Health Canada

Natural Health Products Regulation

Presented by Paula Brock, Ph.D., MCSI

December 4, 2025 | 1 PM Eastern

Canada regulates Natural Health Products (NHPs) as a subset of drugs, very different from the U.S. dietary supplement model. In this fast-paced, practical session, EAS senior consultant Paula Brock, Ph.D., MCSI demystifies Health Canada’s framework so you can plan confident market entry, label accurately, and substantiate claims that will pass review.

Drawing on real regulatory practice, Paula walks through how NHPs are defined and classified; how monographs work; what evidence is required for claims; and how to secure a Natural Product Number (NPN). You’ll leave with a clear checklist of what Health Canada expects, and what can slow you down.

What we’ll cover

• Regulatory landscape & authority: Health Products and Food Branch (HPFB) and the Natural and Non-prescription Health Products Directorate (NNHPD); how NHPs differ from U.S. dietary supplements.

• NHP scope & ingredients: Schedule 1 categories (e.g., botanicals, vitamins/minerals, amino/essential fatty acids, probiotics) and notable exclusions.

• Monographs 101: Single-ingredient and category monographs; how to leverage them for faster approvals and compliant claims.

• Product licensing & NPN: Class I–III pathways, evidence expectations, typical review timelines, and the Licensed Natural Health Products Database.

• Claims & advertising: Risk-based claim types (general health through higher-risk therapeutic claims), acceptable evidence, and qualifying statements.

• Clinical trials (when needed): When monographs/evidence aren’t enough, CTA basics and GCP expectations.

• Labeling essentials: Principal Display Panel (PDP), inner vs. outer label requirements, bilingual elements, allergens, warnings, and lot/expiry.

• Pharmacovigilance basics: Recordkeeping and reporting of serious/unexpected adverse reactions.

Who should attend

Regulatory affairs, quality/compliance, R&D/formulation, and marketing/labeling teams at companies marketing (or planning to market) NHPs in Canada—plus U.S. dietary supplement firms evaluating Canadian expansion.

You’ll take away

• A step-by-step view of the NPN licensing process and how to position your product (Class I–III).

• A practical map from formula and claims to the right monographs and evidence.

• A labeling and claims checklist you can put to work immediately.

About the Presenter

Paula Brock, Ph.D., MCSI

EAS Consulting Group Independent Consultant

Works directly with EAS’ Senior Director, Labeling, Cannabis and Claims Consulting Services to assure client satisfaction and project management. She collaborates with EAS consultants and clients to provide excellence in service. Dr. Brock facilitates food, dietary supplement, and cosmetic label compliance reviews, develops marketing materials for FDA and FTC compliance, including claims substantiation. She provides scientific services such as clinical study design, data analysis, herb-drug interaction studies, product formulation, safety and efficacy of ingredients, ingredient monograph writing, safety opinions, adverse event investigations, and develops claims and slides for marketing purposes. She serves as GRAS and NDI expert panelist.

Dr. Brock has 22 years of experience in pharmacology and toxicology. Her first 13 years in academia she specialized in clinical and preclinical research, neuroscience, analytical and clinical pharmacology, molecular biology, and personalized medicine. Her last 9 years in industry she added US and international regulations on dietary supplements, cosmetics, drug-herb interaction, adverse event investigations, safety and efficacy claims substantiation, product formulation, and public speaking. Dr. Brock has held Senior Director positions in Scientific and Regulatory Affairs with the U.S. dietary supplement/cosmetic industry. Dr. Brock’s Ph.D. is in Pharmacology and Toxicology from the University of Utah, Master of Science in Clinical Investigation from Howard Hughes Medical Institute, and bachelor’s in chemistry and pharmacy.