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FDA Issues Final Guidance on its Voluntary Qualified Importer Program

On November 10, 2016, the U. S. Food and Drug Administration (FDA) announced a final guidance for its Voluntary Qualified Importer Program (VQIP). VQIP is a “fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security.” FDA expects to begin accepting applications for VQIP participation on January 1, 2018. Program benefits for accepted applicants will begin on October 1, 2018.

The guidance is in a question-answer format to better explain to importers how the program will work. Some examples of questions included in the guidance are below:

Q: What are the benefits of VQIP participation?

A: There are several benefits for importers who chose to participate in VQIP. These include:

  • Expedited entry into the U.S. for foods included on an approved VQIP application
  • Examination and sampling will be limited to situations where public health is at risk
  • Expedited laboratory analysis of samples
  • Sampling will be conducted at importer’s location of choice when possible
  • Access to VQIP Importers Help Desk
  • Importer is listed on FDA’s public VQIP list

Q: Who is eligible?

A: Importers, which are defined as “the person who brings food, or causes food to be brought, from a foreign country into the United States,” are eligible to participate in VQIP so long as they meet the following criteria:

  • Importer must develop and implement a Quality Assurance Program (QAP)
  • Importer must comply with supplier verification and other requirements under FSVP and HACCP
  • Each foreign supplier of food intended for importation under VQIP must be certified under FDA’s Accredited Third-Party Certification
  • Importer must have at least three years of experience importing food to the U.S.
  • Importer and its supply chain cannot have any outstanding FDA judicial or administrative action against the food facility and no other history of non-compliance with food safety regulations.
  • Importer must have a Data Universal Numbering System (DUNS) number

Q: How do I apply?

A: Importers who wish to apply for VQIP must establish an online account on the FDA Industry Systems website. After an online account has been established, importers will submit an online “Notice of Intent to Participate” in VQIP from January 1 to May 31 each year. Complete instructions for submission of a VQIP application can be found here.  Applications must be renewed annually.

Q: Is there a user fee to participate in VQIP?

A: Yes, importers participating in VQIP are required to pay an annual fee to cover the cost of administering the program. In June 2015, FDA estimated fees would total $16,400. FDA will finalize fees for January 2018 by August 1, 2017. Fees must be paid by the beginning of the VQIP year (October 1) to receive benefits under the program.

Q: What kinds of foods are allowed under VQIP?
A: Food from both farms and facilities may be imported under VQIP so long as they are certified under FDA’s Accredited Third-Party Certification regulations for having appropriate food safety practices are allowed under VQI and are not subject to an import alert or Class 1 recall.

Q: Can the FDA revoke my participation in VQIP and how will I be notified?

A: Yes, FDA may revoke participation in VQIP for violating one or more of the program eligibility criteria, or participating in smuggling or other fraudulent activities. FDA will notify the contact person identified on your VQIP application with a “Notice of Intent to Revoke” your participation in VQIP by email.

Q: Can I obtain reinstatement of my participation in VQIP after a revocation?

A: Yes, you can obtain reinstatement of participation in VQIP after a revocation. Reinstatement may be requested after you have corrected any issues associated with your revocation. The request should include documentation of actions that have been taken to resolve the issues.

For more information on FDA’s final VQIP guidance, register for Registrar Corp’s free webinar on Wednesday, December 21.

Registrar Corp can help U.S. food importers obtain eligibility for VQIP participation. Registrar Corp’s FDA Compliance Monitor allows importers to monitor food facilities around the world for FDA Import Alerts. Registrar Corp can also help facilities obtain a DUNS number at no cost. You may contact Registrar Corp for more information at anytime by phone at 1-757-224-0177 or by 24-hour online chat at http://www.registrarcorp.com/livehelp.

 

 

FTC Requiring New Labeling Disclaimers for Homeopathic Drugs

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims:

  1. There is no scientific evidence that the product works.
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts

The FTC issued the enforcement policy after releasing a 24-page report that contained public comments and findings from commissioned studies. The report concluded that “customers were likely to be deceived by labels that did not carry the appropriate disclaimers.”

Prior to the new policy, homeopathic drugs were not required to prove their effectiveness or abide by U.S. Food and Drug Administration (FDA) regulations for other types of drug products. Despite being deemed by the FTC as having “no scientific evidence” to support effectiveness, homeopathic drugs have avoided regulation due to the nature of homeopathy. Homeopathy is built on the belief that small doses of substances that cause symptoms in healthy people can cure similar symptoms in unhealthy people. FDA defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” Homeopathic drug potencies consist of substances that are diluted from 1/10 to 1/50,000 or higher.

