All Posts

Here’s a List of Must-Follow Regulations for Nutraceuticals

01 Aug 2023

The quality and compliance standards are continuously getting stringent for every industry including nutraceuticals. They are not as regulated as the drugs are. They rather fall under different food categories. However, you may find different legal definitions for the nutraceuticals based on the variable state laws. For example, you can refer to the FSSAI regulations for nutraceuticals pdf for the products manufactured in India and USFDA defined the U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements.

What are Nutraceuticals?

Nutraceuticals are the enriched food products that not only serve the purpose of diet supplements but also offer medical benefits such as assisting in the treatment and preventing from the disease.

Nutraceuticals are the combination of Nutrition and Pharmaceutical, but they are not tested to the extent of pharmaceuticals. In fact, the regulatory requirements for the manufacturing of nutraceuticals are different. They are also referred to as dietary supplements and used up to 50-70% in the developing countries.

The significance of the nutraceuticals has expanded now in terms of health betterment and lowered the number of diseases as well as costs of healthcare.

Components of USFDA Guidance Document for Nutraceuticals

The guidance document released by the FDA for nutraceuticals contains the following components:

  • Current Good Manufacturing Practice (CGMP)

The CGMP guidelines for the nutraceuticals are defined for all the areas of the production. CGMP includes the sanitation standards that a company needs to follow in its processing and storage locations while guiding it the process of implementation for the process and production control systems to maintain a consistent flow of quality for every batch.

  • Warning Letters & Safety Alerts

Similarly, like CGMP guidelines, there are certain warning letters and safety alerts that shall be specified by the manufacturers. They also need to provide all the information that backs up the safety component of the product for human consumption. The FDA requires all such information at the time of reviewing the findings to ensure they are consistently maintained and make an informed decision on approval of the product to be further distributed in the market and being sold.

  • Labeling and Regulation

Providing correct information on product labeling is one of the critical requirements defined under regulations for the nutraceuticals. The manufacturers need to continuously demonstrate compliance for the FDA requirements. Nutraceuticals aka dietary supplements are intended to serve health benefits to buyers, and this must be reflected through package labeling. The labeling information should also include the claims that if the supplement’s dosage is taken in a higher amount than what is prescribed, it may induce risks.

The FDA strictly recommends the labeling and regulation for information to make consumers aware of the safe consumption limits for the particular dietary supplements they take. Hence, nutraceutical manufacturers need to follow the guidelines of labeling for consumer’s health as well as their regulatory benefits.

  • Correspondence, Statements, and Agreements Related to Policy

This FDA regulation for the nutraceuticals implies that nutraceuticals manufacturers must upgrade the relevant information about the products, safety consumptions, and much more as soon as new statements or agreements issued by the regulatory. It involves informing consumers about the new ingredients being introduced, new policies to state the nutritional facts that make dietary supplements different from the other beverages, and their improved health significance.

  • Health Claims

With the consumers getting more aware of what they eat in the name of natural health foods and functional foods, it has become important for companies to do bountiful of research to develop the improved quality food products. Most of research results into new findings and health claims that should be included in labeling to communicate all the critical information to the consumers. This makes them even more aware of the nutraceutical products they are investing in.

  • Qualified Health Claims

Qualified health claims are the ones that are backed by some scientific evidence, but do not necessarily meet the standard requirements that one needs for an authorized health claim. Nutraceuticals manufacturers must ensure that these claims are not misleading by providing their information through disclaimer or any other valid communicating label. This also ensures that consumers understand the scientific evidence required for qualified health claims.

  • Adverse Events Reporting

The manufacturers who adhere to all the compliance requirements specified by FDA must follow a practice of creating and maintaining the records of all systems, processes, and events including the ones that may adversely affect them to meet compliance. A well-defined record-tracking and reporting system help nutraceutical manufacturers to demonstrate that they have an established set of processes and procedures to manage the adverse events tactfully.

  • General Compliance and Inspection Information for Industry

The general compliance and inspection information is required to ensure that a consistent approach is implemented for maintaining the environmental regulatory framework. This is intended for the entire nutraceutical industry to demonstrate the regulated processes that every company needs to follow so that they market only the safe health and dietary supplements to the consumers.

  • Codex Activities

Codex standards and guidelines are formulated by the committees that apply to all the countries listed as members. The main purpose of defining CODEX activities is to protect consumer’s health and ensure good practices in international trade with the development of food standards. However, CODEX standards are voluntary. All the countries listed as members are not strictly required to adopt them.

This post was quite a brief on regulatory aspects of nutraceuticals. You can find out more details on the other resources available in ppt and pdf formats. Make sure you search specifically for the region you want to implement regulations for.

For example- if your manufacturers operate from India, you need to check for the resources like regulatory aspects of nutraceutical products in India pdf. For detailed information, you can also explore the history of food and nutraceutical regulations. This doesn’t imply that the implementation of regulated processes is easy. You need a compliant quality management software for nutraceuticals that can help you form a closed-loop system to ensure quality and compliance.

A Quick Help

Qualityze is one of the top-ranked quality management software you need to keep your processes streamlined and compliant. It is a cloud-driven solution that comes with configurable workflow, advanced features, and amazing in-build capabilities. This global capable QMS Software solution assists you in the validation and verification process too.

You must test this solution for your nutraceuticals quality requirements by requesting a free demo today and you will get 1-week free trial. This will help you make an informed decision and figure out the configurations you might need to implement Qualityze.


Every industry including nutraceuticals must follow regulated processes to deliver FDA compliant products to the market. You can ensure regulated processes with the help of a powerful eQMS like Qualityze that can capture, record, and manage all the adverse events accurately and timely.



Request Demo

© 2024 Qualityze | All rights reserved. | Privacy Policy