Dietary Supplement Health Claim Substantiation: A Healthy Balance of Scientific Evidence and Risk Management Create a Winning Combination

July 2, 2013 By

A dietary supplement health claim substantiation assessment during product development may help to bring your product to market with ease.

Dietary Supplement Health Claim Substantiation

Health claim substantiation for your dietary supplements must be based on competent and reliable scientific evidence which has been defined by the Federal trade Commission (FTC) 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”. Furthermore, the United States Federal Drug Administration (FDA) has recently issued warning letters to several companies who are marketing their products using unsubstantiated health claims. To ensure the claims on your product labels and websites are fully substantiated, dicentra has a team of educated and experienced scientists available to assist with your claim substantiation needs.

Dietary Supplement Health Claim Substantiation: Risk Management

As with any review, there is the risk that the results of the health claims substantiation assessment are negative and that our scientific team cannot confirm your desired claims are fully substantiated. To manage this risk, is it advisable to be proactive with your claim substantiation needs and request a claim substantiation assessment during the product development phase of your product launch. Our educated and experienced scientists can provide you with a conclusive evaluation of the available research on your dietary supplement through use of our comprehensive database of research papers. A claim substantiation assessment will provide you with a professional opinion as to whether your preliminary formula is sufficient to support your desired health claims.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or