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Nutraceuticals/Functional Foods

This sector of the market will continue to increase.  This is of particular relevance when you consider that improving health is on the western world's political agenda. 

It is important that companies are fully aware of what claims they can and cannot make about their products and under whose regulations they come under e.g. Medicines and Healthcare Products Regulatory Agency (MHRA) or the UK Food Standards Agency (FSA).

Over the last few years the EU has introduced a wide array of legislation which will eventually replace most relevant national laws.  The purpose of this is to harmonise the legislation for natural health (i.e. nutraceuticals, functional foods, vitamins and supplements and novel foods) across all the Member States with the aim of:

  • enabling free movement of goods of services within the EU, and
  • to provide a high level of consumer protection.

Terms such as "functional foods" or "nutraceuticals" are widely used in the marketplace. In the US, such foods are regulated by the FDA under the authority of the Federal Food Drug and Cosmetic Act, even though they are not specifically defined by law.  Dietary supplements, however, are covered by a different set of regulations.  Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.  The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.  Generally, manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling dietary supplements.  Manufacturers must make sure that product label information is truthful and not misleading.  Further information can be found on the FDA website.

The legislation surrounding nutraceuticals can be complex especially when you consider that the legislation is still evolving worldwide.  At Global Regulatory Services (GRS) we can provide advice on the raft of legislation which affects your nutraceuticals (or health products) to ensure that your products are compliant.  We can also offer advice on the best route to your chosen market.

Please contact us with your specific regulatory compliance requirements.