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FDA Finally Issues Definition of “GLUTEN FREE”!

posted by Jennifer Diaz August 2, 2013 0 comments

HOT OFF THE PRESS!!! FDA issued the update below today DEFINING the term “Gluten Free”.   As a Celiac, this is extremely exciting news! The reason this is a HUGE deal?  Us Celiac’s need to know we can trust food products that are labeled “gluten free”.  If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers…

My sincere hope is FDA will now test imported products that make “GLUTEN FREE” claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA’s own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product – meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA’s Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The “Compliance Date” for this final rule is August 5, 2014. If consumers see products labeled “gluten free” we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here’s what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.

FDA defines “gluten-free” for food labeling

New rule provides standard definition to protect the health of Americans with celiac disease

The U.S. Food and Drug Administration today published a new regulation defining the term “gluten-free” for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term “gluten-free” on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term “gluten” refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published today in the Federal Register.

FDA IssuesFoodFSMAImport

June 10 – FSMA Rules Will be Released!

posted by Jennifer Diaz May 22, 2013 0 comments

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.

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. 

FDA IssuesFoodFSMAImport

FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

posted by Jennifer Diaz January 30, 2013 0 comments

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.  

FDA IssuesFoodFSMA

On February 1, 2013 Many Food Facilities Face Suspension

posted by Jennifer Diaz January 22, 2013 0 comments

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.

FoodFSMA

FDA Extends Until January 31 for Food Facilities to Re-Register

posted by Jennifer Diaz December 20, 2012 2 Comments

 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.

FSMA

FDA Biennial Registration is Up and Running

posted by Jennifer Diaz October 8, 2012 0 comments

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.

FoodFSMAImport

Don’t Let Your Bioterrorism Act Registration Lapse

posted by Jennifer Diaz August 29, 2012 0 comments

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.

FoodFSMA

2012 International Boston Seafood Show

posted by Customs & International Trade Law Blog March 12, 2012 0 comments

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!

FoodFSMA

FDA Administrative Detention of Food… What can you do?

posted by Customs & International Trade Law Blog March 9, 2012 1 Comment

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.

Similarly, in October 2011, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., where the seized products had first been subject to a detention order issued by FDA, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility’s warehouse and processing area.

 

These administrative food detentions are becoming more and more widespread and this trend is not accidental. The January 2011 amendment to the FDA Food Safety Modernization Act (FSMA) granted the FDA a far broader authority than in years past to administratively detain foods suspected of adulteration or misbranding.    According to Dara Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs:

The FDA will not hesitate to take immediate steps to protect the public’s health.  We will aggressively use our enforcement tools to prevent potentially adulterated food from reaching the public.

Previously, the FDA’s ability to administratively detain food products for humans or animals applied only when the agency had credible evidence that the food or feed presented a threat of serious adverse health consequences or death to humans or animals. With this expanded administrative detention authority, the FDA is now able to detain food and feed products that it has reason to believe are adulterated or misbranded. An administrative detention may last up to 30 calendar days, if needed, during which time the FDA determines whether an enforcement action is required, such as seizure of products or federal injunction against a firm.
 

Appealing an administrative detention is an option for claimants who act fast! After receiving the administrative detention order, an owner of perishable foods must file an appeal within two (2) calendar days and the owner of non-perishable foods has four days to file a notice of intent to file an appeal and to request a hearing with the actual appeal due within ten (10) calendar days of the receipt of the administrative detention order. A timely appeal filed correctly can result in a quicker termination of the administrative detention and thus, the return of the food article. Furthermore, it grants the owner of the food articles the opportunity to present evidence supporting the legitimacy of the detained food rather than to simply be at the mercy of the inspectors.

 

For more information, visit the recently published guide entitled “What You Need to Know About Administrative Detention of Foods, available at http://www.fda.gov/Food/guidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm276871.htm

 

As always, if you are unsure, consult with a professional. Failure to appeal an administrative detention of food can result in seizure. Moreover, not only may you lose the food you intended to sell, but also get fined by the U.S. Government.