WHAT WILL IT COST?

The cost to undertake GRAS determinations varies based on a few critical factors.

• Complexity of the food ingredient--considering the chemical composition and physiological considerations.

• Availability and adequacy of supporting data and studies that address safety and intended food uses of the subject materials.  The more complete and rigorous the information supplied to GRAS Associates by our clients, the greater the cost containment, since the time needed to acquire requisite information by GRAS Associates to perform a rigorous evaluation will be reduced.

Non-binding project cost estimates can be provided based on client representations of the collective information that will be provided to GRAS Associates.


PRELIMINARY GRAS ASSESSMENT

Clients occasionally seek a preliminary opinion as to the likelihood of obtaining a GRAS designation without committing to an in-depth GRAS assessment.  GRAS Associates is happy to accommodate such requests from our clients by performing a Preliminary GRAS Assessment (PGA).  Our PGA entails assessing pertinent information, as noted below, in lesser depth than occurs with the Comprehensive GRAS Assessment (CGA) as described more fully below.  Performing our PGA requires core scientific information as supplied by our client which includes the following information:

• Ingredient identify with specifications
• Production procedures
• Ingredient use history and intended food uses
• Safety studies and related information addressing safety

GRAS Associates may then augment the client-supplied materials by performing a limited search of the scientific literature for germane published information related to the safety, prior food uses, and possible adverse effects for the ingredient in question.

PGA DELIVERABLE

What does our client receive from the PGA?  As long as sufficient quantity and quality of critical data are available for our review, we provide a brief written report, with an abridged bibliography, detailing our findings.  Any deficiencies in information are noted, as are any “showstoppers.”  A projection based on the composite strengths of the studies is offered as to whether it is probable, possible, or unlikely that we could provide a GRAS designation for the subject material with a more comprehensive investigation.

Should the conclusion from the PGA reveal that it is possible or unlikely that a GRAS determination would result from the Comprehensive GRAS Assessment, we are available to suggest what studies and supporting information would be needed to overcome initial deficiencies.

COMPREHENSIVE GRAS ASSESSMENT

Clients may elect to proceed directly with a CGA without the preliminary evaluation, or they may elect to do so following the completion of the PGA.   GRAS Associates will provide clients with detailed guidance as to what information would be needed---including pharmacokinetic data, toxicology studies, and projected consumption levels. Given our FDA heritage in dealing with food ingredient safety, GRAS Associates utilizes guiding principles developed at FDA to assist our clients.

Refined cost estimates are provided based on the projected number of hours that would be needed for project completion and the size of the Expert Panel desired by our client. 

CGA DELIVERABLE

GRAS Associates compiles a draft report for review and comment by the client.  Based on all available information and feedback, we prepare a final report that contains all critical information that has a bearing on the GRAS conclusions for the ingredient of interest. Included in the final report are summary tables of pertinent animal and human studies and human exposure estimates.  Critical studies and published articles are appended, and a complete bibliography is incorporated.  All of the items noted form the basis of our GRAS Dossier that is presented to our client.

GRAS determinations can be provided by a single expert or by a panel of 2-5 members with the costs increasing as the panel size increases.