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 uniform, consistent or standardised regulations.

Some countries still lack any sort of surveillance programme. Establishing transparent analytical approaches with emerging technology will ensure worldwide quality and safety of dietary supplements and herbal products. It is imperative to take precautions to reduce the risk of human health being affected. The regulatory landscape has improved considerably in recent years, but improved techniques are still needed to assess the quality and safety of dietary supplements, especially when it comes to purity.

At the moment, there is no harmonisation in nutraceutical classification and regulation across global regulatory markets. It is important for global health regulatory agencies to discuss their regulatory principles in depth in order to understand how these products affect public health since usage of these products is increasing and we know little about their risks or benefits.

The legal definitions for nutraceuticals/functional foods are somewhat dissimilar in different countries; they need to be inline globally to avoid confusion. For instance, the definition of functional foods in Japan is based on natural ingredients. In the US, functional foods can, however, contain ingredients that are derived from biotechnology. Functional foods in India can consist of herbal extracts, spices, fruits, nutritionally improved foods or foods with functional ingredients.

The market is experiencing latency as a result of regulatory frameworks that have yet to be implemented and insufficient resources to do so. Since nutraceuticals blur the line between food and medications, distinguishing among nutrients, food additives, drugs and nutraceuticals can be challenging.

One of the primary topics to be discussed while considering regulatory gaps is consumer safety: the consumer must be able to recognise the label, any claims made on the label, nutritional and ingredient information, and, most importantly, the usage instructions.

In light of the role of nutraceuticals, it is deemed necessary to restructure the entire regulatory framework for dietary supplements in order to first credit their various purposes and definitions, and then to assess their specific role in the prevention and treatment of pathological conditions, only supporting their potential medical use in prevention and therapy when proven by sound scientific and clinical data.

Nutraceuticals would need a pre-market approval system validated by scientific data and clinical data proving their safety and efficacy. Strict guidelines would be needed and shared at the international level to ensure that proper information is used to substantiate any health claims on the product label and detailed in the recommendation/safety guidelines, which should be included in the packaged products.

In conclusion, nutraceuticals require a more consistent and severe regulatory framework worldwide.

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