Warning Letters & Litigation: Call Us for Help
You’ve spent years developing your product and creating well-substantiated marketing claims. And then the dreaded warning letter arrives from the FDA. Or worse: litigation. Don’t worry – we can help. We’ll work with your legal cousel to provide the scientific expertise and substantiation needed to bolster your case. To find out more contact Dr. Risa Schulman for a free 20-minute consultation.
Turning Great Science into Compelling Claims
Tap-Root’s Dr. Schulman was a featured speaker at this year’s Nutracon, the premier conference for ingredient and technology innovation in the health and nutrition industry. Dr. Schulman led a seminar on “Practical Claims Design: You Know the Regs—Now What Do You Do?” She talked about the need to balance science and marketing when developing claims and the advantages of incorporating claims design early in the product development process.
If you weren’t able to attend Nutracon this year, the May 2013 issue of Nutrition Industry Executive includes a wrap-up that provides an overview of Dr. Schulman’s presentation.
Claim Substantiation Dossier Checklist
The June 2013 issue of Functional Ingredients featured Dr. Schulman’s tips on what to include in every claim substantiation dossier:
- Name the exact ingredient/food/extract that is the subject of the dossier
- List the claim(s) or categories of claims and all wording variations
- Define the intake level to which the claims pertain, as derived from literature
- Provide pertinent scientific background on the ingredient, the health area it is affecting or the specific value-adds of the ingredient
- Detail and cite the papers that substantiate the claim, summarizing them concisely but with the necessary detail
- Include the full spectrum of the literature
- Supply a solid, comprehensive, readily available justification of your claims
Contact us if you need help developing your claim substantiation dossier.