{"description":"Documents matching 'fragrance allergen' and from Food and Drug Administration","count":13,"total_pages":1,"results":[{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).","document_number":"2019-25274","html_url":"https://www.federalregister.gov/documents/2019/11/21/2019-25274/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-21/pdf/2019-25274.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-25274.pdf?1574257523","publication_date":"2019-11-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"appreciate these comments supporting our undertaking this survey of reactions to <span class=\"match\">allergens</span> in cosmetics. \n This survey is part of an ongoing effort by FDA to better understand cosmetic ingredients that may be potential <span class=\"match\">allergens</span>, and this constitutes the third contract over the last few years to address <span class=\"match\">allergens</span> in cosmetics. The first contract in 2015-2016 conducted a comprehensive literature review of 26 <span class=\"match\">fragrances</span> that the European Union has identified as <span class=\"match\">allergens</span>. The second contract in 2016-2017 expanded the inquiry to other cosmetic ingredients"},{"title":"Sunscreen Drug Products for Over-the-Counter Human Use","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).","document_number":"2019-03019","html_url":"https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-02-26/pdf/2019-03019.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-03019.pdf?1550756721","publication_date":"2019-02-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"affixed to the test subject's skin, usually on the back, to determine whether the ingredient causes direct skin toxicity. Dermal sensitization studies are conducted similarly but are designed to detect immunologically mediated reactions, which require prior exposure to the <span class=\"match\">allergen</span>.\n \n Nonprescription sunscreens regulated under the OTC monograph system may be used in many product formulations, including those yet unknown. Therefore, cumulative irritation studies that evaluate the sunscreen active ingredient at the highest concentration for which a"},{"title":"Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.","document_number":"2015-32246","html_url":"https://www.federalregister.gov/documents/2015/12/23/2015-32246/fixed-combination-and-co-packaged-drugs-applications-for-approval-and-combinations-of-active","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-12-23/pdf/2015-32246.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-32246.pdf?1450792012","publication_date":"2015-12-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"requirements of this proposed rule for certain allergenic products. <span class=\"match\">Allergen</span> patch tests are diagnostic tests applied to the surface of the skin to determine the specific causes of contact dermatitis. An allergenic patch test kit may contain individual patches in which several chemicals that may elicit allergic contact dermatitis are mixed (\n e.g., \n black rubber mix, paraben mix, <span class=\"match\">fragrance</span> mix). These tests are combined in this manner because a positive diagnosis regarding any of the <span class=\"match\">allergens</span> in the mix would result in the same clinical recommendation"},{"title":"Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, we) is proposing to revise its requirements for cochineal extract and carmine by requiring their declaration on the label of all food and cosmetic products that contain these color additives. The proposed rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract and carmine-containing food and cosmetics and would allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This proposed action also responds, in part, to a citizen petition submitted by the Center for Science in the Public Interest (CSPI). With regard to drug products, FDA plans to initiate rulemaking to implement the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.105-115) provisions that require declaration of inactive ingredients for drugs. The FDAMA provisions have already been implemented for over-the-counter (OTC) drugs.","document_number":"E6-1104","html_url":"https://www.federalregister.gov/documents/2006/01/30/E6-1104/listing-of-color-additives-exempt-from-certification-food-drug-and-cosmetic-labeling-cochineal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-01-30/pdf/E6-1104.pdf","public_inspection_pdf_url":null,"publication_date":"2006-01-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"reactions from occurring following exposure to an <span class=\"match\">allergen</span> (Ref. 6). Fatal reactions have occurred despite appropriate administration of treatment. Thus, avoidance of the <span class=\"match\">allergen</span> is the only method certain to prevent harm and fatal reactions. Reading of labels on food, drug, and/or cosmetic products, and/or education about potential scenarios where contact with <span class=\"match\">allergen</span>-containing sources could occur, are the cornerstone of risk prevention strategies for allergic individuals and their families. \n <span class=\"match\">Allergens</span> have been identified in food, drug, and cosmetic"},{"title":"Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is issuing an advance notice of proposed rulemaking that would establish conditions under which over-the-counter (OTC) drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded. This notice is based on the recommendations of the Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee (NDAC) and is part of FDA's ongoing review of OTC drug products.","document_number":"03-12783","html_url":"https://www.federalregister.gov/documents/2003/05/29/03-12783/oral-health-care-drug-products-for-over-the-counter-human-use-antigingivitisantiplaque-drug-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-05-29/pdf/03-12783.pdf","public_inspection_pdf_url":null,"publication_date":"2003-05-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"States, Austin, TX, pp. 46-59, 1959.