Our Success Continues and Speaks for itself:
- Dr. Soni has been cited as most prolific GRAS Expert Panelist (ranked in top five), as per Food Chemical Toxicology publication by independent authors- http://www.sciencedirect.com/science/article/pii/S0278691517301667
- Over 30 Generally Recognized As Safe (GRAS) Assessments (2017-2018)
- 14 FDA GRAS notifications
For details please see our News section
Consultants in Food Ingredient/Dietary Supplement Safety, Regulatory Affairs, Nutrition and Product Development
About Us
Soni & Associates, Inc. is a consulting team of professionals providing clients with solutions. With our expertise in toxicology and regulatory issues let our dedicated and specialized team work with you to ensure your product safety and regulatory compliance needs relating to FDA, USDA and EPA are satisfied.
We offer the following services and more:
Food and beverage ingredients (Generally Recognized As Safe- GRAS determination/notification, Food Additive assessment, Food and Color Additive Petition, Qualified Health Claims).
Dietary supplements (New Dietary Ingredient Notification- NDIN; Structure Function Claims; DSHEA compliance)
News
Recognition:
As per an independent recent article Dr. Soni has been cited as Most prolific GRAS Expert Panelist [ranked in top five, as per Food Chemical Toxicology 105 (2017) 140-150] Complete article available at: http://www.sciencedirect.com/science/article/pii/S0278691517301667 .
Dr. Soni has been awarded the title of Fellow Academy of Toxicological Sciences (FATS). The Academy of Toxicological Sciences (ATS) has certified toxicologists who are recognized by their peers for their expertise and sound scientific judgment.
Meetings:
Society of Toxicology meeting (San Antonio, TX; March 11-15, 2018) Session Chair and speaker: “Arsenic, a Gift and Malice: From Discovery to Detrimental Effects, a Historical Perspective” (session approved by SOT)
Society of Toxicology meeting (Baltimore, MD; March 12-16, 2017) Invited Speaker at session on: “Clinical and toxicological aspects of Ayurvedic medicinal remedies with high levels of heavy metals”
Some of Our Recent Activities:
During 2017-2018, we were responsible for completion of over 30 Generally Recognized As Safe (GRAS) assessments; 14 FDA GRAS notifications for which we were involved directly or indirectly as either assisted in the preparation of notification or worked as Expert Panel member.
The recent 14 GRAS Notifications and others that received “FDA has No Questions” letters include:
GRN 787; GRN 683; GRN 661; GRN 623; GRN 609; GRN 608; GRN 605; GRN 601; GRN 600; GRN 597; GRN 588; GRN 569; GRN 518; 000483; GRN 000481; GRN 000470; GRN 000460; GRN 000437; GRN 000433; GRN 000427; GRN 000425; GRN 000419; GRN 000418; GRN 000414; and GRN 000413; GRN 000411; GRN 000403; GRN 000401; GRN 000395; GRN 000391.
For some of our recent FDA GRAS Notifications, follow the web-links given below:
FDA GRAS, GRN 661- Fucoidan from Fucus vesiculosus; Available at:
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm549588.pdf
FDA GRAS, GRN 623- Fructooligosaccharide; Available at:
http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm528359.htm
FDA GRAS, GRN 600- Hydroxytyrosol; Available at:
http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm511406.htm
Publications
Recent publications:
Chen, S.N., Chan, C.S., Chen, S., Soni, M.G., 2018. Subchronic toxicity and genotoxicity studies of Antrodia mushroom β-glucan preparation. Regul. Toxicol. Pharmacol. 92: 429-438.
Miraglia, N., Bianchi, D., Trentin, A., Volpi, N., Soni, M.G., 2016. Safety assessment of non-animal chondroitin sulfate sodium: Subchronic study in rats, genotoxicity tests and human bioavailability. Food Chem Toxicol. 93:89-101.
Ravi, K.B., Raghunatha Reddy, K.R., Shankaranarayanan, J., Jayant, J., Deshpande, V., Juturu, V., Soni, M.G., 2014. Safety evaluation of zeaxanthin concentrate (OmniXan™): Acute, subchronic toxicity and mutagenicity studies. Food Chem. Toxicol. 72: 30-39.
Kothari, S.C., Shivarudraiah, P., Venkataramaiah, S.B., Gavara, S., Arumugam, S.N., Soni, M.G., 2014. Toxicologic evaluation of Dichrostachys glomerata extract: Subchronic study in rats and genotoxicity tests. Food Chem. Toxicol. 69:120-131.
Our Team
Madhu Soni, Ph.D.
Fellow Academy of Toxicological Sciences
Fellow American College of Nutrition
Dr. Soni has over 15 years of experience dealing with regulatory issues related to product safety and risk assessment. Dr. Soni has generated over 200 technical reports as a consultant and as a scientist for various clients including corporations, law firms and individuals. He has published over 70 peer reviewed articles in scientific journals. His experience includes Director of Research at Vero Beach Hematology Oncology, Senior Toxicologist at a consulting firm, Research Assistant Professor at the University of Louisiana, and Research Scientist at the National Institute of Nutrition in India. Dr. Soni received his post-doctoral training at Jichi Medical School in Japan and University of Mississippi. He has considerable experience in risk assessment, drug metabolism, toxicokinetics, toxicodynamics, molecular toxicology, cancer biomarkers, and chemoprevention. He is a Fellow of American College of Nutrition and is a member of the Society of Toxicology. Dr. Soni received several awards for his research, the notable ones are the Best Paper Award from the Risk Assessment Specialty Section of Society of Toxicology in 1998, and the Board of Publications Award for the Best Paper Published in Toxicology and Applied Pharmacology in 1999. Dr. Soni may be contacted at msoni@soniassociates.net
Curriculum Vitae
Helen Lopez, M.S.
Research Associate
Ms. Lopez received her Masters degree in Applied Sciences from the University of Tasmania, Australia. She received her Bachelor of Science degree in Marine Biology from Florida Atlantic University. Ms. Lopez specializes in food and dietary supplement labeling, regulatory reviews for the food and dietary supplement industry, scientific data retrieval, and exposure assessment analysis. She possesses strong writing, analytical, and problem solving skills. Ms. Lopez may be contacted at hlopez@soniassociates.net
Melinda Swetz, B.S.
Research Associate
Ms. Swetz received her Bachelor’s degree in Food and Resource Economics from the University of Florida. Ms. Swetz specializes in consumption analysis and scientific data retrieval. She possesses strong project management and report analysis skills. Ms. Swetz may be contacted at mswetz@soniassociates.net
Amol A. Soni, M.S. Ortho (USAIM); DNB (Ortho)
Research Associate
Dr. Amol received his bachelor’s degree in medicine from Mahatma Gandhi Mission's Medical College, Aurangabad. Subsequently, Dr. Amol received extensive training in the treatment of musculoskeletal problems and completed his M.S. in orthopedics at Cooper Municipal General Hospital, Mumbai and D.N.B. also in orthopedics at YCM Hospital Pune. Dr. Amol handles our business activities in India. He can be reached by email at asoni@soniassociates.net or by phone at +91-973-003-7070.
Contact
USA Office:
Address: 973 37th Place
Vero Beach, FL 32960, USA
Phone: 772-299-0746 (USA)
Fax: 772-299-5381
Mobile: 772-538-0104
Email: msoni@soniassociates.net