Substantiation is the foundation
The workshop opened with a critical reminder of the baseline requirement for all dietary supplement claims: “competent and reliable scientific evidence” (CARSE). While randomized, double-blind, placebo-controlled human clinical trials remain the headline standard, the industry must account for the totality of the evidence. This means companies cannot simply cherry-pick a single positive study, sample, or result while ignoring ten contradictory ones.
Furthermore, substantiation and claims must be aligned. Factors such as dosage, formulation, and study population need to reflect the actual product being marketed. For instance, if a study was conducted on a specific demographic subpopulation or used a narrowly specified, unusual botanical extract, using it to support a broad dietary supplement claim for a different population or ingredient carries significant regulatory and litigation risk.
Emerging enforcement and litigation trends
While the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) remain the primary regulatory authorities, the dietary supplement industry is often a playground for increasingly technical and detail-oriented private litigators.
- The rise of the "establishment" claim: Claims like "clinically proven" or even "tested" are high-priority targets. These are arguably easier for plaintiffs to challenge because they need to prove only that the claim isn't "proven" or subject to direct scientific testing, rather than proving the product does not provide the claimed benefit.
- Targeted substance litigation: We continue to see cut-and-paste putative class action complaints focused on ingredients like citric acid and malic acid that can play multiple roles. Plaintiffs commonly argue these are "artificial flavors" or "preservatives," even if they are not used for those purposes, in attacking "natural" or "preservative-free" claims.
- The "price premium" theory: New litigation theories focus on consumer understanding of capsule counts. For example, if a bottle touts "300mg," but a consumer must take two gummies to obtain that dose, courts are increasingly siding with the view that consumers are not obligated to check a secondary panel to verify the per-serving amount.
- Autorenewal and pricing hazards: Beyond label claims, California and New York are targeting "affirmative consent" for autorenewal programs. Additionally, "strike-through" pricing is under fire; in California, a "former price" must have been the prevailing price within the last 90 days to be considered legal.
Competitive and Proposition 65 actions
The workshop also noted a steady volume of health-claim challenges before the National Advertising Division (NAD) and an increase in Lanham Act litigation between competitors. At the state level, California’s Proposition 65 remains a dominant force, with heavy metals continuing to trigger the majority of actions against dietary supplement industry members. Companies are cautioned against overreliance on the "naturally occurring" exemption, which too often creates a false sense of security.
Looking forward
As we look toward the next AHPA Botanical Congress in Portland, OR, this September, AHPA remains committed to providing the tools necessary for our members to navigate these complexities. Whether it is managing micro-contamination risks or ensuring that responsible AI-assisted product research accurately reflects the evidence, the message is clear: how you handle the "small things" in substantiation will ultimately define your professional branding, your credibility, and your bottom line.
