Letters of Support (Pre-DSHEA)
Verifying Old Dietary Ingredient (ODI) Status
Ingredients used in dietary supplements prior to the Dietary Supplement Health and Education Act (DSHEA) of 1994 are considered Old Dietary Ingredients (ODIs) and require documentation to verify their status as such in order to be exempt from the submission of a New Dietary Ingredient (NDI) notification to the FDA.
A letter of support verifying ODI status is a cost-effective and efficient way to validate that an ingredient is safe for consumers based on historical use, supported by product and manufacturing records.
KGK Science’s regulatory operations experts conduct thorough investigations into the available marketing information and scientific literature supporting the sale of your product or ingredient prior to the enactment of DSHEA.
- Research via a robust library of old, grandfathered, pre-DSHEA dietary ingredients
- Independent and verifiable evidence in the form of product labels, bills of lading, ingredient supply catalog entries, and other available records
- Official letter of support summarizing findings required to substantiate ODI status
- Expert advice to minimize regulatory risk.
Regulatory Consulting Expertise
Led by a former FDA Regulator, KGK’s seasoned regulatory experts are uniquely equipped to provide an insider’s perspective into regulatory operations and the most effective way to navigate a timely and compliant path-to-market. Backed by a vast network of scientific, legal, and regulatory professionals, you’ll receive dedicated support throughout each step of the process.
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As a premium full-service contract research organization, KGK Science provides clinical trial research and regulatory services that meet the highest quality standards, customized to meet the needs of our clients. Contact us today and stake your claim.