Food products with specified health benefits represent one of the most exciting
product development opportunities. Today, consumers are not only demanding more
from the foods that they eat, they are also demanding increasing levels of reassurance
concerning the safety and efficacy of these products. The regulatory authorities
of Europe, the USA and Japan are also demanding tighter controls. Therefore
you will require expert scientific and regulatory advice in order to successfully
market these products.
Health food ingredients are known by several names:
- Nutraceuticals - food with a specific health benefit, often sold in the
form of a drug, such as a pill or capsule
- Functional Foods - a whole food product, containing added supplements or
health ingredients for a specific benefit.
Some example would include:
- Japanese yoghurt extract
- Plant sterols
- Mushroom extract
- Lycopene
- Broccoli seed extract
- Vitamins and minerals
- Herbal remedies
- Consultancy and advice
- Contact with regulatory authorities
- Analysis of functional components
- Screening of functional components
- Efficacy studies (clinical trials)
- Toxicology and metabolism studies
A single package is required to satisfy clinicians and the regulators.
- Single-dose oral study in rats
- 4-week oral repeat-dose study in rats
- 90-day oral repeat-dose study in rats
- In vitro mutagenicity (Ames test, metaphase analysis, mammalian
cell mutation assay)
- Safety pharmacology (Irwin dose range, locomotor activity, cardiovascular
and respiratory effects in the dog, gut motility)
- In vitro digestion study
- In vivo intestinal studies
- Pharmacology (in vitro and in vivo)
- Receptor binding studies
- Enzyme interactions
- Immunologic effects
- Animal disease models
- Isolation and identification of the functional component(s)
- Quantification of functional component(s)
- Characterisation of impurities
- Stability in final product
|
