Jim Heimbach of JHeimbach LLC is a consultant with more than 17 years of experience dealing with products regulated by FDA and USDA and claims regulated by these two agencies as well as FTC. He has performed GRAS determinations for more than one hundred substances and probiotic bacteria added to foods as well as developed new dietary ingredient notifications for dietary supplement ingredients and substantiation for health claims, qualified health claims, and structure/function claims.

• Regulatory compliance assessments
• Regulatory strategy formulation and advice
• Generally recognized as safe (GRAS) evaluations, feasibility assessments, and FDA notifications
• GRAS expert panel participation, recruitment, and management; preparation of consensus statements
• New dietary ingredient (NDI) notifications
• USDA ingredient approval petitions
• Threshold of regulation determinations
• Food additive petitions, color additive petitions
• Food contact notifications (FCN)
• Biotechnology consultations
• Development and evaluation of substantiation packages for health claims, qualified health claims, and structure/function claims

Telephone or e-mail for more information about services and fees.