\n \n \n 56. Shelanski, H. A., and M. V. Shelanski, “A New Technique of Human Patch Tests,” in \n Proceedings of Scientific Section \n , The Toilet Goods Association, 19:46-49, 1953.\n \n \n 57. Kligman, A. M., “The Identification of Contact <span class=\"match\">Allergens</span> by Human Assay; III. The Maximization Test: A Procedure for Screening and Rating Contact Sensitizers,” \n Journal of Investigative Dermatology \n , 47:393-409, 1966.\n \n \n 58. \n The United States Pharmacopeia—23, The National Formulary—18 \n , United States Pharmacopeial Convention"},{"title":"Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cosmetic Product Voluntary Reporting Program","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that the proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"02-25642","html_url":"https://www.federalregister.gov/documents/2002/10/09/02-25642/agency-information-collection-activities-submission-for-omb-review-comment-request-cosmetic-product","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-10-09/pdf/02-25642.pdf","public_inspection_pdf_url":null,"publication_date":"2002-10-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain information about which products do or do not contain a specified ingredient and about the levels at which certain ingredients are typically used. Dermatologists use FDA files to cross-reference <span class=\"match\">allergens</span> found in patch test kits with cosmetic ingredients. The Cosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a review of ingredients used in cosmetics, has relied on data provided by FDA in selecting ingredients to be reviewed based on frequency of use. \n The Cosmetic Product Voluntary Reporting Program"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Cosmetic Product Voluntary Reporting Program.","document_number":"02-17076","html_url":"https://www.federalregister.gov/documents/2002/07/08/02-17076/agency-information-collection-activities-proposed-collection-comment-request-cosmetic-product","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-07-08/pdf/02-17076.pdf","public_inspection_pdf_url":null,"publication_date":"2002-07-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain information about which products do or do not contain a specified ingredient and about the levels at which certain ingredients are typically used. Dermatologists use FDA files to cross-reference <span class=\"match\">allergens</span> found in patch test kits with cosmetic ingredients. The Cosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a review of ingredients used in cosmetics, has relied on data provided by FDA in selecting ingredients to be reviewed based on frequency of use. \n The Cosmetic Product Voluntary Reporting Program"},{"title":"Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cosmetic Product Voluntary Reporting Program","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"99-28111","html_url":"https://www.federalregister.gov/documents/1999/10/28/99-28111/agency-information-collection-activities-submission-for-omb-review-comment-request-cosmetic-product","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-10-28/pdf/99-28111.pdf","public_inspection_pdf_url":null,"publication_date":"1999-10-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain \ninformation about which products do or do not contain a specified \ningredient and about the levels at which certain ingredients are \ntypically used. Dermatologists use FDA files to cross-reference \n<span class=\"match\">allergens</span> found in patch-test kits with cosmetic ingredients. The \nCosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a \nreview of ingredients used in cosmetics, has relied on data provided by \nFDA in selecting ingredients to be reviewed based on frequency of use.\n     The Cosmetic Product Voluntary Reporting"},{"title":"Surgeon's and Patient Examination Gloves; Reclassification","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing regulations to reclassify all surgeon's and patient examination gloves as class II medical devices because it believes that general controls are insufficient to provide a reasonable assurance of safety and effectiveness. The reclassified gloves, including those made of natural rubber latex (NRL) or synthetic material, will be regulated in four categories: Powdered surgeon's gloves, powder-free surgeon's gloves, powdered patient examination gloves, and powder-free patient examination gloves. The proposed special controls are in the form of a proposed guidance document entitled ``Medical Glove Guidance Manual,'' which includes recommended protein and glove powder limits, and new label caution statements including protein and powder labeling requirements. FDA is also proposing to require expiration dating. This proposed rule is intended to reduce the adverse health effects from allergic and foreign body reactions caused by the natural latex (NL) protein allergens and glove powder found on surgeon's and patient examination gloves and to reduce the adverse health effects from defects in the barrier integrity and quality of surgeon's and patient examination gloves. DATES: Written comments by October 28, 1999. Written comments on the information collection requirements should be submitted by August 30, 1999.","document_number":"99-19191","html_url":"https://www.federalregister.gov/documents/1999/07/30/99-19191/surgeons-and-patient-examination-gloves-reclassification","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-07-30/pdf/99-19191.pdf","public_inspection_pdf_url":null,"publication_date":"1999-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"the reactions depend on both the amount of \npowder and the amount of NL protein <span class=\"match\">allergens</span> on the finished products. \nMeasurements of airborne particle levels in environments where NL \ngloves were used frequently demonstrated that the level of airborne \n<span class=\"match\">allergen</span> is directly related to the frequency of powdered NL glove \nusage in particular areas and to the level of <span class=\"match\">allergen</span> and/or powder on \nthe gloves used (Refs. 12 and 14).