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FDA Publishes FY 2019 Medical Device and Generic Drug User Fees

The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes to these fees below.

Fees for Drug Facilities
GDUFA requires user fees from certain types of drug facilities. On October 1, 2018, generic drug facilities are required to pay any applicable facility fees to FDA. Additionally, GDUFA requires fees for new Type II Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions to FDA. You will find a table of these fees below.

Notable Changes to GDUFA in FY 2019

  • ANDA Program Fees – In FY 2018, FDA introduced program fees for ANDA holders. These facilities pay a user fee based on the number of approved ANDAs they hold on October 1 of a given year.  The FY 2019 ANDA program fees reflect an approximate 17% increase from the previous year.
  • Type II DMF Submission Fees – In FY 2018, the fee for a single Type II DMF submission to FDA was $47,829. FY 2019 will see an approximate 15% increase to $55,013.

You can view a comparison between the FY 2018 and FY 2019 GDUFA fees below:

FY 2019 GDUFA Fees

Fee Type 2018 2019
Facility Fees Domestic Foreign Domestic Foreign
Active Pharmaceutical Ingredient (API) $45,367 $60,367 $44,226 $59,226
Finished Dosage Form (FDF) $211,087 $226,087 $211,305 $226,305
Contract Manufacturing Organization (CMO) $70,362 $85,362 $70,435 $85,435
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) $1,590,792 $1,862,167
Medium (6 – 19 ANDAs) $636,317 $744,867
Small (5 or fewer ANDAs) $159,079 $186,217
Application Fees
ANDA $171,823 $178,799
Type II DMF $47,829 $55,013

Fees for Medical Device Establishments
MDUFA requires all FDA-registered establishments to pay a user fee during their annual registration renewal. The FY 2019 establishment registration fee for all establishments is $4,884.  According to the publication of MDUFA fees, FDA does not recognize an establishment as legally registered until this fee is paid.

Additionally, MDUFA requires fees for the submission of certain medical device applications to FDA.  Small businesses, defined by MDUFA as having gross sales or receipts of no more than $100 million during the most recent tax year, may qualify for discounts to application fees. All medical device application fees reflect an approximate 3-4% increase from the previous year.

You can view a comparison between the FY 2018 and FY 2019 MDUFA fees below:

FY 2019 MDUFA Fees

Fee Type 2018 2019
Annual Establishment Registration $4,624 $4,884
Application Fees Standard Small Business Standard Small Business
510(k) $10,566 $2,642 $10,953 $2,738
513(g) $4,195 $2,098 $4,349 $2,175
De Novo Classification $93,229 $23,307 $96,644 $24,161
PMA, PDP, PMR, BLA $310,764 $77,691 $322,147 $80,537
panel-track supplement $233,073 $58,268 $241,610 $60,403
180-day supplement $46,615 $11,654 $48,322 $12,081
real-time supplement $21,753 $5,438 $22,550 $5,638
BLA efficacy supplement $310,764 $77,691 $322,147 $80,537
PMA annual report $10,877 $2,719 $11,275 $2,819

Not sure which fees you may be subject to?  Registrar Corp’s Regulatory Specialists can help determine your applicable fees and facilitate payment with FDA.  Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

The Current Implementation Status of FSMA: What’s Required Now, What’s Next, and FDA’s Enforcement to Date

The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as:

  • Preventive controls for human and animal food
  • Foreign supplier verification programs
  • Prevention of intentional adulteration of the food supply
  • The registration of food facilities

Many of the deadlines for complying with FSMA rules have already passed. There are also multiple upcoming deadlines that covered businesses should be aware of. A summary of several important FSMA requirements and deadlines may be found below.

Rules On Preventive Controls For Human and Animal Food

Preventive Controls Overview
Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each HARPC plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility.

Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.

Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards. Registrar Corp’s Food Safety Specialists are PCQIs and can develop or review a facility’s HARPC plan for FDA compliance.

Rule On Foreign Supplier Verification Programs

Foreign Supplier Verification Program Overview
Under the Foreign Supplier Verification Program (FSVP) rule, U.S. importers must have a written FSVP that is developed by a qualified individual and documents that they have completed risk-based activities meant to verify that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. Among other things, FSVPs must include an analysis of hazards associated with imported products and their suppliers and a plan for conducting verification activities, such as annual supplier audits, testing and sampling imported products, or reviewing a supplier’s HARPC Food Safety Plan. As part of the supplier analysis, importers must monitor and document the FDA compliance status of each of their suppliers by tracking FDA warning letters, import alerts relating to food safety, and other FDA enforcement actions.

