The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.
August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).
One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. […]
Whether you are a new or experienced exporter, the next webinar is essential!
- When do you get to hear from a Board Certified Expert on actual horror stories and when it’s in your best interest to file a Disclosure?
DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!
U.S. Customs & Border Protection (CBP)
- Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
- Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
- Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
- Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
- Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.
Do you import food products (or any FDA regulated product) into the U.S.? I’ve launched a new website (www.FDA-USA.com) to assist you in learning the basic requirements for FDA regulated products. The website features information for importers of food, drugs, cosmetics, medical devices, dietary supplements and alcoholic beverages.
Don’t forget, if you are a registered food facility with the FDA and don’t comply with FDA’s mandatory biennial registration, FDA can cancel your FDA Food Facility Registration. Learn more about the Biennial Registration requirement in my previous post here.
At today's Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA's Joint Team 488 - which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows...
The U.S. Food and Drug Administration ("FDA") has strict labeling requirements for cosmetic products. One area that consistently causes confusion among companies that distribute cosmetic products to countries on different continents is the area of labeling.