Dietary supplement executives, the head of a consumer advocacy group and a Massachusetts physician weigh the pros and cons of the 25-year-old Dietary Supplement Health and Education Act of 1994 (DSHEA) and the forces that led to its enactment.
Differences of opinion over the law are striking. Consider, for example, these remarks:
“The area of dietary supplements continues to be a kind of Wild West.” – Peter Lurie, M.D., Center for Science in the Public Interest
“[The] overall safety of dietary supplements has remained high by any standard of measure.” – Loren Israelsen, United Natural Products Alliance
“In an overexuberance of enthusiasm for access, the law forgot about safety basically.” – Pieter Cohen, M.D., Harvard Medical School
The … law’s not much good if we don’t enforce, so somehow, someway, we need to have it configured so that the government can support the rule followers while going after the rule breakers.” – Jim Emme, CEO, NOW Foods
A full transcript of this podcast is below.
Josh Long, Legal & Regulatory Editor: The grassroots movement to promote access to dietary supplements in the early 1990s began as a “slow burn.” That’s according to Loren Israelsen, the president of the United Natural Products Alliance who fought for passage of a law that has endured for a quarter century. The temperatures steadily rose, Israelsen said, eventually boiling over into Congress, culminating in the passage of the Dietary Supplement Health and Education Act of 1994. Many now just call it DSHEA.
Israelsen: Then when we began to talk about and go public with our concerns and our proposed solution, we were astonished by the level of outpouring not just from health food retailers that you would expect or practitioners—natural product practitioners—but from the average consumer. And we’re literally talking coast to coast, every walk of life, socioeconomic strata. It got to the point that the number of contacts to Congress during the course of DSHEA, in the words of key members of Congress, exceeded anything they had ever seen other than public protests of the Vietnam War.
Long: The grassroots movement in support of DSHEA reflected a deep-seated mistrust of the federal government and ambiguity over what we now call dietary supplements, industry sources said.
Israelsen: First of all, we had no legal definition. What is a dietary supplement? Therefore, we … got pinballed around by other definitions that FDA preferred to use. Food additive. New drug. These are not good things. FDA was very aggressive at that time. They were challenging companies. They were conducting raids. Some of these raids became very aggressive—guns, flak jackets. The acrimony between industry and FDA had grown to a fever pitch.
Audio: Courtroom gavel
Long: In the late 1980s, FDA seized certain dietary supplement products and asserted they were unapproved food additives. Steven Shapiro is of counsel to Rivkin Radler, a law firm in New York, and he counsels dietary supplement firms on compliance with DSHEA. Shapiro was part of a team of litigators who fought the feds in two landmark cases decided by appeals courts in 1993. He explained what was at stake.
Shapiro: Who would bear the burden of establishing safety? If … the companies had the burden, then FDA could basically shut down any company by seizing their product.”
Long: The judiciary did not find the government’s arguments persuasive. In one of the cases, the U.S. Court of Appeals for the Seventh Circuit described FDA’s strategy as a “Alice-in-Wonderland approach” that was intended to “make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances.” In a similar case involving Oakmont Investment Company, the U.S. Court of Appeals for the First Circuit readily dismissed FDA’s theory that putting black currant oil in a capsule turned it into a food additive not proven to be safe. During a recent interview, Shapiro read an excerpt from the court’s 1993 opinion.
Shapiro: We are reluctant to believe that Congress traffics in absurdities. Since it defies common sense to say that a substance can be a ‘food additive’ when there is no (other) food to which it is added, we think that the FDA's reading of the Act is nonsensical, and, hence, must be incorrect.
Long: Shapiro said he believed the cases were instrumental in helping to foster support for a law that created a specific framework around dietary supplements.
Shapiro: These two cases allowed the industry to go to Congress and say, ‘FDA just does not know what to do or FDA is not capable of properly regulating dietary supplements.’ FDA’s attempts are, as the court said, ‘non-sensical, Alice-in-Wonderland,’ just … crazy basically.
Audio: Bill Clinton (‘But others must recognize that open markets and rule-based trade are the best engines we know of’).
Long: On October 25, 1994, then-President Bill Clinton signed DSHEA. The law defined certain foods as dietary supplements and placed the burden on FDA to demonstrate that a dietary supplement is unsafe. Congress reported in the law that nearly half of the 260 million Americans regularly consumed dietary supplements of vitamins, minerals or herbs to improve their nutrition. Steve Mister, president and CEO of the Council for Responsible Nutrition, said it’s a ‘very different industry’ today.
Mister: Twenty five years ago, this was … seen as sort of a niche industry.
Long: At the time, Mister reflected, the stereotypical user of dietary supplements was a 60s-era hippie who wore Birkenstocks.
Mister: I’m not sure that that was every accurate, but what you see now is that our consumer is everybody. It’s the soccer moms. It’s the gym rats. It’s the professional athlete. It’s the 40-year-old weekend warrior who’s …. still trying to train for a half marathon or a bike ride.
