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Labeling a Nutraceutical Product – an Introduction to Labeling and Claims Regulations Across the Globe


Nutraceuticals industry has gained, and will continue to benefit, from the changing lifestyle of the modern-day consumer whose priorities are shifting towards health and wellness. Companies in this space have leveraged both traditional channels such as mass media advertising and product labelling as well as internet and social media for disseminating information.

Over the years, multiple legislations across the globe have been passed to ensure safety of nutraceutical products and also to provide directions to nutraceutical companies on information to be declared and permissible claims to be made on the product label.

This blog post is the first in a series that attempts to answer a few basic questions about nutraceuticals and guidelines related to labeling of such products.

Is a nutraceutical product food or medicine?

Nutraceuticals are closer to the famous dictum of Hippocrates, the founding father of modern medicine, “Let food be thy medicine and medicine be thy food.”

By definition, nutraceuticals comprise of functional foods (including beverages) and dietary supplements. The focus of these products is prevention and wellness over a longer period of time as opposed to pharmaceutical products whose purpose is to treat specific illnesses or biological conditions.

You have used another buzzword: functional foods and beverages. What does that mean?

The Functional Food Center defines “functional foods” as “Natural or processed foods that contain biologically-active compounds; which, in defined, effective, non-toxic amounts, provide a clinically proven and documented health benefit utilizing specific biomarkers, for the prevention, management, or treatment of chronic disease or its symptoms.”

Broadly, functional foods are foods or beverages enriched with specific nutrients. It could be from plant or animal sources. Here are a few examples:

  1. Functional Foods – omega-3 enriched eggs, oats, fatty fish, fortified margarines, iodized salts, soy, tomato products, probiotics, prebiotics, stanols and sterols.
  2. Functional Beverages – essentially non-alcoholic drinks; performance and sports drinks, ready-to-drink teas, enriched water, energy drinks, soy beverages and enhanced fruit drinks. 

Dietary Supplements are also included under Nutraceuticals, right?

Absolutely. As the name suggests, products in this category are supplements to a diet and contains one or more of following dietary ingredients: vitamin, mineral, herb or other botanical product, amino acid, a concentrate or an extract.

Also, all organic food in India is categorized as Nutraceuticals as well.

In different parts of the world, there are agencies who implement and enforce regulations to ensure safety of food and drugs. Will these agencies regulate nutraceuticals as well?

Before we look at the regulations, it is vital to understand how nutraceuticals differ from pharmaceutical products. Except for OTC drugs, all pharma products can be bought only with a prescription whereas nutraceutical products do not require a prescription. Furthermore, drugs sold in the United States are approved by the FDA. The Food, Drug and Cosmetic (FD&C) Act which gives authority to FDA does not have a definition for functional food. However, dietary supplements and dietary ingredients are regulated by the FDA under the Dietary Supplement Health and Education Act (DSHEA).

To help you understand the regulations across the globe, we have plotted different events on a timeline chart given below:

MHLW – Japanese Ministry of Health, Labor and Welfare;

EFSA – European Food Safety Authority;

Codex Alimentarius – a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety;

Codex Alimentarius Commission – a body that was established in November 1961 by the Food and Agriculture Organization of the United Nations (FAO) and was joined by the World Health Organization (WHO); has 186 member countries and one-member organization, the European Union (EU); 215 Codex observers: 49 intergovernmental organizations, 150 non-governmental organizations, and 16 United Nations organizations.

Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.

In the next post, we will address questions related to labelling and claims of dietary supplements.

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