Novel Ingredients for Human or Animal Food; Cell-Based Meats
Novel substances intended to be used as food additives or ingredients for human or animal consumption generally require premarket approval by the U.S. Food and Drug Administration or equivalent agencies in other countries. In the U.S., developers of such products have several options to successfully get such products to market, including the traditional food additive petition (FAP) process or a determination that the substance qualifies for Generally Recognized as Safe (GRAS) status. For animal food ingredients, there is a third alternative, seeking a new ingredient definition from the Association of American Feed Control Officials (AAFCO). The different options each have advantages and disadvantages, which can be challenging for companies to understand and make informed decisions.
In addition, recent advances in biotechnology, cell culture
techniques and other innovative technologies have led to the
development of plant-based and cell-based meat alternatives.
Questions have been raised about how well government regulatory
systems are equipped to efficiently oversee these new products
in a manner that ensures product safety and consumer confidence
while not overburdening or overly-delaying the introduction of
novel products. In the U.S., the key regulatory agencies have
reached agreement on a set of principles for how these products
would be regulated, but the details are still not known.
D. Glass Associates, Inc. can assist companies learn about or comply with regulations governing novel food ingredients for human or animal consumption, and with the emerging regulatory framework for cell- or plant-based meats, including the following:
|David J. Glass, Ph.D. has over 30 years experience in the biotechnology industry, including extensive experience with the regulation of industrial biotechnology, and recent experience managing regulatory affairs for a major U.S. renewable fuels company. Dr. Glass has assisted several companies in preparing and filing GRAS Notices, Food Additive Petitions and AAFCO Definition requests, and he has also advised clients on regulatory requirements for several types of FDA-regulated products, including food and feed additives, cosmetics, color additives and dietary supplements (nutraceuticals). Dr. Glass has extensively published and presented on numerous topics in biotechnology regulatory affairs, including FDA regulatory regimes for animal food ingredients and cell-based meat products.|
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