FDA Issues First Warning Letter Since February

The US Food and Drug Administration (FDA) has sent a letter to the CE) of Perfectly Posh, LLC after a March 2017 review of the Salt Lake City, UT-based company’s website. FDA determined that claims establish several products as drugs under the Federal Food, Drug, and Cosmetic Act (the Act). The products include Share Skin Joy Coconut Oil, Goodnight Kisses Overnight Lip Mask, Purifier Snarky Bar, Call it a Night Nighttime Facial Oil, and Lemon Wedgie Caffeinated Lip Balm. 

It was the first letter posted by FDA since February 17,  2017.
 
FDA cited the following examples of some of the website claims:
 
Share Skin Joy Coconut Oil:
·       “Coconut oil … is known to help treat eczema, psoriasis, and can even help treat and prevent acne.”
·       “Rosemary Leaf Extract … is helpful in treating skin issues such as acne, eczema, and chronic dry skin.”
·       “Sunflower seed oil … is effective in combating acne, eczema, inflammation, redness, and irritation.”
Goodnight Kisses Overnight Lip Mask:
·       “Mango Seed Butter also aids in cellular regeneration and is excellent for soothing sunburns…”
Purifier Snarky Bar:
·       “Eucalyptus oil functions as an anti-inflammatory, antiseptic, and antibacterial ingredient. The oil is also a skin-conditioning agent used to treat skin infections and help alleviate skin irritation.”
·       “Peppermint oil is used to relieve skin irritation, itchiness, and redness where inflammation is present. The high menthol content of the oil is also known to allow blood vessels to relax and improve circulation.”
·       “Tea tree Oil, also known as Melaleuca Oil, has anti-microbial, anti-viral, and anti-fungal properties which help with the treatment of acne, dandruff, rashes, sunburns, and other skin conditions.” 
Call it a Night Nighttime Facial Oil:
·       “Lavender Oil has anti-inflammatory and antimicrobial properties and can soothe minor burns and insect bites.”
·       “Green or White Tea Extract has strong antimicrobial … [and] anti-inflammatory … properties.”
·       “Safflower Seed Oil … is known for its ability to treat psoriasis, eczema, and acne.”
Lemon Wedgie Caffeinated Lip Balm:
·       “Caffeine… acts as an anti-inflammatory… and can help protect the skin against sun damage.”
·       “Shea Butter… is effective in improving or treating skin inflammation and irritation such as burns and acne, dark spots, eczema, and psoriasis.” 
 
According to FDA, the June 2, 2017 letter is “not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products on your website that are intended for use as drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.”
 
FDA said it advised the firm to review its website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
Perfectly Posh was given 15 workings day to notify the FDA office in writing of the receipt of the letter as to the specific steps it has taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur.