Another Shot Across the Bow of Cholesterol Health Claims – Pharmavite Changes Labels and Advertising for CholestOff in Face of FTC ChallengeMay 31, 2009
The FTC has closed its investigation of Pharmavite’s advertising campaign for CholestOff dietary supplements, which contain free form phytosterols and are promoted to lower cholesterol. According to the April 2009 letter, Pharmavite used “advertising and labeling claims that CholestOff is clinically proven to lower to lower cholesterol and, more specifically, that CholestOff lowers LDL cholesterol up to 24% or 42 points.” FTC questioned whether there is adequate substantiation for these claims because most studies testing the effect of phytosterols on cholesterol involve either conventional foods, or dietary supplements that contain phytosterols in their esterified form (CholestOff contains phytosterols in their free form). FTC also noted that the more specific cholesterol-lowering claims made by Pharmavite “singled out the most dramatic reductions” in the underlying studies. FDA recently challenged similar claims made for General Mill’s Cheerios based on the allegation that the claims are illegal drug claims.
FDA regulations authorize health claims that “describe the relationship between diets that include plant sterol or stanol esters and reduced risk of heart disease,” but only in the labeling of certain types of conventional food and dietary supplements, and only those that contain esterified phytosterols (21 C.F.R. § 101.83). In 2003, FDA issued a letter stating that the agency would consider exercising enforcement with respect to these requirements, thereby opening the door to the use of the claims in the labeling of other types of conventional food and dietary supplements, including those that contain phytosterols in their free forms.
Citing FDA's letter of enforcement discretion and Pharmavite’s agreement to remove the claims to which the FTC had objected, FTC decided not to take action against Pharmavite’s more general claims even though in the FTC’s view there are concerns about whether even these claims are substantiated.