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The U.S. Food and Drug Administration (FDA) has been court ordered to set firm dates for FSMA's implementation.  Details of the court case forcing FDA to set these dates, and the organization that sued the FDA to make this happen follow.

Background

The Center for Food Safety (CFS), a national non-profit public interest and environmental advocacy organization, filed a lawsuit against the FDA on August 29, 2012.  The complaint alleged FDA failed to promulgate 7 food safety regulations required by the Food Safety Modernization Act (FSMA).  Congress enacted the FSMA – which was signed into law on January 4, 2011 – to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA’s inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. CFS documented the foodborne illness outbreaks since FSMA was signed into law, January 4, 2011.

Court Order

The court case is being heard by Judge Phyllis Hamilton, in the U.S. District Court for the Northern District of California.  Yesterday, May 21, 2013, Judge Hamilton ordered that the FDA and CFS have an extended deadline of June 10, 2013 to file a joint statement with a mutually agreeable proposed schedule for the outstanding food safety rules.

Rationale for Suit and Missed Deadlines

The ongoing battle between the CFS and FDA to complete this process has lasted for several months. On August 2012, the CFS filed a suit against the FDA Commissioner after the FDA missed a series of deadlines for publishing the regulations mandated by the Food Safety Modernization Act. After numerous deadlines went by without the release of the mandated rules, CFS went to court to try to force FDA to adhere to these time constraints. Following the court appearance, Judge Hamilton ruled that the FDA must come up with a new schedule for issuing the proposed rules by May 20.  This extension came about as a result of the inadequacy in time provided for the FDA and CFS to resolve their differences regarding the schedule FDA suggested to issue the proposed rules.

The FDA sent its updated schedule to CFS on May 15; however, CFS was not satisfied with the proposed timeline. Due to the fact that there were only five days left until the deadline expired, the parties filed a Joint Stipulation for Extension of Time. This extension was granted by Judge Hamilton.

New Rules Released by FDA & What's to Come

Since CFS filed its complaint last year, FDA has released some of the key FSMA mandated rules it failed to publish on time, including preventive controls for human food and standards for produce safety, both released in early January. However, there are some rules that are yet to be released. Among them is the foreign supplier verification program (section 301).  This program is set to overhaul import safety, an establishment of regulations to ensure the safe transport of food products and a rule ensuring neutrality of third-party audits.  I think of it akin to C-TPAT (Customs-Trade Partnership Against Terrorism).  It's a self policing and auditing type program that includes functions like  monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

I look forward to seeing and reporting on FDA's implementation of FSMA.

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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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I'm thrilled to be included as a speaker in the upcoming Global Clinical Sourcing and Supply Summit in Philadelphia.  I've included all the pertinent details about the summit and even a discount for you, my loyal readers! 

WHAT: Global Clinical Sourcing and Supply Summit.  Includes a FDA Address by Domenic Veneziano, Director of FDA's Division of Import Operations and Policy, and Industry Perspectives by speakers from Merck, Novartis Pharmaceuticals Corporation, AstraZeneca, and much more. The full agenda may be seen here.

WHEN: March 4-5, 2013

WHERE: Radisson Plaza - Warwick Hotel, Philadelphia, PA

WHO: You will benefit by attending if you are a Vice President, Director, Manager, or other Senior Executive from a pharmaceutical or biotech company with responsibilities in: Clinical Supplies, Supply Chain Planning and Forecasting, Clinical Labeling, Clinical Sourcing, Procurement, Investigational Materials, Global Logistics, Clinical Contracting, Clinical Packaging

WHY: My portion of the Summit will cover an update on current import and export control, discussion of free trade agreements in place and top trading partners, top tips to utilize when importing or exporting to assure compliance with federal government laws and regulations, and how to effectively resolve issues from U.S. Customs and Border Protection (CBP) when importing. 

To give you EVEN MORE of an incentive, email me for the Promo Code to save $500 off the registration fee!  Offer expires on March 4, 2013 - so don't delay!

If that's not enough for you, I leave you with an additional TOP 10 Reasons to Attend: 

1. Hear directly from the FDA on Import processes and requirements
2. Optimize your communication strategies with clinical operations
3. Understand the risks and rewards with central versus local sourcing options
4. Ensure efficiency while meeting the expectations of sites, patients and regulators
5. Develop strategies to monitor the changing regulatory requirements in emerging markets
6. Analyze the complex logistical and distribution challenges in India
7. Effectively resolve U.S. Customs and Border Protection (CBP) issues
8. Establish a metrics-driven system to enhance contractor performance
9. Reengineer current packaging process to streamline efficiency
10. Navigate global quality, compliance and regulatory challenges

To give you EVEN MORE of an incentive, tell them Jennifer Diaz sent you by using Promo Code GCSSP5 and save $500 off the registration fee! Offer expires on March 4, 2013 - so don't delay!

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The FDA has proposed two new rules issued under the Food Safety Modernization Act (FSMA) that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods.  If you want your voice heard, you have until May 16, 2013 to submit your comments to the FDA on the proposed rule. The FDA does take comments seriously, we're here to help if you want assistance in drafting your comments. This rule is expected to be published shortly following the conclusion of the comment period on May 16, 2013.  

