Tuesday 3 January 2012

Food and Nutraceutical Regulations - Global Snapshot

 January 03, 2012

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 that the EU has undertaken in the realm of food safety regulation.

The Japanese government enacted a regulatory system called 'Foods with health claims' in April 2001, which consists of Foods for Specified Health Use (FOSHU) and Foods with Nutrient Function Claims (FNFC). The FOSHU was set up by the ministry of health and welfare in 1991 to approve descriptions on a label regarding an effect of food on the human body. It was enacted as a part of 'food for specified dietary use' under the Nutrition Improvement Law.

There are three important requirements for FOSHU approval. The first is scientific evidence of the efficacy, including clinical testing. The second is safety for consumption. The third is analytical determination of the effective component. Most of the descriptions of foods under the FOSHU system are similar to the category of enhanced function claims of Codex. Under FNFC, 12 vitamins and two minerals (calcium and iron) are standardised. These claims are similar to the nutrient function claims approved by Codex in 1997. The FOSHU certification is not easily obtained. There is a 3-stage approval process and in the case of domestic manufacturers (applicant) there is a process which amounts to a self-regulatory peer review by the Japan Health Food Association (JHFA). FOSHU can be applied to foods only and not isolated nutrients or manufactured nutritional supplements and only those foods which have identifiable health benefits based on sound scientific research. This marks the opportunity for the marketing and promotion of a wide range of foodstuffs which already have a significant degree of consumer acceptance.

In Canada, the Food and Drugs Act and Regulations is the primary statute which governs the sale of foods, drugs, cosmetics and medical devices. This statute which is remarkably simple in concept, can trace its origins to an 1860 British law entitled A Bill for Preventing the Adulteration of Articles of Food and Drink. The Canadian law evolved from an 1874 statute to the current Act which was passed in 1953.

In Canada there are no specific regulations dealing with functional foods and such foods are governed by the existing legislative and regulatory framework; The Food and Drugs Act and Regulations.

Under Canadian food and drug law, ingestible products must be either sold as a "food" or "drug." The term "Health Food," though widely used by industry and the consumer, is problematic for the Health Protection Branch (HPB).

The definition of "food" in the Food and Drugs Act makes no differentiation about types of food and states in another section that food must be free from poisonous or harmful substances. Thus, in legal terms, any food in compliance with the Food and Drugs Act and Regulations should assist in sustaining good health and should not present any appreciable hazard to the consumer. "Health Foods" should not be confused with "organically produced" foods which represent, by international consensus, foods derived from organic agriculture and are part of the broad spectrum of methodologies supportive of the environment.
The State Food and Drug Administration (SFDA) was founded on the basis of its former counterpart, SDA, and got its current name on April 16, 2003. SFDA is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, medical devices, food supply and cosmetics. As a direct part of the State Council, SFDA has regulatory and legal enforcement functions.

The National Institute of Nutrition and Food Safety (NINFS) is a research agency for nutrition and food hygiene. The institute facilitates improvement of nutritional status, preventing food-borne diseases, and strengthening the physical fitness of the people. The institute was formerly known as the Nutrition Division of the National Institute of Health of the Public Health Administration, which was established in 1941. After the founding of the People's Republic of China, the institute was affiliated with the following leading bodies under the title of the Department of Nutrition or the Department of Nutrition and Food Hygiene:

The first such national law, the Food Hygiene Law of the People's Republic of China, was adopted on October 30, 1995, and it defined food as "any finished product or raw material intended for people to eat or drink, as well as any product that has traditionally served as both food and medication, with the exception of products used solely for medical purposes.

In June 2003, SFDA took over the responsibility of health food registration approval from the Ministry of Health (MoH). The SFDA's Department of Drug Registration is completely responsible for the approval of health food, including nutrition supplements. In accordance with the Food Hygiene Law of the People's Republic of China and the Administrative Licensing Law of the People's Republic of China, the Interim Administrative Measures for Health Food Registration were promulgated by the SFDA and went into effect on July 1, 2005. With these provisions, the responsibility for the assessment and review of food safety, effectiveness, quality control, and labelling content was assigned formally to SFDA and its subsidiaries.

In contrast to the well-substantiated scientific evidence collected according to strict scientific procedures employed by many countries, Chinese regulations rely more on long established and accepted practice and experience developed in Traditional Chinese Medicine. Health claims are allowed on health foods provided requirements for public health are met and the claim in question does not employ medical jargon or terms likely to be confused with pharmaceuticals. Since August 1, 2005, no health food advertisements have been allowed to be released in the media prior to examination and approval by food and drug administration departments at the provincial level.

China is fast becoming a global powerhouse, and its impact has certainly been felt in the nutraceuticals industry, especially in ingredient segments. So while the evolution for China was being a net supplier to the global nutraceuticals industry, now China is entering the next phase of its evolution where it eventually becomes a net consumer of nutraceuticals.

There were multiple laws and regulations covering the foods in India, but there was no single law that could have significantly regulated the functional foods or dietary supplement or nutraceuticals.

In 2006, the Indian government passed Food Safety and Standard Act, 2006, to integrate and streamline the many regulations covering nutraceuticals, foods and dietary supplements. The Act calls for the creation of the Food Safety and Standards Authority (FSSA). The FSSA is responsible for drafting rules and regulations for companies in the food sector to be licensed by local authorities, a system of checks and balances, including product-recall procedures enforcements and penalties, and to develop science-based standards for food and to regulate and monitor the manufacture, processing, and storage. All food imports will therefore be subject to the provisions of the Act and any rules and regulations made under the Act. Further, it incorporates the salient provisions of the Prevention of Food Adulteration Act, 1954, and is based on international legislations, Instrumentalities and Codex Alimentarius Commission. Unlike the US, where the DSHEA is in place to regulate health-related products, in India, the government is in the process of drafting a law to regulate manufacturing, importing and marketing of health foods, dietary supplements and other nutraceuticals.

The concept of "nutraceuticals" is still developing in India. It has been defined in the FSSA but it is yet to be implemented as the rules are not completely framed.

However, FSSA lays down the suggestive structure of the regulation for Foods for Special Purpose and Nutritional Uses FSSA Act based on the learning from international best practices; the Food Safety and Standards (Packaging and Labelling) Regulation, 2011, deals with nutrition and health claims.

Final Comments
Every system of regulation has its pros and cons. The labelling of health-related foods should be based on scientific evidence, always bearing in mind harmonisation with global international standards. There should be a harmonisation of food regulations around the world. Economic growth and urbanisation are not enough evidence of the future growth of nutraceuticals, health demographic trends also support these growth forecasts. Consumers are deeply concerned about how their health care is managed, administered and priced. As health care cost has become high the consumers are frustrated with the expensive disease-treatment approach predominant in modern medicine; the consumer is now seeking alternative beneficial products like dietary supplement, functional food and nutraceuticals.

With innovative delivery mechanism to facilitate the use of nutraceuticals amongst its target groups, the world market is expected to witness a gradual shift toward natural ingredients. Further, EU focussing on the food safety regulation system by centralising of food regulatory powers, which would protect the public health as well as the future of the EU in a more general sense

Globally, the US and Japan are the most developed markets for nutraceuticals, due to the consumer acceptability achieved in these regions. India, China and Brazil are developing nations which show huge potential for the nutraceuticals market, India and China have emerged as a key sourcing destination for natural ingredients.

(The writer is partner, Corporate Law Group, New Delhi)       


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