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The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco.

What is a warning plan?

A warning plan details how a company plans to achieve random distribution of the required warning statements on cigar packages and advertisements. For each brand of a cigar product, FDA requires that all statements be displayed on packaging an equal number of times within a 12-month period.  All statements must be randomly distributed in all areas that the product is marketed in the US. For advertising, all warning statements must rotate quarterly in an alternating sequence. There are six required warning statements:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  3. WARNING: Cigar smoking can cause lung cancer and heart disease.
  4. WARNING: Cigars are not a safe alternative to cigarettes.
  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  6. There are two options for the reproductive health warning: 1) WARNING: Cigar use while pregnant can harm you and your baby, or 2) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Who submits the cigar warning plans?

A cigar product manufacturer, distributor, importer, or retailer should submit the warning plan. In most circumstances, FDA believes that manufacturers are most capable of creating a sufficient warning plan for packaging.

What is the compliance deadline?

Warning plans for cigars should be submitted to FDA by May 10, 2017 or 12 months before advertising and marketing begin, whichever date is later. FDA expects that a large volume of plans will be submitted near this deadline and thus suggests they be submitted as soon as possible to ensure they are reviewed in time to comply with the warning requirements that take effect on May 10, 2018.   FDA has deemed it unlawful for cigar products to be produced, manufactured, or distributed in the United States without the packaging containing one of the required statements once the warning requirements take effect.

FDA encourages cigar product manufacturers, distributors, importers, and retailers to submit warning plans electronically, with all content in Portable Document Format (PDF) format.  Electronic submissions must be submitted through FDA’s Electronic Submissions Gateway.

Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations.  Registrar Corp can help tobacco product manufacturers determine how FDA’s guidance apply to their particular products.  Additionally, Registrar Corp can also review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations. For more information, contact Registrar Corp at
+1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp

         

The U.S. Food and Drug Administration (FDA) recently issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and on February 8, 2018 for small-scale manufacturers. The original date for compliance was February 8, 2017.

The compliance deadlines have been extended  to allow manufacturers and importers additional time to prepare quality submissions.  The extension also allows some manufacturers to submit multiple lists for multiple tobacco products.

Ingredient submissions should include the following information:

  • Manufacturer/Importer Identification
  • Product Identification
  • Ingredient Identification
  • Ingredient Quality

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements.  For more information on FDA regulations for tobacco manufacturers, including the recently finalized refuse to accept tobacco rule, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

         

On December 29, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 95863) describing the circumstances under which the agency will refuse to accept a tobacco product submission.  Covered submissions include:

  • Premarket tobacco product applications (PMTAs)
  • Modified risk tobacco product applications (MRTPAs)
  • Substantial equivalence (SE) applications
  • Exemption requests

According to the rule, FDA will refuse to accept submissions that:

  • Are not in English
  • Do not pertain to a tobacco product
  • Do not identify the tobacco product or the type of submission
  • Are submitted in an electronic format that cannot be processed, read, reviewed, or archived
  • Do not include the applicant’s contact information (or for foreign applicants, the U.S. Agent’s contact information)
  • Do not include the required forms
  • Do not include the signature of a responsible official authorized to represent the applicant
  • Do not include an environmental assessment or claim of a categorical exclusion, if applicable

Submissions that meet these circumstances will be refused before they enter FDA’s review queue.  FDA will inform the listed contact as to whether or not the submission was accepted.  FDA expects this rule to accelerate the review process for submissions that meet all requirements by freeing the agency’s review resources.

This rule applies to covered submissions for all tobacco products.  Until last year, FDA’s authority over tobacco products was limited to cigarettes and cigarette, roll-your-own, and smokeless tobacco.  In May 2016, FDA finalized a rule that extended the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco (81 FR 28973).  The rule became effective in August 2016 and requires tobacco manufacturers to submit new products to FDA for premarket review.

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements.  For more information on FDA regulations for tobacco manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

         

On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 90186) that establishes user fees for the agency’s accredited third-party certification rule. Finalized in November 2015 as part of the Food Safety Modernization Act (FSMA), the rule establishes a voluntary program for certification bodies to audit foreign food facilities and provide certification when their food safety controls are up to U.S. standards.

There are essentially three steps to the accredited third-party certification program:

  1. FDA recognizes accreditation bodies.
  2. Recognized accreditation bodies accredit qualified third-party certification bodies.
  3. Accredited certification bodies audit and issue certifications for foreign food facilities and their products.

For more information on the program requirements and use of certifications, read here.

FDA’s final rule establishes two types of user fees: application and annual.

Application Fees

Application fees apply to accreditation bodies applying for FDA recognition, recognized accreditation bodies applying for renewal, and to third-party certification bodies applying for direct accreditation from FDA or a renewal of their direct accreditation. The application fees are intended to cover the costs of FDA’s review and evaluation of initial and renewal applications.  These fees must be submitted concurrently with an application and are non-refundable.  Applications will be considered incomplete until payment is made.

Annual Fees

Annual fees apply to recognized accreditation bodies.  The annual fees also apply to accredited certification bodies, whether they were accredited directly through FDA or through an accreditation body. Annual fees are intended to cover the costs of FDA’s performance monitoring efforts. Annual fees must be paid within 30 days of receiving billing.  Failure to pay FDA’s user fees may result in suspension or revocation of a participant’s recognition or accreditation.

The application fee for accreditation bodies applying for initial recognition in fiscal year (FY) 2017 will be $35,100 (81 FR 90363). This cost is slightly lower than the application fee estimated in the 2015 proposed rule.  In the future, FDA will announce the fee schedule prior to the beginning of each FY.

Circumstances under which accredited third-party audits are required are likely to be rare. These audits are only required when a facility’s product is being imported to the US as a VQIP food and in the event that FDA issues a requirement for certification of a specific food due to safety concerns. In the case that your facility does require a third party audit, Registrar Corp offers a mock inspection service to help prepare. Registrar Corp’s Food Safety Specialists will inspect all aspects of your facility, from employee hygiene to equipment maintenance to recordkeeping. Our mock inspection service is also beneficial in preparing for a routine FDA inspection.

For questions regarding FDA’s accredited third-party certification program or other final FSMA rules, 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.

 

         

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

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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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