The proposed rules would apply to facilities that manufacture, process, pack or hold human food. The rules focus on commonly identified routes of microbial contamination of produce, including:

(1) agricultural water

(2) farm worker hygiene

(3) manure and other additions to the soil

(4) animals in growing areas, and

(5) equipment, tools and buildings.

In general the facilities that are required to register include manufacturers, processors, warehouses, storage tanks, and grain elevators. However, there are a number of exemptions and modified requirements. We would be pleased to assist you in determining whether or not your facility may be exempt from these requirements.  

Below is a recap of the proposed rules.

Rule #1 - Preventative Controls for Human Food.  The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

• hazard analysis;
• risk based preventive controls;
• monitoring procedures;
• corrective actions; 
• verification; and
• recordkeeping

Do you have your written plan in place yet?

Rule #2 - Produce Safety.  The second rule proposes enforceable science- and risk-based safety standards for growing, harvesting, packing and holding fruits and vegetables on foreign and domestic farms. These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:

• Irrigation and other agricultural water
• Farm worker hygiene
• Manure and other additions to the soil
• Intrusion of animals in the growing fields.
• Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.

The rules still to come are:

•  Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
• Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
• Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.

As FDA implements more of FSMA, we will keep you informed. 

Do you need assistance in submitting a comment to FDA? Does your company need training on FSMA? If so, contact me anytime.  

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The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S. 

Here's what you need to know about FDA's new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I've summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn't lapse. 

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012 (which FDA extended until January 31, 2013, as renewals did not start until October 22).

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– January 31, 2013 extended registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

Contact Jennifer Diaz with any questions  and ensure your importation are not delayed come February 1, 2013.

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 Below are the latest and greatest updates  regarding compliance with the FDA's Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA's extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration - meaning they can NOT import into the U.S.

FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Reinspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required. U.S. Agents will be responsible to assure these fees are collected.

FDA Extension

Because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA's guidance document advised that FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.

FDA Published 2 Guidance Documents:

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). This guidance document contains helpful questions and answers regarding food facility registration.

Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide. Thus guide was updated to reflect FSMA amendments to the FD&C Act, and discusses: who is required to register pursuant to the Bioterrorism

Suspension of Registration

FSMA also amended section 415 of the FD&C Act to provide FDA with the authority to suspend a food facility’s registration in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA already used this power and suspended the registration of Sunland, a producer of nuts. The full story may be read here.

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Biennial Registration Renewal for Food Facilities is now available, as of October 22, 2012.

Here's what you need to know about FDA's new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I've summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn't lapse.  If your not re-registered by December 2012, FDA will cancel your Bioterrorism Act registration and your importations will be delayed.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?
The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

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The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I've summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn't lapse.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders.  Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety.  The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year.  For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?
The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

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Attorney Jen Diaz will be presenting the first seminar "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices" at the FIME Show at 10:00 AM on Wednesday, August 8, 2012 at the Miami Beach Convention Center.  This will be Jen's third consecutive year teaching at FIME.

After attending this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the "worst case scenarios."  We will discuss how we handle everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP).  FDA issues include what to do if you receive a "Notice of FDA Action" stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a "Warning Letter" that could potential state you must stop producing certain medical devices because they are adulterated or misbranded.   Effectively resolving CBP issues includes the appropriate response when CBP says your goods are under "detention," will be "seized" and "forfeited" or are included in the "detention without physical examination" list and how your company can get off the list.  You will also learn the appropriate response after you receive a "liquidated damages claim" up to $50,000 from CBP.  

FIME brings together the worldwide medical community for the largest and most comprehensive trade show in the United States, and features medical manufacturers from all over the globe. If you can find it in a hospital, surgery center, physician’s office, medical laboratory, or medical supply store, you can find it at FIME.

View the complete seminar schedule for FIME Show 2012 here.

If you want more information about medical device compliance issues with FDA and/or CBP, please contact Jen Diaz at (305) 260-1053 or by email at JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

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On May 24, 2012, U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages (TTB Ruling 2012-2).

Currently, there is no Food and Drug Administration (FDA) regulation that defines the term “gluten-free”.  

FDA proposed to define gluten free as: 

• an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
• an ingredient derived from these grains and that has not been processed to remove gluten;
• an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
• 20 ppm or more gluten.

Pending the issuance of a final rule by FDA, TTB is providing interim guidance on the use of the term “gluten free” on alcohol beverage labels and advertisements subject to TTB’s authority.

Alcohol Products Made from Gluten-Free Materials

TTB’s position is that the term “gluten-free” will be interpreted by consumers of alcohol beverages to mean that the product contains no gluten. TTB provided the example of wine fermented from grapes, or vodka distilled from potatoes. If  there are good manufacturing practices – meaning no cross-contamination, no additives, no yeast, and no storage materials with gluten – a ‘gluten-free’ claim in the labeling of the alcohol beverage will be permissible in the interim period awaiting FDA’s final rule.

Alcohol Products Made from Gluten-Containing Materials

FDA and TTB both assert that there are currently no scientifically valid testing methods to determine the gluten content of fermented products. This includes companies that undertake a process to remove the gluten from its alcohol beverages.

TTB’s position is that these methods cannot be used to substantiate a “gluten-free” claim at this time. Further, a “gluten-free” statement on labeling for a product made from gluten would be misleading.

However, the following statement is permissible: "Processed/Treated/Crafted to Remove Gluten". This statement must be accompanied with a conspicuous qualifying statement informing the consumer:

Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten.
- OR -
This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.

The full interim policy can be found here.

For more information regarding your company's strategy for remaining in compliance with FDA and TTB to break into the gluten-free consumer market, contact attorney Jennifer Diaz at (305) 260-1053 or by email at JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

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This Friday, May 25, 2012 is officially designated as Don’t Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn’t want you to fry either. On June 18, 2012 the FDA’s new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013.

Here are some major changes you should see as a result of the new requirements:

1. The terms "sunblock", "sweatproof", "waterproof", "all‐day", "instant protection", and "extended wear" will be eliminated from your beach-going vocabulary. The FDA found these claims to be false and misleading to consumers and they are now prohibited for sunscreen labeling. A word of caution: these or similar claims will cause the product to be misbranded under section 502 of the FD&C Act (21 U.S.C. 352).
2. A plain statement of "water resistant" is not going to be sufficient, either. There are newly required label statements regarding the length of time a sunscreen product is truly water resistant. This is to ensure that the consumer is aware of how long the sunscreen will last in the water. But how will a manufacturer know how much water resistance is provided in terms of time? There are new FDA effectiveness testing requirements to determine water resistant sunscreen times.
3. Are you used to buying the sunscreen with the highest SPF number? A combined ‘‘Broad Spectrum SPF’’ statement is now required on the principal display panels [PDP’s] for sunscreen products. If the sunscreen does not pass the broad spectrum test, or it is broad spectrum with an SPF value of less than 15, the product will bare a required skin cancer and skin aging warning label in bold, indicating the adverse consequences of spending time in the sun. What does that mean for consumers? The broad spectrum labels and warnings will make shopping for sunscreen more apples-to-apples. It will be easier to determine which different types of sunscreen are really protecting your skin from the sun the way you need them to, and which ones don’t go the distance.

For more information regarding all the new changes to sunscreen product testing and labeling, please visit Federal Register’s "Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use".

For assistance in complying with these new requirements, please contact Jennifer R. Diaz, senior attorney in the customs and international trade division of Becker & Poliakoff, P.A. at (305) 260-1053, or by email at JDiaz@becker-poliakoff.com.

Here’s to not frying this Memorial Day weekend!

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The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center.  The Show attracts 19,000 visitors, and is the largest seafood show in North America.  See www.bostonseafood.com.  I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know - now.

My topic is "Food Safety Compliance under the New Food Safety Modernization Act of 2011."  My fellow panelists discussing the FSMA, and import safety generally, include Ted Poplawski from the FDA, Judith Webster from U.S. Customs and Border Protection (CBP), Howard Tennen from Quirch Foods, Dean Leaman of ABC Research Laboratories, and Dan Fone of NSF International.  Since 80% of the seafood consumed in the United States is imported, compliance with the food safety laws and regulations that have now been implemented by the FDA, in cooperation with CBP, is critical.

There were a record number of FDA Import Alerts for seafood in 2011, and a higher number of imported shipments of seafood are now the subject of Detention Without Physical Examination (DWPE). What is surprising to many people is that the seafood is not just being stopped and inspected from China, but also Vietnam, Chile, and Canada, to name a few.  Moreover, seafood fraud in many forms such as species substitution or false country of origin to avoid the payment of anti-dumping duties is now being discovered by the FDA, CBP, and NOAA.  Criminal prosecutions and civil penalties by CBP are now front page news.

Thank you to Diversified Business Communications, based in Portland, Maine, for again inviting me to be a speaker at the Show.  See www.divbusiness.com.

By the way, the abundance of free seafood is FABULOUS at the Show!

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Just a few weeks ago, FDA investigators ordered an administrative detention of a Maine company’s cold-smoked salmon product, a ready-to-eat food, during an inspection. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision, after inspectors found Listeria monocytogenes within the company’s facility and on its processing equipment.

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I authored "Recent Developments in Food and Drug Law, 2012 Edition" which was just published by Thomas Reuters.  It is part of a series called "Inside the Minds" written by attorney thought-leaders in food and drug law from the top law firms across the United States.  It analyzes the latest food and drug laws, regulations and policies that affect food and drug companies.  It also focuses on violations by persons and companies, and how to successfully defend any investigation by the U.S. Food and Drug Administration (FDA) without having to go to court.

The full title  of the 408 page publication is "Recent Developments in Food and Drug Law, 2012 Ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, and Developing Compliance Practices".  The book is written for C-level executives to learn the very latest trends about food and drug law enforcement and compliance requirements by the FDA.    According to the press release

This Aspatore legal title provides an authoritative, insider's perspective on complying with FDA regulations and staying up-to-date on the latest trends in food and drug law.

