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Nutraceutical Safety Regulations (Nutravigilance)

Nutravigilance is defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food". In the US, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of regulations as compared to those that cover “conventional” food and drug products.

Safety Regulations

According to the Dietary Supplement Health and Education Act from 1994 (DSHEA) Dietary Supplement Health and Education Act of 1994 it is the manufacturer's responsibility to ensure that a nutraceutical is safe before it is marketed.

In the European Union (EU), food legislation is largely under the umbrella of the European Food and Safety Authority (EFSA) European Food Safety Authority – EFSA | European Union. This legislation focuses on “food supplements,” which are defined as concentrated sources of nutrients like proteins, minerals, and vitamins, as well as other substances that offer a beneficial nutritional effect. The main EU legislation related to food supplements is Directive 2002/46/EC EUR-Lex - 32002L0046 - EN - EUR-Lex .

Because of the expanding use of nutraceuticals use and the increased number of product recalls, aspects of efficacy, quality and safety have arisen that call for enhanced regulation.

Your Partner in Meeting Global Nutravigilance Challenges

As your global partner, our nutraceutical industry experts can help assist you with your nutravigilance requirements.

Adverse Event Monitoring

Regulatory Submissions

Training and Support

Nutravigilance Challenges

Nutravigilance Literature Monitoring

Monitoring the scientific literature for adverse events is a critical component for nutravigilance and regulatory submissions of nutritional products and supplements.

The biologit's MLM-AI platform is a validated and compliant SaaS solution for nutraceuticals companies of all size, with a flexible workflow, unified scientific literature database and unique AI productivity to help ensure your products are compliant and audit ready.

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