The first problem: The “clinically proven absorption” claim only applies to vitamins C and D3, but the claim is not effectively limited within advertising, such that consumers could reasonably take away a message that the vitafusion products have all been tested and that all of their ingredients demonstrate clinically proven absorption. NAD notes in the release that there are some places on vitafusion’s site where the company integrates the disclosure into the claim, but that the disclosure is not clear and conspicuous or in close proximity to the main claim on product labels or in video advertisements.
The second problem: Assuming vitafusion appropriately limited the claim, Pharmavite called into question whether or not the claim is backed scientifically, even with regard to vitamins C and D3. Church & Dwight submitted an acute clinical study evaluating a high-dose, single nutrient formulation of vitamin C, and two acute clinical studies evaluating a high-dose, single-nutrient formulation of vitamin D3. NAD noted that the studies tested dramatically different dosages from the dosages present in vitafusion products, but recognized that it is undisputed that vitamins C and D3 are absorbed through both active and passive transport mechanisms. However, Pharmavite argued that the claim communicates that vitafusion has clinical proof of absorption at clinically meaningful levels; vitafusion, on the other hand, maintained that the claim communicates only the fact that vitamins C and D3 are absorbed, and says nothing about the amount of vitamins C and D3 absorbed from vitafusion products. NAD’s conclusion: “Clinically proven absorption” communicates, among other things, that the advertiser has clinical proof of absorption in consumer meaningful amounts. Thus, the claim that vitafusion gummy vitamins will deliver a meaningful amount of nutrients to the body must be supported by evidence in the record.
Related: FDA, FTC Issue Warning Letters to 7 Companies for Coronavirus Claims Ben & Jerry’s Removes “Happy Cow” Claims from Packaging The Dietary Supplement Consumer Bill of Rights
NAD noted that there was no reliable evidence in the record to support Church & Dwight’s argument that any increase in the amount of the essential nutrients vitamins C and D3 in consumers who do not receive enough of them from other sources will benefit these consumers in a clinically meaningful manner. Church & Dwight contends, according to NAD’s press release, that there is no set amount of absorption of vitamins C and D3 that can be defined as “clinically meaningful” across the general population of consumers of dietary supplements. In response, NAD noted: “if the [company] wishes to tout the ‘clinically proven absorption’ capabilities of its vitafusion gummy vitamins, it has the burden of demonstrating the consumer meaningfulness of its results.” Therefore, NAD concluded that the vitamin C and D3 studies were not a good fit to support the messages conveyed by the “clinically proven absorption” claim and recommended that it be discontinued.NAD quotes a statement from Church & Dwight saying that the company will appeal the decision—it “fundamentally disagrees with NAD’s conclusion that the claim ‘clinically proven absorption’ reasonably communicates to consumers the implied message that absorption of vitamins C and D3 occurs ‘at clinically meaningful levels’… or that the challenged advertising making the claim is not substantiated.”
