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The Industry’s Responsibility in an Era of Regulatory Uncertainty

Kaneka
 
CapsCanada

The dietary supplement industry has experienced another challenging year—good in many ways but difficult in others. Even though sales increased at a healthy rate, our industry has not been immune to supply chain disruptions, labor shortages and inflationary pressures.

Amid that landscape, regulatory uncertainty has posed numerous challenges stemming largely from the lack of clear direction and predictable enforcement.

Lack of FDA Enforcement Creates Uncertainty

Consider these examples: The FDA (U.S. Food and Drug Administration) periodically issues a new series of warning letters for claims it insists cross the line into disease claims—from hangovers to stress, anxiety and depression; and from COVID-19 treatments to blood sugar regulation—but with little, if any, follow through.

In July 2020, FDA issued letters questioning the legitimacy of NAC as a dietary ingredient, followed by more than a year of silence as to the ultimate fate of the ingredient. Just before Thanksgiving, the agency finally responded to CRN’s citizen’s petition by announcing its need to gather further research. FDA’s refusal to admit its error and delay in clearing up the status of NAC by asking for more data disregards the law. The Dietary Supplement Health and Education Act of 1994 (DSHEA) makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace. FDA’s delay is a disservice to the dietary supplement industry, retailers, health care practitioners, and most importantly, the more than 200 million supplement users who rely on FDA to do its job.

Dr. Pieter Cohen has published numerous articles identifying illegal drug ingredients in products labeled as supplements with little response from FDA. His findings are particularly disturbing because, in some cases, the products name their true contents on the label and, in one case, a follow-up study found even higher levels of the offending ingredient two years after FDA was notified of the first investigation.

These facts are the reality in which we operate. The dietary supplement industry must adapt to a climate where the agency charged with overseeing the marketplace is underfunded, under-resourced, understaffed, and perhaps, even under-incentivized to aggressively enforce the law as it was envisioned. If industry members want to maintain and enhance the consumer confidence that brought us to this point of tremendous growth, we are on our own to chart a course forward. The larger the industry grows, the more we have at stake.

Responsibility Amid Regulatory Uncertainty

So how do you exercise responsibility in an era of regulatory uncertainty? The industry must advocate for new agency tools without altering DSHEA’s framework that balances consumer access with safety assurances. Giving the agency new tools might seem counterintuitive, but the industry needs to do its part to strengthen its regulators.

This advocacy calls for a careful balancing act: nudging the FDA toward more enforcement and raising attention to areas where public health and safety are truly at stake, while ensuring we don’t compromise the underlying tenets of DSHEA in the process.

For example, there has never been a more critical time to enact mandatory product listing (MPL). Greater visibility into product ingredients could combat the bad actors who join our sector for quick profits. Without MPL, FDA simply doesn’t know who—or what—is out there. MPL would give regulators the ability to see the breadth of products and companies and to easily target those who simply fail to provide their labels to the agency.

At the same time, MPL must be considered as more akin to a birth certificate than a driver’s license. MPL should be a registry of the products currently in the market. It should capture the information listed on the product’s label, making it easy for a regulator—or, just as importantly, a consumer—to search the database for products matching the publicly available criteria.

MPL should not be overly burdensome or costly to companies. It also should not hinder or slow down entry to market. Our industry is built on innovation and speed to market for new products, and a product registry should not become a speed bump to their roll out or availability.

Similarly, MPL should not become a fishing expedition by allowing FDA to collect extraneous information that is not otherwise publicly available. Some stakeholders have suggested companies should be required to disclose their ingredient suppliers in their product listings. That idea is not a birth certificate, but closer to a driver’s license, a first step toward pre-market review—and the industry must object.

Giving FDA this type of pre-market review authority would defy 50 years of work to keep the agency at bay. We fought against setting maximum levels for vitamins in the 1970s. Existing ingredients were grandfathered into the market unless they were shown to be unsafe, and new ingredients are held to a reasonable expectation of safety, with each manufacturer defending its own products and the burden placed on FDA to demonstrate that a product is unsafe in order to remove it from the market.

