Frequently Asked Questions

There are so many steps involved in the process in getting my product approved – it seems overwhelming. How do I get started?

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You can’t be expected to do everything yourself. The process of approving a new food or dietary supplement ingredient can be overwhelming and the territory unfamiliar. The FDA is very particular about observing regulations, but protocol as well, so choosing an experienced partner mitigates your risk. Choosing the right partner is critical and how better to demonstrate experience with a track record of proven success.

How does this process work?

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It is important to understand the process your consulting firm uses when conducting product assessments and approvals for your company. It is advantageous to both parties to ensure that the project starts and finishes on time, as expected, with a realistic and clearly defined path. Burdock Group has designed a system that works, and our clients agree after experiencing it firsthand. Upon contacting Burdock Group, you will be invited to schedule a discussion which will include a thorough needs assessment. We want to know about your company, your new product, your budget, timeline, anticipated outcome and the ultimate goal for your product .

Even if you are unsure of the next steps, we can guide you through complex questions to help ascertain the best plan of action. After identifying your unique needs, we will design a customized plan for your next steps. This includes our recommendation of a feasibility study to evaluate publicly available data or your own data to determine what research and tests (if any) should be conducted. The feasibility study usually takes between 4-6 weeks and allows us to determine how best to proceed with your product based on the data set available. While every product is unique and every project will be crafted and designed differently, we have streamlined the process so we do not need to “reinvent the wheel”. We believe there is no “One Size Fits All” approach to regulatory work, and we will determine the exact needs for your project.

We will review the feasibility study with you in detail and, from there, plan our next path forward which will include a detailed plan on how your product will progress through all pertinent and necessary steps to approval, notification, or a “No Objection” letter from the FDA.

For every step of each plan, you are provided with a clear understanding of how your product will move through the approval process.

How and when will I know if my ingredient will be approved or notified?

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Burdock Group believes our clients should never be left in the dark throughout the stages of each project. To ensure each one of our clients receives has a project manager assigned to your project that will keep you abreast of all pertinent points in the process including adherence to a preapproved timeline and course of action plan.

The Burdock Group feasibility study offers our “theory of approvability” for your ingredient before you sign on for the “big project.” This allows a company to clearly understand what will be required (time and cost) to generate the necessary data to prove safety. While Burdock Group can not guarantee approval, with appropriate data supporting safety, our work products focus on presenting the data to accomplish the burden of persuasion required for proving safety. We will work with you to create a communication plan that works best for you. Our assigned Project Managers oversee the entire project from beginning to end and keep you in the loop at all pertinent stages in the process. We always welcome phone calls and emails and are happy to engage in regular scheduled phone conferences or conversations with your team.

Can this get done in time and within my budget?

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Many companies offer a “cheap” price up front and then add on extra hours when unexpected challenges arise. At Burdock Group, we believe providing a fair and realistic budget can help your company organize and plan accordingly without any hidden surprises or added costs.

Most of our projects are quoted at a fixed price, allowing you to know the actual cost of the project up front. We’re empowered to follow this model because we have the experience and management in place to understand what resources are required for your project from start to finish. Burdock Group utilizes formal project management to plan, manage and communicate the milestones and timelines for your project. We can also work with you to structure billing according to your budgetary needs. It is critical to ensure that your project is feasible and financially practical. Prior to project initiation, our firm will provide a fair and realistic plan that outlines a realistic timeline and budget considerations.

Getting your product to market quickly has great advantages. Burdock Group wants you to be the one to get there safely. With our customized strategic plan, you can be assured we will create a practical course of action for your product with our Feasibility Study.

The procedure for GRAS submission is very specific and I cannot risk a second submission, what is the history of success with your firm

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Approving a new ingredient requires strict adherence to the FDA’s submission protocol. The FDA requires special forms, studies, reviews , and submission procedures. Burdock Group prides itself on having a 100% success rate on GRAS notifications because we know what it takes to get the job done right the first time.

Burdock Group welcomes prospective clients to peruse the FDA website to see for themselves how successful their consulting firm has been. GRAS Notifications are a matter of public record and may be seen at http://www.cfsan.fda.gov/~rdb/opa-gras.html. With Burdock Group, you can be assured your project will get done right the first time.

I may need more than just GRAS work, and I am not sure of the current laws and regulations for my product. What other services does your firm provide?

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Although industry knows and recognizes us by our GRAS services, Burdock Group also specializes in many other areas of expertise in the United States for the Food/Beverage, Dietary Supplement and Personal Care industries.

Our expertise includes:

* GRAS Feasibility Studies

* GRAS/GRAS Notifications

* New Dietary Ingredient Notifications

* Claims Substantiations

* Food/Color Additive Petitions

* Risk Assessment

* FDA/USDA Representation

* Consumption Analysis

* Label Reviews

* Study Placement and Monitoring

* Manuscripts

We will work with you to determine your needs, goals, and product expectations to ensure your product is on track for success.

What has your consultant published lately?

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Credible scientific consulting firms keep current via regular publishing in recognized and respected journals. You can determine what the firm has published by reviewing its Web site, requesting copies of its most recent publications or reading its research findings directly in the latest issues of scientific journals and trade journals. You may visit http://www.burdockgroup.com/publications.php to see our current list of publications with links to the articles. Happy reading!