{"id":956992,"date":"2026-11-03T17:10:09","date_gmt":"2026-11-03T17:10:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/956992\/"},"modified":"2026-11-03T17:10:09","modified_gmt":"2026-11-03T17:10:09","slug":"supplement-industry-counsel-talk-regulatory-patchworks-legal-risks-and-free-riders","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/956992\/","title":{"rendered":"Supplement industry counsel talk regulatory patchworks, legal risks and free riders"},"content":{"rendered":"

Speaking during a recent Business Leaders Forum hosted by NutraIngredients+<\/a>, Christine Burdick-Bell, executive vice president and chief legal officer at Pharmavite, Mike DiMaggio, chief legal officer and general counsel at Nutrabolt, and Carlos Lopez, senior vice president and general counsel at Niagen Bioscience, walked through legal and regulatory priorities for 2026 and beyond, flagging some of the more significant forces coming to bear.<\/p>\n

They highlighted proposed federal oversight of substances considered generally recognized as safe (GRAS), unresolved questions around new dietary ingredient notifications (NDINs), state restrictions on products marketed for weight loss or muscle building and increasingly sophisticated advertising claims as the issues most likely to test the industry.<\/p>\n

In this environment, regulatory strategy is having to look beyond technical compliance and prepare for the what ifs<\/a> by establishing stronger evidence governance, state monitoring, retailer coordination, influencer oversight and a clear plan for defending innovation against both free riders and litigation.<\/p>\n

Pathway reform: Interlocking pieces and capacity questions<\/p>\n

The panel identified potential changes to the GRAS pathway as one of the most consequential developments facing supplement companies since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.<\/p>\n

Proposed in August<\/a> and open for consultation through Dec. 9, a new rule would replace FDA\u2019s voluntary notification system for substances considered GRAS with a mandatory program covering substances used in human and animal food. Many newer ingredients have also entered the market through the self-affirmed GRAS pathway introduced in 1997, which has allowed companies to independently evaluate and determine an ingredient\u2019s safety before putting it in the food supply and transition it to a dietary ingredient.<\/p>\n

DiMaggio remarked that self-GRAS was initially introduced because FDA was overwhelmed with submissions and undersupplied with resources. He also called attention to the \u201ctremendous risk\u201d for companies having to submit a mandatory GRAS notification for self-GRASed products already on the market.<\/p>\n

\u201cIf [FDA makes] a determination that they disagree with the evidence in support of the safety, now you have a product on the market, you have potential legal exposure,\u201d he said. \u201cThere are so many potential repercussions that have not yet been discussed that I have grave concerns about the approach that\u2019s articulated.\u201d<\/p>\n

For Burdick-Bell, the GRAS proposal cannot be viewed separately from the FDA\u2019s approach to NDINs or the agency\u2019s interpretation of what qualifies as a dietary ingredient\u2014both of which emerged as areas of focus this year<\/a>.<\/p>\n

On Oct. 19, the FDA released its long-awaited final guidance on recommendations for the information required to demonstrate the identity and the safety of a new dietary ingredient (NDI)<\/a>.The agency has repeatedly expressed a desire to increase the number of NDIs received. Industry stakeholders have voiced concerns about the FDA has sufficient staff capacity to review a significant increase in submissions in a timely manner.<\/p>\n

\u201cIt\u2019s not that there\u2019s one piece; it\u2019s a set of interlocking pieces that move together,\u201d Burdick-Bell said, warning that policy changes moving on different timelines could constrain innovation.<\/p>\n

There are also continued apprehensions over what she described as the \u201ccoattails problem\u201d, which creates commercial disincentives for compliance. Companies can spend significant time and money developing safety dossiers, only for competitors to piggyback on publicly available work without making the same investment or using the approved form and dose of the ingredient. Niagen\u2019s nicotinamide riboside chloride ingredient has received FDA \u201cno objection\u201d responses to two NDINs and a \u201cno questions\u201d response to a GRAS notification for specified uses in conventional foods.<\/p>\n

\u201cWe have a problem here where responsible actors carry this cost, and free riders get the benefit,\u201d Lopez said. \u201cIf FDA expects NDI notifications, it has to act like it and has to enforce against companies that skip that, otherwise the system just rewards people who ignore it. <\/p>\n

To protect its intellectual property, Niagen, relies on its patents and market surveillance testing of competitor products on the market. When testing reveals that NAD+ boosting ingredients fall short of label claims<\/a>, Niagen shares these results with regulators and retailers. <\/p>\n