Foreign Supplier Verification Program Deadlines
Importers’ deadlines are based on factors such as the size of a foreign supplier, the nature of the importer, and whether the foreign supplier must meet various regulatory requirements. The deadlines for complying with this rule passed for most importers in May 2017 and March 2018. The deadlines for other importers are scheduled to occur on dates ranging from July 26, 2018 to July 27, 2020.

Foreign Supplier Verification Program Enforcement and Compliance
FDA has begun inspecting importers for FSVP compliance. In 2017, failure to develop an FSVP was cited by FDA 108 times. FSVP inspections are based upon a review of records. Though such inspections may take place at an importer’s place of business, FDA may also ask that an importer provide FSVP records electronically or by some other remote means that quickly delivers records to the agency.

Registrar Corp’s Food Safety Specialists can develop new FSVPs on behalf of importers or review existing FSVPs for compliance. Registrar Corp also offers a tool to assist with the supplier monitoring aspects of FSVP.  In order to monitor supplier compliance on their own, an importer would need to routinely search each individual FDA database for each of their foreign suppliers. In order to make this process easier, Registrar Corp developed the FDA Compliance Monitor.  Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, Recalls, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s requirements.

Rule For Mitigation Strategies To Protect Food Against Intentional Adulteration

Intentional Adulteration Overview
Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.

Intentional Adulteration Deadlines
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019.  Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply. If you are unsure of whether your business qualifies as small, you can read Registrar Corp’s earlier blog post on how FSMA defines small businesses.  Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.

Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.

Amendments to the FDA Registration Process

FSMA made significant changes to the FDA registration process. Food facilities are now required to provide an email address for registration and must assure that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, FSMA requires facilities to renew their FDA registrations during each even numbered year. For example, because 2018 is even numbered, food facilities will have to renew their registration later this year between October 1 and December 31. It is very important that facilities comply with renewal requirements. In 2017, FDA removed 28% of food facility registrations from its database. Many of these removals resulted from a failure to properly renew registration as was required in 2016.

Registrar Corp’s Regulatory Specialists can help facilities register or renew their registrations with FDA quickly and properly.

Responding to the Implementation of FSMA

FSMA imposes many complex requirements on food businesses. The deadlines for complying with these various requirements have already passed or will soon pass. Businesses should take measures to ensure that they are in compliance. One such measure would be to enlist the help of Registrar Corp’s Regulatory Specialists who have expert knowledge of FSMA and extensive experience in helping businesses comply with FDA regulations. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

U.S. FDA Permits 8 Additional Non-Digestible Carbohydrates To Be Declared As Dietary Fibers

In a recent guidance document, the U.S. Food and Drug Administration (FDA) announced the intention to permit eight isolated or synthetic non-digestible carbohydrates to be declared as dietary fiber on the nutrition facts label.  Pending rulemaking, FDA intends to exercise enforcement discretion when the following are included in a label’s dietary fiber declaration:

  • Mixed plant cell wall fibers
  • Arabinoxylan
  • Alginate
  • Inulin and inulin-type fructans
  • High amylose starch (resistant starch 2)
  • Galactooligosaccharide
  • Polydextrose
  • Resistant maltodextrin/dextrin

Why Is FDA Permitting These Fibers?

Prior to publication of the 2016 Revision of the Nutrition and Supplement Facts Label Final Rule, existing FDA regulations did not define “dietary fiber.”  Under the revised rule, isolated or synthetic non-digestible carbohydrates may only be included in dietary fiber declarations if FDA determines them to have “physiological benefits.”  The final rule named seven isolated or synthetic fibers that met this requirement:

  • Beta-glucan soluble fiber
  • Psyllium husk
  • Cellulose
  • Guar gum
  • Pectin
  • Locust bean gum
  • Hydroxypropylmethylcellulose

After reviewing petitions and scientific literature surrounding twenty-six isolated or synthetic non-digestible carbohydrates, FDA determined that the eight additional fibers demonstrate the required physiological benefits.

How Does This Affect My Label?

