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Dietary supplements: Regulatory challenges
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Wednesday, 02 March, 2022, 15 : 00 PM [IST]
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Aayushi Balyan & Sumit
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To be nourished and healthy, food is an essential source of nutrients. Poor and unhealthy diets have increased the prevalence of many non-communicable diseases (NCDs), demanding the development of a food-based approach to stem the tide.
The expansion of food commodities in India, including medicinal sorts such as health supplements, plants, herbs, and creative substances, adds a new degree of complexity to laws. Awareness of the legal and regulatory standards for foods, including dietary supplements, may help to concentrate attention on the specific difficulties that exist, such as safety judgments, claim substantiation, and customer understanding.
Dietary supplements are goods taken orally and include a ‘dietary component' that is meant to augment a person's diet. Vitamins, minerals, herbs or other botanicals, amino acids, enzymes, organ tissues, glandular, and metabolites are all examples of substances.
As the global market for dietary supplements grows, many of the scientific and regulatory challenges that arise in research on their safety, quality, and effectiveness are shared by all nations. In India, the regulatory framework for food goods has evolved through time. There was no independent national organisation for food product regulation in India by the 1990s.
Rather, the food processing standards were divided into different laws governing vegetables, mineral oils, animal products, and other topics, which included state laws as well as the eight fundamental laws mentioned below:
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S.NO
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LIST
OF LAWS
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1.
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The
Prevention of Food Adulteration Act (PFA), 1954.
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2.
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The
Fruit Products Order (FPO), 1995.
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3.
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The
Meat Food Products Order (MFPO), 1973.
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4.
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The
Vegetable Oil Product (Control) order, 1947.
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5.
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The
Edible oil packaging (regulation) order, 1998.
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6.
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The
Solvent Extracted Oil, De-oiled Meal, and Edible Flour (Control)
Order, 1967
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7.
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The
Milk and Milk Products Order, 1992.
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8.
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Any
other order under the Essential Commodities Act, 1995 relating to
food.
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With the introduction of the World Trade Organization (WTO), Sanitary and Phytosanitary (SPS), Agreement at the turn of the twentieth century, and India's developing competence in the global food trade market, there was an increase in the need for improved food safety measures.
Consequently, a consolidated food law in India, controlled by a single statutory body, became necessary to meet the high food safety criteria, enforce them, and clear any misunderstanding produced by the diversity of food laws. Consequently, in 2004, the Parliamentary Committee on Pesticide Residues urged all food rules to be unified.
In 2005, Parliament's Agriculture Standing Committee recommended uniform food legislation. The Food Safety and Standards (FSS) Act, passed in August 2006, has hastened to build a safe food culture. The FSS act merged eight earlier laws, orders, rules, and regulations into one document. The Act's preamble states that it will "consolidate the laws relating to food and establish the Food Safety and Standards Authority of India for laying down science-based standards for articles of food and regulating their manufacture, storage, distribution, sale, and import, in order to ensure availability of safe and wholesome food for human consumption."
The FSS Act's main goals were to (1) demonstrate food safety regulations; (2) certify food laboratories through organised standards; (3) offer scientific as well as technical support to the Central Government; (4) act under international guidelines to build better food standards in India; & (5) lookup, assemble, investigate, and contextualise data on food contamination, consumption, and safety. The basic problem with any discussion of dietary supplement regulation is that there is no global agreement on how to define commodities classified as dietary supplements, natural health products (NHPs), complementary medicines, or food supplements in different countries.
A food supplement, a therapeutic good (complementary medicine), a therapeutic good (prescription medication), or even a forbidden substance in another country might be classified as a food supplement, a therapeutic good (prescription medication), or even a prohibited drug. The scenario becomes considerably more convoluted when nations like China and India are added. In some countries, traditional medicine, often known as phytomedicine, which includes unprocessed botanicals, already has a legal framework in place.
Even in nations with comparable cultures, legal systems, and levels of economic development, dietary supplement regulations differ widely. Using examples from Australia, Canada, and the United States, which are all English-speaking nations with generally comparable cultures and legal systems, some of these contrasts are discussed further below. Other countries with comparable legal systems discuss the issue, including the United Kingdom, New Zealand, South Africa, and other African countries.
Finally, "dietary supplement" health products are often extremely passionate and divisive topics, provoking a broad range of feelings and viewpoints. While some say that these products should be examined in the same manner as for regular drugs and foods, others contend that a more specialised approach is necessary since there is often a traditional or historical evidentiary underpinning, and things generally include many ingredients. Because of the lucrative nature of the global dietary supplement industry, increased participation of a burgeoning industrial sector producing them, and the introduction of various new and creative goods onto the market, the situation has become more problematic.
Attitudes regarding supplement safety, effectiveness, and perspectives on what is important in eating and living will all play a role in defining future supplement scientific standards. Safety is crucial, and certain commodities, especially those with worldwide markets, need a more stringent chain of custody and product characterisation than is now in place.
Efficacy, or whether or if the product's health-promoting promises are true and not deceptive, is also important. Clinical studies with well-defined items and robust experimental designs are required to prove efficacy, and the research must be repeatable. High-quality research is critical to the success of any regulatory regime, regardless of the kind of health product. To offer the scientific knowledge that regulators want, assessments of nutrients' safety, quality, efficacy, and other bioactive are required.
(Balyan belongs to Shoolini University, Solan, H.P; Sumit belongs to Dairy Engineering Division, ICAR-NDRI, Karnal)
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