The provisional settlement will see NBTY reimburse consumers to the tune of $2.1m after the FTC took umbrage at claims and contents of the omega-3 products marketed by characters such as Winnie the Pooh, Cinderella and Nemo from the film, Finding Nemo.
The agency said the settlement with NBTY and two subsidiaries – NatureSmart LLC and Rexall Sundown – was part of its ongoing crackdown against products making “bogus health claims”. It found the products were making misleading and unsupported brain and eye claims as well as overstating the amount of DHA (docosahexaenoic acid) in the multivitamin supplements and gummy bears.
“Product packaging and print ads promoting the vitamins had bold graphics highlighting that the products contained DHA, but in reality, the products allegedly had only a trace amount of DHA,” the FTC wrote of the settlement.
“While the vitamins’ packaging touted the purported health benefits of 100 milligrams of DHA, a daily serving of the Disney and Marvel multivitamins for children ages four years and older contained only one thousandth of that amount (0.1 mg or 100 mcg), according to the FTC’s complaint.”
Adam Ismail, the executive director of the Global Organization for EPA and DHA Omega-3s (GOED) welcomed the settlement, and highlighted its signal of increased FTC vigilance in dietary supplements.
“The broader industry should take it as another signal that the FTC is increasing its enforcement activities related to omega-3s and children’s products, so companies need to ensure they have substantiated claims that are not misleading,” he said, noting the $2m fine, “sent a strong message”.
But “scientific substantiation” is not something that is set in stone. Unlike recent settlements with Nestle and Iovate Health Sciences, the FTC did not specify how many human, clinical trials are necessary to achieve substantiation. In those cases the number was two.
In the NBTY settlement it stated only that products must, “possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”
That meant, it added, “competent and reliable scientific evidence means tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results.”
NBTY responded by stating: “This resolution reaffirms our commitment to labeling transparency and adherence to the highest standards of regulatory compliance. It also allows us to continue to focus on providing high-quality nutritional supplements that help improve health and quality of life for millions of customers nationwide.”