Generally Recognized As Safe . . .


WELCOME


              2
0482 Jacklight Lane                                                      541-678-5522
              Bend, OR 97702                                                                mcquate@gras-associates.com
                                                                                                             www.gras-associates.com

         


Clyde A. Takeguchi, Ph.D.


Biography


Clyde A. Takeguchi, Ph.D has over three decades of experience in FDA and independent consulting,specializes in regulatory issues regarding food, drugs, devices and animal feed. He has experience with premarket procedures for food additives, food irradiation, GRAS and Food Contact Substances; CMC sections for NDAs, ANDAs, DMFs and INDs; and compliance issues for dietary supplements, LACF registration, food labeling and imports. His FDA experiences with food and food irradiation issues and his pharmacology research at the National Institutes of Health and at the Medical University of South Carolina provides a good basis for assisting clients with regulatory and scientific issues.   Dr. Takeguchi has a B.A. in Chemistry, a M.S. in Food Science, and a Ph.D. in Pharmaceutical Biochemistry. 

FDA Experience

As a consumer safety officer in the Food Additives Policy Staff, Division of Food and Color Additives, Center for Food Safety and Applied Nutrition:

  • Reviewed food additive petitions and authored regulations on food irradiation, retortable pouches, adhesives, and plastics
  • Participated in an internal review and evaluation of issues pertaining to the total food label
  • Monitored indirect additive petition review as Project Officer in the Food Additives Program
  • Conducted an analysis of the time needed to complete reviews of food additive petitions
  • Dealt with controversial issues on the use of various food additives and GRAS ingredients, such as food irradiation and monosodium glutamate
  • Detailed to supervise the Direct Additives Branch dealing with direct food additives, color additives, and GRAS petitions for several months
  • Involved in Congressional hearings, FDA briefings, and talks and lectures to industry, international visitors and the public on the subject of food             irradiation

As a consultant,

  • Provided expert consultative advice on regulatory issues regarding food and animal feed, food irradiation, drugs, devices, and labeling, with expertise in food additive petitions (direct, indirect and animal feed additives), GRAS, FCS, and NDI notifications, expert panel management, low acid canned food registration, and food labeling,
  • Considered an international expert on food irradiation and was a temporary advisor to World Health Organization (WHO) on food irradiation in 1997 – 1998.

Phoenix Regulatory Associates, LTD. - Sterling, Virginia - 1991 to Present

As a Senior Consultant, provides expert consultative advice on regulatory issues regarding food and animal feed, food irradiation, drugs,devices, and labeling, with expertise in food additive petitions(direct, indirect and animal feed additives), GRAS, NDI and FCS notifications, expert panel management, food labeling, and the CMC sections of INDs, NDAs, ANDAs, and DMFs.  He is considered an international expert and was contracted by FDA to draft an expert report on MSG.  He has directed major compliance projects for pharmaceutical, medical device and food companies. He has also managed large projects to aid pharmaceutical companies in meeting consent decree requirements.  He was a temporary advisor to World Health Organization (WHO) on food irradiation in 1997 - 1998.

Hazelton Corporation - Herndon, Virginia - 1990 to 1991

As a senior consultant on foods in Hazleton’s Regulatory Affairs Division,provided senior consulting services for regulatory issues regarding GRAS ingredients, food additives and animal feed additives. In this capacity, acted as liaison for clients on matters before the U.S. Food and Drug Administration.

Division of Food and Color Additive - Food and Drug Administration - 1977 to 1990

As a consumer safety officer in the Food Additives Policy Staff,Division of Food and Color Additives, Center for Food Safety and Applied Nutrition, dealt with controversial issues raised by the use of various food additives and GRAS ingredients, such as food irradiation and monosodium glutamate. Conducted an analysis of the time needed to complete reviews of food additive petitions. Also detailed to supervise the Direct Additives Branch dealing with direct food additives, color additives, and GRAS petitions for several months. Monitored indirect additive petition review as Project Officer in the Food Additives Program. Authored regulations on food irradiation, retortable pouches, adhesives, and plastics. Involved in Congressional hearings, FDA briefings, and talks and lectures to industry,international visitors and the public on the subject of food irradiation.

Department of Pharmacology - Medical University of South Carolina - 1975 to 1977

Managed the laboratory and conducted research on membrane receptors and protein-lipid-protein interaction. Instructed graduate students and medical students topics in molecular pharmacology and experimental methods in pharmacology.

National Heart Lung Institute - National Institute of Health - 1973 to 1975

Conducted research and published articles on the sodium potassium AT Pase membrane receptor system.

Earlier Experience

Education

Honors

Membership

Publications