Nutraceuticals are natural, bioactive chemical compounds that have health-promoting, disease-preventing, or general medicinal properties. This category of medications encompasses vitamins, minerals, herbal supplements, and certain animal products. In addition, nutraceuticals also include “functional foods,” which are defined as food products that tout a specific health benefit based on their ingredients.
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Introduction to nutraceutical regulation
The regulation of nutraceuticals presents a noteworthy challenge to the globalization of nutraceuticals, with a murky and somewhat dissimilar definition of these products that are used in different countries. For example, in Japan, functional foods are defined according to their use of natural ingredients. Comparatively, functional foods in the United States can contain ingredients that are products of biotechnology.
In general, the goals of nutraceutical regulation have been focused on safety and labeling with a lesser emphasis, as compared to pharmaceuticals, on product claims and intended use. This is accomplished through Good Manufacturing Practice (GMP) regulations and a recent increase in enforcement.
Consumers are largely responsible for determining the usefulness and value offered by nutraceuticals. Still, increased regulation related to the quality and safety of these products will significantly benefit the industry and help mitigate the risk of regulatory backlash.
Regulatory rules in different countries
In the United States, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of regulations as compared to those that cover “conventional” food and drug products. According to the Dietary Supplement Health and Education Act from 1994 (DSHEA), it is the manufacturer's responsibility to ensure that a nutraceutical is safe before it is marketed.
The FDA is authorized to take action against any unsafe product after it reaches the market. Manufacturers have to make sure that the information on the product label is truthful and not misleading; however, they are not obliged to register their products with the FDA nor get FDA approval before producing or selling nutraceuticals.
Decoding the Dietary Supplement Industry
In the European Union (EU), food legislation is largely under the umbrella of the European Food and Safety Authority (EFSA). This legislation focuses on “food supplements,” which are defined as concentrated sources of nutrients like proteins, minerals, and vitamins, as well as other substances that offer a beneficial nutritional effect. The main EU legislation related to food supplements is Directive 2002/46/EC.
New products from Europe are presumed to have passed stringent European development and quality requirements. As a result, European nutraceutical companies, which are generally considered leaders in innovation, enjoy the public perception that they are producing the highest quality products. In Canada and Australia, nutraceuticals are regulated more closely as a drug than food category.
As with other countries, Indian legislation does not actually ascribe any specific legal status to nutraceuticals. Regulations for nutraceuticals of the Government of India include the Food Safety and Standards Act (FSSA), which was passed in 2006 and has yet to be implemented.
Global market entry requirements
For the majority of countries, nutraceuticals are regulated as a category of food. In some regions or countries, there is an explicit set of regulations for supplements, as which is present in the United States, European Union, and the Association of Southeast Asian Nations, as well as nutraceuticals, as is the case in India. Taken together, these regulations largely stem from a food-based regulatory paradigm. Therefore, some form of registration or notification-based system is needed to bring new products to market.
In Latin America, the market entry requirements for nutraceuticals vary, with registration-based approaches employed in Colombia, Brazil, and Argentina, and notification-based approaches that are followed in Mexico and Chile. In countries such as Brazil, China, and Taiwan, regulators require animal and/or human clinical studies as a requirement of the product registration process.
Bringing nutraceutical products to market usually follows three basic approaches. The notification-based approach ideally balances pre-market resources, consumer access, and consumer safety. Nevertheless, a key aspect to guarantee product safety and quality in the marketplace, regardless of the pre-market requirements, is robust post-market surveillance.