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US: FDA warns parents of dangers of laser toys; issues draft guidance
07 Aug 2013 -- Categories: Easy availability | Eye effect or injury | Labels and warnings | SLA news
The Food and Drug Administration issued draft guidance for industry, and a press release for the public about the hazards of lasers in toys and used by children.
In an August 6 2013 press release and Consumer Health Information article, FDA warned parents that lasers operated unsafely can cause serious eye injuries and even blindness. FDA said injuries from lasers can go unnoticed for days or weeks since there is no pain. But vision can slowly deteriorate over time, eventually causing permanent eye damage.
FDA gave the following as examples of children’s toy laser products:
Interestingly, the FDA’s press release and article gave tips on safe usage, including not aiming at car drivers or sports players -- but did not say that it is unsafe and illegal to aim at aircraft.
On August 7 2013, FDA issued draft guidance for industry on minimizing the risk of lasers in children’s toys. Comments are invited within 90 days of the Federal Register publication of the guidance, or by November 4 2013. The draft guidance is reprinted below.
In an August 6 2013 press release and Consumer Health Information article, FDA warned parents that lasers operated unsafely can cause serious eye injuries and even blindness. FDA said injuries from lasers can go unnoticed for days or weeks since there is no pain. But vision can slowly deteriorate over time, eventually causing permanent eye damage.
FDA gave the following as examples of children’s toy laser products:
- Lasers mounted on toy guns that can be used for “aiming”;
- Spinning tops that project laser beams while they spin;
- Hand held lasers used during play as “light sabers”;
- Dancing laser beams projected from a stationary column; and
- Lasers intended for entertainment that create optical effects in an open room.
Interestingly, the FDA’s press release and article gave tips on safe usage, including not aiming at car drivers or sports players -- but did not say that it is unsafe and illegal to aim at aircraft.
On August 7 2013, FDA issued draft guidance for industry on minimizing the risk of lasers in children’s toys. Comments are invited within 90 days of the Federal Register publication of the guidance, or by November 4 2013. The draft guidance is reprinted below.
Story at Huffington Post, Fox News, and other news outlets.
Minimizing Risk for Children's Toy Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: August 7, 2013
You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document contact Robert J. Doyle at 301-796-5863 or via email at robertj.doyle@fda.hhs.gov.
Preface
Public Comment
You may submit written comments and suggestions at any time for Agency consideration. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1810) to identify the guidance you are requesting.
Minimizing Risk for Children's Toy Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction
This guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public, of the Center for Devices and Radiological Health’s (CDRH) current thinking on the safety of children’s toy laser products. Lasers with outputs above certain levels that are operated in an unsafe and uncontrolled manner may cause injury to the user and/or others within range of the laser beam. This is a particular concern for lasers intended for entertainment purposes, especially when intended to be used as toys by children.
Federal law requires all laser products sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 Code of Federal Regulations (CFR) 1040.10 and 1040.11). Although most children’s toy laser products would meet the definition of “demonstration laser products” or “surveying, leveling, and alignment laser products” at 21 CFR 1040.10(b)(13) and (39), and thus have to comply with the limits at 21 CFR 1040.11(b) or (c), at present FDA regulations do not specifically address children’s toy laser products. FDA recently issued a proposed rule that proposes to define children’s toy laser products and require them to be within International Electrotechnical Commission (IEC) Class 1 emission limits.1 While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children’s toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to this vulnerable population. This guidance, in question and answer format, is derived from questions CDRH has received from persons in industry, the public, and other stakeholders. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Children’s Toy Laser Products
1. Question: Why is CDRH concerned about the use of laser products?
Answer: FDA has jurisdiction over radiation emitting products pursuant to sections 531 through 542 of the Federal Food, Drug, and Cosmetic Act. Although federal law requires all laser products that are sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11), the unsafe or uncontrolled use of laser products can cause injury to the user and/or others in range of the laser beam. While CDRH cannot require the safe use of lasers by individuals, it can require that manufacturers incorporate safety features, warnings and instructions for safe use, which the agency has done; these requirements are described in 21 CFR 1040.10 and 1040.11.