The Food Safety Modernization Act (FSMA) gave the FDA recall authority, so companies must know how and when to do a voluntary recall and when a product is safe and effective or, alternatively, defective.  The book will precisely explain the labeling requirements acceptable to the FDA and when the statements about the use of a product may be false and misleading so that the product is considered to be "mislabeled" by the FDA.   Readers should understand when is a violation handled administratively by the FDA' Office of Regulatory Affairs (ORA), and when a suspected violation is investigated by the FDA's Office of Criminal Investigations (OCI). Knowing the difference, and how to handle each of these types of inquiries, audits, or investigations may make the difference in avoiding a fine or being arrested. 

The book is available for only $90. Click here for a complete description or to purchase.   

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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.

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The annual seminar "Practical Tools for Trade in the Food Industry" takes place at the Miami Seaport on September 7, 2011 from 8:30 a.m. to 12:30 p.m.  Sponsored by the Miami-Dade County Office of Economic Development & International Trade, and supported by the Port of Miami, this year we will again focus on what importers need to know about both U.S. Customs and Border Protection and U.S. Food and Drug Administration requirements.  There will  be special emphasis on the new Food Safety Modernization Act of 2011.

The seminar takes place at the beautiful Port of Miami Conference Room, 1015 N. America Way, Miami.  Registration may be done on-line.   Questions regarding REGISTRATION may be directed to Adam Peters, Trade Development Specialist at (305) 375-5420 or apeters@miamidade.gov.  Question regarding content of the seminar may be directed to Jennifer Diaz, Senior Attorney, Customs and International Trade Department, Becker & Poliakoff law firm (305) 260-1053.

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The U.S. Food and Drug Administration is increasingly stopping and examining imported shipments of food attempting to enter the United States.  Often, the FDA does not allow the food to enter the United States by declaring it to be misbranded or adulterated by filth or decomposition.  Virtually always, refused food is then either destroyed or exported from the United States. There is a little known, but valuable, option called "reconditioning".

Once reconditioned, food that was originally rejected by the FDA may legally enter the commerce of the United States.  How, when, and why to recondition food is the subject of a webinar on May 25, 2011, sponsored by the Journal of Commerce, and presented by attorney Peter Quinter and FDA manager John Verbeten.

John Verbeten is the Director of Operations and Policy Branch, Division of Import Operations and Policy, at FDA Headquarters.  The discussion will cover detention without physical examination (DWPE), the Food Safety Modernization Act, the FDA Regulatory Procedures Manual, and the practical use of FDA Form 766.

Registration for the webinar is done on-line at the Journal of Commerce website.

Separately, a seminar for importers, customs brokers, and other persons involved in international trade is taking place in Tampa, Florida, on June 1, 2011. This will be a practical "how to" regarding the Food Safety Modernization Act of 2011, FDA's Detention Without Physical Examination (DWPE) and Notice of Refusal procedures, FDA Import Alerts, and U.S. Customs and Border Protection issuance of Liquidated Damages for failure to redelivery FDA refused merchandise.

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I am at the final day of the annual International Boston Seafood Show held at the Boston Convention Center. With record attendance and a record number of exhibitors filling the convention center floor with extravagant booths overflowing with shrimp, fish, crab, lobster, and other seafood delectables from all over the world, the Show is a success.   After all, this is the largest seafood show in North and South America.  Perennial exhibitors Pescanova, Inc. and Preferred Freezer Services had the largest and most memorable displays.  In addition to my speaking on the topic of "Food Safety", my law firm exhibited at the Show for the first time, and shared a booth with food testing laboratory, ABC Research Corp.

Serious topics for the educational seminars included "Rebuilding Consumer Confidence in Gulf Seafood," and "Food Safety".   There was significant discussion of aquaculture.  For pure fun, the Show included a new Game Lounge, the 5th Annual Oyster Shucking Competition, the 2nd Annual Tweet & Meet Tweetup, and a keynote address from Wayne Rogers, the actor from the hit series M*A*S*H.

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In 2010, Americans consumed almost 6 billions pounds of seafood.  The U.S. Food and Drug Administration (FDA) is responsible for ensuring that the nation's food supply, including seafood, is safe, wholesome, and properly labeled. That is a tough task considering 80% of the seafood we eat is imported from countries all over the world.  Unfortunately, the reality is that seafood fraud is common. Moreover, it can have not only economic, but food safety, consequences. 

According to a February 2009 GAO Report provided to the United States Congress which criticized the FDA for its lack of enforcement:

The most common types of seafood fraud are:

1.  shipping products through an intermediary country to avoid customs duties (transshipping),

2. adding excess amounts of water or ice to the seafood to increase its weight (over-treating),

3. substituting a different species of seafood for the species listed on the label (species substitution), and

4. including less seafood in a package than indicated by the label (short-weighting).

Read this typical January 20, 2011 Press Release from the U.S. Department of Justice regarding a company that pled guilty to false labeling of imported fish.  Read this typical Warning Letter from the FDA against a seafood company for misbranding its shrimp.

