Protect your brand from expensive regulatory penalties
"Boosts immune health," "Helps you stay on task," "Soothes sore muscles," "Promotes relaxation." These are all examples of structure / function claims. If your brand is making claims about your product's ability to impact the human body, the FDA requires you to have a professionally compiled scientific substantiation dossier and to register your claims (section 403(r)(6) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 343(r)(6)).
The FTC also has the authority to impose legal penalties for insufficient product claim substantiation. A scientific substantiation audit is one of the best investments into your company's future you can make.
Our team can prepare your entire substantiation dossier, ensuring you meet the FDA and FTC's standard of "competent and reliable scientific evidence." With expertise in both clinical research and integrative health, our team can be sure that your dossier includes not only the evidence supporting your product, but the entire body of literature.
While the compilation of a comprehensive dossier with expert summaries ensures that your product meets regulatory guidelines, it also has benefits for customer confidence and can unlock new marketing potential. By having your entire dossier professionally compiled, you may discover new claims that are already substantiated.
Dossier Review & Analysis
The FDA and FTC use the standard of "competent and reliable scientific evidence" which is defined as "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."
In other words, your substantiation dossier is not a DIY project. This doesn't mean your team cannot or should not play a role in the compilation of your substantiating evidence. If you have already compiled a packet of evidence; you're off to a good start! Our team can professionally review your documents and make recommendations or issue statements of support.
Structure Function Claims Substantiation Includes
Not all scientific evidence is available in the published literature. Our team's expertise allows us to locate additional research, both published and unpublished, providing a more robust and diverse collection of evidence.
Expert opinion adds value to your dossier. Our compilations and reviews include a summary of our findings. This summary may also be published in the scientific literature, adding further weight to your dossier.
Hourly fees and estimates can quickly become costly for complex projects. Our team provides you an affordable, flat rate at the start of the project, ensuring there are no surprises.
In the event that sufficient evidence does not exist in the literature to substantiate your claims, our team will make recommendations for alternate avenues to pursue.
Thanks to our team's expertise in integrative health, dossier compilation services are not limited to a single effect of your product. Your dossier will also include an overview of any additional claims your product may pursue.
New to the FDA structure function claims notification process? No worries. If your team compiles or reviews your dossier, we will also walk you through the notification process so you are fully compliant.