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Food and Nutraceutical Regulations - Global Snapshot
Tuesday, 03 January, 2012, 08 : 00 AM [IST]
Rajashree Sharma
The regulatory framework governing foods in major jurisdictions is evolving. Food research, product and process innovation and change in consumer behaviour facilitate adaptation of food regulations. Increasingly, the awareness is manifested through consumption of particular foods and dietary supplements believed to contribute to good health and in some cases, to hold therapeutic value in the treatment or prevention of specific diseases. Many of these food products are becoming commonly known as nutraceuticals or "functional foods."

Nutraceuticals are products that have the characteristics of both a nutrient and a pharmaceutical. Taken as dietary supplements, they can modulate the symptoms of various disease conditions by providing the additional nutrients our bodies may need to maintain well being. Food laws in every country is the basis of regulations of all kinds of food including health food, dietary supplement, functional food and nutraceuticals as specific guidelines / regulations are framed to regulate health food.

Stephen DeFelice, defined 'nutraceutical' as 'a food or part of food that provides medical or health benefits including the prevention and treatment of disease.'

Overview - US, EU, Japan, Canada, China, India - Regulations

The United States of America introduced the Dietary Supplement and Health Education Act (DSHEA) in 1994, which allowed considerable flexibility between foods and medicines found in other parts of the world. Under DSHEA a dietary supplement may contain 'a herb or other botanical' or 'a concentrate, metabolite, constituent, extract or combination of any ingredient from the other categories.'

The American food safety regulatory system is far more centralised than the European system. The issue of adulteration became a national issue in 1848 when Congress passed the Drug Importation Act, requiring inspection by the US Customs Service to prevent the entry of adulterated drugs from abroad. In 1862, in order to address the issue of adulterated food, the chemical division of the United States Department of Agriculture (USDA) was established and then renamed the Bureau of Chemistry (now FDA).

The genesis of US food legislation goes back to 1906 when a major piece of legislation was passed. The Food and Drugs Act was enacted in June 1906 and prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs. In 1938, the Food and Drugs Act was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). This Act focusses on food misbranding and adulteration and serves as the basic framework for food regulation by the FDA and the USDA. This legislation created food standards, mandated inspections of factories, and provided for the issuance of court injunctions in addition to the already existing seizure and prosecution remedies. Since 1938, the FDCA has been amended a number of times and additional supporting laws have been enacted relating to food safety, security threats, and nutrition. Additionally, this federal framework is supplemented by state laws.

The USDA and the FDA are the main authorities in food regulation in the United States. These two federal agencies encompass all phases of the food regulatory system: They evaluate, investigate, regulate, inspect, and sanction. However, even in a centralised system like the United States, some argue that the USDA and the FDA should consolidate into one single food agency. FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and drug products.

Under the DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. All domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the US, must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control.

In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports. Further, FDA's other responsibilities include product information, such as labelling, claims, package inserts, and accompanying literature.

European Regulation

A wide variety of botanicals and other substances have been sold as dietary supplement ingredients, including many that are considered to be medicinal substances under most regulatory regimes in EU countries. The report published by the European Association of Self-Medication Industry, titled 'Herbal Medicinal Products in the European Union' has found that there was no consistency between the member states in the interpretation of the medicines Directive with respect to herbs. The criteria used to differentiate between medicinal and food herbs varied widely.

The EU food safety regulatory system needed a centralised regulatory power that would bring a more homogeneous type of regulation where member states would let European institutions oversee both risk assessment and risk management. Recognising the need to harmonise laws, the EC issued compositional directives in the 1970s. These directives created standards of composition for certain foodstuffs. The standards allowed some ingredients and prohibited others that did not meet the requirements set by the commission. Pertinently, the goal of those directives at that time was to guarantee the free movement of food within the European Common Market, rather than to advance consumer health. The directives applied only to particular ingredients, including sugars, jams, chocolate products, and preserved milks. Ultimately, however, this formula failed because the differing culinary cultures of the member states prevented them from agreeing on the adoption of those ingredients' requirements. In 1985, the EU came up with a new approach. Instead of trying to harmonise all of the food regulations, it decided to use labelling to indicate the differences in composition and production methods, allowing consumers to make an informed decision. It adopted the principle of mutual recognition, requiring a member state to allow the free circulation of goods produced in conformity to equivalent standards of other member states.

In 2002, the Council of the EU and the European Parliament adopted regulation and created the principles of food law and creating the European Food Safety Authority (EFSA). Each member state had regulated its own foodstuffs. In contrast, the EFSA is an independent agency that provides scientific advice to member states and EU institutions. It gathers data to help anticipate risks and issues opinions on matters and provides scientific assessments but does not handle any of the risk management.

Instead, the EU institutions and the member states themselves are responsible for risk management, a division of authority that poses an obstacle to greater centralisation. Under the European system the authority is not only divided among various countries, but those countries also have flexibility both in the way they control their food safety regulations and in the way they implement EU regulations and directives. Traceability and labelling are probably the biggest part of the harmonisation of standards and principles
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