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Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

posted by Jennifer Diaz January 26, 2017 0 comments

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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.

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Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

posted by Jennifer Diaz November 6, 2015 0 comments
Do you need to know the current issues affecting importing and exporting for international trade professionals?  What about common compliance issues when importing food, cosmetics, and medical devices?  If you answered yes, you will not want to miss the last of our three-part seminar series that will cover these topics and much more.  Plus, members of supporting organizations, clients of Becker & Poliakoff, and future members and clients, will receive a discount!  Here’s all the information about our upcoming seminar:

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3 Part Compliance Seminar Series You DON’T Want to Miss!

posted by Jennifer Diaz August 24, 2015 0 comments
We are excited to announce our upcoming 3 part seminar series on ImportingExporting, and FDA Compliance! Government and private speakers will participate.  
Each seminar will provide resources for new and experienced international trade
professionals including:

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New FDA-USA Website for Importers

posted by Jennifer Diaz October 30, 2014 0 comments
FDA-USA

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.

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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. 

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How to Comply with International Inconsistencies in FDA Cosmetic Labeling Requirements

posted by Customs & International Trade Law Blog October 11, 2011 0 comments

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. Different products have different labeling requirements depending on the application of the product, the type of ingredient being labeled, the size of the product, and the country to which the product will be shipped. For example, the rules regarding how to describe color additives for products entering the U.S. are different than those for Canada and Europe.

Fortunately, it is possible to comply with the labeling requirements for the U.S. as well as Canada and Europe using only one label. In fact, it can even be accomplished with a product bearing a label as small as that of mascara. Accomplishing this is greatly beneficial to these companies because they can take advantage of economies of scale and taper production costs by merely having one label printed to be distributed to several countries.  However, this is a delicate maneuver that, if not done properly, will likely result in seizure and detention by the FDA or a foreign country’s equivalent agency. This will cause delays in the shipments, and may cause civil penalties and forfeiture of the products.

To avoid this common mistake and take advantage of the fact that one label may be used throughout the U.S., Canada, and Europe, you should contact an attorney well versed in the FDA regulations. Taking this precautionary measure is an investment in greater profits and peace of mind.