2. Question: What types of lasers fall within the scope of this guidance document?
Answer: Any toy that constitutes, incorporates or is intended to incorporate a laser or laser system is a laser product. See 21 CFR 1040.10(b)(21). As stated above, laser products are subject to the Federal Performance Standards for Laser Products contained in 21 CFR 1040.10 and 1040.11. For purposes of this guidance, “children’s toy laser product” means a product that is manufactured, designed, intended or promoted for use by children under 14 years of age.2 This guidance provides CDRH’s current thinking on how children’s toy laser products are defined, as well as specific safety recommendations for their manufacture and labeling.
When assessing whether a laser product is a children’s toy laser product within the scope of this document, CDRH considers the following information:
The following are examples of children’s toy laser products:
Answer: CDRH believes that toys containing lasers and lasers marketed as toys are at particular risk of being used in an unsafe or uncontrolled manner. Any laser toy should minimize risk (refer to Q&A #4). The dangers of toys incorporating lasers may not be evident, particularly to children or the adults supervising them. Retinal injuries caused by laser light may go unnoticed and unreported. Lasers can also cause skin burns.
4. Question: What is meant by “minimize risk” as used in this guidance?
Answer: For laser toys to pose minimum risk to users, the levels of laser radiation or light output must not exceed the emission levels for Class I as defined in the Federal Performance Standard for Laser Products or for Class 1 as defined in the International Electrotechnical Commission (IEC),3 under conditions of operation, maintenance, service, failure, or breakage. The inclusion of “breakage” is intended to recognize that play may continue with a broken toy.
Because children’s toy laser products are not specifically addressed in the current standard, children’s toys often contain lasers with power limits that pose a risk to eyesight. As discussed above, FDA recently published a proposed rule that includes a new section to specifically address children’s toys.4 This new section, as proposed, would clarify what category covers children’s toys and make it clear that children’s toys would have to be within IEC Class 1 limits.
5. Question: What is the basis for CDRH encouraging manufacturers of children’s toy laser products not to exceed the emission limits of IEC Class 1?
Answer: CDRH recognizes that IEC Class 1 has a higher power limit than FDA Class I. However, CDRH has determined that lasers with emissions under either the FDA Class I limit or the IEC Class 1 limit pose minimal risk even when used by children. As stated in IEC 60825-1:2007, Annex C.2, Class 1 lasers are “Laser products that are safe during use, including long-term direct intrabeam viewing, even when exposure occurs while using optical viewing instruments (eye loupes or binoculars).” The IEC Class 1 limit provides greater utility for manufacturers who need a safe, but more visible beam than FDA Class I provides; output levels in excess of IEC Class 1 are not necessary for the intended functions of toys. 6. Question: Does CDRH recommend a Class 1 label for children’s toy laser products within IEC Class 1 limits?
Answer: Yes. Although the Performance Standard (21 CFR 1040.10) does not require it, Class 1 designation labeling is encouraged. For children’s toy laser products with emissions within the IEC Class 1 limit, CDRH believes the presence of this designation in the labeling would clearly advise purchasers that the product poses minimal risk (refer to Q&A #4) and has been certified as such by the manufacturer. Such designation would indicate that the product is not in a higher emission level laser class, and lacks the required safety controls and warnings required for such a higher class.
7. Question: For toys that contain parts that emit laser light, does the whole toy need to be certified?
Answer: The whole toy needs to be certified as a laser product, unless the part of the toy that can emit laser light is removable and can emit laser light independently when separated from the other parts of the toy, in which case only that laser-emitting part would need to be certified. For example, a laser gunsight that is detachable from a toy gun is itself subject to applicable laser safety regulations and must be certified because it is a removable laser system (21 CFR 1040.10(c)(2)).
8. Question: Toys are regulated by the Consumer Product Safety Commission (CPSC). Why is CDRH providing this guidance when the CPSC already regulates toys?
Answer: Toys may be subject to laws administered by the CPSC, such as the Consumer Product Safety Act and the Federal Hazardous Substances Act. FDA has jurisdiction over radiation emitting products, such as laser products, pursuant to sections 531 through 542 of the Federal Food, Drug, and Cosmetic Act.5 In the case of children’s toy laser products, CPSC and FDA authorities complement one another to minimize the risk from using these products.
