Like all other food products, nutraceuticals must establish their safety and efficacy in order to win consumer confidence. Presently there are no mandatory clinical trials required before nutraceuticals are manufactured. Also most products are based on alternative medicines, which have existed for thousands of years. This gives rise to the feeling that there is no need for testing and trial. Nutraceuticals may have had their beginning in the alternative medicine space but as they surge ahead as ‘New Age Food’ there is a need for more data on safety, based on scientific evidence.
At present, nutraceuticals are being promoted as being beneficial for health on the basis of scientific investigations about foods and their components like beta carotene, flavonoids, antioxidants, etc. However, with the rise in awareness among consumers there is a need for companies that manufacture nutraceuticals, to conduct tests and make products based on clinical trials. To ensure that nutraceuticals are safe and effective
- they need to be tested for purity as well as potency of ingredients
- standardised testing methods need to be in place to verify quality of ingredients and dosage consistency
- better means of producing ingredients and identifying new ingredients
- need for product evaluation
- clarification in labelling claims
Herbal products versus nutraceuticals
There is a growing concern that calling all herbal medicines and plant ingredients nutraceuticals would be a dangerous trend. It could give the consumer a wrong message about nutraceuticals. Some countries allow companies to make ‘unprecedented claims’ about the foods in nutraceuticals. These claims may not all be true. On the basis of these exaggerated claims, many other companies also begin to categorise herbal remedies and isolated food compounds, as nutraceuticals.
- Herbal medicines that are not edible do not come under the nutraceutical category.
- Also isolated compounds from wild plants that are not dietary ingredients are called nutraceuticals by some pharma and biotech companies
Since nutraceuticals are defined as food or part of food that provides health benefits and prevents disease the above two definitions can confuse the consumer. In fact some herbal preparations are being marketed as nutraceuticals even though they are not fulfilling the minimum standards that WHO has laid down for herbal drugs.
Regulations and Safety
Since nutraceuticals are food products meant for human consumption it becomes important to maintain the quality and safety standards. Government regulatory guidelines can assure both safety and standards and can also become a driver for the industry. In India product approval is required from FSSAI for the manufacture, sale, distribution or marketing of nutraceuticals under the Food Safety and Standards Act (FSSA) 2006. However, internationally nutraceuticals are manufactured on regulations of local agencies that work with international trade associations. Since there is no harmonization of regulations across all jurisdictions consumer safety becomes a major issue.