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New FDA-USA Website for Importers

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

Do you import food products (or any FDA regulated product) into the U.S.? I’ve launched a new website (www.FDA-USA.com) to assist you in learning the basic requirements for FDA regulated products. The website features information for importers of food, drugs, cosmetics, medical devices, dietary supplements and alcoholic beverages.

Don’t forget, if you are a registered food facility with the FDA and don’t comply with FDA’s mandatory biennial registration, FDA can cancel your FDA Food Facility Registration. Learn more about the Biennial Registration requirement in my previous post here.

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FDA IssuesFoodFSMAUncategorized

MANDATORY BIENNIAL REGISTRATION RENEWAL TO TAKE PLACE OCTOBER-DECEMBER 2014

posted by Jennifer Diaz September 11, 2014 0 comments

Manuf foodMandatory Biennial Registration Renewal for Food Facilities will soon be required, on October 1, 2014 until December 31, 2014. If your facility is not re-registered with the FDA by December 31, 2014, FDA will cancel your Bioterrorism Act registration and your importations will be delayed. A FDA Registration number is mandatory to import food products into the U.S.

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Best PracticesFDA IssuesFoodFSMAGluten FreeImportUncategorized

FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

posted by Jennifer Diaz July 8, 2014 0 comments

GFAccording to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

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Customs BrokerFDA IssuesFoodFSMAImport

FDA Released Draft Guidance on Prior Notice of Imported Foods

posted by Jennifer Diaz April 7, 2014 0 comments

For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry.  We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.

The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”.  Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”

FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004.  The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA.  The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Although pursuant to 21 CFR 10.115(g)(5), comments can be made on the guidance at any time, in order to ensure that the FDA considers your comments on this draft guidance before it begins to work on the final version of the guidance, your comments must be submitted either electronically or in writing within sixty (60) days from the date in which the notice announcing the availability of the draft guidance is published in the Federal Register, or March 31, 2014.  If you have questions on FDA’s FSMA or on submitting a comment, please feel free to contact me at (305) 260-1053 or via email at JDiaz@bplegal.com.

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. 

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.