{"product_id":"us-cosmetic-label-review-mocra-fda","title":"US Cosmetic Label Review (MoCRA \u0026 FDA)","description":"\u003cp\u003eUS cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event reports. We review the identity statement, net quantity, ingredient list, responsible person details, warnings and claims, and flag any drug claims. £595 per product.\u003c\/p\u003e\u003ch2\u003eWhat does a US cosmetic label need?\u003c\/h2\u003e\u003cp\u003eUS cosmetic labels are governed by \u003cstrong\u003eFDA's cosmetic labelling regulations (21 CFR Part 701 and 740)\u003c\/strong\u003e, the \u003cstrong\u003eFair Packaging and Labeling Act (FPLA)\u003c\/strong\u003e and \u003cstrong\u003eMoCRA\u003c\/strong\u003e. They need a \u003cstrong\u003estatement of identity\u003c\/strong\u003e, \u003cstrong\u003enet quantity\u003c\/strong\u003e in US units, an \u003cstrong\u003eingredient declaration\u003c\/strong\u003e in the required order, the \u003cstrong\u003ename and place of business\u003c\/strong\u003e of the manufacturer, packer or distributor, and, under MoCRA section 609, a \u003cstrong\u003edomestic US contact\u003c\/strong\u003e for adverse event reports. Claims that a product treats or prevents disease, or affects the body's structure or function, may make it a \u003cstrong\u003edrug\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your label review?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrincipal display panel\u003c\/strong\u003e: Statement of identity and net quantity in US units\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIngredient declaration\u003c\/strong\u003e: Order and naming checked against 21 CFR 701.3\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMoCRA contact\u003c\/strong\u003e: Responsible person name and US contact for adverse event reports\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWarnings\u003c\/strong\u003e: Required warning statements for your product type\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClaims review\u003c\/strong\u003e: Claims that could make the product a drug flagged\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this label review for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK and EU brands adapting labels for the US\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers asked to fix labelling\u003c\/li\u003e\n\u003cli\u003eBrands launching new US products\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this label review not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel design.\u003c\/strong\u003e We review and mark up; artwork changes are yours or a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC drug labels.\u003c\/strong\u003e Sunscreens and other OTC drugs need a Drug Facts review.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eState-law labelling.\u003c\/strong\u003e Some states have their own rules; we flag known issues but do not do a full state review.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSeveral products.\u003c\/strong\u003e Each product label is reviewed separately.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Cosmetic Label Review work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your label\u003c\/strong\u003e: Artwork or photos of every panel, with the formula.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We check each element against FDA, FPLA and MoCRA rules.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive a marked-up report with required changes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck of the revised label is included.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 701\u003c\/strong\u003e — cosmetic labelling, including ingredient declaration (701.3)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 740\u003c\/strong\u003e — cosmetic warning statements\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFair Packaging and Labeling Act\u003c\/strong\u003e — identity and net quantity\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 609\u003c\/strong\u003e — MoCRA label contact for adverse events\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 201(g)\u003c\/strong\u003e — drug definition and claims\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Cosmetics Labeling Guide (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide)\u003c\/li\u003e\n\u003cli\u003e[MoCRA (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/us-cosmetic-safety-substantiation-file-mocra\"\u003eUS Cosmetic Safety Substantiation File (MoCRA)\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/mocra-essentials-annual-package\"\u003eMoCRA Essentials Annual Package\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824342597709,"sku":null,"price":595.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-cosmetic-label-review-mocra-fda.webp?v=1793176386","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/us-cosmetic-label-review-mocra-fda","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}