By Steve Mister, President & CEO, Council for Responsible Nutrition (CRN)09.24.24
Being perceived as responsible is vital for all industries, particularly one that promises better health to its customers. Companies want to project responsibility, but what exactly does it entail to practice what they preach? At CRN, our members have been responsible for 50 years; it's baked into the organization's culture. So much so that we say, “‘responsible’ is our middle name,” and our members live out that mantra through a range of self-regulatory programs they honor in their daily actions.
It starts with our Code of Ethical Practices, a creed that each CRN member agrees to observe when they join and renew their pledge every year. Along with committing to abide by all applicable state and federal laws and regulations, they commit to truthful and non-misleading labeling and advertising, taking appropriate actions to support the safety of their products, and observing fair business practices in their dealings with consumers, the general public, and other industry members.
Another plank of this code is to commit to responsible self-regulation. This pledge includes participating in developing voluntary standards for responsible business behavior and infusing these programs within their own companies. Among them are a collection of voluntary guidelines for such diverse categories as protein, probiotics, caffeine, melatonin, kava, DHEA, and prenatals. They provide recommendations for maximum levels of vitamins and minerals, making claims when using proprietary blends, and best practices for handling enzymes.
Why all this effort around voluntary guidelines that go beyond the requirements of federal law? Self-imposed regulation through voluntary codes and guidelines is critical in fostering trust. While government regulations provide essential guardrails, voluntary codes offer additional layers of oversight that can significantly benefit both businesses and consumers. Here’s why:
1. Voluntary Codes lead to industry-wide practices that everyone benefits from — but that no one company would be likely to do alone. Take CRN’s Caffeine Guidelines that call for certain cautionary statements on the labels of products containing more than 100 milligrams of caffeine. Without a broad commitment among competitors to adopt these advisories to consumers, it’s less likely that any one brand would make these warnings on their own. But when a broad swath of the industry collectively agrees to do it, it’s easier for every company to follow that lead.
Another example is CRN’s 13-year advertising review program with the Council of Better Business Bureaus. CRN invested over $2 million to increase scrutiny of supplement advertising claims, calling out false advertising and claims that stretched the scientific proof. No one company could have leveraged the more than 300 cases evaluated during the program. Still, its impact was undeniable: Mary Engle, formerly with the FTC and now the director of the NAD program, acknowledged that by the time the CRN program concluded in 2020, advertisers were submitting significant evidence in response to challenges of their claims, including clinical testing on the advertised product and testing on ingredients. While substantiation issues still exist, the program raised visibility for the evidence standards for dietary supplement advertising and alerted the industry that it was under scrutiny.
2. At the same time, voluntary codes provide the flexibility to adapt to new challenges and emerging trends more rapidly than formal regulations. Unlike FDA, which takes years to adopt new rules, voluntary codes can be updated regularly to address evolving industry practices, technological advancements, and shifts in consumer expectations. CRN's Best Practices for Probiotics urges marketers to label their probiotic supplements to disclose the quantity of live microorganisms at the end of the stated shelf life, typically as Colony Forming Units (CFU). CRN petitioned FDA to make a similar requirement for all probiotics in 2017. Despite years of review, the best FDA has provided is guidance that permits, but does not require, companies to deviate from the requirement of labeling quantities in metric weight. Our voluntary guidelines didn’t wait for FDA to act.
3. Developing and adhering to voluntary codes can help companies avoid more stringent governmental regulations. A broadly adopted voluntary program can deter government involvement altogether, leading to cost savings and less bureaucratic burdens, as voluntary codes can be more efficient than navigating complex regulatory frameworks. CRN’s recently adopted Guidelines for Melatonin Dietary Supplements include a requirement for child-deterrent packaging for flavored forms of the ingredient. Such proactive efforts by industry may forestall any attempts to promulgate mandatory child-resistant requirements for these products.
