With over 30 years of personal experience in the dietary supplement and nutraceutical industries, Inna Consulting provides the expertise needed to ensure regulatory clarity, product integrity, and compliant marketing.
Navigating FDA and FTC requirements can be complex. The resources below provide foundational regulatory guidance for manufacturers, marketers, and brand owners operating in the U.S. market. These official sources help clarify labeling requirements, structure/function claims, ingredient considerations, and advertising standards.
While regulatory documents establish the framework, applying them correctly requires careful interpretation within the context of your specific product, formulation, and claims strategy.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) establishes the regulatory framework for dietary supplements in the United States. It defines dietary supplements, outlines labeling requirements, and clarifies the responsibilities of manufacturers and distributors.
Dietary Supplement Health and Education Act (DSHEA) – Statutory Text
Source: U.S. Congress (Statutes at Large)
https://www.congress.gov/103/statute/STATUTE-108/STATUTE-108-Pg4325.pdf
The Federal Trade Commission (FTC) provides guidance on advertising and marketing claims for health-related products, including dietary supplements. This resource outlines standards for claim substantiation and truth-in-advertising principles.
Federal Trade Commission (FTC):
https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
The FDA provides updates and safety information on specific dietary supplement ingredients and other substances. This resource is helpful when evaluating ingredient status, safety considerations, and regulatory positioning.
U.S. Food & Drug Administration (FDA):
https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances
This section defines the requirements for structure/function statements, including notification, disclaimer language, and permissible terminology for dietary supplement claims.
Source: Electronic Code of Federal Regulations (eCFR)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-F/section-101.93
Regulatory guidance documents provide the framework — but applying them correctly to a specific product, label, claim, or formulation requires experience and scientific interpretation.
Inna Consulting helps dietary supplement and nutraceutical brands:
By combining scientific evaluation with regulatory expertise, we help brands move from regulatory information to practical, compliant implementation.
If you have questions about how these regulations apply to your products, we welcome the opportunity to support your next steps.
Inna Consulting is not affiliated with the agencies or external sources listed above. These links are provided for informational purposes only. We do not endorse or maintain commercial relationships with the referenced organizations.