The Food Safety Modernization Act, signed into law in January 2011, is a step in the right direction to give the FDA the legal authority to prevent, not just respond to, seafood fraud. As FDA Commissioner Margaret Hamburg stated in a recent press release:

This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.

The topics of seafood fraud and the Food Safety Modernization Act will be discussed in detail at the "Food Safety Reform Update" panel at the International Boston Seafood Show on Sunday, March 20, 1:30 to 3:00 p.m. Learn how to prevent seafood fraud, how to detect seafood fraud, and what to do if you or your company are under investigation by the FDA, U.S. Customs and Border Protection (CBP), or the National Marine Fisheries Service (NMFS) for seafood or other import fraud.

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The Customs and International Trade Department of the law firm of Becker & Poliakoff* regularly holds workshops. Attendees learn the most recent information regarding compliance with the import and export requirements of the various Federal agencies of the United States Government.  Our next workshops will focus on one of my favorite subjects - FOOD, and its increasing regulation by the FDA.  The workshops take place in both Miami and Ft. Lauderdale, Florida.

The 2010 Import/Export Fall Workshop Series hosted in cooperation with the Office of Economic Development  & International Trade of Miami-Dade County  (OEDIT) is entitled "Importing Food into the United States for International Trade Professionals".  The speakers are from the U.S. Food and Drug Administration's Miami Imports Branch and ABC Research Corp., a food testing laboratory, and the Customs and International Trade Department.  The presentation will be from 8 a.m. to 11:30 a.m. on Thursday, November 4, at the Miami Free Zone. The workshop will focus on food, but also include cosmetics, medical devices, and dietary supplements, all of which are also regulated by the FDA.  For more information, you may contact me or the OEDIT at 305-375-1254 or e-mail oedit@miamidade.gov.  The seminar is open only to Miami-Dade County companies.

On Tuesday, November 16, 2010, from 8 a.m. to 11 a.m., at the Port Everglades Administration Building, Ft. Lauderdale, Florida, my law firm, in cooperation with Broward County's Office of Economic and Small Business Development, and the City of Hollywood, will host "Importing Food Products in Compliance with FDA and U.S. Customs Rules".  The seminar is open to all persons and companies.  Registration for the seminar may be easily done on-line.  The seminar is interactive, and focuses on practical "what you need to know" information.  Handouts and real-life scenarios will be discussed regarding detentions by the FDA, liquidated damage claims by CBP, refusals by the FDA because a company is on an Import Alert, Nutrition Facts labeling and medical claims,  Bioterrorism Act registration of food facilities, etc.

I look forward to seeing you at both excellent seminars above.  Importers, customs brokers, attorneys, consultants, and anyone involved in the importation and logistics businesses will benefit.

*Becker & Poliakoff was honored to be listed in the 2010 U.S. News & World Report review of law firms in the area of FDA Law. 

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On December 12, 2003, the U.S. Food and Drug Administration (FDA) implemented the Bioterrorism Act of 2002.  That Act basically required that companies shipping food to the United States must first be registered with the FDA, and that importers of food must provide "prior notice" to the FDA of any particular shipment before it physically arrives in the United States.  Over the past 7 years, has the Bioterrorism Act lived up to its expectations to protect the American consumer from eating dangerously contaminated food?

In an article entitled "Scrap the Bioterrorism Act" published in February 2004, I criticized the Act as not going far enough because it did not require (1) FDA Inspectors to be located in foreign countries sending us food,  (2) cooperation with foreign food inspection governmental authorities, and (3) mandatory recall authority to the FDA for contaminated foods.  In a May 6, 2010 report by the U.S. Government Accountability Office (GAO) entitled "Food Safety:  FDA Could Strengthen Oversight of Imported Food," it came to exactly the same conclusions. 

As stated in the GAO report:

The FDA physically examines approximately 1 percent of imported food.

Imported fish and other seafood is of particular interest to the FDA.  Obviously, FDA Inspectors cannot physically inspect every shipment of imported seafood, but every shipment that contains FDA-regulated products that enters the United States is electronically reviewed by the FDA  to determine if the shipment should be physically examined or a sample laboratory tested.   Hence, the prior notice information enables FDA, working closely with U.S. Customs and Border Protection, to more effectively target inspections at the border to ensure the safety of imported foods before the food enters the commerce of the United States.

Registration of food facilities that manufacture, process, pack, or hold food is suppose to help provide FDA with information on the origin and distribution of food.  The objective is that the registration will aid in the detection and quick response to actual or potential threats to the U.S. food supply, usually by microbiological contamination such as listeria.

If  an importer is attempting to import food from a foreign facility which has not been registered with the FDA, the food will be held at the port of arrival until the registration violation is corrected.  Registration by the foreign food producer and shipper may be easily accomplished, in multiple languages, at www.FDA-USA.com.  

My conclusion is that the FDA is doing a much better job at protecting the international food supply chain, but it needs the U.S. Congress to now pass the Food Safety bill, pending there for over a year, to really do an effective job. Coincidentally, the Sunday New York Times front page article "Senate Bill on Food Safety is Stalled," makes the same argument.

