Nutraceuticals Supplements Regulations, Safety and Standards

The regulatory position of nutraceuticals and dietary supplements depends on the regulatory framework of different countries.

There is a need for a comprehensive regulatory framework for nutraceuticals and dietary supplements to maintain their safety and standards globally.

Post on: 2022-08-04 By Wellwisher

An Overview of Nutraceutical and Dietary Supplement Regulations

Global Nutraceuticals Market to Reach $441.7 Billion by 2026. Nutraceutical is a broad term that includes dietary supplements, and functional foods.

Nutraceuticals and Dietary Supplements are concentrated nutrients that are isolated from food or food products and Used for their therapeutic and preventive qualities.
They are gaining wide popularity because beyond providing basic nutrition, they have several health benefits.

Nutraceuticals & Dietary Supplements: Regulations, Safety & Standards
Nutraceuticals & Dietary Supplements: Regulations, Safety & Standards


People take dietary supplements for many different reasons viz. to improve general health and fitness, to prolong vitality and delay the onset of age-related problems as a tonic for stress symptoms, to enhance performance and bodybuilding in sports and athletics, and also to prevent or treat various signs and symptoms associated with health conditions.

According to the DSHEA, manufacturers and distributors of dietary and herbal supplements must ensure the safety and accurate labeling of their products, to guarantee that they are not adulterated or misbranded.

In the developed country nutraceuticals have become a part of the day to day life. It is used in disease conditions such as joint pain, insomnia, rheumatoid arthritis, degenerative eye condition, enlarged prostate, pre-menopause, weight management, cardiovascular health, immunomodulators, and memory loss.

Regulatory Aspects for Quality, Safety & Standards

People are using dietary supplements for many indications in the belief that they are safer than synthetic substances, although this safety assumption is wrong, because nutraceuticals can be toxic internally or when taken in combination with other medications.

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.

Nutraceuticals & Dietary Supplements Regulatory Agencies

Country Regulatory Agencies


Health Foods and Dietary supplements Association (HADSA) National Institute of Nutrition (NIN) Food and Drug Toxicology Research Centre (FDTRC) National Nutrition Monitoring Bureau (NNMB)


Dietary supplement Health & Education (DSHEA) Act, 1994
Federal Trade Commission (FTC)


Food Standards Agency (FSA) Expert Group on Vitamins and Minerals (EVM) Advertising Standards Authority (ASA) Medicines and Healthcare products Regulatory Agency (MHRA)


Agência Nacional de Vigilância Sanitária (ANVISA) Ministério da Agricultura, Pecuária e Abastecimento (MAPA)


Food of Special Health Uses (FOSHU) Act Japan Health Food Association (JHFA) Japan Health Food and Nutrition Food Association (JHNFA)


National Pharmaceutical Control Board (NPCB) Drug Control Authority ( DCA)


Ministry of Health and Social Development


Food and Drug Authority


Department of Health and aging

Nutraceuticals are generally safe and helps to maintain good health conditions. Their key positive aspect is that they can be consumed by anyone, without worrying about their side effects and without consulting a doctor.

Since nutraceutical products are used to improve health, their labels must be informative. The label of the product should display supplement facts, suggested use, warnings, amount per serving, any other critical information.

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