely to uncover possible supplement interactions with drugs, or allergic reactions, or other negative effects. Of course, the market will have to move swiftly to address these issues—and certainly not fight against them—in order to maintain and grow our credibility as an industry.

Gardner: This would be excellent.

Siegal: This could potentially stagnate the industry. There are minimal cases of safety risks linked to the supplement industry. Additionally, look at what the FDA allows to make it to market from the pharmaceutical industry. If there were any credence in the FDA as a protector of the safety of the general public, the majority of the mass-market pharmaceutical products available today would be outright banned, as they are in many European nations.

Sapsin: This is a hugely controversial topic. My own view is that pre-market safety assessments against an established set of benchmarks should be prerequisites to marketing new supplements. The volume and varieties—not to mention origins—of supplements sold and consumed have reached a level and diversity that there are significant risks to public health. Thinking about this from a public policy perspective, if we believe that supplements are intended to contribute to existing health and well-being and not to the treatment of serious health conditions, the justification for taking risks with consumers’ health—even relatively remote risks—just isn’t there.

What would you think about pre-market GMP inspections?

Sudberg: I find this to be as unnecessary and meaningless as sending a test sample from a large batch of raw material you are planning to get but never actually testing the batch you got. What matters is what’s going to be in the hands of the consumers, not your intentions prior to that. I think more of the normal inspections will do the trick rather than pre-market inspections.

Craven: Who would perform these pre-market inspections? We believe that FDA’s current process will eventually eliminate the non-compliant. We are in favor of more support for FDA to execute against current laws.

Brinckmann: I am in favor of pre-market submission of appropriate safety, quality and efficacy data to a competent authority. At the moment, we do not have such a structure in the US. The pre-marketing safety evidence required, for example, by the Australian TGA, Canadian NHPD and/or UK MHRA, are reasonable for most low-risk ingredients with a long history of use. New or novel ingredients should go through more rigorous safety evaluations before marketing authorization.

Sapsin: I would like to see this for all FDA-regulated products, not just dietary supplements but also conventional foods and even cosmetics. I think consumers, to a large degree, actually believe that this already occurs. Whether it’s realistic in the current political and economic environment is a separate question. But unlike the other proposals, pre-market GMP inspections would require FDA to significantly expand its field workforce so that—across the country and even internationally—it could send consumer safety officers to review facilities in a timely manner. That’s a tough argument to sell, even though I myself would champion it.

Who turned out to be the biggest winner in DSHEA? Industry? The consumer? Both? Neither?

Craven: We believe both industry and the consumer won. Consumer trust is the single largest asset our industry has, and DSHEA continues to raise the bar, which builds more trust. We believe the industry still has some work to do to educate consumers that we are regulated, but by and large, DSHEA has been good for our industry.

Gardner: The only winner is industry, in a rigged game.

Sapsin: Both industry and consumers won early and won in important ways—market size, diversity and access all improved. The question now is how to consolidate and improve upon these gains while mitigating some of the negative consequences, such as greater exposure to safety risks and to misinformation. I think the repeated cycle of adoption-implementation-revision is the natural progression of a law. We do what makes sense initially—or at least what can be achieved, we live with the consequences and hopefully grow wiser, and then we make adjustments to improve in light of our evolving understanding and goals. I believe that’s not only natural but necessary as responsible members of society.

Who was the biggest loser?

Sudberg: Poor quality and cheaters.

Craven: In the early days of DSHEA, there were many innovative companies that produced amazing, creative products. These companies were often too small to ensure safety and quality. We are largely missing these gems today. In the end, they had to go for the sake of broader industry credibility.

Gardner: Consumers, who are fooled about the benefits of many supplements and are at risk from others.

Sapsin: FDA. FDA was not given the tools that would allow the agency to regulate products in the way that consumers seem to want to use them—as ways of treating or preventing health conditions. At the same time, it was not given permission by Congress to publicly take a ‘hands-off’ approach. FDA has a nearly impossible mission now, with all sides—industry, consumers, and even healthcare professionals—frustrated.

Imagine the industry 20 years from now. What does it look like? How is it regulated?

Sudberg: I’m confident genetic-based personalized medicine will be a massive part of the industry. Quality will still be a critical success factor, hopefully made simpler and less expensive by new technologies. I don’t know what to expect from the regulatory side. Since FDA seems to respond to hysteria so quickly, it’s hard to tell what a handful of future, serious adverse events or recalls might produce. Maybe clinical studies will decrease in cost and allow our industry to make new claims. I hope there are some new botanicals discovered, and their properties put to use.

Craven: We believe that consolidation at all levels will continue producing larger companies that will become more adept at living within the regulations—483s and warning letters will drop in number significantly and the industry will grow more credible each year. There will be a significant increase in consumer pressure regarding transparency at all levels of the supply chain. Companies will have to work harder and faster to address the consumer on this issue, especially given that social media provides such a platform for any small issue to quickly spread far and wide.

Ereño: Over 70% of countries all over the world are either developing new regulation on dietary supplements or reviewing the existing regulation. During these processes, we are seeing an interest by regulators to help approximate the criteria. The work of Codex in this area has been critical. In addition, we are currently living through a number of harmonization processes in Africa, Asia, Europe, Latin America and the Middle East that will definitely have an impact on the market in the coming decades. It’s worth noting that, while governments engage in the development of free-trade agreements, they also realize that regulatory harmonization is necessary to actually facilitate that trade.

Siegal: Twenty years from now, the supplement industry will be transformed. Consumers will relate supplements with their fundamental well-being by providing nutritional nourishment from the highest-quality whole-food natural sources. Supplement manufacturers that dominate now will have changed their core values and practices or will be non-existent. This shift will have occurred organically (pun intended), as progressive supplement companies and third-party certification bodies will have educated and enlightened consumers through transparency and verification. Furthermore, supplement labels will display the symbols of the most trusted and significant of third-party certification agencies that will be validated by the FDA and USDA. Ingredients will not only be certified as organic and non-gmo, but be source verified, whole-food verified, raw verified, etc.

Gould & Cleary: In our experience, government regulation is unlikely to fix this. You will never get enough budget to be effective. This requires consumer pressure for transparency, consistency and quality to kill off the bad habits.