FDA Sends Multiple Warning Letters

The FDA’s mail room was quite busy over the summer. The agency issued several warning letters in July for claims made by several skin care companies, the latest of which included Freeze 24-7 (owned by TPR Holdings), Peter Thomas Roth, MiN, Lavian, Finally Pure and Michael Todd True Organics LLC. The agency contends all of the firms were going against the rules of section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. 

The letter sent to TPR Holdings, LLC followed reviews of the company’s Freeze 24-7 website in May and July. FDA contends that claims on the brand’s website establish that Freeze 24-7 Instant Targeted Wrinkle Treatment product is a drug because it is intended to affect the structure or function of the human body.  

Peter Thomas Roth Labs LLC was also cited for claims following website reviews in May 2016 and July 2016 related to its Un-Wrinkle Turbo Line Smoothing Toning Lotion and Mega-Rich Intensive Anti-Aging Cellular Eye Crème.   

MiN New York, based in New York, was cited for claims related to its Calming Facial Oil, ProEnzyme Facial Cleanser, ProEnzyme Facial Scrub, and Complex Age Defying Moisturizer, following FDA reviews in May and July.  

Pure, LLC, based in Wasilla, AK, was issued a similar warning letter following a website review in May 2016 related to its Toner for All Skin Types, Unscented Day Cream for All Skin Types, Unscented Day Cream for Extra Sensitive Skin, Unscented Day Cream for Dry/Mature Skin, and Lemongrass Herbal Sore Muscle Massage Oil.

In the Michael Todd True Organics LLC letter, the agency called into question claims made about the brand’s Intensive Cream Eye Treatment and Knu Cream Anti-Aging Face Lift Serum.

Earlier in the month, the agency issued warning letters to the founders of Annmarie Gianni Skin Care, Orange, CT, and Ageless Aesthetics, Inc, Aurora, CA, after reviewing their websites in May 2016 and June 2016, respectively.