Customer “testimonials” and medical claims made on multiple websites have earned Patricia Constans and her company, PA Constans – Minnesota Emu, an official FDA warning letter for how Constans is marketing emu oil products under her EmuMagic® brand.
From the agency’s letter, which is dated February 23, 2018, we learn that PA Constans – Minnesota Emu was the target of a multi-day inspection that took place at the company’s facility in Nevis, Minnesota. While there, FDA inspectors collected product labels and took a peek at the EmuMagic.com website. Based on that, inspectors singled out some of Constans’ products for rebuke:
- Premier™ Emu Oil
- Deep Pain Relief™ Concentrated Analgesic Liquid
The agency also warned Constans for marketing spiel referencing the primary ingredient in those products – emu oil.
Constans was also cautioned about linking to a second website where additional claims were made in the form of customer “testimonials”, which, from a regulatory point of view, are also treated as marketing claims. That second website reportedly referenced the treatment of burns, shingles, radiation side effects, infections, wasp stings and headache.
Of course, none of the cited products have ever been given the official go-ahead to make such claims, says the agency. And that places products like Premier Emu Oil, Deep Pain Relief and OmegaMagic in violation of the Federal Food, Drug, and Cosmetic Act.
Companies making non-allowed claims about supplements and other health products are typically given 15 working days to address the FDA’s allegations and to submit a plan detailing when such patter will be removed from product labels, websites and social media pages. As you can see from the screenshot I took earlier today, Constans has not yet taken down all the allegedly illegal claims from EmuMagic.com.
Categories: FDA Warning Letters