A Dickens of a Time
By Steve Mister, President & CEO, Council for Responsible Nutrition
It’s the best of times; it’s the worst of times….The dietary supplement industry is poised for remarkable
Steve Mister, President & CEO, Council for Responsible Nutrition opportunities in 2025, but is also burdened by potentially existential threats. How the industry maneuvers these challenges will determine proactive self-care's role for our 190+ million U.S. consumers. This moment will require more companies to get engaged, seize the opportunities, and proactively shape the future.
Let’s start with the opportunities: The next Administration includes several high-profile nominees with pedigrees recognizing the role of supplements in promoting better health. What a refreshing change to have government leaders who acknowledge the benefits of supplements and the role better nutrition plays in disease reduction. Cabinet officials who don’t start from a place of skepticism and distrust can be advocates for a more integrative approach to health that focuses on prevention.
CRN has advocated for several years that consumers should be able to use their Flexible Spending Accounts and Healthcare Savings Accounts for dietary supplements, and this could be the confluence of events to get it done. With significant tax legislation slated to advance in 2025, a pro-business agenda, and interest in reforming healthcare to focus on “well care,” the table is set. CRN has been educating Members of Congress on the potential cost savings of supplement usage and providing financial data demonstrating this change won’t break the bank. Most FSA/HSA holders say they want the flexibility to purchase supplements with these pre-tax funds.
The new year may also finally address the drug preclusion (or supplement exclusion) predicament. While the original intent of that provision is still valid—to protect pharmaceutical companies’ considerable investments from having an ingredient stolen from the drug market and marketed as a supplement—that balance has gotten out of whack. FDA misinterprets the exclusion to give drug firms perpetual monopolies over articles studied and abandoned, investigated for vastly different uses, or that bear little resemblance to the supplement formulation. FDA has promised to answer CRN's citizen's petition on the issue by July, and just in case, we are preparing legislation that would address the matter, too. If FDA doesn't interpret the provision equitably for both drug and supplement interests, then the law can be rewritten to remove any ambiguity.
Getting some much-needed updates to DSHEA may be more challenging in the new Congress, but it's doable. The industry has a short list of requests to make FDA more efficient and its supplement oversight more effective—if we are willing to negotiate in good faith, a receptive Congress might agree. Among the items are new authority allowing FDA to use facility audits prepared by credentialed third parties to set its inspection schedules and modernizing the restrictions on labeling claims to permit science-driven companies to promote clinical studies that include drug-related endpoints or discuss diseases.
A mandatory registry of supplement labels will be part of these discussions, and the responsible industry will continue to promote this tool to give FDA and retailers greater visibility. Our challenge is the misinformation disseminated by companies that don't want government oversight of supplements (No, this is not pre-market approval of supplements!). Still, we can overcome their misinformation campaigns by educating Congress that a mandatory registry is the price of entry a mature, responsible industry is willing to accept.
But 2025 is not without peril. CRN looks forward to oral arguments in our lawsuit against the State of New York to block the age restrictions on weight management and sports nutrition supplements. This misguided law, and the bills in at least eight other states, would scapegoat dietary supplements for the eating disorder epidemic and violate the First Amendment rights of manufacturers and consumers by restricting truthful claims that the state simply doesn't like. These age restrictions could become an existential threat to the industry and must be defeated because they are not grounded in science. They would limit all consumers from accessing safe and beneficial products. Manufacturers must engage with state legislators and advocate for balanced approaches that prioritize consumer safety without unduly restricting access.
Lastly members of the new Administration generally serve as lightning rods for negative media coverage of supplements. In 2025, under this new scrutiny, it will become even more critical for supplement companies to observe voluntary programs that demonstrate our commitment to serving consumers with safe and beneficial products. CRN's collection of self-regulatory initiatives is a counterweight to the misplaced notion that buying supplements is like "the Wild West." Industry will be challenged to adhere to and advance these programs as illustrations of prudence, conscience and restraint.
