Expanding into the U.S. cosmetics market requires precise alignment with FDA regulations under MoCRA. Sobel offers a complete FDA Compliance for Cosmetics package, covering registration, safety, and labelling. So your products meet every requirement and reach the market with confidence.
Get step-by-step assistance, so your cosmetic products meet FDA expectations and are fully prepared for launch.
Save time and minimize the risk of errors with an integrated solution that covers safety substantiation, label review, and product registration.
Keep your brand compliant with MoCRA today and prepared for future regulatory changes.
Non-compliance may lead to recalls, rejections, or reputational harm. By checking documents in advance, we you can avoid setbacks.
With Sobel’s FDA Compliance for Cosmetics package, you can be confident that your brand is fully aligned with MoCRA and FDA requirements.
Our experienced team supports both U.S. manufacturers and international exporters, offering clear guidance and practical solutions tailored to your compliance journey.
Explore additional services that complement FDA compliance for cosmetics:
Pre-registration review of cosmetic documents to identify gaps and guide compliance.
Get FDA- and GMP-ready SOPs for your cosmetics business.
We help cosmetic manufacturers revise documentation for full compliance.
Preparing to enter the U.S. market requires complete regulatory readiness.
With Sobel’s FDA compliance package for cosmetics, you receive integrated support in label review, safety substantiation, and product registration, giving your brand the clarity and confidence to succeed.
Talk to our team today and start your FDA compliance journey with expert guidance.
1. Do cosmetics need FDA approval before sale?
No. In the U.S., cosmetics (and most ingredients) do not require premarket approval from the FDA. However, all cosmetics must be safe for use and have labels that are truthful, accurate, and not misleading. Failure in either area can result in enforcement actions such as recalls, detentions at customs, or reputational damage. At Sobel, we help brands ensure compliance through safety substantiation reports and label reviews—two critical steps that demonstrate product safety and guarantee that your packaging aligns with FDA requirements.
2. Who must register and who must list products?
Manufacturers and processors must register their facilities with the FDA, while the “responsible person” (the company named on the label) must list each marketed product with its ingredients and keep it updated annually. Sobel supports both steps—facility registration and product listing—so your brand stays aligned with MoCRA requirements.
3. What counts as “adequate safety substantiation”?
MoCRA requires companies to maintain evidence proving that a cosmetic product and its ingredients are safe for use. This may include tests, studies, research data, or other information generally accepted by experts. At Sobel, we identify each document and piece of data that must be provided, and prepare a clear Safety Substantiation Report so your brand is fully aligned with FDA expectations.
4. What is the “responsible person”, the U.S. Agent?
The “responsible person” is the company identified on the cosmetic label—usually the manufacturer, packer, or distributor—legally accountable for ensuring the product’s safety, proper labeling, and FDA compliance. Sobel can act as your U.S. Agent, managing these obligations so your brand meets MoCRA requirements with confidence.
5. What happens after completing the FDA Compliance for Cosmetics package?
Once your facility is registered, your products are listed, and safety and labeling are verified, you are ready to launch in the U.S. market. After this stage, ongoing compliance becomes essential: updating product listings annually, renewing facility registration every two years, monitoring regulatory updates, and keeping records of safety and adverse events. Sobel continues to support your brand with follow-up services, ensuring that your compliance remains consistent even after the initial registration process.
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