Nutraceutical Regulation

Nutraceuticals are natural, bioactive chemical compounds that have health-promoting, disease-preventing or general medicinal properties. This category encompasses vitamins, minerals, herbal supplements, and certain animal products. In addition, nutraceuticals also include “functional foods” – i.e. foods that tout a specific health benefit based on their ingredients.

Regulation presents noteworthy challenge to the globalization of nutraceuticals, with murky and somewhat dissimilar definition of these products in different countries. For example, in Japan, functional foods are defined according to their use of natural ingredients. On the other hand, functional foods in the US 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 quality and safety of these products will benefit the industry on the whole and help mitigate the risk of regulatory backlash.

Regulatory rules in different countries

In the USA, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of regulations when compared with those covering “conventional” foods 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.

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, but they are not obliged to register their products with the FDA nor get FDA approval before producing or selling nutraceuticals.

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 a perception of producing the highest quality products. In Canada nutraceuticals are regulated more closely as a drug than food category.In the European Union, food legislation is largely under the umbrella of European Food and Safety Authority (EFSA). This legislation focuses on “food supplements”, which are defined as concentrated sources of nutrients (e.g. proteins, minerals and vitamins) and other substances with a beneficial nutritional effect. The main EU legislation related to food supplements is Directive 2002/46/EC.

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 is 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 (e.g. United States, European Union, and Association of South East Asian Nations) and nutraceuticals (India), which stem from a food-based regulatory paradigm. Therefore some form of a 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 in Mexico and Chile. In countries such as Brazil, China and Taiwan, the regulators require animal and/or human clinical studies as a requirement of the product registration requirement.

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.