Exactly 25 years ago—Oct. 25, 1994—President Bill Clinton signed a bill that has enabled the dietary supplement industry to flourish over the last quarter century.
Consider the following:
- Based on FDA estimates, as many as 80,000 products are on the U.S. market today;
- Annual supplement revenues in 2018 totaled US$46 billion, according to Nutrition Business Journal; and
- Seventy seven percent of Americans (age 18 or older) reported consuming dietary supplements, according to the most recent annual survey conducted by the Council for Responsible Nutrition (CRN).
According to many veterans in the industry, the Dietary Supplement Health and Education Act of 1994 (DSHEA) fulfilled its twin goals of promoting access to dietary supplements while protecting the public health.
Still, DSHEA has critics. For example, many in the industry have complained it’s been poorly implemented and enforced by FDA, while others have maintained the law is inadequate to protect consumers and ensure products are effective.
Adding to the debate, the mainstream press over the years has blasted DSHEA and sometimes mischaracterized how supplements are regulated. Patricia Knight, former chief of staff to retired Sen. Orrin Hatch (R-Utah) and senior political advisor to the United Natural Products Alliance (UNPA), is keenly aware of such criticism.
"While I worked for Sen. Hatch, when a problem developed with a supplement or presumed supplement, we would commonly see a crawler at the bottom of the TV screen indicating that 'dietary supplements are unregulated due to a 1994 law,'" Knight recalled in an email this week. "Senator Hatch always instructed our press person to call the network and set them straight. The last time it happened, the CNN editor laughed and said, 'I knew you’d be calling…we’ve already changed it.’”
Having written extensively about DSHEA for the last several years, I appreciate Knight’s story.
But the 25th anniversary of DSHEA shouldn't just be a time to pat industry on the back and reflect on the law's achievements. We should also ponder the perceived shortcomings of the law, and the agency responsible for implementing and enforcing DSHEA.
Only then can we fully grasp the potential to bolster consumer confidence in dietary supplements, foster innovation, and hold fully accountable illegitimate manufacturers and marketers that threaten to sully the good character of “responsible industry.”
In the spirit of giving due consideration to the law’s successes and shortcomings, I reached out to 18 sources within and outside the industry. Here’s what they had to say. (Comments were edited for clarity).
INSIDER: Looking back over the last 25 years, what is the greatest achievement of DSHEA?
Mark LeDoux, founder, chairman and CEO, Natural Alternatives International Inc. (NAI): “The passage and implementation of DSHEA helped foster product innovation, scientific research and a robust dialogue in academia and industry that has demonstrated bona fide value in improving access to healthy foods and supplements. The law ultimately helped to reduce spending for remedial medical practices dealing with sick care, in favor of wellness through prevention and education. In essence, DSHEA actually breathed renewed vigor into a segment of the industry that had been under unjustified assault by the status quo, anti-innovation bias of overbearing regulators. Advancements in science have demonstrated significant value to the society at large when properly made supplements are deployed as part of the arsenal of rational wellness care with real economic benefits in the reduction of disease states associated with poor nutritional support.”
INSIDER: Do you see CBD fitting within the broader framework of DSHEA and if so or not why?
Karen Howard, executive director and CEO, Organic & Natural Health Association: “CBD absolutely fits within the framework of DSHEA. We’ll have to leave it to lawyers to argue patent protection of CBD isolate in relation to the Epidiolex or Sativex. FDA defines a drug using highly specific criteria for ‘intended use.’ Full spectrum, CBD or any of the other 100-plus cannabinoids in hemp don’t resemble either of these drugs. That said, FDA continues to narrow allowable label language in warning letters. Must industry demonstrate CBD safety through an NDI [new dietary ingredient] [notification]? Perhaps. The market is full of garbage as we’ve seen in our testing of Amazon products. Our cGMPs [current Good Manufacturing Practices], with label requirements and quality controls, are absolutely necessary to protect the consumer from fraud.”
INSIDER: In June 2007, FDA published its final rule for cGMPs for dietary supplements. Based on your conversations with clients, why do many firms continue to struggle with meeting these requirements?
Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting Group LLC: “No doubt, the development and implementation of a cGMP quality system is complex and necessitates the participation of experienced and technical personnel. Unfortunately, many companies in the industry don’t have such personnel, and they lack the resources to hire and train the appropriate staff. This is coupled with a complicated supply chain where operations are spread across a variety of contracting partners (brand owner, manufacturer, packager, distributor, and laboratory) that must, but often do not, communicate and share information with one another about their quality systems. These fundamental challenges have resulted in the same top three observations (related to specifications, recordkeeping and quality assurance/quality control) having been cited consistently by FDA in its inspection reports and warning letters.”
INSIDER: As the former Director of the Division of Dietary Supplement Programs at FDA, what did you find to be the most challenging aspect of policing the dietary supplement market?
Dan Fabricant, Ph.D., president and CEO, Natural Products Association (NPA): “One of the most challenging was the interaction with the trades. They seemed to think there was some invisible scoreboard that decided things when they met with the agency. I explained to them that consistency in messaging around the law, science and public health is the key for partnering with the agency. Many of the trades pushed the agency to allow ‘synthetic botanicals,’ but some of the same folks now are chastising ‘synthetic CBD’ for being synthetic. It’s one thing to change one’s mind; being opportunistic is another altogether. To have a partner in the agency, which many in the industry want, it doesn’t mean you always agree. It does mean, though, you are principled in being consistent scientifically and protecting the consumer.”
INSIDER: To what extent has DSHEA’s implementation exceeded or fallen short of your expectations when the law was passed in 1994 and why?
Scott Bass, partner, Sidley Austin LLP: “Enforcement has been a constant challenge since the law's inception. From the 1996 FDA decision not to utilize their new enforcement powers to stop ephedra, to the failure to review most new dietary ingredients to the decade-long absence of cGMP enforcement, we have seen politics and budget constraints hamper the good intent of this law. When we added the safety powers in Section 402 of the law, it was with the expectation that industry was acting responsibly in order to up its game. Both sides have fallen short, particularly in the novel or NDI review process. Some in industry continue to choose evasive tactics, which harm both the industry reputation and consumers. Finally, FDA has not stepped up to enforce the law it holds.”
INSIDER: In your experience as a public relations professional with deep expertise in the natural products industry, what helps explain the mainstream media’s tendency over the years to criticize the dietary supplement industry as being under-regulated or not regulated at all?
Suzanne Shelton, managing partner, The Shelton Group: “We can thank the influential New York Times and their long track record of attacking our industry for that. Around the year 2001, the media—particularly the Times—started characterizing our industry as ‘unregulated,’ and, unfortunately, the industry did an absolutely terrible job of correcting that fallacy before it became entrenched with reporters and the medical community. By the time a group of people from the industry sat down with writers and editors at the Times to explain specifically how we are regulated, that ship had sailed and didn’t come back into port for another 15 years. Rather than spending money to ineffectively ‘tell the good news’ about supplements, the industry should have reiterated ‘we are strictly regulated, just not regulated the same way drugs are.’”
INSIDER: How did DSHEA facilitate the widespread adoption of dietary supplements in the U.S.?
Steve Mister, president and CEO, Council for Responsible Nutrition (CRN): “Each year, 77 percent of American adults take a dietary supplement, according to CRN’s latest consumer survey, and they have DSHEA to thank for it. By creating a new category of products, ‘dietary supplements,’ the 1994 law established not only requirements for the manufacturing and labeling of dietary supplements, but also created structure/function claims that allow supplement labels to inform consumers how these products positively affect the body in ways distinct from traditional disease treatment and cures. DSHEA made truthful health information more accessible by permitting retailers to share scientific studies with consumers at a time before the internet, when research wasn’t so easy to perform. An informed consumer leads to a proactive consumer who seeks out products to improve their health and wellness.”
INSIDER: Having lobbied for DSHEA, what provision of the law would you change and why if you could go back in time?