Industry previously expressed concern that FDA’s new definition for dietary fiber would exclude fibers they were already declaring on their labels, limiting their ability to make certain nutrient content or health claims.  For example, in order for many foods to say they are a “good source of fiber,” “contain fiber,” or “provide fiber,” their fiber content must be between 10 and 19 percent (2.8 g – 5.32 g) of the daily reference value (28 g) per reference amount customarily consumed (RACC).  FDA’s inclusion of the above fibers will allow more manufacturers to continue to make fiber claims under updated label requirements.

When Do I Need To Comply?

Changes to the dietary fiber declaration take effect following the compliance deadline for FDA’s new label rules.  Food manufacturers grossing $10 million or more in annual food sales have until January 1, 2020 to update their label for compliance with FDA’s new regulations.  Businesses grossing less than $10 million are provided an additional year.

Start compliance now for a smooth transition.  Registrar Corp can review your food labeling for compliance with new U.S. FDA regulations.  In addition to a report of recommended changes, you will receive a print-ready graphic file of your revised label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

New Developments in UDI and GUDID Regulations

Registrar Corp is committed to keeping industry up to date on FDA’s Unique Device Identifier  (UDI) requirements and recently attended the 2018 UDI Conference in Baltimore. The following blog summarizes new and updated information related to UDI and Global Unique Device Identification Database (GUDID) regulations.

Background

In September 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, which requires most medical devices to carry a UDI. A UDI is a numeric or alphanumeric code consisting of a device identifier (DI) and a production identifier (PI) that must be placed on the device label and on the device packaging. The labeler is responsible for complying with this rule.

Compliance Deadlines

The compliance deadlines for Class II devices and for Class III devices have already passed. In June 2017, FDA informed industry that it intended to extend the compliance deadline for these devices due to complex policy and technical issues, among other things.  In January 2018, the Agency issued a guidance document detailing how it would utilize its enforcement discretion:

For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2020
  • Direct Marking requirements beginning September 24, 2022.

For finished class I and unclassified devices manufactured and labeled before September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2021.
  • Direct Marking requirements beginning September 24, 2022.

 

Recent Enhancements and Fixes to GUDID Submission Process

 

GUDID Coordinators Now Able to Correct Errors After the DI Record Grace Period

The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI. In order to ensure data quality, FDA has taken steps to make correcting errors by editing device records easier.

Previously, unlimited edits were only possible during the 30 day grace period following initial publication. After the grace period, edits could only be made through a difficult process. Now, the GUDID Coordinator user has the ability to “unlock” device records. Once previously submitted device records have been unlocked, errors may be corrected. It should be noted that the records’ history will be saved and the public will be able to see what edits have been made.

 FDA to make Premarket Numbers Public

FDA has announced plans to grant the public access to the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI). This data is tentatively scheduled to be made public on July 2, 2018. FDA recognizes that this information may be sensitive and will give labelers the option of keeping their premarket numbers confidential. Specifically, FDA will use the confidentiality information that is included in the device listing information submitted to the FDA Unified Registration and Listing System/ Device Registration and Listing Module (FURLS/DRLM). If a proprietary name is marked confidential in DRLM as part of the device listing information, then FDA does not plan to make the corresponding premarket numbers in GUDID DI record(s) public.

Labelers who would prefer to keep the their premarket numbers confidential may find it advisable to carefully scrutinize and potentially alter the confidentiality designations assigned to the DRLM proprietary names in their device listing records in order to ensure that these designations correspond to their preferences.

Meeting FDA GUDID and UDI Requirements

The deadlines for complying with FDA GUDID and UDI requirements are approaching or have already passed. Therefore, it is prudent for medical device labelers to take measures to ensure that they are in compliance with these complex regulations. Medical device labelers may wish to seek the assistance of Registrar Corp’s Regulatory Specialists, who possess expert knowledge of relevant FDA regulations and can provide guidance on which UDI deadlines and requirements apply to particular devices.

Registrar Corp can provide assistance  by acting as a facility’s Regulatory Contact for UDI purposes, submitting the required device information to GUDID on behalf of the labeler, or by altering the confidentiality information submitted to DRLM in order to ensure that premarket numbers remain confidential.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Adviser 24 hours a day: www.registrarcorp.com/livehelp.

Registrar Corp Establishes UK Office Location

Registrar Corp has partnered with Export Access to offer localized assistance with U.S. Food and Drug Administration (FDA) regulations in the United Kingdom (UK).  Export Access is a UK-based company that provides worldwide market access training and logistics services to exporters in the region.

