Dietary supplements generally contain the dietary ingredients including vitamins, minerals, botanicals, amino acids, enzymes, and other substances such as extracts or concentrates intended to enhance or supplement the diet.

If a dietary ingredient wasn’t marketed in the U.S. before October 15, 1994, it is considered a New Dietary Ingredient (NDI), and an NDIN submission is required. NDIN ensures the ingredient is reasonably expected to be safe under labeled use. SciQra helps companies assess novelty, compile safety data, and prepare submission-ready dossiers.

Evolving regulations make compliance complex. Typical challenges include insufficient safety documentation, unsupported label claims, and failure to meet global contaminant limits. SciQra helps companies overcome these by identifying gaps, providing expert regulatory and toxicology support, reducing the risk of regulatory delays.

The GRAS (Generally Recognized as Safe) notification is a voluntary pathway for companies to inform FDA that a substance is considered safe for its intended use in human food. Unlike NDIN, GRAS is voluntary, but FDA strongly encourages submitting a GRAS notice to demonstrate regulatory transparency and strengthen market credibility. SciQra guides companies through GRAS strategy, safety assessment, and FDA-ready notifications.

SciQra offers comprehensive ingredient safety evaluation, toxicological risk assessment, safety assessment for excipients, impurities, color additives, food additives, and submission guidance for FDA, EFSA, and global markets.