1 See 78 FR 37723 (June 24, 2013), proposed 1040.10(b)(1), (2), and 1040.11(d). Laser class definitions from IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements, Edition 2.0, March 2007, including Corrigendum 1, August 2008 (IEC 60825-1:2007), are proposed to be incorporated by reference into FDA's laser products regulation.
2 This definition is proposed at 78 FR 37723, 37737.
3 IEC 60825-1:2007. See also CDRH Laser Notice No. 50, available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm.
4 78 FR 37723, 37741 (June 24, 2013).
5 21 U.S.C. §360hhh- §360ss
Minimizing Risk for Children's Toy Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: August 7, 2013
You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document contact Robert J. Doyle at 301-796-5863 or via email at robertj.doyle@fda.hhs.gov.
| U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health | Division of Radiological Health Magnetic Resonance and Electronic Products Branch
Public Comment
You may submit written comments and suggestions at any time for Agency consideration. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1810) to identify the guidance you are requesting.
Minimizing Risk for Children's Toy Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction
This guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public, of the Center for Devices and Radiological Health’s (CDRH) current thinking on the safety of children’s toy laser products. Lasers with outputs above certain levels that are operated in an unsafe and uncontrolled manner may cause injury to the user and/or others within range of the laser beam. This is a particular concern for lasers intended for entertainment purposes, especially when intended to be used as toys by children.
Federal law requires all laser products sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 Code of Federal Regulations (CFR) 1040.10 and 1040.11). Although most children’s toy laser products would meet the definition of “demonstration laser products” or “surveying, leveling, and alignment laser products” at 21 CFR 1040.10(b)(13) and (39), and thus have to comply with the limits at 21 CFR 1040.11(b) or (c), at present FDA regulations do not specifically address children’s toy laser products. FDA recently issued a proposed rule that proposes to define children’s toy laser products and require them to be within International Electrotechnical Commission (IEC) Class 1 emission limits.1 While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children’s toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to this vulnerable population. This guidance, in question and answer format, is derived from questions CDRH has received from persons in industry, the public, and other stakeholders. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Children’s Toy Laser Products
1. Question: Why is CDRH concerned about the use of laser products?
Answer: FDA has jurisdiction over radiation emitting products pursuant to sections 531 through 542 of the Federal Food, Drug, and Cosmetic Act. Although federal law requires all laser products that are sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11), the unsafe or uncontrolled use of laser products can cause injury to the user and/or others in range of the laser beam. While CDRH cannot require the safe use of lasers by individuals, it can require that manufacturers incorporate safety features, warnings and instructions for safe use, which the agency has done; these requirements are described in 21 CFR 1040.10 and 1040.11.
2. Question: What types of lasers fall within the scope of this guidance document?
Answer: Any toy that constitutes, incorporates or is intended to incorporate a laser or laser system is a laser product. See 21 CFR 1040.10(b)(21). As stated above, laser products are subject to the Federal Performance Standards for Laser Products contained in 21 CFR 1040.10 and 1040.11. For purposes of this guidance, “children’s toy laser product” means a product that is manufactured, designed, intended or promoted for use by children under 14 years of age.2 This guidance provides CDRH’s current thinking on how children’s toy laser products are defined, as well as specific safety recommendations for their manufacture and labeling.
When assessing whether a laser product is a children’s toy laser product within the scope of this document, CDRH considers the following information:
- Promotion, advertising, labeling, packaging, and product graphics – For example, advertisements, especially in children’s publications or other media, showing a child playing with the product or otherwise suggesting the product is intended for children’s entertainment, would generally indicate it is a children’s toy laser product. Pictures on packages or labels showing play with the product, especially when cartoon characters make the product attractive to children, would also generally indicate it is a children’s toy laser product.
- Product sales – For example, sales in toy stores or other settings especially geared towards children’s entertainment, would generally indicate it is a children’s toy laser product.
- Purpose of the product – Features or the nature of the product itself may indicate it is intended for use by children.
The following are examples of children’s toy laser products:
- Lasers mounted on toy guns that can be used for “aiming”;
- Spinning tops that project laser beams while they spin;
- Hand held lasers used during play as “light sabers”;
- Dancing laser beams projected from a stationary column; and
- Lasers intended for entertainment that create optical effects in an open room.