4. Even when government action is inevitable, fast-acting industry programs can serve as the template for eventual regulation, allowing industry more influence in the outcome. Taking the lead and demonstrating a commitment to self-regulation can influence policymakers to adopt regulations that simply enshrine the existing voluntary programs. CRN’s voluntarily-created Good Manufacturing Practices served as a template for the federal regulations that came years later. Similarly, the Supplement OWL, in which CRN members commit to provide their product labels for public viewing, may serve as the model for the mandatory FDA registry of supplement labels that will likely be enacted.
5. Voluntary Standards can also influence global requirements. In a globalized market, voluntary codes supported by rigorous science can facilitate the adoption of consistent standards across different regions that can simplify compliance for multinational companies and harmonize standards regardless of where supplements are sold. An excellent example of this effect is CRN's Vitamin & Mineral Safety Handbook, which established maximum safe levels of essential nutrients over 20 years ago. Since then, numerous regulatory bodies worldwide have deferred to these standards in adopting safe upper levels for their countries and regions. That's why today CRN is updating these numbers with the latest science to support them.
6. Self-regulatory programs can also be useful in staying ahead of class action litigation. In 2013, several CRN members began to notice that protein levels on certain supplements did not match the labeled amounts and discovered that a computational error resulted in overestimations of the protein content. CRN developed, and our members implemented, voluntary Guidelines for Labeling of Protein that instruct companies how to back out the nitrogen contributions of amino acids and other ingredients that might contribute to the heightened nitrogen levels in their product (a proxy for determining actual protein content). Several years later, when a rash of class actions dogged some companies by alleging false labeling of protein content, CRN members who had already adopted the program were relatively unscathed by the litigation.
7. Voluntary codes can provide small and medium companies with a framework for achieving industry-recognized standards without investing extensive resources. These industry-developed programs, where competitors, large and small come together to solve problems, give all participants equal voice in the outcomes and avoid having to address the issues alone, with duplicative investments of talent and resources. This helps small to midsize firms compete more effectively with larger companies and ensures they can deliver high-quality, compliant products. CRN’s just-adopted Considerations for the Manufacturing of Gummy Dietary Supplements illustrates how manufacturers of all sizes can agree on quality measures that should apply regardless of the company’s size.
8. Voluntary codes often include mechanisms for self-assessment and internal auditing. This allows companies to regularly evaluate their adherence to the guidelines and identify areas for improvement. Self-assessment promotes a culture of continuous improvement and accountability within the industry. That’s why CRN recently revisited its melatonin guidelines that were first adopted in 2015. More recent adverse event data has revealed increasing numbers of accidental childhood ingestions of melatonin products, that gave rise to new guidelines adopted this year that caution parents to keep the products out of children’s reach.
9. Self-regulation can help industry control the narrative when it proactively implements and adheres to a voluntary code in the face of negative press. Getting ahead of public criticism by addressing it can demonstrate commitment to quality, safety, and ethical conduct and diffuse the issue. CRN did just that in the face of media reports that Selective Androgen Receptor Modulators (SARMS) were increasingly identified in products marketed as supplements. Our Guidelines on SARMS dictate that no CRN member should distribute or market any dietary supplement products containing SARMs, putting a clear stake in the ground: These products are illegal and not representative of our members or the mainstream industry. Informing retailers of our self-imposed prohibition put them on alert that products with SARMS were also illegal.
Similarly, we responded to negative press about labeling proprietary blends in ways that oversell the health benefits of "fairy-dusted" levels of certain ingredients. CRN's Regulatory Responsibilities and Best Practices for Proprietary Blends holds members accountable that if a claim is made on the product label for the proprietary blend, the product should contain the ingredient in a quantity equivalent to the substantiated amounts to achieve the benefits in the claim (even if the amount is not disclosed on the label). This self-imposed requirement helps the industry retain the intellectual property advantages of the proprietary blends exception in the law by committing not to abuse that privilege. This positive image can be leveraged in marketing and communications efforts, helping to build goodwill with stakeholders, including customers, investors, and regulatory bodies.
