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Consultants in Food Ingredient/Dietary Supplement Safety, Regulatory Affairs, Nutrition and Product Development


Our Success Continues and Speaks for itself:


Over 35 Generally Recognized As Safe (GRAS) Assessments (2012-2013)


17 FDA GRAS notifications




For details please see our News section

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)




Fellow of the Academy of Toxicological Sciences.

On January 25, 2012, Dr. Soni was accepted as the fellow of this prestigious organization




Society of Toxicology meeting (San Antonio, Texas; March 11, 2013) Chaired session on: “Health Risks of Sodium (Salt) Intake: Too Much or Too Little?”


Society of Toxicology meeting (San Francisco, California; March 15, 2012) Chaired session on: Chemical standardization of botanical products for safe and effective use as therapeutic agents.


Some of Our Recent Activities:


During 2012-2013, we were responsible for completion of over 35 Generally Recognized As Safe (GRAS) assessments; 17 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; 3 New Dietary Ingredient Notifications.


The 17 GRAS Notifications that received “FDA has No Questions” letters include: GRN 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:


http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm368039.htm (FDA-GRAS)


http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm267323.htm (FDA-GRAS)


http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm287614.htm (FDA-GRAS)






Recent publications:


Ravi, K.B., Raghunatha Reddy, K.R., Shankaranarayanan, J., Jayant, J., Deshpande, V., Juturu, V., Soni, M.G., 2014. Safety evaluation of zeaxanthin concentrate (OmniXanTM): Acute, subchronic toxicity and mutagenicity studies. Food Chem. Toxicol. (In Press)


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. 69C:120-131.


Moran, D.L., Marone, P.A., Bauter, M.R., Soni, M.G., 2013. Safety assessment of Apoaequorin, a protein preparation: subchronic toxicity study in rats. Food and Chemical Toxicology 57:1-10.


Kothari, S.C., Shivarudraiah, P., Venkataramaiah, S.B., Gavara, S., Soni, M.G., 2012. Lack of toxicity of Irvingia gabonensis extract (IGOB131): Subchronic toxicity in rats and genotoxicity studies. Food and Chemical Toxicology 50: 1468-1479.


Kothari, S.C., Shivarudraiah, P., Venkataramaiah, S.B., Koppolu, K.P., Gavara, S., Jairam, R., Krishna, S., Chandrappa, R.K., Soni, M.G., 2011. Safety assessment of Cissus quadrangularis extract (CQR-300): Subchronic toxicity and mutagenicity studies. Food Chemical Toxicology 49: 3343-3357.


Ravikrishnan, R., Rusia, S., Ilamurugan, G., Salunkhe, U., Deshpande, J., Shankaranarayanan, J., Shankaranarayanan, M.L., Soni, M.G., 2011. Safety assessment of lutein and zeaxanthin (LutemaxTM 2020): Subchronic toxicity and mutagenicity studies. Food Chemical Toxicology 49/11: 2841-2848.


Chen, S.N., Nan, F.H., Chen, S., Wu, J.F., Chung, C.C., Soni, M.G., 2011. Safety assessment of mushroom β-glucan: Subchronic toxicity in rodents and mutagenicity studies. Food Chemical Toxicology 49: 2890-2898.


Dadhaniya, P., Patel, C., Muchhara, J., Bhadja, N., Mathuria, N., Vachhani, K., Soni, M.G., 2011. Safety assessment of a solid lipid curcumin particle preparation: Acute and subchronic toxicity studies. Food Chemical Toxicology 49(8): 1834-1842.


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.

Soni-CV-SA 2014


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