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2016 Round Up – U.S. FDA Food Regulations



December 22, 2016 by David Lennarz

2016 proved to be a landmark year for the U.S. Food and Drug Administration (FDA).  The agency wrapped up the finalization of major rules under the Food Safety Modernization Act (FSMA), as well as finalized long-awaited rules that mandate a complete overhaul of food and beverage labeling.  This article presents an overview of the past year in FDA regulations for food and beverage companies.

FDA Finalized the Sanitary Transportation Rule under FSMA

In April, FDA published its final rule for Sanitary Transportation of Human and Animal Food.  The Sanitary Transportation Rule was the sixth major rule to be finalized under FSMA.  The rule created requirements for shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States to use sanitary practices to prevent contamination of food during transportation. Most covered businesses are required to comply by April 6, 2017.   Read here to learn about specific requirements of FDA’s Sanitary Transportation rule.

Canada’s Food Safety Systems were Recognized as Comparable to the US

In May, FDA, the Canadian Food Inspection Agency, and the Department of Health Canada signed a Food Safety Systems Recognition Arrangement.  Canada’s food safety systems are now recognized as providing public health protection comparable to those of the United States.  This means that facilities exporting from Canada and importers importing from Canada benefit from certain modifications and exemptions under FSMA.  For example, importers are exempt from the FSVP requirements of conducting a hazard analysis, approving and verifying suppliers, and conducting FSVP activities for their Canadian suppliers, so long as those suppliers are in good compliance standing with their country.

FDA Finalized Changes to Food Labeling

On May 20, FDA finalized two rules that mandate significant changes to labeling of food and beverages.  Changes range from cosmetic (i.e., a larger font size for calories and serving sizes) to new additions (i.e., adding a line for added sugars and adding vitamin D and potassium as listed nutrients) to data-driven (i.e., new daily value calculations for sodium, dietary fiber, and vitamin D).  Most facilities must comply by July 26, 2018.

FDA Finalized the Intentional Adulteration Rule under FSMA

On May 27, FDA published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major FSMA rules.  FDA’s Intentional Adulteration rule requires facilities registered with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility.  A facility’s Food Defense Plan must include a vulnerability assessment, mitigation strategies for each identified vulnerability, and a plan to continuously ensure proper and effective implementation of those strategies.  Most facilities are required to comply by May 2019.  Read here to learn more.

FDA Finalized Amendments to Food Facility Registration

In July, FDA published a final rule in an effort to improve the accuracy of the agency’s registration database.  The rule, titled “Amendments to Registration of Food Facilities”, made numerous changes to FDA’s registration requirements and codified some rules that were implemented upon the enactment of FSMA (i.e., registration renewal requirements and inspection permissions).  Some amendments were immediate, such as updates to product and activity categories. Others do not take effect until 2020.  In January 2020, FDA will require food facilities to submit their registrations electronically, and in October 2020, FDA will require facilities to list Unique Facility Identifiers (UFI) in their registrations.  Read here to learn more.

FDA Opened Up The Term “Healthy” For Discussion

In September, FDA published a request for information regarding the term “healthy”.   The decision was sparked by the agency’s desire to reflect current nutrition science as well as petitioning by industry.  FDA is accepting comments through January 26, 2017.  Until the agency lands on a new definition, it is using enforcement discretion to allow manufacturers to use the term “healthy” to describe products 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.

These are but some highlights in a busy year for FDA food industry regulators.  Registrar Corp will continue to work to keep industry updated through 2017.  For assistance with U.S. FDA regulations, contact Registrar Corp by phone at +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This blog was originally published as an article in Food Online.

         

FDA Bans Powdered Medical Gloves



December 21, 2016 by David Lennarz

On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (21 CFR Parts 878, 880, and 895) banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. According to the rule, FDA banned these products due to the fact that they present a substantial risk of illness or injury that cannot be corrected by eliminating or altering product labeling.  Adverse events related to powdered gloves include:

  • Severe airway inflammation
  • Hypersensitivity reactions
  • Allergic reactions
  • Lung inflammation
  • Damage to post-surgical adhesions
  • Respiratory allergic reactions

The final rule becomes effective on January 19, 2017. The ban applies to all powdered gloves currently in commercial distribution, those already sold to consumers, and gloves intended to be distributed in the future. All banned gloves must be removed from the market by the effective date.

FDA defines a medical device ban as “a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.” (21 USC 360f) FDA may analyze a device’s risks and benefits in many ways, including, but not limited to, evaluating medical literature, meeting with experts, or comparing the device to its alternatives. Only one other medical device has been banned by FDA since June 1983.

Registrar Corp is an FDA consulting firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their products are banned under this final rule and review product claims for FDA compliance.  For assistance with FDA regulations for medical gloves or other devices, contact Registrar Corp at +1-757-224-0177 or through our 24-hour Live Help chat service: http://www.registrarcorp.com/livehelp

         

On November 29, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule that establishes requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) system and other authorized systems.

FDA, along with 46 other government agencies, is implementing ACE in collaboration with U.S. Customs and Border Protection (CBP). Some requirements established in the rule include:

  • Clarification that FDA may reject an import filing for failure to provide required data elements
  • Clarification that written notice can be provided electronically by FDA to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction
  • FDA is now allowed to provide notice of sampling directly to an owner or consignee

ACE is a “commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy.” ACE replaces the Automated Commercial System (ACS), the current commercial database used to submit data through CPB to FDA. FDA plans for ACE to be fully functional by December 29, 2016.

There are several benefits to ACE. FDA reports in the final rule that ACE has dramatically reduced the inspection and review times at U.S. ports for customs brokers and importers registered with the ACE system. The average processing time for manual review of ACS-submitted entries was about 28 hours in 2015, and that has been reduced to less than 2 hours in ACE.  The automated “May Proceed” determination has been reduced from approximately 7.1 minutes in ACS to approximately 2 minutes in ACE.  According to John Verbeten, Acting Director of Import Operations, “since July 23 when ACE became required for all FDA entries, ‘May Proceed’ determinations are now issued for 72% of entries, up from 50% before ACE.” ACE also provides cost savings to both the industry and FDA.

In June 2016, Registrar Corp published this blog to help importers and brokers avoid common errors made when filing in ACE.  Brokers and importers may receive further assistance with ACE filings by e-mailing FDA at ACE_Support@fda.hhs.gov.

For more information on regulations for importing FDA-regulated products to the United States or how Registrar Corp can assist, contact us at
+1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.

 

         

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.

 

 

         

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.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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