\u201cThere are real costs both in terms of dollars and reputation,\u201d Lopez added. \u201cIt\u2019s not our role, it\u2019s the role of the regulators.\u201d<\/p>\n

He called on FDA to use its established authority to strengthen enforcement against companies who do not comply with regulatory requirements and suggested that policymakers consider data protection or another form of market incentive for businesses that undertake the work needed to establish safety.<\/p>\n

Legislative consideration: Preclusion, patchwork and preemption<\/p>\n

Beyond proposed rulemaking and updated guidance, the sector has witnessed substantial legislative activity this year, spanning both potential new regulatory burdens and measures intended to expand or clarify the market. <\/p>\n

The Dietary Supplements Innovation Act, the latest piece of legislation proposed to affect the industry, drew qualified support from the panel but also exposed disagreement over whether its drafting could create unintended enforcement risks. Introduced in September by Rep. Diana Harshbarger,<\/a> the bill would revise the federal drug-preclusion framework governing when ingredients associated with drug development can be marketed as dietary supplements.<\/p>\n

Although DiMaggio said the legislation\u2019s goal of addressing drug preclusion concerns was broadly supportable, he pointed to troubling nuances in the drafting including the proposed relocation of the drug-preclusion from Section 201(ff), which defines \u201cdietary supplement\u201d under the Federal Food, Drug, and Cosmetic Act, to Section 301(II), where it could be treated as a prohibited conduct and establish grounds for enforcement.<\/p>\n

Burdick-Bell countered that FDA may already possess comparable authority under existing food adulteration provisions and framed the question as whether the bill offers greater certainty than the status quo.<\/p>\n

Under FDA\u2019s current interpretation, expressed in its September 2025 pronouncement on nicotinamide mononucleotide (NMN), an ingredient need not have been lawfully marketed\u2014including compliance with applicable NDIN requirements\u2014to secure priority over a drug.<\/p>\n

\u201cWe think that\u2019s wrong as a matter of law,\u201d Lopez said. \u201cWe also think it doesn\u2019t provide the clarity that we would like to see from revisions to drug preclusion, so future versions of this, in my mind, would take a position and state clearly that marketing needs to have been lawful in order to get somebody into the ball game, if you will.\u201d<\/p>\n

All three panelists viewed near-term passage as unlikely but expect the debate to return.<\/p>\n

Other acts introduced or re-introduced in 2026 include the Dietary Supplement Listing Act<\/a> by Sen. Richard Durban (D-IL), which would require manufacturers to list products in a public database with the FDA ; the Dietary Supplements Access Act<\/a> introduced by Rep. Darin LaHood (R-IL), which would allow eligible consumers to use tax-advantage health accounts to purchase supplements; and the Dietary Supplement Uniformity Act<\/a> introduced by Rep. Nick Langworthy (R-NY), which would clarify FDA\u2019s authority to preempt certain conflicting state supplement requirements.<\/p>\n

Much of the conversation about lawmaking focused on the bills passed at the state level that restrict minor\u2019s access to products marketed for weight loss or muscle building, creating unnecessary barriers to purchase and a challenging patchwork of regulations.<\/p>\n

Added requirements in those states now apply to how retailers verify age, how online orders are delivered and what penalties apply, and similar proposals have spread to more than a dozen state legislatures where they sit at different and often pending stages. <\/p>\n

Regarding the states that have enacted restrictions, DiMaggio hopes the laws can be amended to avoid forcing lawful adult purchasers to be home to present identification for Amazon deliveries or forcing retailers to keep products behind glass cases. He noted that these requirements affect big-box retailers that have invested heavily in their wellness aisles.<\/p>\n

\u201cOnce they start taking product and putting it behind glass or making it more difficult for a minor to reach because they want to make sure that they\u2019re having the appropriate oversight to comply with the law, they\u2019re now meaningfully impacting sales,\u201d he said. \u201cThe data shows the consumer does not purchase or is less likely to purchase the product that\u2019s behind glass than they are to grab the product that\u2019s on the shelf.\u201d<\/p>\n

Lopez, drawing on his previous experience as general counsel at supplement retailer The Vitamin Shoppe, said vague definitions of what the laws covered create difficult product-by-product judgments. Complicating matters further, even if a product is not generally marketed for weight loss or muscle building, a single social media post connecting it to either category could potentially affect how it is classified.<\/p>\n

