Tag

FDA Issues

Best PracticesE-CigaretteFDA IssuesImportSeizuresTobacco

The End of Vape Shops, Hookah Shops, & E-Cigs? FDA’s New “Deeming” Laws

posted by Jennifer Diaz May 26, 2016 0 comments

 How to comply

On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.

What Are Tobacco Products and What’s Being Regulated?

Continue Reading

BISCBPDepartment of Homeland SecurityExportFDA Issues

Federal Government Shutdown ENDS

posted by Jennifer Diaz October 17, 2013 0 comments

Co Authored by Omar Franco 

Last night Congress voted to end the first federal government shutdown in seventeen years and avert a default on U.S. debt. The deal brokered between Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY) provides government funding through Jan. 15, 2014, at almost the same rate as in FY-2013 after automatic spending cuts. The debt limit would be extended through Feb. 7, 2014, if requested by President Obama. The legislation includes a mechanism to allow Congress to block the suspension through action on a resolution of disapproval. The Health and Human Services Department would be required to ensure that health-insurance exchanges verify the eligibility of all individuals applying for tax credits and cost sharing under the Affordable Care Act. Federal employees would be paid for furlough days resulting from the shutdown and members of Congress would be denied their cost-of-living increase in FY-2014.

The Senate passed the bill first with 81 senators voting in favor and 18 voting against the compromise. The House then passed the legislation 285-144, relying mostly on Democratic votes to pass the bill. Alongside the bill, the Senate agreed to a provision that House and Senate leaders would appoint a conference committee to negotiate a budget agreement by Dec. 13.

 

BISCBPDepartment of Homeland SecurityExportFDA Issues

Impact of Government Shutdown

posted by Jennifer Diaz October 2, 2013 0 comments

Co Authored by Omar Franco 

The impact of the federal government shutdown, which began October 1, 2013, will be deeply felt by importers and exporters alike. Most government services deemed "essential" by the federal agencies will continue, but “non-essential” services will be discontinued until funding is restored. 

This early on, there is no obvious resolution of the budget dispute to tie the FY-2014 government funding to Affordable Care Act (ACA) reforms. Both the House and Senate are entrenched in their positions and they are not scheduled to negotiate any time soon. One side will have to capitulate or bipartisan negotiations will have to lead to a resolution. We feel that negotiations will probably not occur this week as both sides need to assess how the markets and voters will respond to the federal government shutdown. Depending on the public response, we will see movement by one side, probably by Republicans, if the reaction is seen as damaging. As of today, the Dow was up, so the market reaction has been subdued. The reaction from voters is still unknown, but if it is subdued as well, the shutdown will be prolonged. We anticipate the shutdown will last through this week at a minimum.

Some lawmakers are considering broadening the debate by including the debt ceiling. Pressure from resolving the government shutdown could also resolve the debt ceiling issue. The longer the shutdown continues, the more likely the resolution will be tied to the debt ceiling. We do foresee a resolution emerging, however, we do not have any real idea as to what the time frame will be.

To get a glimpse of the impact on the importing and exporting community, we’ve included updates from the BIS and ITC below.

For example, on the export side, the Department of Commerce’s Bureau of Industry and Security (BIS) has this note on its website — they are completely SHUT DOWN, and not accepting licenses – except for emergencies.  See more here: 

The Federal Government is currently shut down due to a funding lapse. As a result, the Department of Commerce’s Bureau of Industry and Security (BIS) is no longer accepting export license applications, classification requests (CCATS), encryption reviews, encryption registrations, or advisory opinion requests. Similarly, BIS will not be issuing any final determinations. The SNAP-R application on BIS’s Website is not available and will not reopen until the Federal Government shutdown ends. All pending export license applications, commodity classification requests, encryption reviews, encryption registrations, and advisory opinion requests will be held without action by BIS until the shutdown ends.

Applicants may request emergency processing of export license applications for national security reasons by submitting email requests to Deputy Assistant for Export Administration Matthew Borman.

The subject line of the email should read "Request for Emergency License" and the email must identify the applicant (including point of contact), intermediate and ultimate consignees, and end user(s), items, end use, and national security justification for the emergency processing.

On the import side, the impacts are distinctly felt with the U.S. International Trade Commission (ITC).  The interactive HTS that I love is not active – and ADD/CVD investigations are tolled.  CUSTOMS Info Global Data Mining has taken the opportunity to present a PDF copy of the HTSUS during the ITC’s hiatus here (note you will have to provide your contact information).

