Heading to Anaheim next week for Engredea/Natural Products Expo West? Our clinical and regulatory team will be there with bells on, ready to answer all your burning questions!
Manufacturers bringing new substances to the U.S. market must notify the Food and Drug Administration (FDA) 75 days in advance. The requirement, known as New Dietary Ingredient (NDI) notifications, was well-intentioned at the time it was implemented in 1994 but remains a source of debate and confusion for the dietary supplement industry.
GRAS is an acronym for Generally Recognized as Safe. GRAS status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act). Its purpose was to exempt certain food ingredients from the definition of food additive.
It's no secret that bringing a product to the next level can be a challenge. There are many hurdles you'll need to overcome, whether your goal is to support a new claim or re-position your product for a new market segment (read about some of these regulatory and R&D challenges here).
In today's post we've rounded up some of the most common questions we hear at industry events like Engredea and Ingredient Marketplace in the hopes that our answers will help you overcome your latest product development challenge.
Authored By: Dr. Robert S. McQuate, Ph.D., and Dr. Richard C. Kraska, Ph.D., DABT of GRAS Associates LLC, a Nutrasource company
April 17th will mark 18 years since The United States Food and Drug Administration (FDA) published its 1997 proposal to modify the operating procedures for Generally Recognized as Safe (GRAS) evaluations. Besides providing a wealth of information on the GRAS concept with detailed guidance on the requisite information to support a valid GRAS determination, FDA’s 1997 publication proposed discontinuing the GRAS petitioning process while instituting voluntary GRAS notification procedures. Interestingly, FDA began implementing the procedures shortly after they were proposed in the Federal Registerdocument, presumably in anticipation that the procedures would be finalized without substantial changes. The proposed GRAS procedures that are operational with FDA today have not been finalized.
Nutrasource is pleased to announce the acquisition of GRAS Associates LLC. Located in Bend, Oregon, GRAS Associates is a premium supplier of regulatory consulting services for companies seeking a wide range of approvals to bring their products to the marketplace.