FDA Warning Letters to Cosmetic Companies

The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics. Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning letters; however, in the past few months FDA has sent warning letters to two cosmetic companies.

In a June letter to Set-N-Me-Free Aloe Vera Company  FDA objected to therapeutic claims on the cosmetic products.  Cosmetics may be marketed to cleanse, beautify, promote attractiveness and alter appearance but not to affect the structure or function of the skin.  While in this warning letter FDA objected to some outrageous claims about cancer, it also included the following claim, which is a lot like many seen in the market today:

“Natural B-vitamins in the safflower and avocado oils
[ingredients in this product] help in cell formation and build skin-immune
functions. These oils renew skin flexibility by permeating natural vitamins A
and E into skin cells, making regeneration of these cells occur faster.”
The claims about immune function and regeneration are problematic, going well beyond cleansing, beautifying, promoting attractiveness and altering appearance. Last week FDA published a letter sent to Vienna Beauty Products.This was the most disturbing warning letter I have ever read about a cosmetic company. According to the letter Vienna Beauty Products were producing cosmetics under unsanitary conditions that included:
“Apparent filth and dust build up on manufacturing equipment in the production area” 
“A layer of sediment and encrusted material was observed on the exterior and tops of production kettles.”
“The last cleaning [of the production room floor] was performed November 2010.”
“The 250 and 500 gallon kettles were last cleaned 15 years ago.” 
“The last cleaning of the 400 gallon shower gel kettle could not be determined.” 
“Additionally, the finished product storage tank and storage totes were said to have last been cleaned over 20 years ago.” 
Not surprisingly, these conditions led to production of products with high bacterial counts.  The scary thing is that Vienna Beauty Products manufactures several private label lines of product for major retailers. Since registration of cosmetic manufacturing facilities is voluntary, I wondered how the FDA ever discovered all the problems at Vienna Beauty Products.  I noticed that the warning letter was signed by Paul Tietell, District Director of FDA’s Cincinnati District Office.  Mr. Tietell used to be in the Denver District Office and I had the pleasure of serving with him on the board of the Rocky Mountain Regulatory Affairs Society, so I wrote to ask him how cosmetic companies come to FDA’s attention.
Here’s his reply,
“Cosmetic establishments may find their way to FDA’s OEI (Official Establishment Inventory) in a variety of ways.  In addition to the firm registering with FDA through the VCRP, the firm may also be a manufacturer required to register under one of many existing regulations. The firm may have been involved in a complaint (Consumer, Med-Watch other agency referral) and have been entered into our OEI in conjunction with our receiving and recording of that complaint. The firm may have come to the attention of the FDA through general surveillance of retail sales, by observation during and employee’s day to day operations, or perhaps through observation of an advertisement.”
This means that if you advertise or sell cosmetics, you could be subject to FDA inspection.  It also means that you should review your manufacturing methods against FDA’s Inspection Checklist and be sure to have your labels reviewed for regulatory compliance.
Cosmetic companies provide products to help make the world beautiful and attractive.  The folks at FDALabels.com and Bioscience Translation & Application would like to help you keep your business beautiful.  Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

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