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Americans are constantly bombarded with warnings that the seafood we eat is contaminated with salmonella, listeria, or some other antibiotic, fungicide, or microorganism that will make us sick.  The U.S. Food and Drug Administration (FDA) is taking more samples of imported seafood, holding more seafood for laboratory analysis, and rejecting more seafood than in past years. That is true of basa from Vietnam, crabmeat from Indonesia, and a variety of seafood from countries as far away as China, or as close to the United States as the Bahamas.

The FDA issues 'Import Alerts' to attempt to prevent  contaminated seafood (or specific products) from certain overseas suppliers from entering the food supply chain in the United States.  Seafood importers should be very familiar with Import Alert 16-81 - "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella". 

The Obama Administration's Import Safety Working Group Food Protection Plan encourages the FDA to issue more Import Alerts.  An Import Alert is an order to all FDA district officials to detain and examine imported seafood that is identified on an Import Alert, or to detain and examine any seafood shipped by an overseas company  that is listed on the Import Alert (i.e. the "Red List"). 

Import Alerts are issued on an almost daily basis by the FDA.  For Import Alert 16-81, the "Charge" reads as follows:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to contain salmonella, a poisonous and deleterious substance, which may render it injurious to heath. [Adulteration, Section 402(a)(1).]

The explanation for such a food safety procedure was explained in a 2004 report to Congress by the U.S. General Accountability Office in Report 04-426 with a scathing criticism of the FDA's "Food Safety" program.

More than 80% of the seafood that Americans consume is imported from an estimated 13,000 foreign suppliers in about 160 nations. If contaminated, imported and domestic seafood can cause foodborne illnesses with problems ranging from mild gastrointestinal discomfort to neurological damage.

Next year, when Congress passes, and the President signs, a new food safety law, suppliers, importers, warehouses, and transportation companies should all expect a lot more changes from the FDA.  The U.S. House of Representatives already approved H.R. 2749 entitled "Food Safety Enhancement Act of 2009," and the Senate is now debating S.B. 510 entitled "Food Safety Modernization Act of 2010." With reports that now 90% of our seafood is from overseas, the increased use of aquaculture, and the continuing threat of contaminated seafood, companies which are manufacturing, shipping, warehousing, and transporting seafood will have to face the reality of more government regulation.

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The U.S. Food and Drug Administration has issued notices to all foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011.  Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act.  Foreign food facilities that do not properly respond to the FDA notices may have their registrations automatically terminated. In effect, that will result in a detention of any food that arrives in the United States from those canceled facilities.

It is no secret why the FDA is visiting foreign food facilities shipping food to the United States.  See blog post "The FDA is Flexing Its Enforcement Muscles".  The Foreign Food Inspection Team at the FDA's Center for Food Safety and Applied Nutrition (CFSAN) based in College Park, Maryland, is responsible for coordinating the foreign food inspections.  The recent FDA notices state, in part:

The inspection will be conducted by an investigator of the FDA to determine if your facility is operating in accordance with U.S. Food, Drug, and Cosmetic Act and its regulations, including Title 21 CFR Part 110, Good Manufacturing Practices (GMP) regulations.

Any foreign food facilities not yet registered may register with the FDA using a website www.FDA-USA.com established and operated by my law firm for a fee.  It is very easy to register on-line in English, Spanish, Portuguese, or German.  Companies should properly prepare prior to the FDA inspection.

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All those dietary supplements advertised on television and readily available on the Internet claim to do one thing or another.  Taking certain pills allegedly will make you smarter, give you a burst of energy, end problems with erectile dysfunction, or even cure cancer. The United States Food and Drug Administration (FDA) is the primary Federal agency responsible for protecting the American consumer from such false claims.  The FDA does this through its Office of Regulatory Affairs (ORA), and pursues criminal investigations through its Office of Criminal Investigations (OCI). 

The mission of the Office of Criminal Investigations (OCI) is to conduct and coordinate investigations of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA). OCI has an office at FDA Headquarters in Rockville, Maryland, and field offices around the United States.  For example, the Miami Field Office is located in Ft. Lauderdale, Florida, and covers 8 Southeastern States, plus Puerto Rico and the U.S. Virgin Islands.  Special Agents of the OCI investigate street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices.

In Miami, Florida, two importers were recently arrested for importing cheese contaminated with Staphylococcus aureus, making the food adulterated.  A conviction for introducing contaminated food into the United States may result in 3 years in prison and a fine of $250,000.

Whenever contacted by a Special Agent of the FDA's OCI, be sure to contact an attorney knowledgeable in FDA laws, regulations, policies, and procedures.

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FDA is proposing to expand disclosure of certain information which is currently not openly shared with the general public.  The twenty-one draft proposals are in response to comments received by FDA’s Transparency Task Force as a way to make the decision-making of the FDA more apparent to consumers and regulated industries.  The proposals are available on-line as a complete report or by specific topic area. 

