Unsure where to start navigating the complex world of regulations ?We understand.
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With our extensive expertise, comprehensive assessments, and understanding of global regulations, we assure your products to be compliant ensuring a smooth market entry. |
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🌐 How We Navigate the US Cosmetic Market
Comprehensive Regulatory Assessments: We conduct meticulous assessments of your cosmetic products to ensure they comply with the specific regulations set by the FDA and other relevant authorities, paving the way for successful market entry. Labeling and Claims Compliance: Avoid costly pitfalls by ensuring your product labels and claims meet US regulatory standards. Our regulatory team reviews your cosmetic branding and messaging to align it with legal requirements, protecting your brand and fostering consumer trust. Documentation Perfection: The devil is in the details, especially when it comes to regulatory documentation. We meticulously prepare and review all necessary documentation, from ingredient lists to safety assessments, ensuring your products sail smoothly through regulatory channels. Selling in the US: a brand must consider the Federal cosmetics legislation from all applicable regulatory bodies: FDA, FTC and the USDA.; which apply universally to all states, along with state specific regulations. The US is one nation, but the rules may vary from state to state. |
artwork review
ARTWORK REVIEW Avoid costly pitfalls by ensuring your product labels and claims meet the regulatory standards. Our meticulous artwork review includes a thorough assessment to ensure your cosmetic visuals adhere to specific regulations outlined by global authorities. This process forms the foundation for successful market entry across diverse regions. OTC Compliance
OTC COMPLIANCE What is an OTC: A drug product that is available for consumers without a prescription. Some of the OTC products include acne treatments, SPFs, antiperspirants, dandruff control, hair growth/regrowth, scar care, anti-inflammatory and weight control, and more. Our team of regulatory experts specializes in conducting thorough OTC compliance reviews. From active ingredient assessments to label claims scrutiny, we ensure your Cosmetic or OTC products align with the stringent requirements outlined by regulatory authorities. INGREDIENT LABELING
AND COMPLIANCE INGREDIENT LABELING AND COMPLIANCE We use our expertise to confidentially review your formulation(s). We create your Formulation breakdown (Quant/ Qual) to ensure your ingredient deck will be fully compliant with the latest rulings from the FDA. We work with you to collect any and all supporting documentation to alleviate the stress and ensure you have a proper ingredient deck listed on your packaging. Your customer will feel assured the product they are purchasing is from a company which values transparency. CLAIM
SUBSTANTIATION CLAIMS SUBSTANTIATION We thoroughly review all packaging verbiage, including ingredients for compliance. We research and validate all product claims, ensuring they are supported by credible evidence and following regulatory standards. Your claims on your packaging and/or your website can define you product as an OTC or a cosmetic. We will review all of your copy to ensure your product is recognized in the correct category. Are you sure 100% sure all claims and certifications on your packaging and marketing are supported? If your answer is not 100% yes, contact us free sale
certificate FREE SALE CERTIFICATE We will help you acquire a Free Sale Certificate which confirms that a specific product is available for sale in the United States or suitable for export. It also certifies that the manufacturer hasn't faced any pending or past enforcement actions from the U.S. Food and Drug Administration (FDA). P.I.F.
product Information file P.I.F. PRODUCT INFORMATION FILE A Product Information File (PIF) is a comprehensive and meticulously organized document that encompasses all pertinent details pertaining to a specific cosmetic product. Serving as a helpful tool for the US market, this is a vital prerequisite for international market placement, each product must possess its own PIF. This file includes essential information such as the Cosmetic Product Safety Report (CPSR), detailed product description, manufacturing methods, and more. cosmetic product safety assessments and reports
COSMETIC PRODUCT SAFETY ASSESSMENTS AND REPORTS By law, cosmetics must uphold safety standards for consumer use. A Safety Assessment is a mandatory validation process, conducted by a Safety Assessor that proves the product is safe for market. Certification
GUIDANCE CERTIFICATION
GUIDANCE Allow us to guide you through the processes and explore how certifications, though a significant investment, can convey a powerful message, enhancing your brand's marketing efforts.
