Spherix Consulting provides comprehensive food industry practice guidance and advisory. Services include all aspects of science and regulation affecting the food industry, including U.S. and EU regulation of food ingredients and packaging materials, labeling, advertising and promotion of food products and food enforcement.
Food and Nutrition Advisory provides strategic, legal, regulatory and scientific support for:
- GRAS (Generally Recognized as Safe) self-determinations and notifications—covering GRAS ingredients or food additives for functional foods, nutraceuticals, medical foods, infant formulas and animal feed. Spherix consultants have prepared over fifty GRAS determinations of new and novel food ingredients including bioactive ingredients, macronutrients, fermentation products, and bioengineered foods.
- Food Labeling and Advertising—covering all aspects of label, health claim or structure/function claim support and substantiation. Spherix consultants assist clients in the identification and screening of candidate ingredients against agreed-upon criteria to evaluate bioactive compounds for potential use as functional food or dietary supplement ingredients, in dossier preparation and in handling FDA or FTC label claim investigations.
- Dietary Supplements and New Dietary Ingredients—covering foods that claim beneficial health effects and are subject to The U.S. Dietary Supplement Health and Education Act (DSHEA) of. Spherix consultants evaluate the composition and market history of the proposed supplement to determine if an NDI notification is necessary, perform a critical, technical review of the available chemical, toxicological, and clinical data and documentation, provide analytical, pre-clinical and clinical study support, assist in the preparation of NDI dossiers and provide regulatory support.
- Food Contact Substances (FCS)—covering paper and plastic packaging, active packaging and others that fall under the Food and Drug Administration Modernization Act of 1997 (FDAMA). Spherix prepares food contact notifications, and can assist clients with fulfilling the data needs to complete the chemistry, use, intended technical effect, migration testing, consumer exposure, safety, and comprehensive toxicological profile sections of the food contact notification.
Spherix Consultants with expertise in Food and Nutrition include Claire Kruger, Ram Nimmagudda, Wally Hayes, Rob Lodder, Nancy Booth, Yongming Lu
