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Sunscreen Innovation Act

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The Sunscreen Innovation Act ( S. 2141 , Pub. L.   113–195 (text) (PDF) ) is a 2014 law that amended the Federal Food, Drug, and Cosmetic Act to establish an expedited process for the review and approval of over-the-counter (OTC) sunscreens . The US Food and Drug Administration (FDA) had not approved a new active ingredient in sunscreen since 1999, despite some sunscreens having been approved and used overseas for a decade. The new law gave the FDA one year to respond to the existing backlog of sunscreen ingredient approval requests, and then 18 months to reply to any future applications.

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57-408: The bill was introduced during the 113th United States Congress by Rep. Ed Whitfield (R, KY-1) and Sen. Jack Reed (D, RI) , and signed into law by President Barack Obama on November 26, 2014. Sunscreen (also commonly known as sun screen , sunblock , suntan lotion , sunburn cream , sun cream or block out ) is a lotion , spray, gel or other topical product that absorbs or reflects some of

114-500: A 38 fold increased risk of pancreatic cancer. Other mutations confer lower risk, but are more common in the population. People with mutations in the MC1R gene are two to four times more likely to develop melanoma than those with two wild-type (typical unaffected type) copies. MC1R mutations are very common, and all red-haired people have a mutated copy. Mutation of the MDM2 SNP309 gene

171-593: A candidate appears. In-person inspection of suspicious skin lesions is more accurate than visual inspection of images of suspicious skin lesions. When used by trained specialists, dermoscopy is more helpful to identify malignant lesions than use of the naked eye alone. Reflectance confocal microscopy may have better sensitivity and specificity than dermoscopy in diagnosing cutaneous melanoma but more studies are needed to confirm this result. However, many melanomas present as lesions smaller than 6 mm in diameter, and all melanomas are malignant when they first appear as

228-428: A confocal microscope, the doctor may biopsy the suspicious mole. A skin biopsy performed under local anesthesia is often required to assist in making or confirming the diagnosis and in defining severity. Elliptical excisional biopsies may remove the tumor, followed by histological analysis and Breslow scoring. Incisional biopsies such as punch biopsies are usually contraindicated in suspected melanomas, because of

285-464: A dermatoscope. Amelanotic melanomas and melanomas arising in fair-skinned individuals are very difficult to detect, as they fail to show many of the characteristics in the ABCD rule, break the "ugly duckling" sign, and are hard to distinguish from acne scarring, insect bites, dermatofibromas , or lentigines . Following a visual examination and a dermatoscopic exam, or in vivo diagnostic tools such as

342-407: A different direction – vertically up into the epidermis and into the papillary dermis – cell behaviour changes dramatically. The next step in the evolution is the invasive radial growth phase, in which individual cells start to acquire invasive potential. From this point on, melanoma is capable of spreading. The Breslow's depth of the lesion is usually less than 1 mm (0.04  in ), while

399-727: A further professional exam is required. The " Little Red Riding Hood " sign suggests that individuals with fair skin and light-colored hair might have difficult-to-diagnose amelanotic melanomas . Extra care is required when examining such individuals, as they might have multiple melanomas and severely dysplastic nevi. A dermatoscope must be used to detect "ugly ducklings", as many melanomas in these individuals resemble nonmelanomas or are considered to be " wolves in sheep's clothing ". These fair-skinned individuals often have lightly pigmented or amelanotic melanomas that do not present easy-to-observe color changes and variations. Their borders are often indistinct, complicating visual identification without

456-466: A low- molecular weight protein inhibitor of cyclin-dependent protein kinases (CDKs) – which has been localised to the p21 region of human chromosome 9 . FAMMM is typically characterized by having 50 or more combined moles in addition to a family history of melanoma. It is transmitted autosomal dominantly and mostly associated with the CDKN2A mutations. People who have CDKN2A mutation associated FAMMM have

513-480: A melanoma, but lack of elevation does not mean that the lesion is not a melanoma. Most melanomas in the US are detected before they become elevated. By the time elevation is visible, they may have progressed to the more dangerous invasive stage. One method is the " ugly duckling sign". Correlation of common lesion characteristics is made. Lesions that deviate from the common characteristics are labeled an "ugly duckling", and

570-467: A more specific expression pattern in melanoma compared to other forms of cancer. Examples of melanoma specific genes are tyrosinase , MLANA , and PMEL . UV radiation causes damage to the DNA of cells, typically thymine dimerization, which when unrepaired can create mutations in the cell's genes. This strong mutagenic factor makes cutaneous melanoma the tumor type with the highest number of mutations. When