“Given the parallel goals of our companies, we see this as a natural partnership that will benefit industry,” said Registrar Corp Vice President David Lennarz. “Registrar Corp already works with UK export associations like FDEA to keep industry updated on US regulations, so we’re happy to have a local provider to refer them to.”

Registrar Corp assists food, beverage, medical device, pharmaceutical, and cosmetic companies with U.S. FDA requirements for exporting products to the United States, including (but not limited to):

  • FDA Registration, Listing, and U.S. Agent Requirements
  • Labeling and Ingredient Regulations
  • Food Safety Modernization Act (FSMA) Requirements
  • Unique Device Identifier (UDI) Regulations
  • Detention and Import Alert Assistance

Export Access founder Gary Baylis will manage Registrar Corp’s UK office.  Mr. Baylis is a Member of the Institute of Export & International Trade and has worked closely with government agencies, industry associations, and the like to understand how to identify and overcome barriers to trade and successfully access foreign markets.

“The combination of market access and regulatory knowledge provided by this relationship creates an easy-to-access and powerful resource for UK companies looking to expand their business to the lucrative US market,” said Mr. Baylis.

Companies seeking assistance can contact Registrar Corp UK by email: [email protected] or by phone: +44 (0) 7828 090 393.

Registrar Corp UK joins 19 other international Registrar Corp office locations.  Registrar Corp is committed to providing companies worldwide with access to the US market while facing minimal location-based barriers such as time zone and language. View all of Registrar Corp’s office locations here.

FDA EXTENDS DEADLINE FOR MANDATORY USE OF eCTD FORMAT FOR TYPE III DMF SUBMISSIONS.

On April 25, 2018, the U.S. Food and Drug Administration (FDA) extended the deadline for the mandatory use of electronic common technical document (eCTD) format for type III Drug Master File (DMF) submissions by one year. eCTD format will now be required for type III DMF submissions beginning May 5, 2019.

Type II, type IV, and type V DMF submissions to FDA must be in eCTD format beginning May 5, 2018. Additionally, FDA recommends using eCTD format to file Type III DMF submissions despite the extension.  eCTD submissions must be filed through FDA’s Electronic Submissions Gateway (ESG).  The process to obtain access to ESG can take several weeks, so it is prudent for businesses to begin working toward compliance as soon as possible.

You can make compliance easy by having Registrar Corp manage your DMF submissions.  Our Regulatory Specialists use FDA’s ESG to submit new DMFs to FDA in eCTD format as well as convert existing DMFs to eCTD to make future updates, reports, and amendments easier. If you are not certain if your DMFs qualify for the extension, Registrar Corp can verify your classifications at no cost.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

FDA Deems Highly Concentrated Caffeine In Dietary Supplements Adulterated

A recent U.S. Food and Drug Administration (FDA) guidance document affirms that certain pure or highly-concentrated caffeine products marketed as dietary supplements are “adulterated” under the Federal Food, Drug, and Cosmetic (FD&C) Act, effectively prohibiting their sale in the U.S. market.

FDA determines that highly-concentrated powder or liquid caffeine supplements sold to consumers in bulk quantities meet the Act’s definition of “adulteration” in that they “[present] a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or…under ordinary conditions of use.”

What Risks Do These Supplements Present?

Many of these supplements are intended to either be taken in very small quantities or diluted prior to consumption.  Some bear warning statements on their labeling urging to not consume more than the recommended serving.  Despite this, FDA maintains that simple measurement errors can result in consumption of toxic or lethal doses of caffeine.

For example, FDA explains that 1 teaspoon of pure or highly concentrated powdered caffeine product can contain approximately 3200 mg of caffeine, nearly two and a half times the amount of a toxic dose (1200 mg).  Additionally, safe serving sizes for these products are generally 1/16 of a teaspoon (200 mg) or less, but the smallest standard kitchen measuring spoon is typically 1/4 of a teaspoon (800 mg).  Given this example, an erroneous measure of just 1/8 of a teaspoon (400 mg) is twice the amount of a safe serving.

Does FDA Consider All Caffeine Supplements Adulterated?

FDA states that they do not expect caffeine supplements containing pre-measured or pre-diluted safe quantities of caffeine to be adulterated.  These products may contain caffeine in the form of tablets, capsules, packets, and significantly diluted bulk quantities.  Such products prevent the need for a consumer to precisely measure a safe quantity.  As a result, they “would not normally be expected to lead to toxic or life-threatening symptoms.”

