Marketers call it a nutraceutical, R&D says it’s a dietary supplement, but FDA calls it a Drug - what is it?!
In the world of regulatory affairs, the regulatory category to which your ingredient belongs can drastically impact your ingredient compliance pathway. This is a crucial strategic consideration for your business as the difference in the timeline to compliance for GRAS or a drug approval can easily be 10 to 15 years, not to mention the significant increase in supporting scientific data for a drug approval that can easily cost millions more than the requirements for GRAS. With that, it is absolutely essential to understand the regulations, guidance, and ethos that determine how regulators categorize your ingredient as these will determine your strategic decisions when it comes to your claims, product development, and sales strategies.
As ingredient safety and regulatory consultants, Burdock Group strives to meet both your regulatory and strategic goals. Founder and President, Dr. George A. Burdock, explains the differences between food, drugs, and supplements and equips you with the tools necessary to understand which category works best for your ingredient.
*The information contained in this video is provided for informational purposes only and should not be construed as legal advice on any subject matter. You should not act or refrain from acting based on any content included in this video without seeking legal or other professional advice. Please contact Burdock Group by visiting https://www.burdockgroup.com to help answer any questions you might have or to engage our service.*