The FDA regulates cosmetics — including luxury skincare — primarily under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, since 2022, the Modernization of Cosmetics Regulation Act (MoCRA). Understanding where your product sits in the regulatory framework is essential before you launch.
The first question is whether your product is a cosmetic or a drug. The FDA defines a cosmetic as a product intended to cleanse, beautify, or alter appearance without affecting the body's structure or function. A moisturizer that hydrates skin is a cosmetic. A product that claims to 'rebuild collagen,' 'treat wrinkles,' or 'reverse aging' at the physiological level may be classified as a drug, which triggers a completely different and far more expensive approval pathway. Luxury skincare brands frequently walk this line in their marketing copy — and the FDA has issued warning letters to brands that crossed it. Stay on the cosmetic side of the claim.
Under MoCRA (signed into law December 2022 and phased in through 2024–2025), cosmetic brands selling in the US must: register their manufacturing facilities with the FDA, list each cosmetic product with the FDA (including a complete list of ingredients), maintain safety substantiation records for each product, and report serious adverse events to the FDA within 15 business days. These requirements now apply to most brands regardless of size, with limited exemptions for very small businesses.
Ingredient restrictions are the next compliance layer. The FDA maintains a list of prohibited and restricted cosmetic ingredients. Certain color additives require pre-market approval. Fragrance allergens do not currently require individual labeling in the US (unlike the EU, which has a more expansive allergen disclosure requirement). However, if you intend to sell in both the US and EU, you need to design your formula and label to meet the stricter EU standard from the start.
Labeling requirements for cosmetics sold in the US include: identity of the product, net quantity of contents, distributor name and address, ingredient declaration in INCI nomenclature in descending order of predominance, and any required warnings. At the luxury tier, brands sometimes under-label to maintain a clean aesthetic — that is a compliance risk.
The common first-timer mistake is treating FDA cosmetics compliance as simpler than it is because it doesn't require pre-market approval (unlike drugs). MoCRA changed the landscape significantly. Non-compliance can result in FDA warning letters, mandatory recalls, or market withdrawal.
AJ Cosmo Labs connects indie founders with cosmetic chemists and compliance-aware contract manufacturers who build FDA-compliant products from the start. Open the AJ Cosmo Labs app on your iPhone, post your brief, and ask specifically for suppliers with MoCRA compliance experience — it is one of the filters that matters most right now.
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