Companies should ensure they are packaging and labeling their caffeine supplements as discussed above in order to avoid potential adulteration charges.  Adulteration charges may result in Warning Letters, Import Alerts, refusal at the U.S. border, and other public information that can damage a brand’s reputation.

Registrar Corp’s Regulatory Specialists are well-versed in FDA supplement regulations and can conduct a full review of your product’s labeling and ingredients for compliance.  In addition to a thorough report of recommended revisions, you will receive a print-ready, FDA-compliant label incorporating these changes.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

Frequently Asked: FDA Labeling Requirements for “Added Sugars”

As part of the U.S. Food and Drug Administration’s (FDA) Revision of the Nutrition and Supplement Facts Labels Final Rule, many foods, beverages, and dietary supplements are required to bear a declaration for “added sugars.”  The requirement is perhaps one of the most perplexing aspects of the rule, leaving many businesses with a lot of questions as they transition their label to meet FDA’s new regulations.

What is the Requirement?

Under the rule, labels for products containing 1 gram or more of “added sugars” per serving must indent “Includes ‘X’ g Added Sugars” beneath a declaration for “Total Sugars.”  Labels for products containing less than 1 gram of added sugars are not required to declare the values if they do not make any sweetener or sugar claims.  These labels may instead be required to display “Not a significant source of added sugars” at the bottom of the table of nutrient values.

The rule defines “added sugars” as “sugars that are added during food processing, or are packaged as such,” meaning they are packaged with the intention of being added to a food.  The definition includes sugars from syrups and honey as well as sugars from concentrated juices that exceed amounts typically expected from 100 percent fruit or vegetable juices of the same volume and type.  Labels for certain honey, maple syrup, and cranberry products are permitted to explain that these sugars are either naturally occurring or used to improve palatability.

FDA requires manufacturers to keep records of sugars added before and during processing as well as sugars packaged with the food as separate ingredients.  If the sugars are reduced through fermentation or caramelization, the manufacturer may keep records of scientific data that verify the declared amount is correct or petition an alternative means of compliance.  The manufacturer must justify the accuracy of all data.  FDA requires records to be kept for two years following the product’s introduction to the U.S. market.

Why is FDA Requiring the Added Sugars Declaration?

Certain public comments to the 1990 proposed rule that mandated nutrition labeling for most foods favored requiring a declaration for added sugars rather than total sugars.  Some comments proposed requiring both.  At the time, FDA determined such a requirement was not necessary, nor was it feasible to differentiate between added and naturally occurring sugars in most foods.

The 2015 Dietary Guidelines Advisory Committee (DGAC) report recommended a reduction of added sugar in the American diet, due to a strong correlation between low sugar intake and a decreased risk of cardiovascular disease.  The DGAC report contributed to FDA’s reconsideration of its previous determination, and the Agency cited this data to rationalize the added sugars declaration in its 2016 final rule.

The added sugars declaration is just one requirement in two comprehensive new food labeling rules, which issue changes to daily values, serving sizes, and more. Businesses averaging $10,000,000 or more in annual food sales have less than two years (January 1, 2020) to comply.  Businesses averaging less than $10,000,000 in annual food sales have an additional year.

Updating your label to meet new requirements can be a lengthy process. We urge companies to transition now to ensure compliance before the deadline.  Registrar Corp can update your labeling to comply with FDA’s new label rules.  In addition to a comprehensive report explaining our recommended revisions, you will receive a print-ready, FDA-compliant label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Orders First Ever Mandatory Recall Under FSMA

On April 3rd, 2018, the U.S. Food and Drug Administration (FDA) ordered a mandatory recall of all food products that contain powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. The Agency issued the order after several samples of kratom products manufactured by the Las Vegas based company tested positive for salmonella, a potentially dangerous pathogen known to cause diarrhea, fever, and abdominal cramps. This is the first time FDA has ever issued a mandatory recall order. FDA Commissioner Scott Gottlieb, M.D. stated that the action was “based on the imminent health risk posed by the contamination of this product… and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions (FDA.gov).”

Section 206 of the Food Safety Modernization Act of 2011 (FSMA) grants FDA the authority to order responsible parties to recall certain food articles if the Agency determines that there is a reasonable probability that a particular food product is adulterated or misbranded and that the use of or exposure to that food product will cause serious adverse health consequences or death to humans or animals. Despite this authority, FDA still relies on responsible parties to voluntarily recall products that are in violation of regulations. The Agency issued this mandatory order only after Triangle Pharmanaturals LLC failed to comply with earlier requests that the firm cease distribution and recall the product voluntarily.