\u201cI think these are challenging laws that are misguided to say the least,\u201d he added. \u201cI agree that there are concerns about eating disorders and how they affect young people for sure, but I think it\u2019s a little cynical to put the blame on dietary supplements and use our industry as a scapegoat.\u201d<\/p>\n

Burdick-Bell noted that California presents broader exposure because the law covers protein products and can be enforced by several layers of public authorities. She also warned that retailers may shift the burden to brands by demanding product lists and indemnification, urging industry to work proactively with state regulators on implementing rules that provide clearer definitions and workable compliance standards. <\/p>\n

Blind spots: Claims litigation, influencer scale and fly-by-nights <\/p>\n

As the supplement industry evolves so does the litigation against it from an increasingly aggressive and sophisticated plaintiff\u2019s bar pursuing a broader range of legal theories.<\/p>\n

DiMaggio highlighted disputes over whether particular ingredients and flavors can be described as natural, such as when citric acid is used rather than lemon juice but noted that the plaintiff\u2019s attorney does not always fully understand the burden of proof before bringing a case.<\/p>\n

\u201cThese are attempts at interpretation of statutes that have enough ambiguity that you can argue either way that are creating massive litigation, so we have taken a position that we are going to defend them, and we are not going to just settle them and move on because there needs to be an end to these fraudulent claims,\u201d DiMaggio said, adding that these plaintiff\u2019s bar cases are not actually preventing any harm. <\/p>\n

Plaintiffs are also using National Advertising Division decisions as a basis for state false advertising actions, however an unfavorable NAD decision is not by itself proof that an advertising claim is false or misleading under state consumer-protection laws.<\/p>\n

NAD proceedings assess whether advertising is adequately substantiated, Lopez explained, but plaintiffs may try to recast an unfavorable decision as proof that a claim is false or misleading. Because plaintiffs do not have standing to challenge substantiation, these types of cases have historically been dismissed.<\/p>\n

\u201cIt\u2019s becoming a little more difficult I think because plaintiffs\u2019 lawyers are sophisticated, and they understand how to articulate their allegations in a way that attempts to sidestep that issue,\u201d he said. \u201cBut I think it\u2019s also become challenging because the NAD itself in a string of recent decisions, including one against my company, has gone beyond the legal standard of what is an allowable structure function claim and what type of evidence is required to substantiate that.\u201d<\/p>\n

Burdick-Bell also expressed concern over the recent NAD decision involving Niagen, noting that plaintiffs increasingly seek to create factual disputes that are expensive to resolve and difficult to dismiss early. She further raised concerns about the increasingly close relationships between self-regulatory bodies and state attorneys general.<\/p>\n

Other growing areas of exposure identified included influencer marketing, particularly as companies work with hundreds or thousands of micro-influencers across multiple platforms. This, Lopez suggested requires clear written guidance is essential but that companies must also audit posts to ensure that relationships are disclosed and product messaging remains compliant.<\/p>\n

Social-first supplement brands also continue to cloud the industry with their ability to harness algorithms to reach large audiences without the compliance screening often imposed by major retailers or marketplaces. That low barrier to entry can allow products with unlawful ingredients or unsubstantiated claims to scale before regulators intervene.<\/p>\n

In the face of numerous and growing pressures, Burdick-Bell suggested that corporate leaders strengthen their own systems for monitoring and influencing state legislative and regulatory activity rather than relying solely on trade associations, whose resources may be insufficient to fully track developments across the country.<\/p>\n

\u201cI think that leadership at companies really needs to be thinking ahead, which is how do I address this legislation? How do I monitor it? How do I influence it and take a much more proactive role so that the FDA knows who we are?\u201d she said. \u201cHow do we make sure that every state knows what the dietary supplement industry is and the benefits? And how do we educate so that we\u2019re proactive and we\u2019re not an easy target?\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Speaking during a recent Business Leaders Forum hosted by NutraIngredients+, Christine Burdick-Bell, executive vice president and chief legal…\n","protected":false},"author":2,"featured_media":956993,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[49,48,84,395],"class_list":["post-956992","post","type-post","status-publish","format-standard","has-post-thumbnail","category-nutrition","tag-ca","tag-canada","tag-health","tag-nutrition"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/956992","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=956992"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/956992\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/956993"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=956992"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=956992"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=956992"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}