627-418: A new standardized format. CBO estimates that the direct cost of complying with those requirements would not exceed the annual threshold established by UMRA for private-sector mandates ($ 152 million in 2014, adjusted annually for inflation). The Melanoma Research Alliance supported the bill. In a video produced by the group, a melanoma survivor said that "when I heard that there were actually ingredients that

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684-454: A role for activating transcription factor-2 in cancer progression. Cancer stem cells may also be involved. Large-scale studies, such as The Cancer Genome Atlas , have characterized recurrent somatic alterations likely driving initiation and development of cutaneous melanoma. The Cancer Genome Atlas study has established four subtypes: BRAF mutant, RAS mutant, NF1 mutant, and triple wild-type. The most frequent mutation occurs in

741-410: A second primary tumor. Fair skin is the result of having less melanin in the skin, which means less protection from UV radiation exists. The earliest stage of melanoma starts when melanocytes begin out-of-control growth. Melanocytes are found between the outer layer of the skin (the epidermis ) and the next layer (the dermis ). This early stage of the disease is called the radial growth phase, when

798-491: A small dot. Physicians typically examine all moles, including those less than 6 mm in diameter. Seborrheic keratosis may meet some or all of the ABCD criteria, and can lead to false alarms . Doctors can generally distinguish seborrheic keratosis from melanoma upon examination or with dermatoscopy . Some advocate replacing "enlarging" with "evolving": moles that change and evolve are a concern. Alternatively, some practitioners prefer "elevation". Elevation can help identify

855-447: Is associated with increased risks for younger women. Fair- and red-haired people, persons with multiple atypical nevi or dysplastic nevi and persons born with giant congenital melanocytic nevi are at increased risk. A family history of melanoma greatly increases a person's risk, because mutations in several genes have been found in melanoma-prone families. People with a history of one melanoma are at increased risk of developing

912-451: Is much higher than the roughly 70 mutations across generations (parent to child). Among the 25 melanomas, about 6,000 protein-coding genes had missense , nonsense , or splice site mutations . The transcriptomes of over 100 melanomas has also been sequenced and analyzed. Almost 70% of all human protein-coding genes are expressed in melanoma. Most of these genes are also expressed in other normal and cancer tissues, with some 200 genes showing

969-486: Is not adapted, most notably Australia. Exposure during childhood is a more important risk factor than exposure in adulthood. This is seen in migration studies in Australia. Incurring multiple severe sunburns increases the likelihood that future sunburns develop into melanoma due to cumulative damage. UV-high sunlight and tanning beds are the main sources of UV radiation that increase the risk for melanoma and living close to

1026-628: Is possible, but relatively rare; less than a fifth of melanomas diagnosed early become metastatic. Brain metastases are particularly common in patients with metastatic melanoma. It can also spread to the liver, bones, abdomen, or distant lymph nodes. Melanomas are usually caused by DNA damage resulting from exposure to UV light from the sun. Genetics also play a role. Melanoma can also occur in skin areas with little sun exposure (i.e. mouth, soles of feet, palms of hands, genital areas). People with dysplastic nevus syndrome , also known as familial atypical multiple mole melanoma, are at increased risk for

1083-419: Is removal by surgery of the melanoma and the potentially affected adjacent tissue bordering the melanoma. In those with slightly larger cancers, nearby lymph nodes may be tested for spread ( metastasis ). Most people are cured if metastasis has not occurred. For those in whom melanoma has spread, immunotherapy , biologic therapy , radiation therapy , or chemotherapy may improve survival. With treatment,

1140-418: The melanin -producing cells known as melanocytes . It typically occurs in the skin, but may rarely occur in the mouth, intestines, or eye ( uveal melanoma ). In women, melanomas most commonly occur on the legs; while in men, on the back. Melanoma is frequently referred to as malignant melanoma . However, the medical community stresses that there is no such thing as a 'benign melanoma' and recommends that

1197-522: The 2010 United States census . It first met in Washington, D.C. , on January 3, 2013, and it ended on January 3, 2015. Senators elected to regular terms in 2008 were in the last two years of those terms during this Congress. The Senate had a Democratic majority, while the House had a Republican majority; such a split would not be repeated until the 118th Congress . This was the last time Democrats held control of

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1254-462: The Clark level is usually 2. The vertical growth phase (VGP) following is invasive melanoma. The tumor becomes able to grow into the surrounding tissue and can spread around the body through blood or lymph vessels . The tumor thickness is usually more than 1 mm (0.04  in ), and the tumor involves the deeper parts of the dermis. The host elicits an immunological reaction against the tumor during

