The Sunscreen Innovation Act (, ) is a 2014 law that amended the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...

to establish an expedited process for the review and approval of

over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...

(OTC)

sunscreen Sunscreen, also known as sunblock or sun cream, is a photoprotective topical product for the skin that mainly absorbs, or to a much lesser extent reflects, some of the sun's ultraviolet (UV) radiation and thus helps protect against sunburn and ...

s. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(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. The bill was introduced during the

113th United States Congress The 113th United States Congress 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 Presidency of Barack Obama, Barack Obama's presiden ...

by Rep. Ed Whitfield (R, KY-1) and Sen. Jack Reed (D, RI), and signed into law by President

Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...

on November 26, 2014.

Background

Sunscreen (also commonly known as ''sun screen'', ''sunblock'', ''suntan lotion'', ''sunburn cream'', ''sun cream'' or ''block out'') is a

lotion Lotion is a low-viscosity topical preparation intended for application to the skin. By contrast, creams and gels have higher viscosity, typically due to lower water content. Lotions are applied to external skin with bare hands, a brush, a clean ...

, spray, gel or other

topical A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes ...

product that absorbs or reflects some of the

sun The Sun is the star at the center of the Solar System. It is a nearly perfect ball of hot plasma, heated to incandescence by nuclear fusion reactions in its core. The Sun radiates this energy mainly as light, ultraviolet, and infrared radi ...

ultraviolet Ultraviolet (UV) is a form of electromagnetic radiation with wavelength from 10 nanometer, nm (with a corresponding frequency around 30 Hertz, PHz) to 400 nm (750 Hertz, THz), shorter than that of visible light, but longer than ...

(UV) radiation on the

skin Skin is the layer of usually soft, flexible outer tissue covering the body of a vertebrate animal, with three main functions: protection, regulation, and sensation. Other cuticle, animal coverings, such as the arthropod exoskeleton, have diffe ...

exposed to

sunlight Sunlight is a portion of the electromagnetic radiation given off by the Sun, in particular infrared, visible, and ultraviolet light. On Earth, sunlight is scattered and filtered through Earth's atmosphere, and is obvious as daylight when t ...

and thus helps protect against

sunburn Sunburn is a form of radiation burn that affects living tissue, such as skin, that results from an overexposure to ultraviolet (UV) radiation, usually from the Sun. Common symptoms in humans and animals include: red or reddish skin that is ho ...

. 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).Sunscreens , The Ageing Skin
/ref> Medical organizations such as the

American Cancer Society The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into six geographical regions of both medical and lay volunteers operating in more than ...

recommend the use of sunscreen because it aids in the prevention of squamous cell carcinomas. Many sunscreens do not block

UVA UVA most often refers to: * Ultraviolet A, a type of ultraviolet radiation * University of Virginia, a public research university in Charlottesville, Virginia, United States Uva or UVA may also refer to: Places * Uva, Missouri, an unincorpora ...

radiation, which does not cause sunburn but can increase the rate of

melanoma Melanoma, also redundantly known as malignant melanoma, is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. Melanomas typically occur in the skin, but may rarely occur in the mouth, intestines, or eye ( ...

and

photodermatitis Photodermatitis, sometimes referred to as sun poisoning or photoallergy, is a form of allergic contact dermatitis in which the allergen must be activated by light to sensitize the allergic response, and to cause a rash or other systemic effects o ...

, 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 the development of wrinkles and sagging skin.

Provisions of the bill

''This summary is based largely on the summary provided by the

Congressional Research Service The Congressional Research Service (CRS) is a public policy research institute of the United States Congress. Operating within the Library of Congress, it works primarily and directly for members of Congress and their committees and staff on a c ...

, a

public domain The public domain (PD) consists of all the creative work A creative work is a manifestation of creative effort including fine artwork (sculpture, paintings, drawing, sketching, performance art), dance, writing (literature), filmmaking, ...

source.'' The Sunscreen Innovation Act would amend the

to establish a process for the review and approval of

(OTC)

s. The bill would require the

United States Secretary of Health and Human Services The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...

(HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in 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

(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 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 Sunscreen, also known as sunblock or sun cream, is a photoprotective topical product for the skin that mainly absorbs, or to a much lesser extent reflects, some of the sun's ultraviolet (UV) radiation and thus helps protect against sunburn and ...

(SPF) greater than 50.

Congressional Budget Office report

''This summary is based largely on the summary provided by the

Congressional Budget Office The Congressional Budget Office (CBO) is a federal agency within the legislative branch of the United States government that provides budget and economic information to Congress. Inspired by California's Legislative Analyst's Office that manages ...

, as ordered reported by the House Committee on Energy and Commerce on July 15, 2014. This is a

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

(CBO) estimates that implementing H.R. 4250 would cost $28 million over 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 Pay as you go or PAYG may refer to: Finance * Pay-as-you-go tax, or pay-as-you-earn tax * Pay-as-you-go pension plan * PAYGO, the practice in the US of financing expenditures with current funds rather than borrowing * PAUG, a structured financia ...

procedures do not apply. H.R. 4250 contains no intergovernmental mandates as defined in the

Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (UMRA''(pdf)https://www.govinfo.gov/content/pkg/USCODE-1995-title2/html/USCODE-1995-title2-chap25.htm (text)] restricts the federal government of the United States, federal imposition of unfunded mandates on ...

(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 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).

Debate and discussion

The

Melanoma Research Alliance Melanoma, also redundantly known as malignant melanoma, is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. Melanomas typically occur in the skin, but may rarely occur in the mouth, intestines, or eye (u ...

supported the bill. In a video produced by the group, a

survivor said that "when I heard that there were actually ingredients that the FDA is basically holding hostage, it infuriates me, it's crazy." The

Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...

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. Ashland Global Specialty Chemicals Inc. is an American chemical company which operates in more than 100 countries. Headquartered in Wilmington, Delaware, the company traces its roots back to the city of Ashland, Kentucky, where it was headquarter ...

"significantly expanded its existing sunscreen production facilities in Columbus, Ohio, after 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.

References

External links