The term nutraceutical comes from words “nutrition” and “pharmaceutical,” and it was first coined by Stephen DeFelice, MD, in 1989. He defined nutraceuticals as:
“Food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease.”
Today, over thirty years later, defining nutraceuticals is still not an easy job. Depending on the country and regulations, nutraceutical products overlap with dietary supplements, foods, and pharmaceuticals.
A general nutraceutical definition describes them as foods or bioactive compounds derived from foods that have health-promoting abilities on top of nutritional value. The compounds can include vitamins, minerals, enzymes, herbs, and certain animal products that yield disease-preventing and health benefits. In addition, functional foods can also be considered nutraceuticals, as they have unique health benefits depending on their structure.
Regulations of the nutraceutical industry and products are among current challenges, and lawmakers have various definitions of these products in different countries. For instance, functional foods in Japan are determined based on the use of natural ingredients in them. In contrast, using derivatives of biotechnology in these products is allowed in the US.
By going over regulations in different countries, you can see how tighter regulatory frameworks, safety control, as well as other aspects, can contribute to improving the quality of nutraceuticals.
Nutraceutical Legal Definitions
The nutraceutical market is booming, and it’s mostly because of the accessibility of nutraceutical products. According to the Council for Responsible Nutrition (CRN) survey, 3 out of 4 Americans reported using dietary supplements.
With a growing interest in health and wellness in developed countries, nutraceuticals proved to be an excellent option, which is why they have become so popular. Pair that with looser regulatory frameworks and lower costs, and you get a rapidly expanding market.
Since different state definitions and regulations can often confuse customers, universal terminology is needed.
Nutraceuticals are most commonly found between food and drug categories.
They are described differently in many countries:
- US – Dietary supplements
- Canada – Natural health products
- Japan – Food for special health use
We are going to review the regulations of each region to gain a better understanding of the nutraceutical world.
Dietary Supplement Regulations in the US
The US Food and Drugs Administration (FDA) is overseeing the regulation of food products, pharmaceuticals, additives, cosmetics, and more. However, nutraceuticals are considered dietary supplements, and they do not fall under the scope of the FDA.
According to the Dietary Supplement, Health, and Education Act (DSHEA) of 1994, nutraceuticals aren’t considered foods nor drugs, so the FDA isn’t responsible for their regulations.
DSHEA classifies dietary supplement as:
“A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above.”
To be considered a dietary supplement, a product must also be intended for oral use, have a “dietary supplement” label, and not be designed for use as a conventional food or an only item of a meal or diet.
Unlike drugs that need rigorous safety testing and presenting results to the FDA for approval before going into the market, dietary supplements don’t have to follow the same guidelines.
According to the DSHEA, the manufacturer is responsible for safety testings before products reach the market. If a company is launching a dietary supplement that contains a new ingredient, they must inform the FDA about it, and submit information and evidence that the new component is safe. That means it poses no significant risk of illness.
After the dietary supplement reaches the market, the FDA can determine if the product is safe, and ban it if it’s not. However, only one such case has been recorded so far.
Although dietary supplements are considered safe, many marketed options have no proof of efficacy, which may not harm the patients, but they can divert them from receiving proven therapies.
Regulations in the European Union (EU)
There is no regulatory framework for nutraceuticals in the EU. However, that doesn’t mean they are not regulated. They have to adhere to numerous rules depending on the nature of the nutraceutical product.
The General Food Law Regulation is responsible for food safety, and it applies to functional foods as well. If any nutraceutical product is claiming a health benefit, it must comply with medicinal product regulations. That means that the manufacturer must perform all the testing concerning safety, efficacy, and follow other procedures.
Manufacturers can’t claim medical benefits, such as the cure or prevention of a particular disease. They can only state that it may improve health, with the possibility of reducing the onset of illness.
The Directive 2002/46/EC brands nutraceuticals as “food supplements.” It introduces the rules for labeling, and other food supplement regulation practices, overseen by the European Food Safety Authority (EFSA).
Regulations in Canada
In 2004, Health Canada introduced the Natural Health Product Regulations, which meant that nutraceuticals fall under the category of natural health products. The FDA Canada is responsible for supervising the nutraceutical products, with tighter regulations in place than the DSHEA.
Natural health products include minerals, herbs, vitamins, probiotics, homeopathic medicines, traditional Chinese medicines, fatty, and amino acids, and other products.
Regulations in Japan
In 1991, the Foods for Specified Health Use (FOSHU) concept was introduced, making Japan the pioneer in nutraceutical regulations. Every claim for health benefits must be supported with evidence, and all functional foods are approved by the Ministry of Health and Welfare.
Functional foods must contain only natural ingredients, and they must be nutritious, offer some physiological improvement, and sensory satisfaction.
Regulations in India
The Food Safety and Standards Act (FSSA) regulates the status of nutraceuticals. In particular, Chapter 4, Article 22 of FSSA states that nutraceuticals don’t include drugs, and should be administered orally.
Manufacturers can’t claim to cure any diseases, but they can state health benefits that can indirectly help with certain conditions.
The Future of Nutraceutical Regulations
The nutraceutical market is getting bigger every day. This worldwide production triggered the alarm for researchers and experts to further look into the regulations of nutraceutical products.Many reviews have been comparing regulations around the globe and proposing new regulatory frameworks for the nutraceutical industry. They all conclude that universal definitions, transparent rules, and better control can lead to higher quality products, which will help the nutraceutical industry.