Since the 1994 passage of the Dietary Supplement Health and Education Act (DSHEA)—the foundational legislative framework for dietary supplements—the market for nutritional products has changed significantly.
 
While legislative adjustments have updated the regulatory structure surrounding dietary supplements over time, some within the industry are calling for a number of amendments to DSHEA. These efforts often aim to modernize how agencies like the U.S. Food and Drug Administration (FDA) oversee the industry in order to meet the challenges of an evolved marketplace and to more closely address with the original intentions of Congress. 
 
While talks of “DSHEA 2.0” aren’t new, with the change of legislative and executive administrations at the federal level comes a great deal of unpredictability. At the same time, stakeholders see an opportunity for the industry to voice its primary concerns and advocate for significant proposed changes among a new set of legislators with unique priorities.
 
During a panel discussion hosted by the Council for Responsible Nutrition, experts discussed potential reforms to DSHEA that may be up for future deliberations, many of which are supported by different industry segments.
 
Future Health Claims
Laura MacCleery, director of strategy and program for the Center for Science in the Public Interest (CSPI), said that CSPI’s primary concerns surround whether “DSHEA 2.0” will meaningfully clamp down on unscrupulous actors within the industry. Especially concerning, she said, is that companies often tread the line on “structure/function” claims and implied disease claims.
 
For example, companies can make claims that their product significantly reduces blood sugar levels or insulin resistance, even if all the evidence they provide comes from research done on healthy individuals, and not on people with actual diseases, such as diabetes, she said.
 
While these health claims are not indicative of a cure or treatment for a disease, high blood sugar and insulin resistance are highly characteristic of (but not unique to) diabetes, and MacCleery is concerned there are many diabetic consumers who mistakenly believe there is significant evidence that supplements were efficacious on diabetic people.
 
“These kinds of claims, even when they’re implied disease claims, may pose a risk to consumers who might misunderstand their actual efficacy,” MacCleery said. “We also see some common patterns in terms of evidence that is considered ‘clinically-tested’ by supplement makers. We have concerns that consumers might be misled about a product’s efficacy due to some products we’ve seen which were clinically tested, but didn’t perform any better than a placebo.”
 
Will Woodlee, partner at Kleinfeld, Kaplan, and Becker, LLP, pointed to a “somewhat curious provision” that covers where peer-reviewed, third-party research can appear in relation to a dietary supplements in a retail establishment, and how supplement providers can communicate about these findings.
 
Under the Food, Drug, and Cosmetic Act (FD&C), products cannot make disease claims, however, the industry is currently working under presumptions made by a “two-click” rule. Research covering evidence for non-label disease claims for a given supplement or ingredient shouldn’t be easily accessible through links on dietary supplement websites. Woodlee said that the rule, as it applies to health food stores, should also apply to online sales outlets. “Information one or two clicks away from an online store could provide important information to dietary supplement consumers, if the information is of quality,” Woodlee said.
 
“DSHEA was written prior to 1994, and believe it or not, there was no internet back then. There is a great deal of uncertainty regarding elements of free speech, and DSHEA is not as broad as it could be,” said Patricia Knight, senior political advisor for the United Natural Products Association (UNPA). “The FTC (Federal Trade Commission) wasn’t involved in this legislation prior, and obviously, they’re a player now.”
 
Mandatory Product Listing
A publicly-visible mandatory product listing is among the most likely reforms to DSHEA that will be brought to a vote in the near future. FDA has expressed support for such a measure in its 2020 and 2021 budget justifications to Congress. Requiring all products marketed as dietary supplements to be listed with FDA, along with ingredient panels, would allow the agency to know when new products are introduced, and more quickly identify and act against products that may cause consumers harm.
 
In lieu of a mandatory product listing in the interim, CRN requires all of its members to submit information about their products, known as the Supplement Online Wellness Library (OWL).
 
“CRN actually took this upon its own accord back in 2017,” noted Julia Gustafson, vice president of government relations for CRN. “We require listing of products as a condition of membership with CRN, so all of our members’ products are listed in the Supplement Online Wellness Library. This is based on the FDA making repeated requests for funding to create their own government-administered supplement registry.”
 
Gustafson said that while CRN is collaborating with FDA, they’ve heard various reports about the status of a proposal the agency is working on to allocate funding toward a government-administered, public-facing supplement registry.
 
Products within the Supplement OWL are available entirely for viewing by the public, the FDA, and any organization. “There are a lot of intricacies and topics to talk about surrounding this list, but we think it’s a great start,” Gustafson said.
 

Keeping Consumers Safe  
It’s no secret there are some bad actors within the industry that adulterate products with illegal drugs, and there are certain categories of dietary supplements in which these companies often sell their products.
 
Reputable actors within the industry are, by and large, highly supportive of most measures that aim to weed out dangerous and potentially deadly substances from the marketplace, including more proactive measures that could prevent harmful products from getting to market.
 
