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What do you need to do to ensure nutraceutical industry compliance?

01 Aug 2023

In today’s market, companies that wish to remain competitive and earn consumers’ trust must ensure quality. The nutraceutical industry is no exception, where product safety is crucial to brand success.

Nutraceuticals are subject to different regulations in different countries. Food and Drug Administration (FDA) regulates the processing, manufacture, and sale of dietary supplements in the United States. Companies are prohibited from using misleading marketing and branding schemes. Furthermore, they must adhere to FDA good manufacturing practices (GMP) and test their products for safety.

Related Articles: A Brief Guide to Federal GMPs for Dietary Supplements

An FDA inspection can result from any manufacturing or labeling violations. Even the most minor mistakes can have potentially deadly consequences that can lead to product recalls and millions in lost revenue and a company’s reputation.

To ensure proper controls and an effective quality system, the three main challenges must be addressed to ensure consistent product safety and compliance.

Nutraceutical Companies: 3 Top Challenges

Supply Chain Management.

Taking care of Supplier Quality Management is one of the biggest challenges for nutraceutical companies. Due to the continuous expansion of the global supply chain, businesses source their ingredients and inputs from various vendors and suppliers. To follow good manufacturing practices, a system must be implemented to collaborate with all suppliers. It is also necessary for companies to ensure that ingredients are sourced ethically and in compliance and keep track of non-conformances.


Despite recent advances in technology, paper-based and other disconnected document and quality management systems lack the transparency required for modern business. Trending and reporting are difficult in real-time when data is kept in Excel spreadsheets and disconnected systems. Since safety in the nutraceutical industry is a top priority, monitoring quality, production, and testing data in real-time allows companies to solve problems before they occur.

Integrated processes.

It is not acceptable to complete quality processes in parts. One issue can impact another, so holistically, product and process problems should be considered. It is essential, for instance, to link customer complaints to risk management activities to conduct a re-assessment and to CAPA to complete any necessary actions. Process integration reduces compliance gaps and ensures an effective and efficient quality management system.

Regulatory aspects of nutraceuticals.

Regulatory issues surrounding nutraceuticals present a considerable challenge to the internationalization of these products, with different definitions and definitions of these products in other countries.

Nutraceutical regulation has been mainly concerned with safety and labeling instead of pharmaceutical law. Thankfully, Good Manufacturing Practice (GMP) regulations and increased enforcement have made this possible.

Consumers primarily determine the value and usefulness of nutraceuticals. However, increased regulation concerning the safety and quality of these products would benefit the industry and mitigate any adverse effects.

Regulations for nutraceuticals

Nutraceuticals are subject to a wide range of regulations around the world. Unfortunately, the regulating industry often falls into a grey area of uncertain information and expectations that are sometimes misleading, dangerous, and confusing. To make informed and safe decisions, both manufacturers and consumers should know their nation’s nutraceutical regulations.

European Regulations (EFSA)

Nutritional supplements are defined and regulated by the European Food Safety Authority (EFSA) as products that provide nourishing and physiological benefits and regular dietary intake. In addition to vitamin, mineral, and amino acid content, the strength and amount of the ingredients are essential. Any company wishing to include vitamins, minerals, or other substances not included on this list should apply to the E.C. for consideration. Likewise, vitamins, minerals, and other substances not included in the directive can be added by using the E.C.

Through the Regulation (E.C.) No 1924/2006, the European Commission has established Union rules regarding Nutrition and Health Claims. It became effective on 1 July 2007.

This regulation provides food companies with the legal framework they need when they wish to highlight the specific health and nutrition benefits of a product, either on the label or in its advertising. A nutritional claim and a health claim are subject to these rules.

According to these rules, any claims made about food on its labeling, presentation, or advertisement within the European Union must be accurate, precise, and supported by scientific evidence.

The E.U. prohibits the sale of food that includes claims that could mislead consumers.

It protects consumers, promotes innovation, and ensures free and fair competition. Furthermore, by allowing companies to submit the same claims on their products anywhere within the European Union, the rules provide free circulation of food-bearing claims.

USA Regulations (DSHEA and FDA)

Dietary supplements are regulated differently from standard food and drug products by the U.S. Food and Drug Administration (FDA). It is why DSHEA was passed in 1994 with significant public involvement, both in support and opposition. In the United States, the DSHEA defined and regulated dietary supplements. Manufacturers are prohibited from making unproven claims and must comply with specific FDA regulations.

The DSHEA describes nutraceuticals as “an ingredient intended to supplement the diet, such as vitamins; minerals; an herbal component; an amino acid; an ingredient designed for human consumption as dietary supplements; or a combination or concentration of these ingredients.”

The manufacturer’s responsibility and quality control

In the absence of benchmarks for nutraceutical regulation, supplement manufacturers must maintain a high level of quality controls to keep consumers safe, not to mention pay hefty fees and penalties. Even though country-specific regulations can differ, manufacturers must always maintain quality control and traceability. A thorough test can mitigate many risks at every step, including, but not limited to:

  1. Ingredient inspection to detect contamination from environmental factors to avoid product recalls and wastage.
  2. Process level approach to keep a check on formula measurements. Even a minor change in measures can lead to catastrophic consequences.
  3. Good manufacturing processes to be followed by everyone, ensuring a culture of quality.
  4. Testing the final products if they conform to the standard requirements.

Even though nutraceuticals are composed of natural materials, contamination risks may still exist before, during, and after manufacturing. It implies the need for a comprehensive quality management system that can help manage every aspect of quality before the product gets delivered to the customer.

However, it can be challenging to find the right quality management system.

Nothing to worry about. We’ve taken care of it for you.

You can count on Qualityze Enterprise Quality Management System for Nutraceuticals. It is built on the most powerful and secure cloud platform, i.e., Salesforce.com, to provide you benefits like flexibility, scalability, security, and performance.

If you have questions about Qualityze EQMS Suite, you can contact our customer success team. You may reach us at 1-877-207-8616 or email us at info@qualityze.com, and we will be able to assist you.



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