Spark Pharma Regulatory Consultant provides a concise and streamlined food supplement regulatory service; to help companies successfully market their products without getting held back interpreting complex legislation. Food supplements also known as nutritional supplements, Nutraceuticals or dietary supplements covers many aspects of European and national law such as: Food Safety Regulations, Food Supplement laws, Enzyme, Food additives & Flavoring rules, Nutrition and Health claims, Novel Foods legislation and Import guidelines.
From single in-depth product evaluations, simplified regulatory guidelines to streamlined analysis of whole product lines, we tailor each project to suit the client’s needs
Spark Pharma Regulatory Consultant advise whether your products are classed as a food supplement and provide advice on adjustments in order to comply. We inform companies of the exact status of ‘grey area’ ingredients such as amino acids, botanicals, essential nutrients and enzymes. We also advise whether the product in fact a Medicine, a Traditional Herbal Product or a Medical Device.
Nutrition and Health Claims
We analyze nutrition and health claims and the Scientific Opinions of the Food Standards Agency to advise how to legally market products and build your strategy.
Our services also include the following:
Product Approval (Health Supplement & Proprietary Food)
Health claim dossier
Central License, State License & State Registration
Labelling and Copy Reviews
Spark Pharma Regulatory Consultant assess food supplement product labels and packaging copy to provide simple edited instruction documents for compliance with food supplement labelling legislation.
Advertising and Marketing Reviews
Spark Pharma Regulatory Consultant appraises natural product websites and advertising literature to make sure it complies with Advertising Standards Authority.
Novel Food Applications
A novel food is defined as a food that does not have a significant history of consumption. Such foods require a pre-market safety assessment in the form of a Novel Food application or a simplified procedure for ‘substantial equivalence’ foods.
Spark Pharma Regulatory Consultant compiles novel food applications dossiers; covering history of use, intended purpose, nutritional value, composition, toxicological and nutritional data.