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.
Leading Clinical Research Since 1997
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350
Clinical Trials Across 40+ Indications
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150
Publications
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10M
Data Points Collected
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23
Years In Business
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85
Full Time Employees
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25,000
Participant Database
Supporting Your Business with High-Quality Expertise
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.
As part of our multi-million-dollar research program, KGK has played an important role in helping us confirm the health benefits of our products, especially VitaFiber IMO. Their clinical trial research has contributed to our submission and product acceptance by the world’s top health regulatory agencies. They are a thoroughly professional organization with a strong understanding of businesses’ requirements.
We are so grateful to have been introduced to the professional team at KGK Science. They were patient with our inexperience, assisted us in building a reputable program, created education opportunities with top-notch experts in the field of Dietary Supplements and FDA regulations and guided our models to create truly imaginative studies that will contribute to the scientific body of knowledge in an honorable way.
KGK is responsive and adaptive to our needs, which is important to get a human clinical trial done with good design and within the time frame.
