DIETARY SUPPLEMENTS and NATURAL HEALTH PRODUCTS (NHPs)
US and EU
Natural products sold in these jurisdictions must meet the criterial set by the governmental regulator (e.g. FDA in US) but do not require approval before marketing.
US: The FDA (Food and Drug Administration) regulates dietary supplements through manufacturer responsibility. Companies must follow the GMP (Good Manufacturing Practices) guidelines and are responsible for ensuring their products are safe and the claims made about them are truthful and substantiated. Manufacturers must notify new ingredients to the FDA via NDI (New Dietary Ingredient) applications. Products must be labeled with a “Supplemental Facts“ panel, a list of ingredients and a disclaimer indicating that the product is not intended to diagnose, cure, treat or prevent any disease.
EU: Dietary supplements are regulated as food products. There is not a single approval system. Instead, manufacturers must assure their products meet EU-wide regulations and national requirements for each member state which usually involves a notification process after meeting the safety and labeling criteria. Supplements must contain only authorized vitamins, minerals, and other ingredients. Use of certain ingredients may be subject to specific conditions and restrictions. Novel foods fall under the EU Novel Food Regulation and require separate authorization. Products labelling must comply with strict rules and include a list of all ingredients, instructions of use and recommended daily dosage, storage conditions, and other important information. Only health claims that have been scientifically verified and authorized by the European Commission can be used on product labels.
CANADA
Natural Health Products (NHPs) are defined by Canada Health as naturally occurring substances that are used to restore or maintain good health. They come in a variety of forms (tablest, capsules, creams, etc.) and they are often made of plants but also animals, microorganisms, and marine sources. Examples include: vitamins and minerals, herbal remedies, homeopathic and traditional medicines, probiotics, essential amino acids, and more.
To legally sell a NHP in Canada, a company needs both:
a Natural Product Number (NPN) - a product license, assigned to the product itself after approved by Health Canada for safety, efficacy, and quality. The license verifies that the NHP’s ingredients, dosage and recommended use are acceptable for sale to Canadians.
a Site License (SL) - issued to the Canadian facility or business (manufacturer, packager, labeler or importer) responsible for the activities related to the NHP. The license demonstrates that the activities are conducted in compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
These are separate but interdependent requirements:
a NHP cannot be sold in Canada without an NPN,
a site cannot perform activities of manufacturing, importing, packaging, or labeling of a NHP for sale in Canada without a site license.
a NHP cannot be imported into Canada without an NPN (it is subject to border enforcement by the Canada Border Services Agency (CBSA) who can detain, destroy or ship back a non-compliant product).
applications for NPN and SL licenses are submitted independently to Canada Health authority, in the same time or at different times, as the applicant companies consider best.
How can we help?
AlephAstra LLC provides solutions to a range of compliance requirements including:
Company registration
Health claims substantiation
Registration for NPN licenses
Natural Health Product Site (NHP) licensing
Submission of new ingredients
Technical review and compliance with NHP labeling requirements
New Dietary Ingredient Notification (NDIN)
