Express Pharma

Regulatory framework for nutraceutical industry

Kavita Sharma, International Regulatory and Supply Chain Manager, Nutrify Today, explains why nutraceuticals require a more consistent and severe regulatory framework worldwide

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Nutraceuticals are natural, bioactive substances that promote health and prevent diseases. In 1989, the term nutraceutical was coined by Dr Stephen DeFelice from “nutrition” and “pharmaceutical.”

In recent times, the nutraceutical market is seeing rapid growth, and regulations around nutraceuticals are continuously evolving without a clear regulatory definition. While nutraceuticals fall under the dietary supplement category in one country; in another, the same product is identified as a food for special medical purposes by the Health Authority (HA). The need of the hour is a one defined framework for the nutraceutical sector, globally.

By issuing the Food for Specified Health Use (FOSHU), Japan became the first country to regulate nutraceuticals. The nutraceuticals are regulated by different authorities in different countries, for example, in Australia by Therapeutic Goods Administration (TGA); in Canada, by Health Canada (HC); in Europe, by European Food Safety Authority (EPSA), and in the US, by the Food and Drug Administration (FDA).

Nutraceuticals are regulated in India by the Food Safety and Standards Authority of India (FSSAI). The country has taken an important step by enacting and implementing the Food Safety and Standard Act 2006, and the status of nutraceuticals regulation in India is progressing rapidly. A strong framework for nutraceuticals has been established with the implementation of the FSSAI and the regulation of functional foods and nutraceuticals. To ensure nutraceutical products are safe, and are of high quality, strict guidelines have been laid down regarding the evidence that must support their health claims.

Dietary supplements are defined by the DSHEA as “products (other than tobacco) intended to supplement the diet containing vitamins, minerals, amino acids, herbs or botanicals; or concentrates, metabolites, constituents, extracts and combinations of the dietary ingredients listed above.”

In addition, it must also meet the following criteria:

  • be intended for ingestion in pill, capsule, tablet, powder or liquid form
  • not be represented for use as a conventional food or as sole item of a meal/diet
  • be labelled as a “dietary supplement.”

Nutraceuticals are in a precarious position in the global market since many countries like Brunei Darussalam, Benin, Singapore and Taiwan do not have restrictive regulatory frameworks in place to regulate the supply of nutraceuticals. The manufacturing, sales or marketing of any of these products are not governed by unifo