Long: But over the years, critics have accused the industry of acting irresponsibly selling products that are ineffective and unsafe. The law, some critics maintain, is woefully insufficient to keep companies honest. Enter Dr. Peter Lurie, president of the Center for Science in the Public Interest, a consumer advocacy group in Washington. He previously served as associate commissioner for public health strategy and analysis at FDA.
Lurie: The area of dietary supplements continues to be a kind of Wild West. It used to be a tiny, fledging industry. But with the passage of DSHEA in 1994, it just really opened the floodgates for this industry, and now we have an industry with … over $40 billion annually in sales. Instead of ending up with a law that strengthened the FDA’s hand, what we wound up with was a law and subsequent regulations that have weakened the FDA’s hand.
Long: Jim Emme is the chief executive officer of NOW Foods, a privately held company whose annual revenues he confirmed exceed half a billion dollars. Emme said DSHEA was effective in that it provided clear guidelines to follow, but he highlighted a shortcoming.
Emme: I don’t think it’s been effective in people consistently following the rules. We as a company feel that we as an industry need to work together to … call out the bad behaviors that really put consumers at risk. And that’s got to be the No. 1 issue is taking care of consumers and being transparent.
Long: Lurie pointed out FDA has identified hundreds of products marketed as dietary supplements in such categories as weight loss and sexual enhancement that are tainted with prescription drugs. Government and medical professionals agree that such products endanger the health of consumers.
Lurie: And it’s plainly a waste of money when a product has no proven evidence for its effectiveness when it can actually be diverting a patient from something that could benefit them to a product that may have no benefit whatsoever.
Audio: Phone ringing
Long: Like Dr. Lurie, Dr. Pieter Cohen of Harvard Medical School has identified problems with DSHEA. Over the last several years, Cohen’s peer-reviewed research has identified potentially unsafe ingredients in various products marketed as dietary supplements. But the Massachusetts physician corrected a misconception that he’s anti-supplements.
Cohen: I’m a big fan of supplements and I recommend them to my patients during every clinic, and that’s … multiple times a week.
Long: Cohen, however, articulated perceived weaknesses in DSHEA, including what he described as an attempt ‘to solve a problem that didn’t exist.’
Cohen: The FDA was not trying to take, remove vitamins and minerals from mom-and-pop markets and pharmacies. It became a very hands-off approach to these products where that wasn’t necessary to begin with and has worsened matters.
Long: Cohen said he would likely not have the concerns he does today with DSHEA if the law limited the definition of dietary supplements to vitamins and minerals.
Cohen: The problem is that so many other ingredients—notably all the botanicals, live microorganisms like bacteria and yeast—were included in the same regulatory framework that’s being used to sell vitamins and minerals. In an overexuberance of enthusiasm for access, the law forgot about safety basically.
Audio: Former U.S. Attorney General Loretta Lynch (‘Hello, as part of National Consumer Protection Week, I want to take a moment to talk to you about dietary supplements’).
Long: Federal law does incorporate safety provisions around dietary supplements. Whether they are adequate is open to debate. DSHEA, for example, requires that manufacturers and distributors of new dietary ingredients—or so-called NDIs—notify FDA, providing evidence of safety 75 days before going to market. Distributors and manufacturers also must report serious adverse events to FDA under a law that President George Bush signed on Dec. 22, 2006. Emme stressed FDA must enforce consistently against companies that fail to comply with the NDI notification requirement.
Emme: The … law’s not much good if we don’t enforce, so somehow, someway, we need to have it configured so that the government can support the rule followers while going after the rule breakers.
Long: Sophisticated companies that consider themselves rule followers are frustrated with what they perceive as a lack of a level playing field. An ingredient company may invest hundreds of thousands of dollars in an NDI notification, but a rival perhaps based thousands of miles away in China may take a similar ingredient to market without notifying FDA or investing in the safety data. Adding insult to injury, FDA has been lax with its enforcement of the NDI provision, according to many industry lawyers.
Dr. Vasilios—otherwise known as Bill—Frankos is a senior executive with Herbalife Nutrition and a former FDA official. He led FDA’s Division of Dietary Supplement Programs and was responsible for implementing current Good Manufacturing Practices, a key component of DSHEA intended to ensure that products are made to quality standards. While Frankos agreed the NDI notification process has been underutilized, he said FDA could help solve the problem. The solution? Provide companies incentives to invest in the safety work.
Frankos: I believe that if the NDI notification process would provide more proprietary for companies that have developed safety data and clinical data that people would be inclined to do it.
Long: Frankos and others have envisioned the concept of a master file of NDI notifications FDA would keep confidential. The master file would only be accessible to an ingredient manufacturer’s customers who could rely on that NDI notification and the supporting safety data. It’s a concept FDA is considering.
Frankos: Only the NDI holder could give another company the permission to use the data in the master file or to use the NDI notification letter that they got.