These are difficult challenges that lie before us. CRN is helping its members navigate this tumultuous time with agility and perspective, armed with a plan to deliver results. If successful, we will hear our supplement consumers asking—to quote another Dickens novel—“Please sir, I want some more.”
Steve Mister, President & CEO, Council for Responsible NutritionLet’s start with the opportunities: The next Administration includes several high-profile nominees with pedigrees recognizing the role of supplements in promoting better health. What a refreshing change to have government leaders who acknowledge the benefits of supplements and the role better nutrition plays in disease reduction. Cabinet officials who don’t start from a place of skepticism and distrust can be advocates for a more integrative approach to health that focuses on prevention.
CRN has advocated for several years that consumers should be able to use their Flexible Spending Accounts and Healthcare Savings Accounts for dietary supplements, and this could be the confluence of events to get it done. With significant tax legislation slated to advance in 2025, a pro-business agenda, and interest in reforming healthcare to focus on “well care,” the table is set. CRN has been educating Members of Congress on the potential cost savings of supplement usage and providing financial data demonstrating this change won’t break the bank. Most FSA/HSA holders say they want the flexibility to purchase supplements with these pre-tax funds.
The new year may also finally address the drug preclusion (or supplement exclusion) predicament. While the original intent of that provision is still valid—to protect pharmaceutical companies’ considerable investments from having an ingredient stolen from the drug market and marketed as a supplement—that balance has gotten out of whack. FDA misinterprets the exclusion to give drug firms perpetual monopolies over articles studied and abandoned, investigated for vastly different uses, or that bear little resemblance to the supplement formulation. FDA has promised to answer CRN's citizen's petition on the issue by July, and just in case, we are preparing legislation that would address the matter, too. If FDA doesn't interpret the provision equitably for both drug and supplement interests, then the law can be rewritten to remove any ambiguity.
Getting some much-needed updates to DSHEA may be more challenging in the new Congress, but it's doable. The industry has a short list of requests to make FDA more efficient and its supplement oversight more effective—if we are willing to negotiate in good faith, a receptive Congress might agree. Among the items are new authority allowing FDA to use facility audits prepared by credentialed third parties to set its inspection schedules and modernizing the restrictions on labeling claims to permit science-driven companies to promote clinical studies that include drug-related endpoints or discuss diseases.
A mandatory registry of supplement labels will be part of these discussions, and the responsible industry will continue to promote this tool to give FDA and retailers greater visibility. Our challenge is the misinformation disseminated by companies that don't want government oversight of supplements (No, this is not pre-market approval of supplements!). Still, we can overcome their misinformation campaigns by educating Congress that a mandatory registry is the price of entry a mature, responsible industry is willing to accept.
But 2025 is not without peril. CRN looks forward to oral arguments in our lawsuit against the State of New York to block the age restrictions on weight management and sports nutrition supplements. This misguided law, and the bills in at least eight other states, would scapegoat dietary supplements for the eating disorder epidemic and violate the First Amendment rights of manufacturers and consumers by restricting truthful claims that the state simply doesn't like. These age restrictions could become an existential threat to the industry and must be defeated because they are not grounded in science. They would limit all consumers from accessing safe and beneficial products. Manufacturers must engage with state legislators and advocate for balanced approaches that prioritize consumer safety without unduly restricting access.
Lastly members of the new Administration generally serve as lightning rods for negative media coverage of supplements. In 2025, under this new scrutiny, it will become even more critical for supplement companies to observe voluntary programs that demonstrate our commitment to serving consumers with safe and beneficial products. CRN's collection of self-regulatory initiatives is a counterweight to the misplaced notion that buying supplements is like "the Wild West." Industry will be challenged to adhere to and advance these programs as illustrations of prudence, conscience and restraint.
These are difficult challenges that lie before us. CRN is helping its members navigate this tumultuous time with agility and perspective, armed with a plan to deliver results. If successful, we will hear our supplement consumers asking—to quote another Dickens novel—“Please sir, I want some more.”