1311-685: The Congressional Budget Office , as ordered reported by the House Committee on Energy and Commerce on July 15, 2014. This is a public domain source. H.R. 4250 would modify the review process that allows the marketing of certain new ingredients in non-prescription sunscreen based on a determination by the Food and Drug Administration (FDA) that they are generally recognized as safe and effective. The Congressional Budget Office (CBO) estimates that implementing H.R. 4250 would cost $ 28 million over

1368-641: The five-year survival rates in the United States are 99% among those with localized disease, 65% when the disease has spread to lymph nodes, and 25% among those with distant spread. The likelihood that melanoma will reoccur or spread depends on its thickness , how fast the cells are dividing, and whether or not the overlying skin has broken down. Melanoma is the most dangerous type of skin cancer. Globally, in 2012, it newly occurred in 232,000 people. In 2015, 3.1 million people had active disease, which resulted in 59,800 deaths. Australia and New Zealand have

1425-530: The sun 's ultraviolet (UV) radiation on the skin exposed to sunlight and thus helps protect against sunburn . Depending on the mode of action, sunscreens can be classified into physical sunscreens (i.e., those that reflect the sunlight) or chemical sunscreens (i.e., those that absorb the UV light). Medical organizations such as the American Cancer Society recommend the use of sunscreen because it aids in

1482-587: The 2015–2019 period, assuming appropriation of the necessary amounts. H.R. 4250 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. H.R. 4250 contains no intergovernmental mandates as defined in the Unfunded Mandates Reform Act (UMRA). The bill would impose private-sector mandates, as defined in UMRA, because it would allow FDA to require that marketing applications for certain sunscreen products be submitted in

1539-1140: The 600th codon of BRAF (50% of cases). BRAF is normally involved in cell growth, and this specific mutation renders the protein constitutively active and independent of normal physiological regulation, thus fostering tumor growth. RAS genes ( NRAS , HRAS and KRAS ) are also recurrently mutated (30% of TCGA cases) and mutations in the 61st or 12th codons trigger oncogenic activity. Loss-of-function mutations often affect tumor suppressor genes such as NF1 , TP53 and CDKN2A . Other oncogenic alterations include fusions involving various kinases such as BRAF, RAF1, ALK, RET, ROS1, NTRK1., NTRK3 and MET BRAF, RAS , and NF1 mutations and kinase fusions are remarkably mutually exclusive, as they occur in different subsets of patients. Assessment of mutation status can, therefore, improve patient stratification and inform targeted therapy with specific inhibitors. In some cases (3–7%) mutated versions of BRAF and NRAS undergo copy-number amplification . The research done by Sarna's team proved that heavily pigmented melanoma cells have Young's modulus about 4.93, when in non-pigmented ones it

1596-574: The FDA announced it expected to make decisions on the pending ingredient applications before the end of the year." Five years later, the FDA had still not made a decision and Ashland was unable to sell this type of sunscreen in the United States. [REDACTED]  This article incorporates public domain material from websites or documents of the United States Government . 113th United States Congress The 113th United States Congress

1653-476: The FDA is basically holding hostage, it infuriates me, it's crazy." The Centers for Disease Control and Prevention reported that in 2010 over 60,000 Americans were diagnosed with melanoma. The most common form of cancer in the United States is skin cancer. In 2009, chemical company and sunscreen manufacturer Ashland Inc. "significantly expanded its existing sunscreen production facilities in Columbus, Ohio, after

1710-454: The Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens. The bill would require the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factor (SPF) greater than 50. This summary is based largely on the summary provided by

1767-560: The Senate until the 117th Congress in 2021. Fiscal year 2014 runs from October 1, 2013, to September 30, 2014. Fiscal year 2015 runs from October 1, 2014, to September 20, 2015. Section contents: Senate : Majority (D) , Minority (R) • House : Majority (R) , Minority (D) Senators are listed by state, and the numbers refer to their Senate classes , In this Congress, Class 2 meant their term ended with this Congress, requiring re-election in 2014; Class 3 meant their term began in

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1824-622: The United States are appropriately labeled. The bill would make sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act. The bill would establish a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information. The bill would direct

1881-450: The VGP, which is judged by the presence and activity of the tumor infiltrating lymphocytes (TILs). These cells sometimes completely destroy the primary tumor; this is called regression, which is the latest stage of development. In certain cases, the primary tumor is completely destroyed and only the metastatic tumor is discovered. About 40% of human melanomas contain activating mutations affecting