10. A strong reputation can also be a competitive advantage, setting companies apart from their less proactive peers. Even though CRN publishes all its voluntary programs and invites the entire industry to join, some firms refuse to participate. In these cases, our self-regulatory programs create a point of distinction for those who follow them, demonstrating a commitment to ethical practices and accountability. The Supplement OWL is used by retailers, regulators, and consumers who take notice of the transparency. Self-regulatory programs are a badge of distinction.
11. It’s the right thing to do for our consumers. I’ve saved this reason for last because it’s the most important. Robust, enforced self-regulatory programs demonstrate a mature industry with the ability to self-police. They build trust with consumers. They show willingness to put consumers' interests first. Last year, CRN adopted Guidelines for E-commerce Transactions premised on the belief that consumers who research and purchase supplements online should have access to all the same label information as consumers who buy in store and can read labels before they purchase. Giving online shoppers complete disclosure is just the right thing to do. We self-regulate because that’s what consumers expect of responsible companies.
Self-regulation does not eliminate companies' need to comply with various laws and regulations governing dietary supplements, but it does build confidence among consumers, healthcare professionals, and other stakeholders. Being “responsible” means instilling self-restraint, accountability, and integrity in our businesses. When CRN says “responsible” is our middle name, it represents this commitment and much more.
About the Author: Steve Mister has been President and CEO of the Council for Responsible Nutrition (CRN) since 2005. Under his leadership, CRN has experienced increased membership each year, doubled its annual budget, sharpened its strategic focus to advance the industry, and launched new initiatives that increase industry responsibility and provide consumer education. During Mister’s tenure, CRN has been instrumental in enacting the adverse event reporting law for dietary supplements, the Designer Anabolic Steroid Control Act, and defeating several efforts in Congress that would have over-regulated dietary supplements, limiting consumer access. Mister led the association to launch the Supplement OWL, an industry-run online registry of dietary supplements and their labels. He is a member of the U.S. Chamber of Commerce’s Association Committee of 100, holds a Certified Association Executive (CAE) distinction, and is active in ASAE.
It starts with our Code of Ethical Practices, a creed that each CRN member agrees to observe when they join and renew their pledge every year. Along with committing to abide by all applicable state and federal laws and regulations, they commit to truthful and non-misleading labeling and advertising, taking appropriate actions to support the safety of their products, and observing fair business practices in their dealings with consumers, the general public, and other industry members.
Another plank of this code is to commit to responsible self-regulation. This pledge includes participating in developing voluntary standards for responsible business behavior and infusing these programs within their own companies. Among them are a collection of voluntary guidelines for such diverse categories as protein, probiotics, caffeine, melatonin, kava, DHEA, and prenatals. They provide recommendations for maximum levels of vitamins and minerals, making claims when using proprietary blends, and best practices for handling enzymes.
Why all this effort around voluntary guidelines that go beyond the requirements of federal law? Self-imposed regulation through voluntary codes and guidelines is critical in fostering trust. While government regulations provide essential guardrails, voluntary codes offer additional layers of oversight that can significantly benefit both businesses and consumers. Here’s why:
1. Voluntary Codes lead to industry-wide practices that everyone benefits from — but that no one company would be likely to do alone. Take CRN’s Caffeine Guidelines that call for certain cautionary statements on the labels of products containing more than 100 milligrams of caffeine. Without a broad commitment among competitors to adopt these advisories to consumers, it’s less likely that any one brand would make these warnings on their own. But when a broad swath of the industry collectively agrees to do it, it’s easier for every company to follow that lead.
