Express Pharma

A comprehensive approach to certification, quality control, and consumer trust in nutraceuticals

Nutraceuticals are a promising alternative for people seeking natural ways to enhance their overall quality of life.

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Nutraceuticals, a blend of the words “nutrition” and “pharmaceuticals”, have proven to be a significant ally in the ever-changing field of health and wellness. These functional foods and dietary supplements, derived from natural food sources, provide more than just basic nutritional benefits. The wide range of nutraceuticals includes insoluble and soluble dietary fibres, probiotics, polyunsaturated fatty acids (PUFAs), antioxidant vitamins, polyphenols as well as various spices and herbs to cater to different health needs.

Nutraceutical quality control involves a multi-step approach to the testing process as well as quality assurance methods. The suppliers perform rigorous tests of raw materials and a good number of ingredients just to find out their details like, identity, purity, and potency to be sure they don’t contain heavy metals, pesticides, or any microbial pathogens. The highly analytical and rigorous precision goes beyond just the finished product, where they make the final testing to verify the claims and meet regulatory standards. These may be performed for various reasons such as quantifying active ingredients, dissolution testing, stability tests, and microbial studies. Adding to that, the companies which are specialised in nutraceutical use a high-quality control as the main aspect of manufacturing, packaging, and distribution. The distribution of these roles includes the supervision of production processes and in-process inspections together with keeping complete documentations of manufacturing activities. Compliance with Good Manufacturing Practices (GMP) is of paramount importance because it stands for the quality assured through written documentation of the entire process, strictly defined technique, and continuous checks.

At the Global level, regulatory agencies have set up standards and guidelines for oversight of the nutraceutical market. The European Food Safety Authority offers a definition of nutraceuticals and supplements in which EFSA defines nutraceuticals as those classified as food supplements focusing on certain vitamins, minerals, and amino acids, ensuring that they are present in safe amounts. This requires adherence to Good Manufacturing Practices during production, processing, packaging, and storage for manufacturers to ensure consistent quality standards. In the United States, nutraceutical falls under dietary supplements governed by the Dietary Supplement Health and Education Act (DSHEA). This law provides specific regulations for finished supplements and dietary ingredients; however, GMP rules govern the manufacturing, processing, packing and storage of nutraceuticals to ensure product safety and quality.

In India, the Food Safety and Standards Authority of India (FSSAI) regulates the flourishing nutraceutical industry. The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016, provide thorough guidelines for manufacturers. Furthermore, proposed 2022 regulations aim to enhance safety, labelling, and quality control for health supplements and nutraceuticals, reflecting the industry’s rapid growth, projected to reach $6.1 billion by 2019-2020. To ensure compliance with FSSAI regulations, nutraceutical manufacturers in India must obtain approval for their products before marketing them. Compliance with GMP requirements is a prerequisite for quality assurance, and it is possible to strengthen the consumer’s confidence by requesting independent testing in third-party laboratories. In addition, another critical aspect of transparency is labelling with easy-to-understand information about the composition and possible effects of nutraceuticals. 

The nutraceutical industry is conducive to the quality movement, which is supported by constant research and development work. Clinical trials, studies in the field of improved bioavailability of biologically active ingredients, and new dosage forms help to make nutraceuticals more effective and safer. In addition, manufacturers are major contributors to educating customers about the advantages, hazards, and correct usage of their goods. Transparent labelling, webpages, and advertising materials empower people to act. The nutraceutical sector knows no borders, and this has led to an international realignment of norms and standards. Working together to create a consistent set of definitions for the quality, safety, and labelling of products makes purchasing goods outside their borders easier and protects individuals in markets across the globe. In addition to streamlining regulatory demands, the inquiry on this endeavour strengthens the sector’s ethical responsibility to maintain the highest quality and safety standards.

Nutraceuticals are a promising alternative for people seeking natural ways to enhance their overall quality of life. However, the industry’s success depends on the highest standards of quality assurance, safety, and effectiveness. The unwavering commitment of the sector to building trust, respect, and confidence in consumers around the world is clearly demonstrated through comprehensive certification and control activities, including stringent testing standards, robust quality control functions, regulatory adherence and post-market surveillance, ongoing research and development, consumer education and global harmonisation initiatives. Prioritising these critical aspects allows nutraceutical companies in the sector to demonstrate a strong commitment to the cause and develop as a reliable and responsible partner, which promotes holistic health and serves consumer betterment in future.

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