Long: Since 1997, FDA has received about 1,100 total notices. Israelsen acknowledged the agency would likely concede the number of filings has been low.
Israelsen: But by some measures, I would say that the process itself has not worked as we would have envisioned and hoped for. And yet the overall safety of dietary supplements has remained high by any standard of measure.
Long: But consumer advocates and even industry itself have proclaimed more should be done to address activity that threatens the public health. For example, to help identify potentially unsafe or unlawful products, some people and organizations—including FDA and Lurie—have proposed a requirement that dietary supplements list with FDA. The agency has reported there are an estimated 50,000 to 80,000 dietary supplement products on the market, but FDA doesn’t have an easily accessible list of those products.
Lurie: The FDA knows the names of companies that make this stuff, but they don’t know what they’re making. So next thing you have an outbreak on your hands or some other enforcement priority, and the agency really doesn’t even have the vaguest roadmap of where to go because it has no idea what’s on the market.
Audio: Orrin Hatch (‘Over 150 million Americans regularly consume dietary supplements as a means of improving and maintaining their health. The passage of the Dietary Supplement Health and Education Act, or DSHEA, in 1994 brought clarity’)
Long: One of the fathers of DSHEA—former U.S. Senator Orrin Hatch from Utah—said in a recent interview with me that the concept of a dietary supplement product listing ‘makes sense’ to him. But he suggested any requirement adopted by Congress must be fair, not overly burdensome.
Hatch: In other words, we should not regulate the dietary supplement industry into the ground and which some people will try to do acting like they’re the sole protectors of our health and strength in this country.
Long: Scott Bass, an attorney in Washington who lobbied for DSHEA, said in 2018 that the time has come for a mandatory product listing.
Bass: How can a company offer a product to consumers that’s supposedly a health product and then say, ‘But I don’t want the government to know about it.’ It just makes no sense.
Long: Bass proclaimed a product listing—as he envisions it anyways—would not undermine DSHEA.
Bass: It doesn’t give FDA any power to do anything with that list other than to cite people who don’t put their product label in that list. That’s it. It is not a first step toward premarket approval.
Long: Trade associations have been reluctant to immediately embrace the proposal. For instance, the American Herbal Products Association has taken the position that a product listing isn’t necessary because the current framework provides FDA adequate authority to properly regulate supplements. But its long-time president, Michael McGuffin, said his organization is keeping an open mind.
McGuffin: That’s not to say we wouldn’t modify this position. We would if we had to, or we would if we found some balance; if we found that, for example, a quid pro quo was state preemption. A quid pro quo was more precise clarification of the identity of allowed ingredients.
Long: Dr. Daniel Fabricant is president and CEO of the Natural Products Association, and he previously led FDA’s Division of Dietary Supplement Programs before the division was elevated to the status of an office. He also suggested the possibility of a quid pro quo, namely legislation that would preempt the states in exchange for a requirement that dietary supplement products be listed with FDA. While he didn’t provide specific details on proposed state preemption legislation, Fabricant expressed concerns that plaintiffs’ lawyers could use information obtained in a dietary supplement product registry to sue companies for reasons entirely unrelated to safety. He also noted FDA already has access to labels during its inspections and when it receives certificates of free sale.
Fabricant: I don’t think we’re opposed to necessarily going that route, but still I don’t think you even start that discussion, one without state preemption. Two, if you’re getting labels now and not using them, why does anyone think they’re going to be used in the future.
Long: Herbalife’s Frankos imagined a process in which companies share with FDA the products they are making, the ingredients in their supplements and their marketing claims. FDA could place a number on a product associated with such details.
Frankos: The consumer will be able to see, ‘Oh yah, this is the same product that … the FDA saw, and they didn’t have any problems.’ And I think that would go a long way in helping consumer confidence.
Long: Frankos acknowledged some in the industry fear what he described as ‘mission creep.’
Frankos: They start to see more information. They start to ask more questions. The questions lead to more inspections. The inspections lead to more regulatory action.
Audio: Police scanner
Long: Frankos isn’t worried about mission creep, provided industry, FDA and Congress work together. But as DSHEA approaches its 25th anniversary, and conversations intensify over reform of the law, do competing interests have a legitimate chance of reaching a compromise? Lurie said it’s possible.
Lurie: I think there’s opportunity for some dialogue between a group like ours and some of the more responsible segments of the industry. But I think other less responsible segments have no interest whatsoever in any kind of compromise and are going to try and keep the law just the way it is.
Long: Rest assured industry leaders remain ever mindful of DSHEA’s twin pillars: promoting access to dietary supplements while protecting the public health. Should the government one day seek to limit consumers’ access to supplements, Israelsen predicts another revolt like the one that led to passage of the law he has fought for years to protect.
Israelsen: The notion of the government telling people what to do, which conflicts with your personal belief of how you can care for yourself, crosses a red line. This is what caused people to rise up. And I believe they will again at some point should these that were granted under DSHEA be abridged, I have little doubt that we would see an uprising of the public once again.