Nutraceuticals may be categorized based on their ingredients, intended use, and health claims. Common categories include Dietary Supplements, Functional Foods, Herbal Supplements and Botanical Products. The classification can impact the regulatory requirements they must meet.

Manufacturers of nutraceuticals are typically required to follow GMP standards to ensure product quality, consistency, and safety throughout the manufacturing process. These standards ensure that products are produced in a consistent and safe manner. GMP guidelines cover various aspects of production, including ingredient sourcing, quality control, and cleanliness.

Nutraceutical manufacturers are required to develop the product formulation, ensuring it contains permitted ingredients and adheres to the specified limits. They need to conduct safety and efficacy testing to validate the health claims made for the product, and also to conduct quality control testing to ensure that their products meet established standards for potency, purity, and quality.

The ingredients used in nutraceuticals must be carefully reviewed and approved by the regulatory authority. Regulatory authorities often require that the ingredients used in nutraceuticals be safe and have scientific support for their intended use. Some ingredients may be considered Generally Recognized as Safe (GRAS) in the U.S. or have their safety assessed through other means, while others may require more extensive safety data and testing.

Nutraceutical products must adhere to strict labeling regulations. This includes providing accurate ingredient lists, nutritional content, recommended dosages, storage instructions, nutrient information and any health claims made on the product packaging. Misleading or false health claims about a product’s health benefits can lead to regulatory action.

Regulatory authorities may require safety and efficacy data for nutraceutical products, especially if they make specific health claims. This can involve clinical trials and studies to demonstrate the product's effectiveness and safety.

Depending on the country’s jurisdiction, nutraceutical products may need to be registered or licensed before they can be legally marketed and sold. The application process can involve submitting detailed information about the product, including its composition, labeling, and safety data.

Regulatory authorities often continue to monitor nutraceutical products once they are on the market. Adverse event reporting systems may be in place to track any negative side effects or safety concerns associated with these products.

Determine the classification of your nutraceutical product based on its ingredients, intended use, and health claims. Nutraceuticals can be classified as Food Supplements, Functional Foods, and Food for Special Dietary Use or Health Supplements.

Manufacturers of nutraceutical products are required to adhere to Good Manufacturing Practices to ensure product quality, consistency, and safety throughout the manufacturing process. The FSSAI provides guidelines for GMP compliance.

Develop the product formulation, ensuring it contains permitted ingredients and adheres to the specified limits. Conduct safety and efficacy testing to validate the health claims made for the product, also conduct quality control tests to ensure that the products meet established standards for potency, purity, and quality.

Ingredients used in nutraceuticals must be safe, and their use must comply with the FSSAI regulations. The FSSAI may specify maximum allowable levels of certain ingredients.

Nutraceutical products must adhere to specific labeling requirements outlined by the FSSAI. This includes providing accurate information about the product's ingredients, nutritional content, recommended dosages, storage instructions, nutrient information and any health claims. Health claims must be supported by scientific evidence and approved by the FSSAI. Unauthorized or misleading claims are not allowed.

Prepare and submit the application for nutraceuticals licensing to the FSSAI along with the required documents including details of the product's composition, safety data, and labeling information along with the prescribed fees.