\n    Direct evidence that NL protein <span class=\"match\">allergens</span>, bound to the glove \npowder particles, provoke respiratory allergic reactions"},{"title":"Agency Information Collection Activities: Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Cosmetic Product Voluntary Reporting Program.","document_number":"99-20359","html_url":"https://www.federalregister.gov/documents/1999/08/09/99-20359/agency-information-collection-activities-proposed-collection-comment-request-cosmetic-product","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-08-09/pdf/99-20359.pdf","public_inspection_pdf_url":null,"publication_date":"1999-08-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain \ninformation about which products do or do not contain a specified \ningredient and about the levels at which certain ingredients are \ntypically used. Dermatologists use FDA files to cross-reference \n<span class=\"match\">allergens</span> found in patch-test kits with cosmetic ingredients. The \nCosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a \nreview of ingredients used in cosmetics, has relied on data provided by \nFDA in selecting ingredients to be reviewed based on frequency of use.\n    The Cosmetic Product Voluntary Reporting"},{"title":"Agency Information Collection Activities; Submission for OMB Review; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"96-32426","html_url":"https://www.federalregister.gov/documents/1996/12/23/96-32426/agency-information-collection-activities-submission-for-omb-review-comment-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-12-23/pdf/96-32426.pdf","public_inspection_pdf_url":null,"publication_date":"1996-12-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain \ninformation about which products do or do not contain a specified \ningredient and about the levels at which certain ingredients are \ntypically used. Dermatologists use FDA files to cross-reference \n<span class=\"match\">allergens</span> found in patch test kits with cosmetic ingredients. The \nCosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a \nreview of ingredients used in cosmetics, has relied on data provided by \nFDA in selecting ingredients to be reviewed based on the frequency of \nuse.\n    FDA estimates the burden of the cosmetic"},{"title":"Agency Information Collection Activities: Proposed Collection; Comment Request; Reinstatement","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Cosmetic Product Voluntary Reporting Program.","document_number":"96-22121","html_url":"https://www.federalregister.gov/documents/1996/08/29/96-22121/agency-information-collection-activities-proposed-collection-comment-request-reinstatement","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-08-29/pdf/96-22121.pdf","public_inspection_pdf_url":null,"publication_date":"1996-08-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"request, consumers can obtain \ninformation about which products do or do not contain a specified \ningredient and about the levels at which certain ingredients are \ntypically used. Dermatologists use FDA files to cross-reference \n<span class=\"match\">allergens</span> found in patch test kits with cosmetic ingredients. The \nCosmetic, Toiletry, and <span class=\"match\">Fragrance</span> Association, which is conducting a \nreview of ingredients used in cosmetics, has relied on data provided by \nFDA in selecting ingredients to be reviewed based on frequency of use.\n    FDA estimates the burden of the Cosmetic"},{"title":"Latex-containing Devices; User Labeling","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to amend the regulations to require all medical devices containing natural rubber latex that may directly or indirectly contact living human tissue to be labeled with a statement identifying the product as one which contains natural rubber latex and which may cause allergic reactions. The agency is also amending the regulation to require that hypoallergenicity claims be removed from latex medical gloves and other natural rubber latex medical devices because the modified human Draize test currently used to support hypoallergenicity claims addresses only chemical sensitivity, and it is inappropriate for determining protein sensitivity in humans. These requirements are being proposed in response to numerous reports that have been received of severe allergic reactions to a wide range of medical devices containing natural rubber latex.","document_number":"96-15990","html_url":"https://www.federalregister.gov/documents/1996/06/24/96-15990/latex-containing-devices-user-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-06-24/pdf/96-15990.pdf","public_inspection_pdf_url":null,"publication_date":"1996-06-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"thereof or under such conditions of use as are customary \nor usual.\n    The courts have upheld FDA's authority to prevent false or \nmisleading labeling by issuing regulations requiring label warnings and \nother affirmative disclosures. (See, e.g., Cosmetic, Toiletry, and \n<span class=\"match\">Fragrance</span> Association v. Schmidt, 409 F. Supp. 57 (D.D.C. 1976), aff'd \nwithout opinion, Civil No. 75-1715 (D.C. Cir. August 19, 1977), even in \nthe absence of a proven cause-and-effect relationship between product \nusage and harm; Council for Responsible Nutrition v. Goyan, Civil"}]}