Loren Israelsen, president, United Natural Products Alliance (UNPA): “First, set a hard deadline (say three years) for FDA to work out cGMP regulations. This took far too long and we lost the means to teach cGMPs and urge FDA to enforce those regulations in the early post-DSHEA period (1994 - 2000). Second, had we understood the rapid evolution of the internet and information flow, our efforts to create a ‘physical separation’ between products and third-party literature would have shifted to the digital realities. And not that we could have figured this out, but we could have saved a lot of confusion and frustration had we been able to envision how consumers create and share their personal health experiences online. Even today, it would be a daunting task to craft legislative language to address this.”
INSIDER: As a former principal deputy commissioner at FDA, what did you perceive to be the biggest strength in DSHEA and its biggest weakness, and why?
Joshua Sharfstein, M.D., vice dean for public health practice and community engagement, John Hopkins Bloomberg School of Public Health: "DSHEA created a framework for oversight of dietary supplements, based on the principle of access with safety. However, while the law has promoted access, it has failed to protect consumers from unsafe new ingredients, mislabeling and adulteration with pharmaceuticals. Enhancing DSHEA will protect the public and support a robust and legitimate supplements industry."
INSIDER: Since DSHEA was passed into law, how has the science evolved to demonstrate that botanicals and other dietary supplements are effective for specific conditions and not simply "snake oil?"
Douglas Kalman, Ph.D., vice president, scientific affairs, Nutrasource: "It is unquestionable that the advent of the DSHEA law has coincided with an increase in nutrition studies. More specifically, over the past 25 years, there have been more global (from all over the world) studies on dietary supplements, including botanicals, herbals, vitamins, minerals and related compounds. DSHEA opened the door for dietary supplements to have greater place and focus in society. This also happens to be one reason why academic and other studies with and on dietary supplements occurred. Said another way, DSHEA not only opened the door for the greater distribution and commerce of dietary supplements, but also a sharp and very real uptick in academic and related interest in supplements. All in all, this was and is a net good thing."
INSIDER: In terms of protecting consumers from unsafe products marketed as dietary supplements, what is the most significant shortcoming of DSHEA and why?
Pieter Cohen, M.D., associate professor of medicine, Harvard Medical School and general internist at Cambridge Health Alliance: "Several fundamental problems with DSHEA create unnecessary risks for consumers in search of safe vitamins, botanicals, live microorganisms and many other popular products. Multiple loopholes in the law have been used to introduce dietary ingredients, which are as potent as pharmaceutical drugs. The law is interpreted as permitting the introduction of highly concentrated ingredients, either from a botanical source or synthetically produced, at levels consumers were never before exposed to in conventional food or traditional botanicals. Structure/function claims encourage this approach because they permit manufacturers to promote supplements as if they will have immediate health benefits. The law failed to ensure FDA could evaluate the safety of all new dietary ingredients or effectively remove dangerous supplements after their introduction onto the market."
INSIDER: Why do you suppose DSHEA has withstood the last 25 years without being undone despite heavy criticism from mainstream media over the years?
Patricia Knight, senior political advisor, United Natural Products Alliance (UNPA): "The law’s basic construct has been improved over the years, including requirements for serious adverse event reporting and facility registration. Most criticism by media and others is based on a lack of knowledge about the multiple ways supplements are regulated, including strict consumer protections such as cGMP and labeling requirements.Many in the media suggest erroneously that ‘regulation’ of supplements equates to ‘pre-clearance.’ Congress explicitly rejected the latter approach for a number of reasons, including because supplements are a category of foods, the majority of which have been used safely for decades (as opposed to drugs which FDA must approve). Nor do media appear to be aware of DSHEA’s grandfather clause, which requires the safety of new dietary ingredients be submitted to FDA prior to market."
INSIDER: Has DSHEA effectively protected American consumers from harm? Why or why not?
Peter Lurie, M.D., president, Center for Science in the Public Interest (CSPI) and former associate commissioner for public health strategy and analysis at FDA: “DSHEA was designed to be ineffective, so in that sense, it has fulfilled its promise. In the 25 years since its passage, it has become increasingly clear that the law fails to protect consumers from products that don’t work as marketed, that aren’t what they claim to be, or that are just plain dangerous. Predictably, the industry has exploited the law’s shortcomings, with many fly-by-night operators avoiding any kind of meaningful regulatory scrutiny. The last thing we need is for DSHEA to celebrate yet another birthday in its current form.”
