D. Glass Associates, Inc.

Government and Regulatory Affairs
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.

Services Offered

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:

  • Analysis of company plans, and recommendation of best regulatory option for new food ingredients.

  • Preparing and submitting GRAS notifications or Food Additive Petitions to the U.S. FDA.

  • Preparing and submitting AAFCO animal feed ingredient applications.

  • Make recommendations for representation outside U.S. for food regulatory assistance, and serve as liaison to regulatory counsel in other countries.

Qualifications

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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