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.”
“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.”
“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.”