INSIDER: Has DSHEA effectively protected American consumers from harm? Why or why not?
Michael McGuffin, president, American Herbal Products Association (AHPA): “The Food, Drug and Cosmetic Act, as amended by DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, provides an excellent legal framework to ensure a reasonable expectation of safety for dietary supplement consumers. These laws forbid interstate commerce of any unsafe supplement and require FDA be informed promptly if a consumer reports a serious adverse event (SAE) associated with a supplement. The record over the past 25 years shows these provisions to be more than adequate. For instance, AHPA found less than two percent recalls reported by FDA for the first six months of 2019 were for dietary supplements. AHPA’s internal reviews indicate SAEs associated with supplements are also much lower than for other categories of regulated goods.”
INSIDER: Since the passage of DSHEA, how has the relationship between FDA and the industry evolved?
Beth Lambert, CEO, Herbalist & Alchemist Inc.: “FDA had a rather adversarial view of the industry at first. The agency took a long time to issue cGMPs and did not issue guidance about how to meet their expectations, especially for smaller companies. But FDA has journeyed down the learning curve with us. It recognizes properly documented macro botanical identification and organoleptic skills used by small herbal companies working from fresh/whole herbs. Regional differences in inspections still must be harmonized, and FDA must finalize NDI guidelines. However, today's FDA seems more willing to work with industry than past years. Each FDA chief nominee has cited adequate authority under DSHEA to regulate the industry, but the agency still doesn't seem to differentiate between outliers and the responsible majority of the industry.”
INSIDER: Looking back over the last 25 years, has FDA effectively used the enforcement tools that Congress granted the agency in DSHEA? Why or why not?
Marc Ullman, of counsel, Rivkin Radler LLP: “FDA has not come close to using the enforcement tools granted to it in DSHEA. The most obvious failure relates to new dietary ingredients, where the agency has simply refused to take any action to protect companies that have gone through the notification process. DSHEA is clear that any NDI for which no notification has been filed is adulterated. Going through the process is complex and can be costly. Yet FDA has no procedure in place, even one as simple as issuing an import alert against ingredients for which no NDI notification has been submitted. This has created a situation where scofflaws/criminals can knock off a branded ingredient and move their product (frequently containing potentially dangerous impurities) into the U.S. market with impunity.”
INSIDER: What evidence do we have that DSHEA has helped improve the health status of U.S. citizens?
Vasilios "Bill" Frankos, Ph.D., senior corporate advisor, product science, safety and compliance, Herbalife Nutrition: "Based on my experience working at Herbalife and FDA, I can confidently say DSHEA has accomplished its main goal of empowering consumers so they can make their own decision about what dietary ingredients they want to use to improve their health and support a healthy lifestyle. Each year since the passage of DSHEA, more and more people are using dietary supplements and functional foods. CRN’s latest usage survey shows more than 75% of the adult population has used dietary supplements in the last year. I think this kind of growth reflects the innumerable reasons consumers turn to dietary supplements to complement, enhance, increase, or replace dietary ingredient (vitamins, minerals, amino acids, herbs, and botanicals) deficiencies."
INSIDER: How has DSHEA helped or hindered dietary supplement innovation?
Loretta Zapp, CEO, Applied Food Sciences Inc.: “DSHEA afforded dietary ingredient companies an opening for innovation because it offered a framework that could help assure consumer confidence. Stronger mandates brought definition to safety and quality, which is where many companies now find their competitive advantage. When I first entered the industry, I was head of an independent third-party testing lab. One of our focus areas was testing food ingredients. We established a division specific to analytical testing of botanicals. While the need was clearly there, the demand had not yet been realized. So, when we went to our first trade show in 1995, many ingredient companies criticized our services, thinking it excessive. We still believe that when the rules are clear, it makes the possibilities for innovation even greater."