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In manufacturing industries, there are few things as important as staying compliant with ISO standards and FDA regulations.  Notably, the food industry is strictly monitored, and that includes the nutraceutical industry.

The regulation of the manufacturing and use of nutraceuticals varies around the world, but in the U.S. it’s regulated by the FDA.  As such, manufacturers of nutraceuticals need to stay compliant with its regulations at all times. There are a few critical regulations that must not be disregarded to ensure the safety and compliance in the industry.

Responsibility Is on the Manufacturers

Staying compliant with quality control guidance for any nutritional supplement is the responsibility of the manufacturer, according to the FDA Rule 21 CFR Part 111. Current Good Manufacturing Practices (CGMPs) states that suppliers and manufacturers are expected to monitor, record and improve their process continuously. In addition to that, you also have to demonstrate your environmental compliance with the GMPs by performing validation studies of the areas that they use for storing and processing products.

.Important Regulations for Nutraceuticals

For nutraceuticals manufacturers and distributors to keep up with FDA’s compliance standards, they need a system for managing and processing data. Implementing corrective and preventive action procedures (CAPA) is one of the necessary regulations to meet, but there is more of them:

  • Implementing Current Good Manufacturing Practice — following the Dietary Supplement Health and Education Act of 1994 to make sure Current Good Manufacturing Practices are being met;

  • Careful classification — as dietary supplements, nutraceuticals have to be strictly controlled when it comes to their classification used in marketing;

  • Recording and traceability — it’s imperative for FDA-regulated manufacturers to keep accurate and precise records for all their systems and processes, and trace supplement products down to the lot number;

  • Labeling and notifications — labeling rules and regulations are stringent for dietary supplement products. Besides, nutraceutical providers need to submit data that confirms the ingredients used in the product are safe for human consumption.

Meeting all these regulations ensures that business for manufacturers of nutraceuticals and distributors will be going smoothly compliance-wise.


How An Automated Quality Management Solution Will Enable Nutraceuticals Manufacturers and Distributors

A quality management system solution is imperative in order to effectively comply with FDA regulations. Workflow automation along with different applications to fit your quality assurance needs  is becoming a necessity in order to remain efficient and compliant, and critical to facilitate increased productivity and employee efficiency.  Quality applications developed specifically for nutraceutical companies include:

Label Management

Track any label change with ease.  Capture, track and manage labeling data and documentation for your product, including properties, ingredients, compliance data, and related file.  Once a change is made, Intellect's automated workflow will trigger an update for any related document.  Maypro, an Intellect Customer, utilized Intellect's Smart Quality Automation solution to become and remain compliant.

Track and Trace

If you are in the business of manufacturing or distributing dietary supplements or nutraceuticals, then you need to be able to track and trace all ingredients in your products.  Track the life cycle of products and lots that include Bill of Materials (BOM) information, including raw materials being used, test results, certifications, regulatory compliance, and product specification performance.  Integrate with other quality apps and automate the visibility of internal and external compliance, automatically update interdependent information based on a single modification (e.g., raw materials supplier changes).  


Request A Demo today and see how Intellect's eQMS solution can revolutionize your quality and compliance processes within the Nutraceutical industry. 

Peter Hargittay

Written by Peter Hargittay

Peter Hargittay is the Chief Marketing Officer (CMO) and VP of Corporate Development at Intellect. Peter is responsible for rebranding the company as Intellect from Interneer and for positioning the company for significant growth. Peter joined Intellect in 2013, and is responsible for corporate, product, and online marketing, business development through the Intellect partner channel, demand generation, sales enablement, and go-to-market strategies. Peter has more than 15 years of experience in building successful software and services businesses. Prior to Intellect, Peter served as the VP of Marketing and Sales Operations at Arise Virtual Solutions, and previously held executive marketing roles at Aegis, PeopleSupport, Intersil, and FileNet. Peter received both his BA in Economics and MBA from California State University, Fullerton.