FDA Cosmetics Rules and Regulations
Did you know that FDA can inspect cosmetics facilities without prior notice? An FDA inspector must show his credentials and written notice of inspection at the door, but then he is free to explore the machinery, take samples of products, inspect labeling, and assess worker expertise while he is there. Many such inspections end with at least one “violation” written up.
FDA will tell you it needs to make sure the products are safe for use and unadulterated, and that it wants to err on the side of caution. Some others would say that once FDA gets involved, it doesn’t want to walk away empty-handed. Finding violations makes FDA look like it is doing a good job as a “watchdog.”
Imported cosmetic products may be examined and sampled by FDA at the time they arrive at the port of entry. If they merely “appear” to be adulterated or misbranded, they may be refused entry into the U.S. If a shipment does not comply with U.S. laws and regulations in even one way, the entire shipment may be subject to FDA detention. At this point, the products must be brought into compliance, destroyed, or re-exported.
To forestall this sort of thing happening, importers are responsible for truthful labeling, in English, as well as assuring that there are no prohibited ingredients such as drug or color additives, in their products.
If there are any “drugs” in a cosmetic, or if the cosmetic has drug claims in its labeling (i.e., claims that the product will affect the structure or function of the body or cure some medical condition), the rules change completely. FDA will then inspect facilities (and shipments) according to the stringent standards for drug facilities and products, and will undoubtedly find dozens of violations. FDA will detain cosmetics with drug claims on their labels or in their advertising (including internet advertising) on the grounds that they are new, unapproved, illegal drugs.
FDAImports.com regularly assists cosmetic manufacturers and importers with all of the U.S. requirements as well as Mexican, Canadian, European and many Asian country regulations.
FDAImports.com was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. FDAImports.com specializes in making the complex understandable.