GRAS Associates

offers a focused array of food ingredient and food safety consulting services that assist clients to obtain, maintain and defend GRAS opinions
while supporting related business objectives.

New Dietary Ingredient Notifications to FDA

Section 413(c) of the Federal Food, Drug, and Cosmetic Act requires the submission of a notification for a dietary ingredient that was not marketed in the United States as a dietary supplement before October 15, 1994.  GRAS Associates is well versed with these requirements and assists clients in compiling the needed information and prepare and submit the notification. GRAS Associates is especially valuable in responding to any FDA questions.

Research and Testing

We design  any scientific studies, such as toxicology and residue/impurity determinations, that are needed to support a GRAS determination, NDI notification, or food additive submission.  GRAS Associates can  negotiate, monitor and undertake data review associated with the placement of studies at high quality contract or university laboratories.

Technical Writing

GRAS Associates generates accurate and effective marketing literature on behalf of our clients. We ensure that this literature is developed with appropriate sensitivity to FDA and FTC regulatory concerns.

Customer Presentations

We can strengthen the marketing of your GRAS ingredients and NDIs by accompanying you on customer calls and giving high quality presentations on the legal and scientific elements of GRAS determinations and NDIs.

Literature Surveillance

GRAS Associates offers continuing service contracts for monitoring the scientific literature on your GRAS substances and NDIs. We can devise a schedule of periodic reports to meet your needs and will immediately alert you of any important new findings.

Food and Color Additive Petitions