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On March 15, 2015, Mike Pompeo, R-Kan., and G. K. Butterfield, D-N.C., reintroduced the Safe and Accurate Food Labeling Act of 2015, a bill that aims to, among other things, modify the Food, Drug, and Cosmetic (FD&C) Act to include regulations for labeling food products as natural, genetically modified (GMO), and Non-GMO.

According to Pompeo’s fact sheet on the bill, “nearly 30 states are attempting to require government warning labels on food products containing ingredients derived from biotechnology.”  Pompeo believes GMO foods are safe and fears that warning labels will mislead consumers and lead to higher food prices.  Pompeo believes the Safe and Accurate Food Labeling Act of 2015 will avoid these outcomes while still allowing Non-GMO food manufacturers to advertise their foods as such.

Labeling Foods as GMO and Non-GMO

The bill directs the Secretary to promulgate regulations for permissible levels of bioengineered organisms (another term for GMO organisms) that a food may consist of and still be labeled as Non-GMO.  Foods would be deemed misbranded if they claimed to be Non-GMO without complying with the regulations set by the Secretary.

The bill prohibits the Secretary from requiring GMO food labels to declare the use of bioengineering “solely because the food was developed with the use of bioengineering”. The bill also states that neither GMO nor Non-GMO food labels can claim or imply to be safer than the other.

Along with the regulations above, the bill aims to establish a USDA-accredited certification program for non-bioengineered foods, similar to the USDA-Certified Organic program.  The program would be added to the Agricultural Marketing Act of 1946. The Secretary would establish criteria that products would need to meet to be deemed “certified Non-GMO.”  The Secretary would then accredit “certifying agents” who could work to identify agricultural products eligible to be certified Non-GMO.

Labeling Foods as Natural

As of now, there are no requirements for use of the term “natural” and similar terms on food labels. The bill directs the Secretary to establish regulations for labeling food products with “natural claims”, such as  ”natural”, “100% natural”, “naturally grown”, “all natural,” “made with natural ingredients”, and other terms defined by the Secretary.  Foods labeled as natural that do not fit the standard defined by the Secretary would be deemed misbranded.

If the Safe and Accurate Food Labeling Act of 2015 is enacted, the Secretary of Health and Human Services will have 12 months to issue proposed regulations and 24 months to issue final regulations to amend the FD&C Act.  The Secretary of Agriculture would have 24 months to carry out the Certified Non-GMO program.

Registrar Corp stays up-to-date on U.S. Food and Drug Administration (FDA) food labeling regulations.  We will continue to update industry as the Safe and Accurate Food Labeling Act of 2015 progresses through Congress.

U.S. FDA food labeling regulations are constantly changing, so it can be difficult to identify the most recent requirements.  Registrar Corp’s Label and Ingredient Review Specialists can review a food product label for FDA Compliance.  When Registrar Corp conducts a review of your label, you will receive a detailed report that documents all FDA regulations applicable to your label and a print-ready graphic file of your revised label.  For questions or assistance with FDA food labeling requirements or other food and beverage regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

To view the full text of the Safe and Accurate Food Labeling Act of 2015, click here.

         

You may be surprised by the number of different Unique Device Identifiers (UDIs) a company may need for a single type of device. A separate UDI is needed for certain variables, such as:

  • Size
  • Color
  • Material
  • Style
  • Package Size

For example, if the same surgical glove was available in latex and vinyl, each glove would need its own UDI.

Registrar Corp put together the infographic below to demonstrate to industry how to determine the number of UDIs a company may need for a single device type.  Registrar Corp can help medical device companies determine the UDI requirements for a particular device and submit a company’s UDI data to the GUDID.  For assistance with FDA UDI requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

UDI Infographic

         

On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices.  Most devices will soon be required to bear a UDI on their labels and packaging.  For a device that is intended to be used more than once and intended to be reprocessed before each use, the UDI will also need to be permanently affixed to the device itself. This is called direct marking.

FDA considers “intended to be used more than once” to mean “intended for repeated uses on or by different patients.”  Devices that are intended for multiple uses on the same patient do not need to comply with direct marking requirements.  FDA defines “reprocessing” as “validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent use.”  For direct marking purposes, FDA only considers a device as “intended to be reprocessed” if it is intended to be cleaned and either disinfected or sterilized between uses.  A device that is intended only to be cleaned between uses does not qualify.

How to Directly Mark a Device

The entire UDI must be directly marked on a device.  During a January 2015 UDI and GUDID Webinar, FDA clarified that only the UDI must be placed directly on the device, not the device’s entire label. UDIs on labels and packaging must be displayed in both human-readable and machine-readable format.  However, directly marked UDIs may be displayed in only one of the two formats.  A directly marked UDI does not have to be the same as the UDI on the device’s label and packaging.

FDA does not have a specific method that labelers must use to mark a device.  It is up to the labeler to determine an appropriate method.  The labeler should consider the device’s expected usage and reprocessing, as FDA expects directly marked UDIs to last throughout the expected use life of the device.  Some examples of marking methods offered in the guidance include:

  • Etching
  • Attaching a permanent plaque to durable equipment
  • Affixing a permanent tag to the device

Exceptions to Direct Marking Requirements

A device is exempt from direct marking requirements if:

  • Direct marking would interfere with the safety or effectiveness of  the device;
  • Direct marking of the device is not technologically feasible;
  • The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use; or
  • The device has been previously marked under 21 CFR 801.45(a)

If a company decides to make use of a direct marking exception, the company should document its rationale and evidence for doing so within the device’s design history file.  When submitting information to GUDID, the labeler should check the box for “Device Subject to Direct Marking (DM), but Exempt”.

