Nutraceuticals – Foods or Medicines? (Article)

There are so many different definitions for the term "nutraceutical" that it comes as no surprise there is confusion over what they are. The Nutraceuticals Institute defines them as:

"naturally derived bioactive compounds that are found in foods, dietary supplements and herbal products, and have health promoting, disease preventing, or medicinal products."

In this one definition, the less discerning consumer could easily believe they were taking a medicine. If you look closely at the definition, however, you will see that there is no reference to treating disease. The emphasis is on preventing disease and promoting health.

The term "nutraceutical" was the creation of Dr Stephen De Felice, the founder and chairman of the Foundation for Innovation in Medicine (USA), an educational organisation set up to encourage medical health research. He defined a nutraceutical as a

"food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of a disease."

Interestingly his definition includes the treatment of disease. When considering UK and EU law, if a nutraceutical makes a claim to be able to treat disease then it will be classed as a medicine and be subject to the Medicines Act.

By considering the following facts, a UK company can make an informed decision on the legal classification of their nutraceutical.

There are two main legal classifications:

1) Licensed medicines

These are preparations which are assessed for safety, efficacy and quality in line with UK and EU legislation. Once a Marketing Authorisation (MA) has been granted, the company is allowed to make medical claims.

2) Unlicensed preparations

In the UK, supplements, functional foods and many nutraceuticals have to abide by the food legislation of the Food Standards Agency (FSA) with local trading standards authorities being the main point of contact. If the product is unlicensed, a company is not allowed to make any medicinal claims. Health maintenance claims, however, are allowed. In addition, the product must be safe with the labelling complying with the Food Labelling Regulations 1996. If the product is a supplement, the label must also state the nutrient content in relation to the EU Recommended Daily Allowances (RDAs).

It doesn't end there. Other regulatory aspects also need to be considered:

The European Commission Directive on Food Supplements 2002/46/EC. This regulates all supplements which contain vitamins and minerals. The Directive has a list of permitted vitamin and mineral substances. If the substance isn't on this list then a safety dossier has to be submitted for approval.
The Food Supplements (England) Regulations 2003. This was implemented in 2005 and requires certain mandatory labelling in addition to those of the UK Food Labelling Regulations.
Any health claims used must be on the list of approved health claims. This list was established, along with an agreed code of practice, by the Joint Health Claims Initiative (a voluntary system). Approved health claims can be used without the need for the product to be classed as a medicine. It is still 'work in progress' with more claims being approved and added.

Currently unlicensed products are regulated on a national basis. The EU, however, has been introducing a wide array of legislation with the aim of replacing the relevant national laws. These EU laws aim to

facilitate the free movement of goods or services between Member States, and
provide a high level of consumer protection.

The legislation surrounding nutraceuticals, functional foods and supplements is complex and ever changing. It's no wonder then that companies often turn to the professionals for help but even this can be problematic as many consultants and consultancies either have knowledge of medicinal regulations or food regulations but not both. Ideally a company needs to find an organisation, such as Global Regulatory Services, who is knowledgeable and experienced in both areas of legislation.

So is a nutraceutical a food or a medicine? The answer is both! It all depends on whether or not a company wants to make any health or medical claims.

Author: Greer Deal, Director of Global Regulatory Services