MacCleery said CSPI advocates for a list of qualifiers required for listing on a mandatory product registry. There should be certain checkpoints or steps verifying safety and efficacy of a given product prior to its listing, rather than, in essence, receiving the FDA’s blessing simply for being registered, she said.
 
Additionally, she believes the current adverse events reporting system (AER) has shortcomings, in terms of how likely consumers are to report adverse events, or if they even know how to in the first place.
 
Furthermore, she believes the FDA should have the authority to test product types deemed to be high-risk, based on categories which have seen the lion’s share of adulterants. “Weight loss, sexual enhancement, workout, and cannabinoids categories should have additional certifications regarding purity or supplement quality,” MacCleery said. Additionally, supplement ingredients with drug interactions should be treated with the same precautions and warning labels as OTC medications, she advised. 
 
Tying into adulterated products is CRN’s concern with what it calls an “illicit substances loophole.” The organization recently called on Congress to amend DSHEA in order to provide FDA with clear authority to take action against products which are marketed as dietary supplements, but do not contain dietary ingredients, Gustafson said.
 
She explained that FDA contends action against products that don’t contain dietary ingredients falls beyond the agency’s regulatory reach, even in instances when a product in question has a Supplement Facts label, or is specifically marked as a dietary supplement. “It seems right now that FDA is a bit reticent to go after too many products that are out there if they can’t be sure that they’re going to be able to win. There’s strain on agency resources. We want to clarify with a restatement of DSHEA and FDC&A to go after these products. If it walks like a duck, and quacks like a duck, it’s a duck,” Gustafson said. “FDA needs to have very, very clear authority to act and enforce on products trying to masquerade as dietary supplements.”
 
Woodlee noted advocacy for some kind of multi-agency task force dedicated to adulteration—a step that would go beyond merely allocating funds to FDA in order to address strictly illegal drugs. The collection of agencies could report back to Congress regarding collaborative efforts to stop the flow of these adulterants into the dietary supplement market, and could be made up of members of the FDA, Customs and Border Protection, and the Department of Justice.
 
Closing the ‘GRAS Loophole’
While many safe and efficacious dietary ingredients have gone through a self-affirmed Generally Recognized As Safe (GRAS) process, critics of this path to market consider it insufficient, as it avoids a costly New Dietary Ingredient Notification (NDIN) process, which has direct premarket FDA oversight.  
 
Some, such as MacCleery, would like any upcoming DSHEA reform to do away with the self-affirmed GRAS process entirely for something that would require ingredients to undergo FDA oversight before market entrance. DSHEA “dramatically weakened, or, I would say, gutted, requirements for what kinds of premarket safety reviews supplement ingredients must go through,” MacCleery said.
 
Further, she is skeptical there was any Congressional intent to allow for companies to self-affirm the safety of their own ingredients, if those ingredients are substantially different or more concentrated than how they appeared in the existing food supply.
 
CBD’s High Profile
John Dutton, principal of Veritas Advocacy, LLC, said that any significant changes to the GRAS or NDI process will ultimately be informed by the overwhelming impact that CBD is having on the dietary supplements marketplace.
 
“The politics and the policies of CBD are going to impact this legislative process from start to finish,” Dutton said. “It is simply true that the bill could be used as a vehicle to facilitate the use of CBD as a dietary supplement. There’s some interested in using the ‘GRAS loophole’ for CBD, but there is also plenty of interest in trying to preclude that.”
 
GRAS declarations and NDI notification are fundamental parts of DSHEA, Dutton said, and recommendations to change these processes were largely triggered by concerns surrounding CBD, both from proponents and opponents of its current status.
 
“It sets an entirely different starting context for reform that otherwise wouldn’t exist in the absence of CBD,” Dutton said. “If the high-profile issue of CBD is resolved, it will help propel reforms through the legislative process.” These implications include the “low-hanging fruit” of securing additional funding for FDA, and emboldening enforcement against adulterated products, Dutton said, adding that sometimes, smaller appropriations bills are easier to pass than larger authorizing bills. He pointed to the Cannabidiol and Marijuana Research Expansion Act, which he said is “ripe for compromise and passage in this cycle,” though much more narrow and modest with a focus primarily on research.
 
More Resources, Tougher Penalty Enforcement
There’s significant consensus among industry stakeholders that the Office of Dietary Supplement Programs could benefit from reforms to its regulatory authority, but only in so far as it has the resources to make such reforms actionable. Many believe the FDA needs additional funding and authority in order to keep pace with a marketplace which has grown exponentially.
 
“The agency can’t keep pace with large numbers of producers and products,” MacCleery said. “The marketplace has about 50,000 different supplement products, which isn’t calculated into the scope of the Office of Dietary Supplement Programs.”
 
