Valisure LLC have found evidence of benzene in 78 sunscreen and after-tanning care products


Valisure LLC, an online pharmacy company that also conducts independent testing of consumer products, has issued a petition to the FDA to enact stricter rules regarding the presence of benzene in sunscreen products.

In an article published on their website, the company claims to have found evidence of benzene in 78 sunscreen and after-tanning care products.

Benzene is a liquid hydrocarbon; it is commonly found in petroleum, cigarette smoke and coal tar. For many years, it has been used as a solvent in a wide range of products. It has also been found to cause cancer, most particularly leukemia.

Because of its toxic properties, the FDA has disallowed the intentional introduction of the chemical into commercial products. The agency does, however, allow benzene-containing products to be sold if the product provides a “substantial therapeutic advance,” provided that levels in the product are at or below 2% and introducing benzene into the product is unavoidable.

The agency does not currently have guidelines regarding benzene levels in sunscreen products.

Over the past several years, Valisure has become a respected name in product testing – they were behind efforts to have the carcinogen NDMA removed from heartburn medications in 2018, and more recently led the effort to recall hand sanitizers that contained benzene.

In this new effort, the company tested almost 300 brands of sunscreen and after-tanning products sold by 69 companies – they found some amount of benzene in 78 products.

They note that the products were being advertised as a way to prevent skin cancer in adults and children. They also note that some of the products they tested had levels that were higher than the 2% cap mandated by the FDA.

They also note that because most of the products they tested did not have any detectable amounts of benzene, it clearly is not an unavoidable byproduct of production. T

hey also point out that the FDA recently discovered that sunscreen chemicals can be readily absorbed through the skin.

In their petition, they are asking the FDA to ban any amount of benzene in sunscreen and after-tanning care products and to issue a recall for those that have measurable levels of benzene that have already been sold. They have also published a table listing sunscreens brands that did not have any detectable levels of benzene.

Developing effective prevention strategies against cutaneous squamous cell carcinoma (cSCC) non-melanoma skin cancer (NMSC) is extremely important because many people receive extensive exposure to sunlight early in life and develop skin cancers later in life even without further exposure to sunlight [1]. Because of the increasing incidence of NMSC, the effectiveness of sunscreens in preventing skin damage and cSCC is debatable.

Solar ultraviolet (SUV) radiation is an environmental carcinogen that can result in skin aging, inflammation, and skin cancer development, which is the most common malignancy worldwide in Caucasian populations [2,3]. Approximately 1/3 of all new cancers are skin cancers, and in particular the incidence of cSCC NMSC increases every year, with an estimated annual incidence of 700,000 in the USA [4,5].

As incidence rates for NMSC continue to rise, a substantial impact on morbidity and health care costs occurs and accounts for a significant financial burden in skin cancer treatment [6]. Basal cell carcinomas (BCCs) rarely metastasize, whereas cSCCs can metastasize to regional lymph nodes or other distant organs, resulting in death.

The number of cSCC-related deaths is estimated to be between 3932 to 8791 annually and the upper limit approaches the total annual melanoma-related deaths [7,8]. Reducing the incidence of possibly dangerous cSCCs would not only reduce their potentially severe morbidity and mortality, but also reduce the multibillion-dollar costs associated with surgical and medical treatments required for NMSC.

Actinic keratosis (AK) is believed to act as a precursor to cSCC. AKs are premalignant skin lesions induced by SUV and characterized by the proliferation of atypical keratinocytes confined to the epidermis [9,10,11,12]. Regardless of the type of treatment chosen, individuals with an increased risk of developing AKs should be advised to apply a protective sunscreen as preventive skin care.

Even though people widely use sunscreens to protect the skin against solar UV irradiation, the ability of sunscreens to prevent cSCC still remains controversial. Furthermore, people are using moisturizing lotions topically, but most of these lotions have not been tested for carcinogenic activity during the course of SUV radiation. Several commercially available moisturizing lotions reportedly increased the rate of formation and the number of tumors when applied topically to the skin of UVB-pretreated high-risk mice [13].

Thus, we made a non-toxic moisturizing lotion formulation and tested its safety in an in vivo mouse skin model (Patent International Application Number: PCT/US2018/036720; title: skin care formulations and skin cancer treatment). Furthermore, the prevalence of cSCC continues to increase annually, suggesting that commercially available sunscreens might not be used appropriately or are not completely effective.

Thus, here we investigated the efficacy of the most commonly used Food and Drug Administration (FDA)-approved sunscreen components in an in vitro human skin model and in an in vivo SSL-induced cSCC mouse model.

The current FDA-approved list of sunscreen ingredients contains 16 components that can be included in sunscreens. However, only 8 of the 16 are regularly used in US-produced sunscreens, and only 2 of those offer full UVA protection.

The eight most commonly used sunscreen components include octocrylene, oxybenzone [14], avobenzone [15,16], octinoxate, octisalate [17], homosalate [18], titanium dioxide [19], and zinc oxide [20]. The absorbance wavelengths of each FDA-approved sunscreen component and maximum peaks of UV absorption are shown in Supplementary Figure S1.

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