Direct Marking Effects on 510(k), PMA, and BLA

If direct marking does not affect the safety and effectiveness of a device, then a new 510(k) submission or a supplemental PMA or BLA should not be necessary.  The change should instead be reported in an annual report.  As mentioned above, if direct marking does affect the safety and effectiveness of a device, the device may be exempt from direct marking requirements.  If the company still wishes to directly mark the device, then a new 510(k) submission or a supplemental PMA or BLA will generally be required.  In this case, the company must pay the applicable user fees.

Compliance Dates for Direct Marking Requirements

In some cases, the compliance dates for direct marking requirements differ from the compliance dates for including UDIs on labels and packaging.  See the compliance date chart below:

FDA, UDI

Compliance Dates for FDA UDI Requirements

Registrar Corp helps medical device companies comply with FDA UDI requirements.  Registrar Corp Regulatory Specialists can assist you in determining the UDI requirements applicable to a particular device and can submit information to GUDID on behalf of your company.  Registrar Corp also assists with other FDA medical device regulations, such as FDA registration and 510(k) development.

For questions about or assistance with UDI requirements or other FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

eMDR Compliance Date Less Than 2 Months Away



June 22, 2015 by David Lennarz

In February 2014, the U.S. Food and Drug Administration (FDA) published a final rule requiring medical device manufacturers and importers to submit mandatory initial and supplemental adverse event reports in electronic format.  Companies have until August 14, 2015 to comply.

Companies must obtain a Web Trade Account from FDA’s Electronic Submission Gateway.  FDA urges users not to wait until August 14 to create an account, as the process has many steps, including submitting a letter of non-repudiation to FDA and submitting a test electronic medical device report (eMDR).  Voluntary electronic reporting has been available since 2008, so companies may begin creating accounts and reporting electronically now.

Once a company has an account, eMDRs can be submitted through FDA’s eSubmitter, which allows submission of one report at a time, or through Health Level 7 (HL7), which allows multiple reports to be submitted at once.

When are eMDR reports required to be submitted?

Device manufacturers and importers are required to submit eMDRs to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury.

What other requirements does the final rule establish?

The final eMDR rule requires companies to keep copies of all adverse event reports, both paper and electronic, submitted to FDA and all acknowledgements received from FDA.

Registrar Corp helps medical device companies comply with U.S. FDA regulations. We can register a company with FDA, list a company’s devices, review device labels, assist with UDI requirements, and more. For questions about FDA’s eMDR rule or for assistance with FDA device regulations, contact Registrar Corp at +1-757-224-0177. Live help is available 24 hours a day at www.registrarcorp.com/livehelp.

         

On June 16, 2015, the U.S. Food and Drug Administration (FDA) released itsTrans-Fat Food Label final determination that Partially Hydrogenated Oils (PHOs), the largest cause of artificial trans-fat in processed foods, are not Generally Recognized as Safe (GRAS).  Food products will no longer be able to contain PHOs unless approved by FDA.  Food manufacturers and processors have until June 18, 2018 to comply by either removing PHOs from their food products or petitioning FDA for approval for use.

Why are trans-fats no longer GRAS?

Research has revealed that trans-fats are directly related to increased levels of low density lipoprotein (LDL) cholesterol, which clogs and damages arteries.  This can lead to heart attacks and heart diseases, and according to FDA, “Cardiovascular disease is the leading cause of death in both men and women in the U.S.”  FDA made a tentative determination that PHOs were no longer GRAS in 2013.  After further review of stakeholder comments and the effects of trans-fats, FDA finalized its decision.  FDA expects its new determination will prevent thousands of heart attacks and deaths each year.

Where are trans-fats currently found?

PHOs are used to improve the taste, shelf-life, and texture of food products.  Trans-fats are found in many popular foods, including coffee creamer, premade baked goods and frostings, frozen pizzas, microwave popcorn, and more.  FDA mandated that trans-fats be listed on Nutrition Facts Charts in 2006.  However, labels can state that a food has 0grams of trans-fat if it has less than .5 grams, making it difficult for consumers to truly measure their trans-fat intake.

What does this mean for the food industry?

Over the next three years, food manufacturers and processors that currently use PHOs in their food products will need to rework recipes to exclude PHOs from their ingredient lists.  Alternatively, industry can begin gathering data to petition FDA to allow specific use of a PHO by proving its use meets FDA’s standard of safety.  Industry should begin the compliance process as soon as possible, as foods that still contain unapproved PHOs on June 18, 2018 will be considered adulterated.  It is illegal to export or market adulterated food in the United States. 

Registrar Corp, a firm that helps food companies obtain FDA compliance, stays up-to-date on FDA regulations, including the regulatory status of food ingredients.  Registrar Corp Label and Ingredient Review Specialists can review food labels for unapproved ingredients and other potential labeling errors.

For questions about the regulatory status of trans-fat or other food ingredients, or to request a label review, 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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