Nutraceutical Regulation

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.

Image Credit: Voloshyna Anna / Shutterstock.com

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.

References

Further Reading

Last Updated: Dec 22, 2022

Dr. Tomislav Meštrović

Written by

Dr. Tomislav Meštrović

Dr. Tomislav Meštrović is a medical doctor (MD) with a Ph.D. in biomedical and health sciences, specialist in the field of clinical microbiology, and an Assistant Professor at Croatia's youngest university - University North. In addition to his interest in clinical, research and lecturing activities, his immense passion for medical writing and scientific communication goes back to his student days. He enjoys contributing back to the community. In his spare time, Tomislav is a movie buff and an avid traveler.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Meštrović, Tomislav. (2022, December 22). Nutraceutical Regulation. News-Medical. Retrieved on October 31, 2024 from https://www.news-medical.net/health/Nutraceutical-Regulation.aspx.

  • MLA

    Meštrović, Tomislav. "Nutraceutical Regulation". News-Medical. 31 October 2024. <https://www.news-medical.net/health/Nutraceutical-Regulation.aspx>.

  • Chicago

    Meštrović, Tomislav. "Nutraceutical Regulation". News-Medical. https://www.news-medical.net/health/Nutraceutical-Regulation.aspx. (accessed October 31, 2024).

  • Harvard

    Meštrović, Tomislav. 2022. Nutraceutical Regulation. News-Medical, viewed 31 October 2024, https://www.news-medical.net/health/Nutraceutical-Regulation.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Spirulina shows promise in battling heart disease and diabetes