Claims, Evidence & Scientific Credibility / Service
Evidence-to-claim mapping, claim-risk assessment, competitive claims review, substantiation files, and consumer-facing language options — built to hold up under regulatory, retailer, and investor scrutiny.
The Work
There is almost always a gap between what the science actually supports and what marketing, sales, or leadership want to say. That gap is where the risk lives. A claim that overreaches the evidence invites FDA warning letters, FTC enforcement, NAD challenges, and class-action exposure. A claim that underreaches the evidence leaves business value on the table and weakens competitive positioning. The work is not to pick a side — it is to make the trade-off visible, defensible, and decision-ready.
RGM works the evidence-to-claim bridge in both directions. Starting from claims, the question is “is this defensible, and against what?” — tested against FTC substantiation expectations for consumer health, the FDA structure/function versus disease claims line, DSHEA boundaries for dietary supplements, and the increasingly active claim-review processes run by major retailers (Amazon, club channels, large grocery, and specialty health). Starting from evidence, the question is “what can this credibly support?” — including the language options that go beyond the literal study endpoint without crossing into territory the evidence cannot defend. The output is grounded in decades of operating experience leading regulatory, scientific, and claims strategy across OTC, supplements, women's health, and consumer healthcare.
Brands preparing a launch, reformulating, repositioning, or responding to a warning letter, demand letter, retailer claim review, or competitive challenge. Investors doing diligence on a brand whose claims drive revenue.
A substantiation file, a claim-risk matrix, a set of approved/conditional/declined claim options with the rationale for each, or a defensible response to a retailer or regulator review.
More in This Pillar
