FDA compliance for cosmetics and personal care.

What changed with MoCRA

The Modernization of Cosmetics Regulation Act gave FDA authority over cosmetics it had not previously had. The obligations that matter most to an exporter:

• Registration of facilities that manufacture or process cosmetics for the United States market, with renewal.
• Listing of each cosmetic product and its ingredients.
• Safety substantiation: adequate evidence of safety for each product, held on file and available to FDA.
• Adverse event reporting, with records retained.
• A responsible person named on the label to receive those reports.
• Good manufacturing practice requirements for cosmetics.

Colour additives

More cosmetic entries are refused over colour than over anything else. Every colour additive must be approved for that specific use, must meet its identity and specification requirements, and — for most synthetic organic colours — must come from a batch certified by FDA. Colours that are legal in other markets are frequently not permitted in the United States, and a formula that has sold for years elsewhere can be refused on its first entry.

Adulteration and misbranding

A cosmetic is adulterated if it contains a poisonous or deleterious substance, contains an unapproved colour additive, or is prepared under insanitary conditions where it may have become contaminated. It is misbranded if the labeling is false or misleading, if required information is missing, or if the claims cross into drug territory. An anti-acne, anti-dandruff or sun protection claim makes the product a drug, with an entirely different regulatory burden.

What we do

• Preparing the MoCRA registration and product listing submissions.
• Formula review against the colour additive regulations and prohibited substances.
• Safety substantiation files that hold together as evidence.
• Label and claims review, including the cosmetic-drug line.
• Microbiological control programmes for manufacturing.
• Removal petitions prepared for products already on alert.

Common questions

Does FDA approve cosmetics before they are sold?

No, with the exception of colour additives, which require approval and in most cases batch certification. Everything else is the firm's responsibility — but FDA can act against a product after the fact, and MoCRA gave it new tools to do so.

Our product is certified organic and natural. Does that help with FDA?

Not directly. Those terms are not FDA cosmetic categories. A natural extract can still be an unapproved colour additive, a source of contamination, or the basis of a claim that turns the product into a drug.

What makes a cosmetic a drug?

The intended use, shown mainly through claims. Anything saying the product treats or prevents a condition, or affects the structure or function of the body, moves it into the drug framework regardless of the formula.

We already sell in Europe. Can we reuse the dossier?

Parts of it. A CPSR contains much of the underlying safety data, but the ingredient rules differ, the colour regime is different, and the labeling requirements are not interchangeable.