ExportFDA IssuesImportMedical Devices

Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 1 Comment

Screen Shot 2017-01-26 at 1.40.53 PMThis article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.” The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

Continue Reading

Best PracticesCBPImportU.S.Customs

CBP Launches New E-Commerce and Small Business Branch … Just in Time for the Holiday Shopping Season

posted by Jennifer Diaz December 1, 2016 0 comments

santaWith Thanksgiving in the rear view mirror and the Christmas holiday season kicking into high gear, now is the time to think of Pre-Compliance especially with the grave risks associated with shopping online and not knowing your supplier. As Small Business Saturday and Cyber Monday commercial activity spikes, CBP is, in specific connection with online sales, warns consumers and merchants alike to be on the lookout for holiday shopping scams and/or criminal trade practices. Red flags to watch for in this regard include offers designed to induce the purchase of counterfeit and/or unsafe goods, prices that are too good to be true, e-commerce sites that lack legitimate phone numbers and/or addresses, and sellers who lack good customer feedback.

Continue Reading

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.


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.

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 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.

FDA IssuesFood

Seafood Fraud

posted by Customs & International Trade Law Blog March 9, 2011 0 comments

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.


U.S. Consumer Product Safety Commission: Not Just Toys and Games

posted by Customs & International Trade Law Blog May 14, 2010 1 Comment

U.S. Consumer Product Safety Commission  (CPSC) officers will target more imported merchandise for safety risk assessments using information filed with U.S. Customs and Border Protection by importers or their customs brokers. The CPSC is an independent health and safety regulatory agency that is responsible for protecting the American public from unreasonable risks of injury and death from about 15,000 types of consumer products. Since the passage of the Consumer Product Safety Improvement Act (CPSIA) of 2008, CPSC increased the number of staff co-located with U.S. Customs at U.S. ports of entry.  Recently, U.S. Customs Commissioner Alan Bersin and CPSC Chairman Inez Tenenbaum signed a memorandum of understanding to create an Import Safety Commercial Targeting and Analysis Center (CTAC). 

CTAC is the culmination of President Obama’s Food Safety Working Group  focused on (1) prevention, (2) surveillance, and (3) responding to the attempted importation into the United States of unsafe products.  The authority of CPSC officers is modeled after the authority and actions by the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). 

CPSC will soon issue its own Detention Notices, rather than having U.S. Customs do it, for imported cargo that is suspected of being unsafe.  CPSC will not only target and detain toys, games, and other children’s’ products, but also products previously screened only the FDA – food, cosmetic, medical devices, and dietary supplements. 

The $600,000 penalty that Target Corp., of Minneapolis, Minn. has agreed to pay to CPSC for allegedly violating the federal lead paint ban on toys is merely a prelude to the type of civil penalties to be assessed against importers for attempting to import and sell unsafe products.

Is the CPSC doing enough to keep unsafe products out of the United States, or being too aggressive and bureaucratic? Sound off with a comment below. 

FDA IssuesFoodImport

I am Not Worried That My Food Is “Safe”, Are You?

posted by Customs & International Trade Law Blog November 10, 2009 2 Comments

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.   

Continue Reading