Another example is CRN’s 13-year advertising review program with the Council of Better Business Bureaus. CRN invested over $2 million to increase scrutiny of supplement advertising claims, calling out false advertising and claims that stretched the scientific proof. No one company could have leveraged the more than 300 cases evaluated during the program. Still, its impact was undeniable: Mary Engle, formerly with the FTC and now the director of the NAD program, acknowledged that by the time the CRN program concluded in 2020, advertisers were submitting significant evidence in response to challenges of their claims, including clinical testing on the advertised product and testing on ingredients. While substantiation issues still exist, the program raised visibility for the evidence standards for dietary supplement advertising and alerted the industry that it was under scrutiny.
2. At the same time, voluntary codes provide the flexibility to adapt to new challenges and emerging trends more rapidly than formal regulations. Unlike FDA, which takes years to adopt new rules, voluntary codes can be updated regularly to address evolving industry practices, technological advancements, and shifts in consumer expectations. CRN's Best Practices for Probiotics urges marketers to label their probiotic supplements to disclose the quantity of live microorganisms at the end of the stated shelf life, typically as Colony Forming Units (CFU). CRN petitioned FDA to make a similar requirement for all probiotics in 2017. Despite years of review, the best FDA has provided is guidance that permits, but does not require, companies to deviate from the requirement of labeling quantities in metric weight. Our voluntary guidelines didn’t wait for FDA to act.
3. Developing and adhering to voluntary codes can help companies avoid more stringent governmental regulations. A broadly adopted voluntary program can deter government involvement altogether, leading to cost savings and less bureaucratic burdens, as voluntary codes can be more efficient than navigating complex regulatory frameworks. CRN’s recently adopted Guidelines for Melatonin Dietary Supplements include a requirement for child-deterrent packaging for flavored forms of the ingredient. Such proactive efforts by industry may forestall any attempts to promulgate mandatory child-resistant requirements for these products.
4. Even when government action is inevitable, fast-acting industry programs can serve as the template for eventual regulation, allowing industry more influence in the outcome. Taking the lead and demonstrating a commitment to self-regulation can influence policymakers to adopt regulations that simply enshrine the existing voluntary programs. CRN’s voluntarily-created Good Manufacturing Practices served as a template for the federal regulations that came years later. Similarly, the Supplement OWL, in which CRN members commit to provide their product labels for public viewing, may serve as the model for the mandatory FDA registry of supplement labels that will likely be enacted.
5. Voluntary Standards can also influence global requirements. In a globalized market, voluntary codes supported by rigorous science can facilitate the adoption of consistent standards across different regions that can simplify compliance for multinational companies and harmonize standards regardless of where supplements are sold. An excellent example of this effect is CRN's Vitamin & Mineral Safety Handbook, which established maximum safe levels of essential nutrients over 20 years ago. Since then, numerous regulatory bodies worldwide have deferred to these standards in adopting safe upper levels for their countries and regions. That's why today CRN is updating these numbers with the latest science to support them.
6. Self-regulatory programs can also be useful in staying ahead of class action litigation. In 2013, several CRN members began to notice that protein levels on certain supplements did not match the labeled amounts and discovered that a computational error resulted in overestimations of the protein content. CRN developed, and our members implemented, voluntary Guidelines for Labeling of Protein that instruct companies how to back out the nitrogen contributions of amino acids and other ingredients that might contribute to the heightened nitrogen levels in their product (a proxy for determining actual protein content). Several years later, when a rash of class actions dogged some companies by alleging false labeling of protein content, CRN members who had already adopted the program were relatively unscathed by the litigation.
7. Voluntary codes can provide small and medium companies with a framework for achieving industry-recognized standards without investing extensive resources. These industry-developed programs, where competitors, large and small come together to solve problems, give all participants equal voice in the outcomes and avoid having to address the issues alone, with duplicative investments of talent and resources. This helps small to midsize firms compete more effectively with larger companies and ensures they can deliver high-quality, compliant products. CRN’s just-adopted Considerations for the Manufacturing of Gummy Dietary Supplements illustrates how manufacturers of all sizes can agree on quality measures that should apply regardless of the company’s size.
