Güneş kremi gerekliliklerinin standardizasyonunda yeni kurallar.
Geçen yaz FDA, ABD’de satılan güneş kremlerine yönelik yeni standartları duyurmuştu…
New Rules to Standardize Sunscreen Claims
Posted: 05/17/2012; AccessMedicine from McGraw-Hill © 2012 The McGraw-Hill Companies
Last summer, the FDA announced new standards for sunscreens (as well as sunscreen-containing cosmetics and moisturizers) sold in the US. The new requirements standardize the quantitative test that each product will need to pass to be designated as having broad spectrum ultraviolet (UVB plus UVA, 290-400 nm) protection. The standards are codified in 21 CFR 201 and 21 CFR 310 and becomes effective on June 18, 2012 for all new sunscreen-containing products marketed after this date. Existing products are required to be in compliance by June 18, 2012 except sunscreens with annual sales <$25,000 which have until June 17, 2013 to become compliant.
Prior FDA rules for sunscreens (21 CFR 352) focused narrowly on protection from sunburn as measured by the SPF (sun protection factor) ratio (see Equation 1). The new designation, “Broad Spectrum SPF”, will keep the old SPF scale and simply add the words “broad spectrum” for products demonstrating in vitro absorption of UVA radiation at a critical wavelength (λc) calculated to be ≥370nm (see Equation 2 and Figure 1 ). While products with SPF ratings as low as 2 are legally marketed, a Broad Spectrum SPF rating of 15 or higher is required for products claiming protection against the development of skin cancer and early aging when used in conjunction with limiting sun exposure and wearing protective clothing.
Figure 1. Critical wavelength (λc). The UV absorption spectra of two sunscreen ingredients (blue and red spectra) and a Broad Spectrum sunscreen (green spectrum) are shown with the λc of each marked by a vertical line. Only the Broad Spectrum sunscreen has a critical wavelength >370 nm.
Equation 1: SPF value = the ratio of the minimal erythema dose (expressed as Joules/m2) for Protected skin relative to the minimal erythema dose for Unprotected skin. Protected skin is skin after application of 2 mg/cm2 of the formulation. Unprotected skin is skin to which no sunscreen product has been applied.
Equation 2: Critical wavelength (λc) = the wavelength at which the integral of the spectral absorbance curve reaches 90% of the total area under the absorbance curve of the UV spectrum (290-400nm).
The conditions under which sunscreens can be labeled water-resistant are also standardized by the new FDA requirements. Water-resistant products will be required to state whether the sunscreen remains effective for 40 minutes (previously “water-resistant”) or 80 minutes (previously “very water-resistant”) under wet conditions due to water immersion or perspiration. In addition, all sunscreens will be labeled with directions to apply “liberally,” “generously,” or “evenly” at least every 2 hours during sun exposure. It should be noted that at least one study has documented that consumers typically under-apply sunscreens at a rate of less than 50% that required for the basis of the official SPF test (2mg/cm2).
In accordance with the timeline for the new requirements, sunscreens labeled with “waterproof,” “sweatproof,” or “sunblock” claims, sunscreens claiming longer than 2 hours of protection, and sunscreens promising to prevent ‘‘lip damage,’’ ‘‘freckling,’’ or ‘‘uneven coloration’’ will be considered misbranded and subject to regulatory removal from the marketplace. In addition, FDA is proposing a cap on SPF values at 50 due to a lack of evidence to support greater skin protection above this mark (see 76 FR 35672).
Finally, the FDA is inviting public comment and requesting additional data to address the efficacy and safety of various dosage forms including lotions, sprays, oils, sticks, gels, butters, ointments, creams, and pastes (see 76 FR 35669), as well as determining that wipes, powders, towelettes, body washes, and shampoos are not appropriate formulations for sunscreens. If warranted, approval for the future marketing of novel sunscreen dosage forms will be subject to the FDA granting them individual new drug application petitions.
The new rules apply to sunscreens that contain active ingredients that have a USP compendial monograph. The 16 ingredients that currently have a monograph and are generally recognized as safe and effective (GRASE) sunscreens in the US are shown in Table 1 . The FDA is considering eight additional ingredients for GRASE status under time and extent applications (TEAs). The FDA offers the TEA process as an alternative to filing a new drug application (NDA) for unapproved drugs initially marketed in the US after the over the counter (OTC) drug review began in 1972 and for foreign-marketed drugs without US marketing experience. As clarified by the FDA, products containing active ingredients eligible for possible inclusion in the OTC sunscreen monograph under a TEA are not considered legal for sale until cleared by the agency for marketing.
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The new requirements for sunscreens represent another step forward in a process started by the FDA in 1978 with the aim of publishing a final OTC drug monograph for this therapeutic category of products. Additional FDA guidance for sunscreens containing insect repellants and the two other issues mentioned above (the SPF 50 “cap” and applicable dosage forms) is still to come. In the mean time, products covered by these ongoing OTC drug monograph proceedings will be allowed to remain on the market. Once a final OTC drug monograph for sunscreens is published, new entrants to the market encompassing ingredients or claims outside the scope of the OTC drug review will require a new drug application (NDA). FDA’s NDA and OTC drug monograph systems are designed to prevent the risks associated with potentially unsafe, ineffective, and fraudulent drugs. Given that exposure to ultraviolet (UV) radiation is associated with harmful effects ranging from photoaging to skin cancer, FDA efforts to assure the efficacy of sunscreens represents an important public health safeguard.
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- Food and Drug Administration. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. [Final rule] http://www.regulations.gov/#!documentDetail;D=FDA-1978-N-0018-0698. Fed Regist 2011 Jun 17;76(117):35620-65.
- Reich A, Harupa M, Bury M, et al. Application of sunscreen preparations: a need to change the regulations. Photodermatol Photoimmunol Photomed. 2009 Oct;25(5):242-4. [PMID: 19747242]
- Food and Drug Administration. Rulemaking History for OTC Sunscreen Drug Products [webpage]. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm. Last accessed 8/1/11.
- Food and Drug Administration. Guidance for Industry: Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application [Draft Guidance]. June 2011. Last accessed 8/1/11. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf.
- Sambandan DR, Ratner D. Sunscreens: an overview and update. J Am Acad Dermatol. 2011 Apr;64(4):748-58. Epub 2011 Feb 3. [PMID: 21292345]
AccessMedicine from McGraw-Hill © 2012 The McGraw-Hill Companies