Global Compliance Expertise for Dietary Supplements, Food, and Beverages
At Starya Labs, we offer comprehensive regulatory consulting services designed to ensure your products meet the highest standards of safety, quality, and compliance in key global markets. Whether you’re navigating the U.S., Canadian, European, Australian, or Indian regulatory landscapes, we provide expert guidance tailored to your needs.
USA Compliance (FDA, USDA, FTC)
- FDA Compliance: Guidance on Current Good Manufacturing Practices (cGMP) under 21 CFR Part 111, Food Safety Modernization Act (FSMA) implementation, and adherence to Hazard Analysis Critical Control Points (HACCP) for dietary supplements and food.
- USDA Support: Assistance with the FSIS regulations for meat, poultry, and egg products.
- FTC Compliance: Ensuring that all product claims (including health and structure/function claims) comply with Federal Trade Commission standards to prevent misleading advertising.
Canada (Health Canada & Natural Health Products Directorate)
- Health Canada Regulatory Support: Ensuring your products meet Natural Health Product (NHP) regulations and are listed under the Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).
- Food Labeling: Ensuring full compliance with Canada’s Food and Drug Regulations, including ingredient declarations, allergens, and nutritional facts.
- FSMP & cGMP: Navigating regulations for Food for Special Medical Purposes (FSMP) and ensuring cGMP compliance for supplements and food products.
European Union (EFSA & EC)
- EFSA Approvals: Providing support for compliance with European Food Safety Authority (EFSA) regulations for health claims and novel foods.
- EU Food Labeling: Guidance on EU Regulation (EU) No 1169/2011 for food information, including allergens, nutritional content, and claims.
- Novel Foods & Food Additives: Assisting with applications for Novel Food Authorization and compliance with Regulation (EC) No 258/97 for new food ingredients.
Australia (Therapeutic Goods Administration - TGA)
- TGA Compliance: Helping you navigate the Therapeutic Goods Administration (TGA) regulations, including the classification of products as Listed Medicines (AUST L), Registered Medicines (AUST R), or Assessed Listed Medicines (AUST L(A)).
- Australian GMP: Ensuring your manufacturing processes meet Australian GMP standards, which are essential for all therapeutic and dietary products.
- Advertising & Labeling: Assisting with compliance to ensure all advertising materials and product labels meet TGA standards, preventing misleading claims.
India (FSSAI)
- FSSAI Compliance: Assisting with the Food Safety and Standards Authority of India (FSSAI) regulations for dietary supplements and food products, including Food Safety Management System (FSMS) certification and adherence to FSSAI Guidelines for claims and labeling.
- Food and Supplement Testing: Ensuring compliance with FSSAI standards for nutritional labeling, safety, and quality testing.
Global Testing & Certification
- In Vitro Digestion Models: Utilizing simulated gastric and intestinal models for humans, pets, and animals to assess bioavailability, efficacy, and safety.
- GRAS & NDI Notifications (USA): Preparation and submission of Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) notifications to the FDA.
- Amazon Compliance: Ensuring your dietary supplement products meet Amazon’s Dietary Supplement Compliance requirements, including:
- COA (Certificate of Analysis) submission to verify product quality and safety.
- Heavy Metal Screening: Ensuring products are tested for contaminants like lead, arsenic, cadmium, and mercury.
- Microbiological Testing: Meeting Amazon’s standards for the testing of pathogens such as Salmonella and E. coli.
- Good Manufacturing Practices (GMP) compliance to ensure that all dietary supplements listed meet Amazon’s stringent safety and quality standards.
- Product Reviews and Documentation: Assisting with ensuring your dietary supplements have proper documentation to avoid compliance issues or listing suspensions.
Labeling & Claims Support
- Global Labeling Compliance: Expert support to ensure your product labels are compliant with FDA, EFSA, FSSAI, Health Canada, TGA, and EU regulations. This includes nutrition labeling, ingredient declarations, allergens, and health claims.
- Health Claims & Structure/Function Claims: We help substantiate and navigate the approval process for health claims, including claims for disease prevention and structure/function claims.
- Allergen and Ingredient Compliance: Guidance on labeling allergens (e.g., gluten, soy, dairy) and other regulated ingredients to meet international food safety standards.
Amazon Dietary Supplement Compliance
As of April 2, 2024, Amazon mandates that dietary supplement products be verified through a third-party Testing, Inspection, and Certification (TIC) organization. This includes:
- Annual Verification: Products must undergo annual testing to ensure compliance with Amazon’s safety standards.
- Certificate of Analysis (COA): Submission of COAs confirming the amount per unit or per serving of each dietary ingredient claimed.
- Contaminant Testing: Screening for heavy metals, microbial contaminants, pesticides, and THC (if applicable), following standards like NSF/ANSI 173-2024 and USP <2021>, <2022>, <62>, <561>.
We assist clients in navigating these requirements, coordinating with approved TIC organizations, and ensuring all documentation meets Amazon’s criteria.
Label Compliance & Regulatory Support
- Nutrition Labeling: Assistance in developing accurate Nutrition Facts panels in accordance with FDA and international guidelines.
- Health Claims Verification: Scientific substantiation of health and nutrition claims to support marketing and regulatory approval.
Let Starya Labs Guide You Through Global Compliance
At Starya Labs, we're more than just a lab — we're your scientific partner.
Whether you’re launching a new product or expanding into new markets, Starya Labs provides the regulatory expertise needed to ensure your product is compliant with the relevant guidelines in the USA, Canada, EU, Australia, India, and Amazon’s requirements. Our team of experts helps you navigate complex regulatory environments and ensures that your products are market-ready.
Ready to get started?
Contact Us today to discuss how we can assist with your global regulatory needs and ensure your products meet the highest standards of safety and compliance.
