Requesting Changes at the U.S. FDA
When bringing your product or ingredient to market, it may be necessary, advisable, or strategic from a marketing perspective to make a formal citizen petition to the Food and Drug Administration (FDA), requesting them to take (or refrain from taking) an action. Citizen petitions provide opportunities to validate the standard of quality and efficacy of your product, increase consumer confidence, and increase profitability.
Citizen Petition – Dietary Fiber
Petitioning the FDA that a non-digestible carbohydrate ingredient is a dietary fiber through the demonstration of a beneficial physiological effect in a human via clinical trials.
Citizen Petition – Exemption from 100% Identity Testing
Petitioning the FDA to do less than 100% identity testing, showing that such a sampling model of less than 100% testing does not result in a reduction in product quality.
Citizen Petition – Health Claims and Qualified Health Claims
Petitioning the FDA to make an authorized disease claim can provide market distinction from competitor products in the marketplace.
Submitting a citizen petition can be complex. KGK Science’s team of regulatory experts is uniquely equipped to facilitate a customized solution to meet your regulatory needs, including:
- Expert regulatory toxicologists providing an insider perspective on the quality, safety, and efficacy of your food product or ingredient
- Technical review and GAP analysis to ensure that evidence will meet FDA requirements
- Plan studies or analyses to support the data requirements if required including protocol development, study management, and analysis of results.
- Thorough assembling of data and literature into a comprehensive petition dossier
- Direct, ongoing correspondence with FDA and the submission of the citizen petition on your behalf.
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
Clinical Trials Across 40+ Indications
Data Points Collected
Years In Business
Full Time Employees
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.