Nutraceutical Products Consulting
Recognition of a substance as safe requires reasonable
certainty in the minds of competent scientists that the substance is not
harmful when used as intended. GRAS self-affirmation requires a complete
review and assessment of the safety of the ingredient. The process of achieving
GRAS self-affirmation requires a consensus of safety by a panel of experts
who are qualified by training and expertise to evaluate the safety of food.
AIBMR Life Science’s experience, knowledge and success with GRAS Self-affirmations
is an excellent asset for guiding you through the process. Our expert panel
comprises well-respected former senior-level FDA and EPA toxicologists. In
addition, our library has many rare publications that are useful when determining
the historical usage of ingredients.
We create a detailed, professional GRAS dossier for your product that is
signed by the expert panel. The dossier includes a thorough introduction
of your product, all available toxicology and safety data, extensive literature
reviews and references. When appropriate, we prepare GRAS self-affirmation
notifications for FDA review.
The acronym GRAS stands for Generally Recognized As Safe. GRAS ingredients
are becoming increasingly valuable as the functional foods market explodes.
The FDA’s proposed regulation, issued on April 17th, 1997 created a
GRAS self-affirmation and FDA notification procedure. A GRAS determination
is made by an expert panel if, after an independent and collective critical