FDA has been considering changes to homeopathic drug regulations since 2014 due to homeopathy growing into a multimillion dollar industry in the United States. In addition to the growth of the industry, homeopathic drugs have been seen to cause adverse effects on consumers.  A 2012 report showed there were 10,311 poison exposure cases related to “homeopathic agents”.  In August 2015, the FTC recommended that FDA reevaluate its regulatory framework for the regulation of homeopathic drugs after FTC research found that a significant number of consumers don’t understand:

  • Homeopathy or homeopathic products
  • How homeopathic products are regulated
  • The level of scientific evidence supporting homeopathic claims

Registrar Corp is an FDA consulting firm that helps drug companies understand and comply with FDA regulations.  For any questions about changes to homeopathic drug regulations or other current FDA regulations for drug companies, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day through Live Help.

FDA Releases Draft Guidance for Food Facility Registration; Only One Month Left to Renew

Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their U.S. Food and Drug Administration (FDA) registrations every even-numbered year between October 1 and December 31.  Facilities have just one month left to renew their registrations for 2017.

FDA recently published a draft guidance to help food facilities better understand FDA’s registration and renewal requirements.  Entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry,” the guidance aims to provide answers to frequently asked questions received from stakeholders regarding FDA registration regulations and the final rule titled “Amendments to Registration of Food Facilities” that was issued in July 2016.

The seventh edition builds upon former versions of FDA’s food facility registration guidance.  Several new questions were added regarding FDA’s renewal period since the sixth edition.  Some examples include:

Q: “Do new food facilities need to wait until October 1 of a biennial renewal year to register?”

A: No. A facility can register with FDA initially any time throughout the year.  The operator, owner or agent must register the facility before beginning to manufacture, process, pack or store food for consumption in the U.S.  If the initial registration occurs prior to October 1 of a biennial renewal period, the facility must renew their registration.  This is true even if the registration is only months, or even days, old.

Q: “Will a food facility be issued a new registration number during the registration renewal process?”

A: No, a facility will keep its original registration number as long as its registration is renewed by the deadline. In the event that a facility misses the renewal period it would be required to re-register, resulting in a new registration number.

Q: “How will FDA conduct the verification process for U.S. agents?”

A: FDA will send an email to the individual listed as a facility’s U.S. Agent.  The individual must confirm that they accept responsibility as the U.S. agent for the specified facility. The identified individual has 30 days to respond to FDA verification request. A registration is not valid until FDA receives confirmation from the U.S. Agent.  If the individual denies responsibility or if FDA receives no response within the 30 days, the agency will remove the registration from its database. FDA’s new verification step makes it more important than ever to designate a reliable U.S. Agent.  Learn about the benefits of designating Registrar Corp as your U.S. Agent here.

Q: “Is a foreign facility required to provide assurance that FDA will be permitted to inspect the facility?”

A: Yes, foreign food facilities are required to assure that FDA will be permitted to inspect their facility in ways outlined by the Food, Drug, & Cosmetic Act (FD&C Act.) Registrar Corp can provide a mock inspection service to ensure that foreign food facilities meet all FDA inspection requirements.

Q: “If a foreign facility has not renewed its registration by December 31 of a biennial renewal period, will the facility still be able to import food into the United States?”

A: If a food facility does not renew its registration by December 31, its registration will be deemed expired and FDA will cancel the registration. Food exported to the US by a foreign facility with a canceled registration is subject to being held at the port of entry.

Q: “If I am the owner, operator, or agent in charge of a facility, may I authorize another individual to update the facility’s registration?”

A: Yes, the owner, operator, or agent may authorize another individual to update a facility’s registration. This person may or may not be the facility’s U.S. agent. As a facility’s U.S. Agent, Registrar Corp will update and renew a facility’s registration at no additional cost.

FDA also added many questions regarding the Unique Facility Identifiers (UFIs) finalized in the July 2016 rule.  Examples of some new UFI questions include:

Q: “When will I be required to submit a UFI in my registration submission?”

A: A UFI will be required in registration submissions beginning on October 1, 2020.

Q: “Which UFI or UFIs are recognized as acceptable to FDA for food facility registration purposes?”

A:  FDA recognizes Data Universal Numbering System (DUNS) numbers as acceptable UFIs.  Though FDA’s UFI requirement does not come into effect until 2020, it is prudent to apply for a DUNS number for your facility in advance, as it may take some time to obtain. Registrar Corp can assist a facility in obtaining a DUNS number free of charge.

FDA has opened up the draft guidance for public comment. You may submit your comments for here.  Submit by February 6, 2017 to ensure your comments are considered before FDA begins working on its final draft.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, registration renewal, and new requirements under the Food Safety Modernization Act (FSMA).  Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world.  Contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp for assistance.