The report divides the draft proposal into the following eight general topic areas:

• Adverse Event Reports
• Docket Management Process
• Enforcement Priorities and Actions
• Import Procedures
• Inspections
• Product Applications (including Investigational applications)
• Recalls
• Warning and Untitled Letters

Ten of the twenty-one draft proposals are applicable to the food industry.  They are listed below with links provided to background information, summary of public comments, agency considerations and reasoning for the draft proposal.

Draft Proposal 2 [Docket Management Process]

FDA is accepting comments on the proposals through July 20, 2010.

--------

Co-authored with Dean Leaman, Director of Business Development

Import/Export - Miami, FL, ABC Research Corporation

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On May 20, 2010, the top management of both U.S. Customs and Border Protection (CBP) and the U.S. Immigration and Customs Enforcement (ICE) testified before the U.S. House of Representatives' Committee on Ways and Means Subcommittee on Trade.   Chairman Tanner said the hearing was "to strike the right balance" between trade facilitation and security.  Unfortunately, the Committee heard all about the enforcement success of both ICE and CBP without hearing about the difficulties faced daily by importers and customs brokers.

Chairman Tanner accurately stated:

There has been a growing concern that, in particular, CBP's modernization of trade functions, facilitation of trade, and enforcement of traditional customs laws have appeared to lag while the agency tightened security screening of passengers and cargo.

ICE was particularly proud of its accomplishments by its National Intellectual Property Rights Coordination Center.  In ongoing Operation Guardian, ICE has interdicted substandard, tainted, or counterfeit products, including food and medicine that pose health and safety risks to American consumers.  $26 million of such condoms, circuit breakers, toys, extension cords, honey, and shrimp were seized by ICE and CBP.

What was not revealed was how many unnecessary delays and expenses were caused by ICE and CBP for the legitimate merchandise that entered or transited the United States.  In order to determine the effectiveness of the targeting programs used by CBP, Congress needs to inquire about the number of detentions and examinations by CBP, and the consequential financial costs to importers.  The U.S. Government Accountability Office (GAO) is also concerned with properly targeted imported food shipments, as indicated in its May 6, 2010 report on "Food Safety".

Does CBP do a good job at targeting imported shipments?

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The largest North American seafood event is the annual International Boston Seafood Show which next takes place March 20-22, 2011, in Boston, Massachusetts.  Not only will I be there, I welcome everyone to visit our exhibition booth!  This reflects the growth of our focus on FDA issues within the Customs and International Trade Department of my law firm.

With the U.S. Food and Drug Administration (FDA) holding, detaining, examining, testing, and refusing more imported food than ever before, our attorneys are constantly interacting with FDA Inspectors, Compliance Officers, and Investigators.  We typically represent the U.S. importer who has received a Notice of FDA Action, and is given 10 days to explain to the FDA that the food product  should enter the United States rather than be refused.  We also represent overseas suppliers who unfortunately find themselves listed on an FDA Import Alert, and want to get off that list. 

For example, on May 20, 2010, the FDA issued Import Alert #16-18, which is "Detention Without Physical Examination of Fresh  and Frozen Shrimp from Bangladesh, Hong Kong, Indonesia, Taiwan, and Thailand" for filth, decomposition and Salmonella.  Shrimp from those countries will automatically be detained by the FDA until a United States laboratory provides sufficient documentation to the FDA that the product meets U.S. standards.  The secret is getting on what the FDA calls the "Green List" of approved shrimp suppliers from these countries so that the product proceeds through the FDA entry process without delay.

Please comment on form below to let me know your experiences from attending or exhibiting at the Boston Seafood Show in prior years.  Remember, it's all the seafood you can eat!

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At today's Food and Drug Law Institute's annual conference in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States.  Dr. Hamburg stated that the FDA "cannot wait until the food arrives at our borders," that "extending the FDA's global reach is key to our success," and that the FDA's new PREDICT system will focus FDA Inspectors to select, stop, and examine high-risk shipments being imported into the United States.

Ralph Tyler, FDA's new Chief Counsel, stated that the laws enforced by the FDA affect 25% of the American economy.  The crowd in attendance applauded when Ralph stated that "FDA lawyers are not doing their jobs when they simply say 'no'" to the food, drug, and cosmetic companies regulated by the FDA.

Michael Chappell, FDA's Associate Commissioner for the Office of Regulatory Affairs (ORA), is the person responsible for managing the import, inspections and enforcement policy of the FDA.   He stated that companies are now operating in "an age of heightened enforcement by the FDA."  He stated that "salmonella and listeria remain major problems in food manufacturing facilities."  He advised that there were 19 million customs entries in 2009, and the number is ever increasing.   He stated that the FDA had in 2010 already issued a record number of Warning Letters to importers, producers, and distributors of FDA regulated products, especially dietary supplements and cosmetics.

In summary, my take away after hearing from the top 3 people at FDA is that it is a much more aggressive agency under the leadership of Dr. Hamburg than previously.  Importers should be more careful than ever to understand and comply with the FDA regulations, or not be surprised to receive a Notice of Refusal, a Warning Letter, or even a civil penalty or subpoena.

