Across various jurisdictions, nutraceutical supplements, health supplements, and functional foods are subject to regulations, primarily designed to ensure public safety. These regulations play a vital role in guaranteeing that:
- Ingredients used in nutraceutical supplements are safe, with minimal contamination and free from harmful chemicals.
- Packaging, shipment, and storage conditions of ingredients prevent adulteration.
- The manufacturing process maintains the integrity of the supplements, and ingredients are proportioned correctly.
- Blending of ingredients is uniform, avoiding any deviation from intended formulations.
- Final products are not adulterated during packaging, storage, or shipment.
“Adulterated” refers to alterations beyond acceptable levels according to quality control standards.
At the Nutraceutical Alliance, we’re committed to ensuring your products meet regulatory requirements. We can assist you with:
- Crafting scientific dossiers for each supplement, summarizing evidence-based research for functionality and safety.
- Handling submissions of scientific dossiers and applications for ingredient or product registration.
- Reviewing and crafting label claims for regulatory compliance across markets.
For Regulatory Compliance, we can develop:
- Quality control manuals with procedures ensuring ingredient sourcing, manufacturing, packaging, and distribution meet standards.
- Periodic oversight of manufacturing processes before regulatory inspections, to ensure compliance.
Navigating Regulations in Different Regions
United States: In the US, the Food and Drug Administration (FDA) oversees human and animal nutraceutical supplements. The FDA conducts inspections to ensure safety and enforces regulations. Animal food regulations are overseen by the Center for Veterinary Medicine (CVM) and enforced by the American Association of Feed Control Officials (AAFCO).
Canada: Health Canada oversees human and animal food safety, enforced by the Canadian Food Inspection Agency (CFIA). Nutraceutical ingredients can be included in pet foods without registration. Animal feed supplements are categorized into nutrient-based and veterinary health-based products, notifying under the Veterinary Health Products program.
Europe: The European Food Safety Authority (EFSA) manages human and animal food safety regulations in the EU. EFSA reviews and adds approved ingredients to the safe database.
Australia: The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates animal nutraceutical ingredients and supplements.