Were you aware that the FDA can conduct, without any notice in advance, a cosmetic facilities inspection? The areas this surprise visitor, the FDA inspector, is there to check up on includes employee productivity, machinery and labeling, and may also take product samples, all by simply showing his credentials and a written approval allowing inspection. Usually in these instances, there is at least one violation made note of in these cosmetics facilities inspections.
The FDA informs companies of the importance of ensuring the safety of merchandise being sold and that they don’t want to end up on the wrong side of the coin. There are those who have been quoted saying as soon as the FDA moves into the picture, there’s no getting out empty-handed. When the FDA uncovers an infringement, it makes it seem as though they are doing an excellent job as the nation’s “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.
Importers should particularly make sure they avoid prohibited ingredients (especially illegal color additives and drug ingredients) and provide truthful labeling (in English!).
The FDA really clamps down if a cosmetic product claims on its label the ability to cure a medical condition or affect in any manner how one’s body functions. FDA import regulations allow the agency to apply the most stringent of standards for drug products or facilities as they perform inspections. On the grounds that a product makes claims in company advertising – even on the Internet -that it contains drugs, the FDA will detain it as not only unapproved, but as a new illegal drug.
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.