
FOCUSED EXPERTISE
DIETARY SUPPLEMENTS
CONFIDENCE THROUGH EXPERIENCE
At Burdock Group, we understand that the safety and compliance of your dietary supplement are critical to protecting your brand's reputation. That’s why we are dedicated to thoroughly researching the science behind your product before beginning the regulatory process for any functional ingredient.
With the rapid growth of the dietary supplement, functional food, and nutraceutical markets, ensuring your product meets safety and compliance standards is more important than ever. Without the right regulatory expertise, your brand and company’s reputation could be at risk. Let us help you navigate this complex landscape with confidence.
In the U.S., dietary supplements are a key segment of the health and wellness industry, offering a broad array of products aimed at supporting overall well-being. The regulatory framework for these products is defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which outlines how supplements are categorized, marketed, and overseen. Unlike pharmaceuticals, it is the responsibility of manufacturers to ensure their supplements are safe and accurately labeled. A solid understanding of this regulatory landscape is essential for companies looking to thrive in this competitive space.
In this webinar, ChemLinked welcomes Erik Hedrick, EVP and Director of Toxicology at Burdock Group, to unpack the complexities of dietary supplement regulation. The session will explore key topics such as regulatory agencies, product categories and definitions, labeling, claims, and requirements for new dietary ingredients. Attendees will also gain clarity on the distinctions between food additives and GRAS (Generally Recognized as Safe) determinations, along with insights into which regulatory pathways may best suit their products.
With unmatched expertise in dietary supplement safety and regulatory assessments, claim substantiation, and DSHEA compliance, Burdock Group is your trusted partner in ensuring your products meet all necessary standards. Our team helps you avoid meritless or frivolous claims that, while seemingly reasonable, could attract scrutiny from the FDA and FTC. We work with you to ground your claims in robust, scientifically validated evidence, safeguarding you from potential legal costs, loss of customer trust, and damage to your brand’s reputation.

FEASIBILITY & GAP ASSESSMENTS

CLAIMS CONSULTING & SUBSTANTIATION

RISK & RECALL ASSESSMENTS

NEW DIETARY INGREDIENT NOTIFICATIONS (NDIN)

REGULATORY ASSESSMENTS

LABEL REVIEWS

SAFETY ASSESSMENTS & OPINION LETTER

STUDY PROTOCOL DEVELOPMENT & STUDY MONITORING
