The open letter from the public health service division points out that the brand holders are violating provisions of the FDA Cosmetics Act because of the marketing claims they use for their products.
The three brands are RapidLash Eyelash Renewal Serum, NeuLash Eyelash Technology and NeuveauBrow Active Eyebrow Technology.
Violation of the Cosmetic Act
The open letter from the public health service division points out that the brand holders are violating provisions of the FDA Cosmetic Act because of the marketing claims they use for their products.
The FDA claims that the products violate marketing claims reserved for cosmetic products because they actually claim to make physiological differences to the body by encouraging hair growth – a claim that cannot be made by a product marketed in the cosmetics category.
The warning letter contains specific references to each of the marketing campaigns for the products, giving examples of where the brand owners are said to be in conflict with the Cosmetics Act.
Unapproved new drugs
The FDA also claims that the products violate the Cosmetics Act because they contain unapproved new drugs. All three of the products include the active ingredient isopropyl cioprostenate.
This ingredient is a synthetically produced compound that is known to the FDA as an active ingredient for approved drugs, specifically because it is known to lower intraocular pressure in glaucoma patients.
The warning letter advises the brand holders to take prompt action with regards the violations that have been identified, threatening legal action if this does not occur.
Allergan warning letter
Back in 2009 the FDA issued another warning letter to Botox-maker Allergan’s about online promotional materials for its eyelash enhancer Latisse, claiming it did not adequately show the potential risks of the product, according to the US Food and Drug Administration.
In its letter the FDA asked the pharmaceutical giant to stop disseminating promotional material that was deemed to violate the agency’s regulations.
According to the regulatory agency the negative side effects that could result from using the product, such as increased iris pigmentation and risk of infection from the applicators, are played down.