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The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims displayed on their food and drink products, including those marketed to children.  Some food products brazenly claim to increase a person's immune system, reduce the chance of getting a cold, or even cure cancer.  Are they really believable?

The Obama Administration has taken a more aggressive posture to attempt to reduce the obesity of Americans, especially children.  There is a direct connection between what we eat and our health.  Remember the saying "You are what you eat"?   Dr. Margaret Hamburg, the new FDA Commissioner, announced in a March 3, 2010 letter to food companies:

I have made improving the scientific accuracy and usefulness of food labeling one of my priorities...It is clear to me as a working mother that the use of front of package nutrition symbols and other claims can be helpful to busy shoppers who are often pressed for time in making their food selections.

In a typical December 4, 2009 Warning Letter to one of the worlds' largest food companies, Nestle,  the FDA complained about Juicy Juice All Natural 100% Juice Grape products.  The FDA alleged that the product was misbranded because the labels were misleading in that the label was designed to imply that the producct was 100% grape juice when it truly was not.

The FDA regulations regarding food, including drinks, are complex.  True and accurate health claims are allowed on certain food products under specific circumstances, according to the FDA guidance.  Hopefully, the food industry will be more responsible, and if not, I encourage Commissioner Hamburg to pursue civil penalties against companies and the corporate officers of those companies who deceive the public. 

A seminar about health claims on food products and how to respond to FDA Warning Letters will take place on June 3, 2010 in Miami, at a seminar entitled "Importing Food Products in Compliance with FDA and U.S. Customs Rules". 

In solidarity with FDA Commissioner Hamburg, I am a working Dad, and I don't like to be lied to either!

Peter Quinter, Partner, Customs and International Trade Department.

pquinter@becker-poliakoff.com or (954) 270-1864

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The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure".  In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy.  The U.S. Food and Drug Administration (FDA) already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human (or animal) consumption.  The current FDA system is working very well, and  the only achievement of the proposed legislation will be to increase the price of food.  We need enforcement of the current laws, not a bunch of new laws.

Granted, there are numerous instances of imported food making people sick, and even causing death.  15% of the food we eat is imported. Nevertheless, the overwhelming number of Americans who get sick or die from consuming food had nothing to do with imported food.  You may get sick at your local restaurant with food poisoning because of the poor handling of the food at the restaurant, not because the food came from overseas.

Currently, for any food to enter the United States, the importer must submit an electronic entry to both U.S. Customs and Border Protection and the FDA.  The entry information includes the name of the importer, a description of the imported food, the name of its manufacturer, the country of origin, the value, the buyer of the food, and where the food is to be delivered.  The requirements of the Bio-terrorism Act of 2002 require "prior notice" which means that the importer must advise U.S. Customs and the FDA far in advance of the arrival of the food at a border crossing of the United States. The U.S. General Accountability Office just issued a thorough Food Safety Report which has an excellent graphic at page 58-59 describing the imported food procedures.  The Report did state that our food supply is safe, but that U.S. Customs and FDA could do better. 

The Government made significant changes already regarding the traceability of food in the Bioterrorism Act which went into effect in December 2003. It required all foreign companies involved in the manufacturing, processing, packing, or holding food that enters the United States to first register with the FDA so that the food may be traced all the way back from the retailer to its source overseas.  Companies may register on-line at www.FDA-USA.com.   

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On August 14, 2009, Jennifer Diaz and I will speak at the annual FIME Conference taking place at the Miami Beach Convention Center, Miami Beach, Florida. The FIME Conference is one of the largest trade shows in the United Stated attended by medical device manufacturers, importers, and distributors from throughout the United States and Latin America.

The seminar topic is “How to Effectively Resolve Typical U.S. Food and Drug Administration and U.S. Customs and Border Protection Issues for Medical Devices.”

Medical devices are strictly regulated by the FDA.  We will discuss how to handle everyday examples of difficult issues with he U.S. Food and Drug Administration (FDA).  FDA issues include what to do if you receive a "Notice of FDA Action" or a "Warning Letter" that could potentially state you must stop producing or importing certain medical devices.  FDA may allege that the device is adulterated because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, the FDA may allege that a device is misbranded because you have not submitted a section 510(k) premarket notification to notify the FDA of your intent to introduce the device into commercial distribution for these new intended uses. Your company may have its imported merchandise authomatically detained by the FDA because it is on the "detention without physical examination" list.  Fortunately, there is a procedure to get off that list.

Effectively resolving U.S. Customs and Border Protection (CBP) issues includes appropriately responding when CBP says your medical devices are under "detention," or will be "seized" and "forfeited".   You will also learn the appropriate response after you receive a "liquidated damages claim" up to $75,000 from CBP.    

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What is the FDA 'Black List'?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s 'Black List').  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page.   You can search by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days.  The company/country, etc. will remain on this 'Black List' until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the 'Black List'.  The specific method to use to get off the 'Black List' is directly related to why you were placed on the 'Black List' in the first place.  For example, if a food product was placed on the 'Black List' because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the 'Black List'.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA's many requirements. 

It is wise to know whether you or your company are on the FDA 'Black List', to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA 'Black List'.

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