Questions arise over regulation of eyelash enhancer

Revitalash, by Athena Cosmetics, is just one example of various eyelash enhancing products claiming to achieve 'long, beautiful, healthy looking lashes​'. Although the product is marketed as a cosmetic under the Food Drugs and Cosmetics Act, Dr Leslie Baumann of the University of Miami suggests in an article in Skin and Allergy News, that these products 'may be acting in ways that are similar to the actions of drugs used to control intraocular pressure in glaucoma patients'​. Increased intraocular pressure, IOP, (the fluid pressure inside the eye) is an important risk factor for glaucoma, a group of diseases affecting the optic nerve that if left untreated can lead to vision field loss and even blindness. Pressure can be limited by either reducing the amount of aqueous humour being produced by the ciliary body, or increasing the outflow of the fluid. Eye drops containing prostaglandin or prostamide analogues are possible treatments for IOP as they improve the drainage of the aqueous humour. An example of such a treatment is Bimatoprost (Lumigan) a prostamide analogue, introduced by Allergan, a global pharmaceutical and medical device company, in 2001. However, past studies have demonstrated that possible side effects of this type of IOP treatment include increased eyelash growth as well as changes to the pigmentation of the skin in the treatment area. Although the lash growth enhancing quality of this type of IOP treatment is simply a side effect, studies have proposed that it could show potential for patients suffering from alopecia in the eyelash area. Dr Baumann suggests that the lash enhancing products recently launched on the market may be acting in similar ways to the IOP medication, adding that 'according to a company spokesperson, the active ingredient in this product (​RevitaLash) is 17-phenyl trinor PGS20 ethylamide, a prostaglandin analogue.'​ ​​Indeed RevitaLash's website states that 'some RevitaLash users have reported some discoloration of the skin at the base of the eyelashes'​ and suggests that if such discoloration is noticed and becomes bothersome individuals should discontinue use. In addition a disclaimer is present on the website stating that 'RevitaLash is not intended to… promote the growth of eyelashes'​ further noting that the product is marketed as a cosmetic intending 'only to​ promote the attractiveness, enhance the beauty and improve the appearance of eye lashes'​ adding that 'all claims for the product shall be limited to these intended uses'​. ​ This kind of disclaimer could result from the FDA policy that distinguishes between a cosmetic and a drug in terms of its intended use. A product's intended use can be established in a number of ways, including claims stated on the promotional material, being classed as a drug if it claims 'to treat or prevent disease or otherwise affect the structure or functions of the human body'. ​​In contrast a product can be classed as a cosmetic if its intended use 'is for cleansing, beautifying, promoting attractiveness, or altering the appearance'​ of the body. The FDA further states that 'whilst drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale​.' Thus, it appears that over-the-counter cosmetics may contain similar active ingredients to prescription medication without being approved by the FDA, a potential loophole in the regulation of the growing cosmeceutical market. Source: Skin and Allergy News​ Volume 38 Issue 7 page 20 'Prostoglandin Analogues' ​L. Baumann