1938-459: The age of thirty years are 75% more likely to develop melanoma. Those who work in airplanes also appear to have an increased risk, believed to be due to greater exposure to UV. UVB light, emanating from the sun at wavelengths between 315 and 280 nm, is absorbed directly by DNA in skin cells, which results in a type of direct DNA damage called cyclobutane pyrimidine dimers . Thymine , cytosine , or cytosine-thymine dimers are formed by

1995-400: The area in question is the most common method of suspecting a melanoma. Moles that are irregular in color or shape are typically treated as candidates. To detect melanomas (and increase survival rates), it is recommended to learn to recognize them (see "ABCDE" mnemonic ), to regularly examine moles for changes (shape, size, color, itching or bleeding) and to consult a qualified physician when

2052-504: The cell divides , these mutations are propagated to new generations of cells. If the mutations occur in protooncogenes or tumor suppressor genes , the rate of mitosis in the mutation-bearing cells can become uncontrolled, leading to the formation of a tumor . Data from patients suggest that aberrant levels of activating transcription factor in the nucleus of melanoma cells are associated with increased metastatic activity of melanoma cells; studies from mice on skin cancer tend to confirm

2109-447: The development of melanoma. Having more than 50 moles indicates an increased risk of melanoma. A weakened immune system makes cancer development easier due to the body's weakened ability to fight cancer cells. UV radiation exposure from tanning beds increases the risk of melanoma. The International Agency for Research on Cancer finds that tanning beds are "carcinogenic to humans" and that people who begin using tanning devices before

2166-401: The development of skin cancers, including melanoma. Possible significant elements in determining risk include the intensity and duration of sun exposure, the age at which sun exposure occurs, and the degree of skin pigmentation . Melanoma rates tend to be highest in countries settled by migrants from Europe which have a large amount of direct, intense sunlight to which the skin of the settlers

2223-767: The development of wrinkles and sagging skin. This summary is based largely on the summary provided by the Congressional Research Service , a public domain source. The Sunscreen Innovation Act would amend the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreens . The bill would require the United States Secretary of Health and Human Services (HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in

2280-407: The equator increases exposure to UV radiation. A number of rare mutations, which often run in families, greatly increase melanoma susceptibility. Several genes increase risks. Some rare genes have a relatively high risk of causing melanoma; some more common genes, such as a gene called MC1R that causes red hair, have a relatively lower elevated risk. Genetic testing can be used to search for

2337-427: The frequencies of UVA-induced thymine dimers, respectively. If unrepaired, cyclobutane pyrimidine dimer (CPD) photoproducts can lead to mutations by inaccurate translesion synthesis during DNA replication or repair. The most frequent mutations due to inaccurate synthesis past CPDs are cytosine to thymine (C>T) or CC>TT transition mutations . These are commonly referred to as UV fingerprint mutations, as they are

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2394-555: The highest rates of melanoma in the world. High rates also occur in Northern Europe and North America, while it is less common in Asia, Africa, and Latin America. In the United States, melanoma occurs about 1.6 times more often in men than women. Melanoma has become more common since the 1960s in areas mostly populated by people of European descent . Early signs of melanoma are changes to

2451-543: The human body is causally related to melanoma; and such areas of only intermittent exposure apparently explains why melanoma is more common on the back in men and on the legs in women. The risk appears to be strongly influenced by socioeconomic conditions rather than indoor versus outdoor occupations; it is more common in professional and administrative workers than unskilled workers. Other factors are mutations in (or total loss of) tumor suppressor genes . Using sunbeds with their deeply penetrating UVA rays has been linked to

2508-428: The joining of two adjacent pyrimidine bases within a strand of DNA. UVA light presents at wavelengths longer than UVB (between 400 and 315 nm); and it can also be absorbed directly by DNA in skin cells, but at lower efficiencies—about 1/100 to 1/1000 of UVB. Exposure to radiation (UVA and UVB) is a major contributor to developing melanoma. Occasional extreme sun exposure that results in " sunburn " on areas of

2565-451: The last Congress, requiring re-election in 2016; and Class 1 meant their term began in this Congress, requiring re-election in 2018. [ Section contents: Senate , House , Joint ] Listed alphabetically by chamber, including Chairperson and Ranking Member. Sources: H.Res. 6 , H.Res. 7 Melanoma Melanoma is the most dangerous type of skin cancer ; it develops from