Answer: CDRH believes that toys containing lasers and lasers marketed as toys are at particular risk of being used in an unsafe or uncontrolled manner. Any laser toy should minimize risk (refer to Q&A #4). The dangers of toys incorporating lasers may not be evident, particularly to children or the adults supervising them. Retinal injuries caused by laser light may go unnoticed and unreported. Lasers can also cause skin burns.
4. Question: What is meant by “minimize risk” as used in this guidance?
Answer: For laser toys to pose minimum risk to users, the levels of laser radiation or light output must not exceed the emission levels for Class I as defined in the Federal Performance Standard for Laser Products or for Class 1 as defined in the International Electrotechnical Commission (IEC),3 under conditions of operation, maintenance, service, failure, or breakage. The inclusion of “breakage” is intended to recognize that play may continue with a broken toy.
Because children’s toy laser products are not specifically addressed in the current standard, children’s toys often contain lasers with power limits that pose a risk to eyesight. As discussed above, FDA recently published a proposed rule that includes a new section to specifically address children’s toys.4 This new section, as proposed, would clarify what category covers children’s toys and make it clear that children’s toys would have to be within IEC Class 1 limits.
5. Question: What is the basis for CDRH encouraging manufacturers of children’s toy laser products not to exceed the emission limits of IEC Class 1?
Answer: CDRH recognizes that IEC Class 1 has a higher power limit than FDA Class I. However, CDRH has determined that lasers with emissions under either the FDA Class I limit or the IEC Class 1 limit pose minimal risk even when used by children. As stated in IEC 60825-1:2007, Annex C.2, Class 1 lasers are “Laser products that are safe during use, including long-term direct intrabeam viewing, even when exposure occurs while using optical viewing instruments (eye loupes or binoculars).” The IEC Class 1 limit provides greater utility for manufacturers who need a safe, but more visible beam than FDA Class I provides; output levels in excess of IEC Class 1 are not necessary for the intended functions of toys. 6. Question: Does CDRH recommend a Class 1 label for children’s toy laser products within IEC Class 1 limits?
Answer: Yes. Although the Performance Standard (21 CFR 1040.10) does not require it, Class 1 designation labeling is encouraged. For children’s toy laser products with emissions within the IEC Class 1 limit, CDRH believes the presence of this designation in the labeling would clearly advise purchasers that the product poses minimal risk (refer to Q&A #4) and has been certified as such by the manufacturer. Such designation would indicate that the product is not in a higher emission level laser class, and lacks the required safety controls and warnings required for such a higher class.
7. Question: For toys that contain parts that emit laser light, does the whole toy need to be certified?
Answer: The whole toy needs to be certified as a laser product, unless the part of the toy that can emit laser light is removable and can emit laser light independently when separated from the other parts of the toy, in which case only that laser-emitting part would need to be certified. For example, a laser gunsight that is detachable from a toy gun is itself subject to applicable laser safety regulations and must be certified because it is a removable laser system (21 CFR 1040.10(c)(2)).
8. Question: Toys are regulated by the Consumer Product Safety Commission (CPSC). Why is CDRH providing this guidance when the CPSC already regulates toys?
Answer: Toys may be subject to laws administered by the CPSC, such as the Consumer Product Safety Act and the Federal Hazardous Substances Act. FDA has jurisdiction over radiation emitting products, such as laser products, pursuant to sections 531 through 542 of the Federal Food, Drug, and Cosmetic Act.5 In the case of children’s toy laser products, CPSC and FDA authorities complement one another to minimize the risk from using these products.
1 See 78 FR 37723 (June 24, 2013), proposed 1040.10(b)(1), (2), and 1040.11(d). Laser class definitions from IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements, Edition 2.0, March 2007, including Corrigendum 1, August 2008 (IEC 60825-1:2007), are proposed to be incorporated by reference into FDA's laser products regulation.
2 This definition is proposed at 78 FR 37723, 37737.
3 IEC 60825-1:2007. See also CDRH Laser Notice No. 50, available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm.
4 78 FR 37723, 37741 (June 24, 2013).
5 21 U.S.C. §360hhh- §360ss