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Best PracticesCosmeticsFDA IssuesFoodFSMAImportImport AlertMedical Devices

FDA Discusses TOP Reasons for Detention of Goods

posted by Jennifer Diaz March 20, 2013 0 comments

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, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

  • Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act.  (You can Register with the FDA here: www.FDA-USA.com)
  • Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)
  • The products are subject to an Import Alert
  • Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Incorrect or missing statement of identity
  3. Failure to list allergens
  4. Failure to declare ingredients
  5. Failure to include a proper “Nutrition Facts” label (incorrect formats for Nutrition Facts labeling is also common) required by 21 C.F.R. 101.9
  6. Color additives are not declared correctly (or at all) on the label or not certified
  7. Food  additives are unsafe or not declared on the label

Dietary Supplements Top Rationales for Detention

  • The products are subject to an Import Alert
  • Product labeling is not compliant (FDA does not pre-approve dietary supplement labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1.  Label is not in English
  2. Unauthorized health claims
  3. Undeclared active ingredients
  4. Lacks a “Supplement Facts” panel required by 21 C.F.R. 101.36
  5. Failure to list the name of product and “Dietary Supplement” or “Herbal Supplement” on the label
  6. Failure  to list the appropriate disclaimer necessary when claims are made

Cosmetics Top Rationales for Detention

  • The cosmetics are subject to an Import Alert (for example IA 66-38 for cosmetics labeled with drug claims)
  • The cosmetics are contaminated and unsafe to use
  • The cosmetics are manufactured under unsanitary conditions
  • The cosmetics contain a non-permitted color additive
  • Product labeling is not compliant (FDA does not pre-approve cosmetic labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1.  Label is not in English
  2. Labeling is missing ingredients
  3. Label lacks warnings and adequate directions for use
  4. Missing the net quantity of contents
  5. Cosmetic  contains a “drug” claim

Drugs Top Rationales for Detention

  • The cosmetics are subject to an Import Alert (for example IA 66-41 – Unapproved new drugs)
  • Drugs are not registered or listed with the FDA
  • Product labeling is not compliant (FDA does not pre-approve drug labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Label does not contain adequate directions for use
  3. Active Pharmaceutical Ingredients (API) is not properly labeled or listed
  4. Drug contains a “new” chemical or a different dosage making the product a “new drug”

Medical Devices Top Rationales for Detention

  • The manufacturers is not registered with the FDA
  • The initial importer is not registered with the FDA
  • The device is not listed with the FDA
  • The product does not contain a 510k or PMA
  • Product labeling is not compliant (FDA does not pre-approve medical device labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Label is false or misleading 

Bottom line, as you can see, it is up to you, the importer to perform pre-compliance and assure you get compliance right before you import.  FDA expects you to know the requirements and has little mercy if you don’t.  Assure you stay compliant and avoid the top rationale for FDA to detain your goods by hiring someone that is extremely knowledgeable with FDA’s laws and regulations and continually stays up to date with the constant changes. 

ExportOFAC

The Journal for Export Control Professionals

posted by Customs & International Trade Law Blog April 29, 2011 0 comments

I am pleased to introduce to you a new periodical, "World Export Controls Review – the journal of export controls and compliance," published by Brightlaw Media Ltd., London, England.  The first issue published in March 2011 is free.  The April 2011 publication contains my article entitled "Good Practice: Responding to an OFAC Administrative Subpoena" (available only upon request).

The publication reports on sanctions programs such as the United States has with Burma, Iran, and Libya, as well as general international trade topics such as "U.S. Tightens Controls on Foreign Workers" or "Evolving Intent Standards in U.S. Prosecutions". The publication is truly for the legal experts in international trade and export controls.

world ecr helps its readers stay on top of:

  • Developments in export control regulation and policy around the world,
     
  • Changing enforcement policies and practice governing export and re-export,
     
  • Legal implications of changing distribution technologies, 
     
  • Best practice in trade regulation compliance, and
  •  
  • Encryption, technology transfer and end-use and end-user controls.

I hope you enjoy reading the article, and will subscribe to the publication. 

Events

2nd Conference of the Americas

posted by Customs & International Trade Law Blog April 26, 2011 0 comments

The International Bar Association’s 2nd Conference of the Americas takes place at the Mandarin Oriental Hotel, Miami, Florida, May 4-6, 2011. The inaugural Conference of the Americas took place in Mexico City in 2008.   The International Bar Association (IBA) is the largest legal organization in the world.

This Second Conference will again be the perfect opportunity for legal professionals from North America and South America to network, share information, and identify issues, concerns and opportunities across the Americas’ legal markets and jurisdictions.  The Program sessions are focused on 8 areas:

  1. The region in the aftermath of the financial crisis.
  2. Cartel enforcement and leniency programs.
  3. International trade.
  4. Taxation
  5. Dispute resolution.
  6. Energy issues and infrastructure.
  7. Social networking.
  8. General Counsel Forum.

This event is also supported by the International Law Section of the Florida Bar Association.  The Conference Program Co-Chairs are Pierre Bienvenu based in Montreal, Peter Quinter based in Miami, and Claudio Undurraga based in Santiago.  To register for the conference, please do so on-line.  For questions, please contact any of the three people above.

I look forward to seeing you in Miami.