FSIS Will Allow Use of New FDA Nutrition Facts Format for Meat and Poultry Product Labels

The USDA Food Safety Inspection Service (FSIS) recently announced that it will allow voluntary use of the U.S. Food and Drug Administration (FDA) new Nutrition Facts format for food labels on meat and poultry labels. This announcement comes as FSIS works to finalize its own nutrition labeling and serving size regulations. FSIS’s goal is to produce nutrition labeling regulations for meat and poultry products that will parallel FDA’s regulations in efforts to help prevent consumer confusion and nonuniformity in the marketplace.

FDA’s new food labeling regulations came into effect on July 26, 2016.  Changes are reflected in the appearance and content of calories, serving sizes of food, nutrient daily values, added sugars, and more. The compliance date is July 26, 2018 for all food facilities, except those with less than 10 million dollars in annual food sales, who will have an additional year (July 26, 2019) to comply.

To help ensure compliance with FDA’s new regulations, meat and poultry companies that would like to use the FDA Nutrition Facts format for their products must first submit their labels to FSIS for review.  FSIS will review only one sketch label submitted per company or corporation. Any additional similar labels from the same company or corporation that use the new FDA format can be generically approved after the approval of the sketch label. Meat and poultry companies may use Registrar Corp’s blog on updated FDA food labeling regulations as guide on how to format their sketch labels.

The new FSIS nutrition labeling regulations will likely be similar to FDA’s, but there is no guarantee that the label requirements will be identical. Therefore, FSIS is advising companies that decide to use the new FDA format that they may need to revise the format again when FSIS issues its final regulations. FSIS is open to all comments regarding the new meat and poultry labeling and nutrition requirements. Comments may be submitted here through December 16, 2016.

Registrar Corp’s Labeling and Ingredient Review Specialists can help update meat and poultry labels to comply with FDA’s new rules. For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

 

 

 

FDA Reminds Medical Device Companies to Renew Registrations for 2017

The U.S. Food and Drug Administration (FDA) recently sent a reminder to medical device establishments that had not yet registered for 2017.  FDA requires establishments involved in the production or distribution of medical devices intended for use in the United States to register their establishments annually between October 1 and December 31.  The registration fee for the fiscal year (FY) 2017 is $3,382, which is a decrease from the fee for FY 2016 of $3,845.

Registrar Corp Reports: FDA Medical Device Registration Renewal (FY 2017)

A majority of the establishments that must register with FDA must also list their devices and the activities performed on those devices. A list of who is required to register, list, and pay fees can be found here.  It is a prohibited act to manufacture or distribute devices in the United States without a valid FDA registration.  Therefore, it is prudent for any device establishments that plan to continue business in the U.S. in 2017 to renew their registration as soon as possible.

FDA has deemed certain establishments and devices are exempt from registering due to low risk to patients and the role they play in advancing digital health. The product codes of devices that meet the exemption requirements are:

  • LMB – Device, Digital Image Storage, Radiological
  • LMD – System, Digital Image Communications, Radiological
  • NFF – Device, Storage, Images, Ophthalmic
  • NFG – Device, Communications, Images, Ophthalmic
  • OUG – Medical Device Data System
  • NXQ – Daily Assist Devices

Establishments dealing with the devices listed above should not list these devices with FDA during their 2017 registration.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations. Registrar Corp can help device establishments determine their applicable FDA registration requirements as well as register establishments and list devices with FDA. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

FDA Proposes to Require Label Submissions for Class II and Class III Home-Use Devices

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.

FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.

According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website.  If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.

FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period.  Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box.  FDA will review all comments before the release of the final rule, expected January 17, 2017.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

FDA Requests Public Comment on “Healthy”

On September 28, 2016, the U.S. Food and Drug Administration (FDA) opened the term “healthy” to public comment through a “request for information.”  The agency’s goal is to promote the development of healthier foods and to assist consumers in making food choices that are consistent with current public health recommendations.  Food manufactures may continue using the term “healthy” as long as they meet the current regulatory guidelines during the comment period.

Examples of questions FDA hopes to have answered during the comment period include “What should healthy mean from a nutrition perspective?” and “How do consumers view the word healthy?” Interested parties can find information for submitting written and electronic comments here.  In addition to allowing industry to submit written comments, FDA plans to host public forums to receive further feedback.

FDA’s request for information on the term was sparked in part by a citizen petition filed by KIND LLC in December 2015 after receiving a warning letter for using the term “healthy” on some of its product labels. In its petition, KIND urged FDA to update its definition of “healthy” to be consistent with evolving information on overall nutrition quality rather than specific nutrient levels.  For example, foods like almonds, avocados, and salmon are too high in fat to meet FDA’s current regulations for “healthy,” but are recognized as having a valuable place in a healthy diet.