2622-486: The most specific mutation caused by UV, being frequently found in sun-exposed skin, but rarely found in internal organs. Errors in DNA repair of UV photoproducts, or inaccurate synthesis past these photoproducts, can also lead to deletions, insertions, and chromosomal translocations . The entire genomes of 25 melanomas were sequenced. On average, about 80,000 mutated bases (mostly C>T transitions) and about 100 structural rearrangements were found per melanoma genome. This

2679-403: The mutations. One class of mutations affects the gene CDKN2A . An alternative reading frame mutation in this gene leads to the destabilization of p53 , a transcription factor involved in apoptosis and in 50% of human cancers. Another mutation in the same gene results in a nonfunctional inhibitor of CDK4 , a cyclin -dependent kinase that promotes cell division . Mutations that cause

2736-428: The possibility of sampling error or local implantation causing misestimation of tumour thickness. However, fears that such biopsies may increase the risk of metastatic disease seem unfounded. Total body photography, which involves photographic documentation of as much body surface as possible, is often used during follow-up for high-risk patients. The technique has been reported to enable early detection and provides

2793-402: The prevention of squamous cell carcinomas . Many sunscreens do not block UVA radiation, which does not cause sunburn but can increase the rate of melanoma and photodermatitis , so people using sunscreens may be exposed to high UVA levels without realizing it. The use of broad-spectrum (UVA/UVB) sunscreens can address this concern. Diligent use of sunscreen can also slow or temporarily prevent

2850-521: The shape or color of existing moles or, in the case of nodular melanoma , the appearance of a new lump anywhere on the skin. At later stages, the mole may itch , ulcerate , or bleed. Early signs of melanoma are summarized by the mnemonic "ABCDEEFG": This classification does not apply to nodular melanoma, which has its own classifications: Metastatic melanoma may cause nonspecific paraneoplastic symptoms , including loss of appetite, nausea , vomiting, and fatigue. Metastasis (spread) of early melanoma

2907-587: The skin condition xeroderma pigmentosum (XP) also increase melanoma susceptibility. Scattered throughout the genome, these mutations reduce a cell's ability to repair DNA. Both CDKN2A and XP mutations are highly penetrant (the chances of a carrier to express the phenotype is high). Familial melanoma is genetically heterogeneous, and loci for familial melanoma appear on the chromosome arms 1p, 9p and 12q. Multiple genetic events have been related to melanoma's pathogenesis (disease development). The multiple tumor suppressor 1 (CDKN2A/MTS1) gene encodes p16INK4a –

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2964-533: The structure of the B-Raf protein , resulting in constitutive signaling through the Raf to MAP kinase pathway. A cause common to most cancers is damage to DNA. UVA light mainly causes thymine dimers . UVA also produces reactive oxygen species and these inflict other DNA damage, primarily single-strand breaks, oxidized pyrimidines and the oxidized purine 8-oxoguanine (a mutagenic DNA change) at 1/10, 1/10, and 1/3rd

3021-530: The sun or other sources, such as tanning devices . Those with many moles, a history of affected family members, and poor immune function are at greater risk. A number of rare genetic conditions , such as xeroderma pigmentosum , also increase the risk. Diagnosis is by biopsy and analysis of any skin lesion that has signs of being potentially cancerous. Avoiding UV light and using sunscreen in UV-bright sun conditions may prevent melanoma. Treatment typically

3078-430: The term 'malignant melanoma' should be avoided as redundant. About 25% of melanomas develop from moles . Changes in a mole that can indicate melanoma include increase—especially rapid increase—in size, irregular edges, change in color, itchiness, or skin breakdown . The primary cause of melanoma is ultraviolet light (UV) exposure in those with low levels of the skin pigment melanin . The UV light may be from

3135-404: The tumor is less than 1 mm thick, and spreads at the level of the basal epidermis. Because the cancer cells have not yet reached the blood vessels deeper in the skin, it is very unlikely that this early-stage melanoma will spread to other parts of the body. If the melanoma is detected at this stage, then it can usually be completely removed with surgery. When the tumor cells start to move in

3192-597: Was a meeting of the legislative branch of the United States federal government, from January 3, 2013, to January 3, 2015, during the fifth and sixth years of Barack Obama's presidency . It was composed of the United States Senate and the United States House of Representatives based on the results of the 2012 Senate elections and the 2012 House elections . The seats in the House were apportioned based on

3249-401: Was only 0.98. In another experiment they found that elasticity of melanoma cells is important for its metastasis and growth: non-pigmented tumors were bigger than pigmented and it was much easier for them to spread. They shown that there are both pigmented and non-pigmented cells in melanoma tumors , so that they can both be drug-resistant and metastatic. Looking at or visually inspecting

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