Nutrivigilance – The need of the hour

Dietary supplements are available over-the-counter and are not believed to pose any health risks. With the availability of online options, some people purchase dietary supplements often without professional guidance or monitoring. A major public health risk that can endanger the lives of such individuals is the paucity of accurate scientific information or medical rationale while using such supplements. For the rational use of dietary supplements and nutraceuticals, strict guidelines and regulations must be imposed regarding the active ingredients, identity, purity, and bioavailability of nutraceuticals.

Nutrivigilance 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.”[1] In the United States, finished dietary supplement products and dietary ingredients are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994. It also includes the reporting of adverse events to the FDA by all important stakeholders, including consumers, manufacturers, distributors, pharmacists, etc.[2] Herbal products or phytopharmaceuticals are included on the drug's list with requirements of safety and quality standards and having the commitment to report adverse events in the European Union. Dietary supplements authorization does not require any safety studies such as preclinical, clinical, or toxicological studies compared to drugs. European regulations refer only to their manufacturing, processing, approving, trading, promoting, marketing, and labeling.[3]

In India, food products are currently classified into nutraceuticals, health supplements, food for special dietary use, food for special medical purposes, prebiotics, probiotics, specialty foods, and novel food, according to the Food Safety and Standards Authority of India (FSSAI). The FSSAI regulates food business licensing and registration, manufacturing, packaging, and labeling, food product standard, sales restrictions, toxin, and contaminants sampling, and laboratory analysis. To maintain the quality and safety concerns of nutraceuticals, it is a prerequisite for all companies to follow the regulatory guidance of FSSAI. However, there are no initiatives taken by FSSAI to proactively monitor or record the adverse events arising due to the consumption of food products.

Relevance of Nutrivigilance to the Current Practice in India

Food products may lead to several adverse events, which are determined by

• The inherent adverse effects of dietary supplements prompted by the active substances

• Drugs and dietary supplements interactions

• Adverse events related to adulteration to improve the activity with pharmacologically active substances such as steroids and neurostimulators.[4]

The examples include Vitamin D3 and calcium phosphate, leading to constipating bloating, metallic taste, thirst, tiredness, weakness, loss of appetite, and muscle pain and also when given along with quinolones, tetracycline lead to decreased antibiotic absorption.[5] Green tea extract (Camellia sinensis) is used to reduce body weight and is associated with liver injury when combined with warfarin.[6] Aloe vera, which is commonly used in India associated with adverse effects such as gastrointestinal complaints, arrhythmias, nephropathies, and edema, and when given along with anti-diabetics, causes hypoglycemia.[6]

Nutrivigilance – Indian Scenario

The concept of nutrivigilance is relatively new in India, unlike that of pharmacovigilance for reporting adverse events due to drugs. The dedicated pharmacovigilance program of India was launched, which mandated adverse drug reaction monitoring.[4] Currently, no specific Indian guidelines exist for dietary surveillance, including postmarket surveillance programs for dietary supplements. Tools and guidelines for signal detection need to be developed.[7] A proper causality assessment structure or algorithm for dietary supplements that considers the intrinsic complexity of the product classes and subcategories is needed. A systematic and regularized framework will be helpful for both the FSSAI and the food industry in deciding whether a particular product or ingredient poses undue health risks with poor risk–benefit ratio that requires adequate risk alleviation strategies. A current requirement is to improve the domestic adverse event reporting process due to the recent surge in dietary supplements. Analysis of reported adverse events and actions taken concerning reported adverse events should be made public.[7]

Role of Clinical Pharmacologist in Nutrivigilance

Apart from reporting adverse events clinical pharmacologist's role may include guidance on the rationale use of nutraceuticals and food-drug interactions. Clinical pharmacologists can also help to build up scientific evidence, proof of concept, and conduct activities which include conceptualization, initiation and implementation of postmarketing surveillance, real-world studies to accumulate evidence on the safety and disseminate the same to healthcare professionals.

Conclusions

Indian regulations regarding food products, dietary supplements, and nutraceuticals are evolving. However, there is a need for more stringent regulations for nutrivigilance, i.e., detecting, monitoring, and maintaining the database of adverse events associated with dietary supplements, including the causality assessment. Important stakeholders in India should come together and adopt a proactive, methodical, structured, scientific, and standardized approach to the safety of food products, and nutraceuticals like the one utilized successfully in the pharmaceutical industry.