FDA Asks for Input on Cosmetic Reporting Requirements
Published Date: 7/17/2026
Notice
Summary
The FDA wants your thoughts on new info they might collect about cosmetic products. This affects companies making or selling cosmetics, who may need to share more details soon. You’ve got until September 15, 2026, to send in your comments—no cost yet, just your voice!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
New FDA Reporting and Recordkeeping Burden
If you are a "responsible person" for cosmetics (the manufacturer, packer, or distributor whose name is on the label), FDA is proposing information-collection requirements under MoCRA that would produce about 417,698 total annual responses and an estimated 367,777 annual burden hours across activities like facility registration, product listing, updates, and safety recordkeeping. The notice cites specific statutory sections (e.g., sections 605, 607, 608) and requests public comment by September 15, 2026.
Labeling and Disclosure Hours for Product Labels
If you label cosmetic products, FDA estimates 5,738 respondents will need to make on average 21–24 label disclosures each (declaration of ingredients, statement of identity, name/place of business, net quantity, contact info), resulting in about 676,170 total annual disclosure hours. The notice ties these requirements to 21 CFR 701.3, 701.11-701.13 and section 609(a) of the FD&C Act.
Adverse Event Record Retention Requirement
If you are a responsible person for cosmetics, section 605(e)(1) requires you to keep a record for each adverse event report for six years (or three years for qualifying small businesses). The notice ties cosmetics adverse event reporting to FDA Form 3500A and existing adverse event reporting collections (OMB Control Number 0910-0291).
Safety Substantiation Recordkeeping Obligation
If you are a responsible person, section 608(a) requires you to maintain records supporting the "adequate substantiation of safety." FDA estimates about 22,564 respondents will each maintain one safety substantiation record, totaling 22,564 annual burden hours for this activity.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
Previous / Next Documents
Previous: 2026-14433, Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Kansas
A major disaster was declared for parts of Kansas after severe storms, tornadoes, and flooding hit in late April 2026. This declaration helps local nonprofits get low-interest loans to repair damage and recover, with physical damage loan applications due by August 31, 2026, and economic injury loans available until March 30, 2027. Cherokee, Morris, Osage, Saline, and Wabaunsee counties are the main areas getting this support.
Next: 2026-14435, Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
The FDA wants your thoughts on how they collect info about food safety programs that stores can join voluntarily. This affects food regulators and businesses aiming to keep food safe and could shape how info is gathered without adding extra costs. You’ve got until September 15, 2026, to share your feedback and help make food safety smoother and smarter!