Under the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act, regulatory oversight of dietary supplements extends well beyond the physical bottle label. Both FDA and FTC evaluate websites, landing pages, email flows, paid social ads, and creator/influencer endorsements. Statements that imply a product diagnoses, treats, cures, or prevents a disease—such as "relieves clinical anxiety" or "treats chronic joint inflammation"—are regulated as unapproved drug claims under 21 CFR § 101.93(g), while efficacy claims lacking competent and reliable scientific evidence face scrutiny under the FTC Health Products Compliance Guidance.
The practical goal of a marketing compliance review is to align your copy with what the law and your scientific evidence actually support—without stripping away clarity for the consumer. At Blue Ocean Regulatory, we review and revise website copy, product detail pages (PDPs), ad scripts, and email funnels by:
- Separating Disease Claims from Structure/Function Claims: Replacing prohibited disease treatment phrasing with compliant structure/function descriptions supported by the formula's ingredients and doses under 21 CFR § 101.93.
- Evaluating Claim Substantiation: Checking whether performance promises, timeframes, or "clinically studied" statements match the underlying human study design, dose, and population per FTC guidance.
- Auditing Testimonials, Reviews & Influencer Copy: Under the FTC Endorsement Guides (16 CFR Part 255), a brand cannot make a disease or unsubstantiated efficacy claim through a customer review or creator script that it could not legally make directly.
Because FDA, customs inspectors, and marketplace algorithms routinely check a brand's website URL printed on the product label, keeping your website and social ad funnels aligned with federal structure/function rules protects both your online ad accounts and your physical inventory.