8. Voluntary codes often include mechanisms for self-assessment and internal auditing. This allows companies to regularly evaluate their adherence to the guidelines and identify areas for improvement. Self-assessment promotes a culture of continuous improvement and accountability within the industry. That’s why CRN recently revisited its melatonin guidelines that were first adopted in 2015. More recent adverse event data has revealed increasing numbers of accidental childhood ingestions of melatonin products, that gave rise to new guidelines adopted this year that caution parents to keep the products out of children’s reach.
9. Self-regulation can help industry control the narrative when it proactively implements and adheres to a voluntary code in the face of negative press. Getting ahead of public criticism by addressing it can demonstrate commitment to quality, safety, and ethical conduct and diffuse the issue. CRN did just that in the face of media reports that Selective Androgen Receptor Modulators (SARMS) were increasingly identified in products marketed as supplements. Our Guidelines on SARMS dictate that no CRN member should distribute or market any dietary supplement products containing SARMs, putting a clear stake in the ground: These products are illegal and not representative of our members or the mainstream industry. Informing retailers of our self-imposed prohibition put them on alert that products with SARMS were also illegal.
Similarly, we responded to negative press about labeling proprietary blends in ways that oversell the health benefits of "fairy-dusted" levels of certain ingredients. CRN's Regulatory Responsibilities and Best Practices for Proprietary Blends holds members accountable that if a claim is made on the product label for the proprietary blend, the product should contain the ingredient in a quantity equivalent to the substantiated amounts to achieve the benefits in the claim (even if the amount is not disclosed on the label). This self-imposed requirement helps the industry retain the intellectual property advantages of the proprietary blends exception in the law by committing not to abuse that privilege. This positive image can be leveraged in marketing and communications efforts, helping to build goodwill with stakeholders, including customers, investors, and regulatory bodies.
10. A strong reputation can also be a competitive advantage, setting companies apart from their less proactive peers. Even though CRN publishes all its voluntary programs and invites the entire industry to join, some firms refuse to participate. In these cases, our self-regulatory programs create a point of distinction for those who follow them, demonstrating a commitment to ethical practices and accountability. The Supplement OWL is used by retailers, regulators, and consumers who take notice of the transparency. Self-regulatory programs are a badge of distinction.
11. It’s the right thing to do for our consumers. I’ve saved this reason for last because it’s the most important. Robust, enforced self-regulatory programs demonstrate a mature industry with the ability to self-police. They build trust with consumers. They show willingness to put consumers' interests first. Last year, CRN adopted Guidelines for E-commerce Transactions premised on the belief that consumers who research and purchase supplements online should have access to all the same label information as consumers who buy in store and can read labels before they purchase. Giving online shoppers complete disclosure is just the right thing to do. We self-regulate because that’s what consumers expect of responsible companies.
Self-regulation does not eliminate companies' need to comply with various laws and regulations governing dietary supplements, but it does build confidence among consumers, healthcare professionals, and other stakeholders. Being “responsible” means instilling self-restraint, accountability, and integrity in our businesses. When CRN says “responsible” is our middle name, it represents this commitment and much more.
About the Author: Steve Mister has been President and CEO of the Council for Responsible Nutrition (CRN) since 2005. Under his leadership, CRN has experienced increased membership each year, doubled its annual budget, sharpened its strategic focus to advance the industry, and launched new initiatives that increase industry responsibility and provide consumer education. During Mister’s tenure, CRN has been instrumental in enacting the adverse event reporting law for dietary supplements, the Designer Anabolic Steroid Control Act, and defeating several efforts in Congress that would have over-regulated dietary supplements, limiting consumer access. Mister led the association to launch the Supplement OWL, an industry-run online registry of dietary supplements and their labels. He is a member of the U.S. Chamber of Commerce’s Association Committee of 100, holds a Certified Association Executive (CAE) distinction, and is active in ASAE.