Some stakeholders are calling for a massive overhaul of DSHEA (DSHEA 2.0) because, after 27 years, some of the law’s weaknesses have been exposed. To modernize the treatment of third-party literature and scientific research for the internet age, FDA needs to authorize accredited third parties to conduct inspections and certify compliance with GMPs (good manufacturing practices) because it can’t possibly conduct enough inspections on its own. Also, the definition of “dietary supplements” needs to be revisited to address shortcomings in the original law.

However, policy must be tempered with political realities. Those promising a wholesale overhaul of the law don’t provide a realistic roadmap to accomplish it in this political climate. Any gains the supplement industry and supplement consumer might achieve would be offset by concessions to those who would see us over-regulated. Be cautious of promises of major reforms that fail to consider the inevitable opposition.

Warding Off Outside Forces, Competing Agendas

The industry must be aware of outside forces looking to step into its regulatory shoes. During this time of FDA instability, it’s not surprising that other actors are lining up to impose their own agendas upon the industry.

State legislatures are but one of these outside forces. This year witnessed efforts to impose mandatory age restrictions on weight-loss and sports nutrition products in three states, and these bills will be re-introduced. Companies must be proactive and identify opportunities for compromise, perhaps with new labeling statements to discourage youth purchases or self-imposed limits on social marketing that appears to target young people.

More concerning is the rise in private class action attorneys looking to exploit the vacuum left by FDA. Many of these lawsuits are frivolous but nevertheless costly to defend. CRN has created an early-warning notification system so other members can be made aware of these attacks when new and creative legal theories arise. Additionally, CRN conducts members-only discussions and webinars with legal experts to address specific strategies for handling these lawsuits or avoiding them in the first place. We also evaluate cases on appeal and file amicus briefs to help shape precedent for future cases.

The best way to deter would-be enforcers is to demonstrate a strong commitment throughout the industry to self-police and observe high levels of quality, even if regulators are distracted or disengaged. That’s why our members agree to adhere to CRN’s guidelines and best practices. Now is the time as an industry to renew our adherence to best practices and consider gaps where we should develop new ones.

In 2020, CRN put forth considerations for solid dosage delivery forms to reduce swallowing hazards. Currently, a working group is evaluating recommendations for the use of proprietary blends. While we vehemently defend the use of proprietary blend labeling enshrined in DSHEA, CRN recognizes the industry should not abuse that ability to hide a practice known as “fairy dusting” (misrepresenting the levels of ingredients that don’t align with their studied clinical benefits). Abiding by these voluntary guidelines will ensure we honor the rightful role of proprietary blends and not risk losing the privilege that protects our intellectual property.

More Education Needed for Consumers and Stakeholders

During this time of haphazard enforcement, we must provide even more education to consumers and other stakeholders. We need to strengthen the conversational ties with our customers and engage stakeholders—including our critics—by demonstrating the benefits of our products.

One way the CRN Foundation is doing this is through Vitamin D & Me! I am particularly proud of this project because it was developed following the wave of new evidence supporting a connection between vitamin D and the severity of COVID-19. Last January, former Surgeon General Dr. Richard Carmona penned an editorial in the face of this growing research. How could CRN not develop a space for consumers to find the collective research, to educate themselves on the emerging data, and to hear directly from the researchers involved? Thirteen subsequent meta-analyses have reinforced Dr. Carmona’s words.

Another CRN education program, Probiotics: What’s Inside is Alive, is directed at retailers. This program encourages our retail partners to curate their shelves with quality, accurately labeled products that deliver the promised health benefits probiotics provide. Focused on the basic aspects of identity, quantity and viability, this program equips retailers with the information they need to provide better products to their customers.

Trade Associations Needed Now More Than Ever

The common thread among these sews up a single solution: The role of a vibrant trade association has never been more critical. When the regulatory landscape is in flux, industry solidarity is even more important.

The dietary supplement business is a diverse one, featuring small independent entrepreneurs, increasingly large CPG companies, and others dominated by outside private equity firms. Unity and consensus have never been harder or more important to achieve. What binds us together are shared values and a sense of responsibility our companies have for our consumers. Like so many other moments in our industry’s history, we must tackle these challenges together.

Steve Mister is president and CEO of the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.

Kaneka
 
CapsCanada