See the latest from the ITC’s website

The U.S. International Trade Commission will shut down its investigative activities for the duration of the absence of appropriation. These activities include, but are not limited to, proceedings conducted under the authority of Title VII of the Tariff Act of 1930, including antidumping and countervailing duty investigations and reviews; investigations and ancillary proceedings conducted under the authority of section 337 of the Tariff Act of 1930; and investigations conducted under the authority of section 332 of the Tariff Act of 1930.

Investigations tolled

During shutdown, the schedules and deadlines for all investigative and pre-institution activities will be tolled. All hearings and conferences will be postponed, subject to the exceptions described below. Once the Commission receives funding and the period of the shutdown ends, all schedules will resume starting with the day on which the Commission recommences operations. For example, if the shutdown lasts four days (e.g., October 1-4), then the deadline for the filing of any document on October 4 would be extended four days to October 8. If a rescheduled deadline falls on a nonbusiness day, the deadline will be extended to the next business day. The agency may reconsider schedules after resuming operations.

Exceptions

Notwithstanding the general tolling of schedules:

The staff conferences in preliminary phase antidumping and countervailing duty investigations scheduled to take place on October 7, 2013 and October 9, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Should the shutdown not end before October 3, 2013, all conferences will be rescheduled pursuant to the general tolling provisions described above.

The hearing in the Hot-Rolled Steel five-year reviews scheduled for October 3, 2013 will take place as scheduled if the Commission resumes operations by October 2, 2013. Otherwise, this hearing will be rescheduled upon further notice.

The hearing for Investigation No. 332-541, Trade Barriers that U.S. Small and Medium-Sized Enterprises Perceive as Affecting Exports to the European Union, scheduled to take place on October 8, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Otherwise, this hearing will be rescheduled upon further notice.

Website

During shutdown, the online services provided on the Commission’s World Wide Web site, at www.usitc.gov, will be unavailable. This includes:

  • USITC website
  • EDIS
  • DataWeb
  • HTS Online Reference Tool
  • All phone communication with USITC staff
  • Restoration of service is expected as quickly as possible after appropriations become available.

If you have an questions on how the shutdown will impact your business contact Omar or me anytime.

FDA IssuesFoodFSMAImport

Join FDA in Miami to Discuss Major FSMA Proposed Rules

posted by Jennifer Diaz September 26, 2013 0 comments

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA – if you have not met your manufacturer yet, now is the time! 

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.  

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules. 

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA.   

These two added meetings will take place in Miami, FL and Long Beach, CA.  

Register here!

  • Miami meeting October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

 

October 11, 2013

8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting – October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

 

October 23, 2013

8:30 a.m. – 12:30 p.m.

 

A sample agenda from the meeting that took place in Washington, D.C. on September 19-20, 2013, may be found here (we anticipate the same content being included for the Miami meeting).

 

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

 

  • Meeting in Miami, FL
    • September 24, 2013: Closing date for request to make oral comment
    • September 24, 2013: Closing date to request special accommodation due to a disability
    • October 1, 2013: Closing date for advance registration
  • Meeting in Long Beach, CA
    • October 1, 2013: Closing date for request to make oral comment
    • October 1, 2013: Closing date to request special accommodation due to a disability
    • October 8, 2013: Closing date for advance registration
  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

FDA IssuesFoodFSMAImport

Miami CANCELLED by Government Shutdown – LA WILL Go On – FDA to Discuss Major FSMA Proposed Rules

posted by Jennifer Diaz September 26, 2013 0 comments

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA – if you have not met your manufacturer yet, now is the time! 

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.  

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules. 

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA.   

These two added meetings will take place in Miami, FL and Long Beach, CA.  

Register here! (FDA HAS INDICATED THE LONG BEACH SEMINAR WILL GO ON).

  • Miami meeting October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

 

October 11, 2013

8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting – October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

 

October 23, 2013

8:30 a.m. – 12:30 p.m.

 

A sample agenda from the meeting that took place in Washington, D.C. on September 19-20, 2013, may be found here (we anticipate the same content being included for the Miami meeting).

 

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

 

  • Meeting in Miami, FL
    • September 24, 2013: Closing date for request to make oral comment
    • September 24, 2013: Closing date to request special accommodation due to a disability
    • October 1, 2013: Closing date for advance registration
  • Meeting in Long Beach, CA
    • October 1, 2013: Closing date for request to make oral comment
    • October 1, 2013: Closing date to request special accommodation due to a disability
    • October 8, 2013: Closing date for advance registration
  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

Best PracticesFDA IssuesFoodFSMAImport

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. 

Best PracticesCBPDepartment of Homeland SecurityEventsExportFDA IssuesImportSpeakingU.S.Customs

Jennifer Diaz Speaks After Dominic Veneziano at Global Clinical Sourcing & Supply Summit

posted by Jennifer Diaz February 27, 2013 0 comments

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!

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.