marketing collateral proficiency
MARKETING COLLATERAL PROFICIENCY We stay updated on relevant guidelines and requirements to ensure that your marketing materials are accurate, transparent, and compliant. Our team conducts thorough reviews of content to mitigate any potential costly risks or issues, helping to safeguard your brand's reputation and minimize the likelihood of any regulatory challenges. FDA Compliance
FDA COMPLIANCE We can help you make sure your cosmetic(s) or OTC (S) are FDA compliant. We are frequently asked about "FDA Approval", as per FDA regulations, cosmetic products generally do not require FDA approval, except in cases involving color additives and New Drug Applications. Products are considered FDA compliant if they are used and labeled as intended and follow the appropriate guidelines. The FDA and the FTC (Federal Trade Commission) has the authority to intervene if products are misused or improperly labeled. The primary laws governing cosmetics in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), under which the FDA regulates cosmetics. mocra
MOCRA The Modernization of Cosmetic Regulation Act (MoCRA) is the first step in expanding the US Regulations. The Consolidated Appropriations Act was signed into law on December 29th, 2022, giving the FDA more authority over the safety of cosmetics. We support brands by conducting meticulous assessments of your cosmetic products to ensure they comply with the specific regulations set by the FDA and other relevant authorities, paving the way for successful market entry. Read more... |
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🌐 How We Navigate the International Cosmetic Market:
Thorough Global Regulatory Assessments: Our comprehensive assessments ensure your cosmetic products adhere to the specific regulations outlined by international authorities. This includes compliance with many regions around the world, I.E. Health Canada, the European Union's Cosmetics Regulation, Australia's TGA, the UAE, the FDA in the United States, and other regional regulatory bodies , ensuring a smooth market entry across continents. Multilingual Labeling and Claims Compliance: Your global success hinges on effective communication. We ensure your product labels and claims meet and exceed regulatory standards in targeted regions, allowing your brand to effectively communicate with consumers in diverse linguistic and cultural settings. Strategic Market Entry Planning: We craft detailed strategies for registering cosmetics and OTC products for each international market you target, considering not only regulatory compliance but also cultural nuances and regional preferences. This global approach positions your brand access for success. Personal Regulatory Support: We go beyond compliance, offering strategic one-on-one guidance to ensure your brand's success in diverse global markets. CLICK TO LEARN MORE ABOUT INTERNATIONAL REGULATIONS |
RESPONSIBLE PERSONS
RESPONSIBLE PERSONS Since July 11, 2013, to sell cosmetics in Europe, an EU Responsible Person (with offices in EU) is legally mandatory (Regulation EC No 1223/2009). It indeed requires a Responsible Person (RP), established within the European Union to be designated for each cosmetic product marketed within the European territory. Read more... eu/UK compliance
We ensure our products meet the standards set forth by both the European Union and the United Kingdom through Artwork and claims review, Ingredient compliance, allergen declaration, proper testing documents, label review, Safety Assessments and Micros testing. cHINA iNGREDIENT
rEGISTRATIONS Thanks to an incredible partnership with Reach24 we are able to process China ingredient registrations, quickly leaving brands and suppliers with one less thing to worry about. SPF International
registration We have helped brands acquire registration of SPF products in USA, EU, Canada, and Australia. u.k. Compliance
assistance with
safety assessments We will work with your brand and lab to obtain all the required information for a PIF such as Product description, Composition, Manufacturing processes, Stability Testing, Packaging, Claims, and Labeling. We will then give this information to the Responsible Person or Safety Assessor to complete the Safety Assessment. canada cosmetic
registration Trading partners with Canada
guidance required
lab testing guidance with
accrediation SDS
REACH 24 Standard ones Move to regular regulatory page- We have much experience in creating Safety Data Sheets for an array of labs and ingredient suppliers across the beauty industry. All of our Safety Data Sheets are able to be completed to Reach Standards for EU compliance. REACH 24
EU only PIF NOTE "A PIF file is used to create a SA, and/or to deal with many internationals reg bodies. use it to give to the Safety Accessor for a Safety Assessment. (we work with many around the world- see Responsible Person section) " |