Until FDA lands on a final definition for “healthy,” the agency is using enforcement discretion to allow certain foods that don’t meet the agency’s current requirements to bear the content claim “healthy.” According to a guidance document recently published by FDA, it has no intention to “enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.”  The criteria outlined in the guidance document apply to foods that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Registrar Corp stays up-to-date on U.S. FDA food labeling regulations and will continue to update industry as FDA’s decision on redefining “healthy” unfolds.  Please feel free to contact us with any questions regarding U.S. FDA requirements for using certain claims or other FDA labeling regulations, including the recently finalized changes to the Nutrition Facts Chart.  You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

FDA Suspends Food Facility Registration of a New York based Facility

The U.S. Food and Drug Administration (FDA) recently suspended the food facility registration of SM Fish Corp, located in Far Rockaway, NY, following a failed re-inspection and re-sampling of their ready–to-eat (RTE) seafood products. An initial inspection of the facility from June 14, 2016 to July 6, 2016 revealed that several environmental samples tested positive for Listeria. FDA requested that SM Fish Corp. recall some of its RTE products and shut down briefly to revise its cleaning and sanitation procedures, to which the facility agreed.

Following the initial inspection SCORE, a decision making body of individuals intended to ”ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks,” requested a re-inspection of SM Fish Corp. in order to ensure the problems found at the facility were resolved.

The decision to suspend the facility’s registration was made under the authority of the 2011 Food Safety Modernization Act (FMSA) after FDA’s re-inspection in August 2016 revealed a continued widespread Listeria contamination within the facility. As a result of this suspension, SM Fish Corp. is banned from marketing food in the United States. FDA may lift the suspension only when the agency determines the facility’s food no longer has reasonable probability of posing serious health issues or death to human consumers.

Facilities are often unaware of the cost and time associated with FDA re-inspections. When FDA initially inspects a food facility, it is financed by the agency, but if FDA finds reason to re-inspect, the agency may charge re-inspections fees. For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate. The FY 2017 hourly rates for FDA re-inspections are as follows:

  • $221 per hour for domestic facilities
  • $285 per hour when foreign travel is required

It is crucial to prepare for possible FDA inspections in order to prevent costly re-inspections that may lead to the suspension of your food facility registration. Registrar Corp can assist facilities preparing for FDA inspections. A Food Safety Specialist can perform mock FDA inspections  at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations. Additionally, if your foreign food facility utilizes Registrar Corp as its U.S. Agent, Registrar Corp will perform a mock inspection free of charge (other than travel and lodging expenses) when FDA issues a Notice of Inspection for that facility.

For more information or assistance regarding FDA inspections, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

Food Facilities Must Renew Their FDA Registrations Between October 1 and December 31, 2016

Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline.  Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that manufacture, process, pack, or store food for distribution in the United States are required to renew their FDA registrations between October 1 and December 31, 2016.

Food facilities have been required to register with FDA since 2003. FSMA updated this requirement in 2011 to include biennial renewals in order to keep FDA’s registration database up-to-date.  Food facilities are now required to renew every even numbered year between October 1 and December 31.

FDA’s Registration Renewal requirement applies to both domestic and foreign food facilities registered with FDA.  Foreign facilities must also designate a U.S Agent for FDA Communications in Section 7 of their renewal.  It’s important to designate a professional knowledgeable on FDA regulations , as this U.S. Agent will have access to information submitted in the facility’s registration and may speak on behalf of the facility to FDA regarding inspections, shipments, and other regulatory matters.

Facilities must renew their FDA registration no matter when they submitted their initial registration.  A facility could have registered with FDA one month or even one day before October 1, and the facility would still need to renew.  If a facility does not renew its registration by December 31, FDA will consider the registration to be expired.  Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by FDA.

There was a 14% decrease in the number of food facilities registered with FDA from January 2014 to January 2015.  Registrar Corp believes the drop was due to facilities failing to renew their registration during the 2014 renewal period.

Registration renewals may be completed directly with FDA by mail, fax, or online, or facilities may authorize a third party individual to complete their renewal.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, U.S. Agent requirements, food labeling, and new requirements under the Food Safety Modernization Act.  Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world.  Contact Registrar Corp for assistance.

This article was originally published as a press release.

FDA issues Final Rule on the Removal of Triclosan and Triclocarban from Antibacterial Soaps

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients).  Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.

FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance.   According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”

FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.

FDA’s final rule only applies to consumer rinse-off antibacterial soaps.  This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.

Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule.  For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.

 





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