She also advocated for amendments to authorize shared enforcement between the FDA, DOJ, and FTC, and for the FDA to be able to independently file criminal charges for severe harm to consumers. At the moment, FDA has the authority to issue misdemeanor fines, and only on rare occasions, and in extreme circumstances, does the agency cooperate with DOJ to pursue criminal penalties. 
 
Lessons from Canada
John Doherty, chief science and innovation officer at Canada-based Jamieson Wellness Inc., laid out some of the key differences between regulatory structures for supplement/health products in Canada vs. the U.S.
 
While there is common ground when it comes to Good Manufacturing Practices (GMPs), licensing relevant to those GMPs, Canada’s similar auditing and application processes, and adverse events reporting, a number of key differences shape the Canadian market much differently than the U.S.
 
Health Canada, the government agency responsible for national health policy, has a centralized library of “old” dietary ingredients complete with product monographs to specify dosage and permissible claims—some of these claims would be considered “disease claims” in the U.S. Dietary supplement companies have little leeway when it comes to pre-authorized health claims, though, practically speaking, Doherty said that minor deviations from pre-authorized health claims typically don’t draw enforcement action.
 
There are some key differences in the way Canada approaches new dietary ingredients. Companies cannot work around a process that involves government oversight. Any ingredient new to science, or used in a dosage which isn’t specified by monographs, is considered “new.”
 
If sufficient safety and efficacy data is provided, it typically takes 210 days for a product to be licensed by Health Canada. A major benefit in this process is that all licensing for dietary ingredients has been free of charge for companies since 2004, Doherty said.
 
“You essentially need to get an ingredient into their database, by establishing in fact that this ingredient is a natural product. It’s far simpler than an NDI process to get an ingredient listed with Health Canada, though the bar for safety and efficacy is quite higher than monographs for ‘old’ ingredients, but there’s a mechanism and a pathway to assess that,” he said. 
 
Lessons from History
Patricia Knight at UNPA was heavily involved in deliberations and the passage of DSHEA in 1994, and shared a great deal of historical context which should inform the likelihood of passing a “DSHEA 2.0,” or at least, the political context which led to the passing of the original legislation.
 
“The situation was very different in the 90s when this movement started,” Knight said. “There was a 30-year history of well-documented animosity held by the FDA against this industry, and by animosity, I mean that FDA had trouble figuring out what dietary supplements were, or how to regulate them.”
 
“FDA tried to regulate the potency of vitamins in relation to RDI,” she added, “and tried to claim that supplements were illegal food additives, based on the legal argument that a capsule was food and the ingredient was an additive. They also issued a report through a task force that was very critical of the dietary supplements industry, and infamously conducted a raid of a health food store in Washington State where guns were drawn.”
 
This “us vs. them” atmosphere ultimately swayed people who were normally sympathetic to FDA to change camps and “put us over the top to get a majority for DSHEA,” Knight said.
 
Back in 1994 there were more elected officials interested in major reform about how dietary supplements were regulated, compared to today, and while the industry does have allies in Congress, there are many more priorities superseding supplement reform, Knight noted.
 
“There is a message that dietary supplements are ‘unregulated,’ which resonates among some people today, and very little grassroots organization advocating for the nutrition industry than before,” she said. “FDA is much more involved than they were last time. We still don’t know the personality of the agency today, and we don’t know who the commissioner will be. We have an industry that isn’t speaking with one voice.”
 
At the time of DSHEA’s original deliberations, “You couldn’t go into a health foods store without seeing petitions to sign—it was a strong, targeted grassroots effort which was highly effective,” Knight said. “A circulating rumor which we’d never be able to quantify is that Congress received more mail regarding DSHEA than it did during the Vietnam War.”
 
Additionally, FDA was only involved through regulatory back channels, whereas today, the agency is going to be heavily involved in legislative discussions regarding substantive, or even less significant, reforms to DSHEA.
 
“We had a documented record back then that FDA didn’t know how to regulate supplements and that there was a need for clarity,” Knight said. “Today, there is a drumbeat that dietary supplements are unsafe and unregulated. While the majority of the industry is safe, it doesn’t take too many outliers for people to characterize the industry as such.”
 
The size and strength of the industry has also expanded immensely, and nutritional products are now blurring the lines between functional foods and beverages, traditional supplements, and cosmetic products, all of which have varying interests.
 
While Knight said she was skeptical that Congress would have the ability to look at a comprehensive “DSHEA 2.0” bill at this time, she believes there is heavy support for a number of factors: establishing a mandatory product listing, and a legal pathway to market for CBD, for instance. “Other issues are bound up in the success of resolving who the FDA is going to be under a new commissioner, how much the industry can unite, and how well consensus can be reached among legislators,” Knight said.

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Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at MMontemarano@RodmanMedia.com.