Both voluntary and mandatory recalls can permanently damage a brand’s reputation. Companies that wish to reduce the risk of facing a recall may take various measures to help ensure that their products meet required regulatory standards and do not pose a threat to human or animal health. Registrar Corp offers a number of services specifically designed to make complying with FDA regulations easier for businesses. For example, Registrar Corp can dispatch a Food Safety Specialist to your facility to help you prepare for an FDA inspection by identifying potential food safety problems in the structure, processes, procedures and documentation used in your daily production. Furthermore, Registrar Corp can develop new food safety plans and programs for your facility or review your current systems and documentation. Businesses may also use Registrar Corp’s FDA Compliance Monitor to track suppliers, importers, and distributors for FDA warning letters, import alerts, and more so that they may become aware of and react to any FDA regulatory difficulties faced by current or potential commercial partners in their supply chain. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours-a-day at www.registrarcorp.com/livehelp.

Frequently Asked: FDA Regulations for Dietary Supplements

Dietary supplement companies often come to us unsure of how the U.S. Food and Drug Administration (FDA) regulates their products.  The requirements are not immediately clear, especially when label claims and terms such as “nutraceuticals” or “functional foods” (not recognized by FDA) can blur the distinction between supplement and drug.  In fact, FDA regulations for dietary supplements mirror those for food and beverages, but with some significant differences.  Below lists some of the key requirements supplement companies should follow to ensure FDA compliance.

FDA Registration

Facilities that manufacture, pack, or hold dietary supplements for U.S. consumption must register with FDA.  Facilities located outside of the United States must designate a U.S. Agent for FDA communications at the time of registration.

FDA requires supplement facilities to renew their registrations between October 1 and December 31 of each even-numbered year, regardless of when they initially registered.  For example, if a facility registers with FDA in September 2018, it will still need to renew its registration between October 1 and December 31, 2018.

Labeling Requirements

Like conventional foods and beverages, dietary supplements require nutrition labeling, but with different content and formatting. “Supplement Facts” charts identify only those nutrients that are present, as well as any additional “dietary ingredients” such as herbs, botanicals, and amino acids.  In 2016, FDA introduced new labeling requirements for supplements.  Among other aspects, the new rules require:

  • Vitamin D and potassium to be listed on the label
  • A declaration for “Added Sugars”
  • Revised units of measure for vitamins A, D, and E
  • A footnote on products intended for children aged 1-3 stating “Percent Daily Values are based on a 1,000 calorie diet.”

As of this publication, FDA has proposed a deadline of January 1, 2020 for dietary supplement businesses grossing ten million dollars or more in annual sales to comply with new label rules. Small businesses are provided an additional year.

Supplement labels and advertisements are not permitted to bear claims that suggest they “treat, diagnose, prevent, or cure disease.”  Such claims may result in FDA classifying them as drugs, which may require FDA approval and have stricter labeling requirements.  Products shipped with these claims risk being charged as “unapproved new drugs” and subsequently detained. FDA’s regulatory procedures manual does not permit an “unapproved drug” to be relabeled or reconditioned in port, forcing the shipper to re-export or destroy the product.

Current Good Manufacturing Practices (CGMPs)

As part of the Dietary Supplement CGMP Rule, FDA requires supplement manufacturers to follow specific procedures and record-keeping to ensure safe production.  Manufacturers must prepare and follow several process controls, including written master manufacturing records (MMRs) for each unique formulation and batch size of supplements.  In order to ensure each batch meets uniform specifications, FDA requires MMRs to outline aspects such as:

  • Identifying information for the supplement, including properties such as concentration or strength of each ingredient for each batch size
  • Specifications for points in the manufacturing process that require controls to ensure quality of the supplement
  • Specific actions needed to implement and verify these controls
  • Corrective actions for when specifications are not met

Prior Notice

Facilities exporting supplements to the U.S. must file prior notice of each shipment with FDA before it enters the country.  The submission timeline for prior notice is dependent upon the shipment’s method of transit.

For more information about FDA dietary supplement regulations, register for Registrar Corp’s free webinar (to take place on April 19) for a comprehensive overview on how to comply.  The webinar will conclude with a live question and answer session.

Don’t want to navigate the requirements on your own?  Registrar Corp makes FDA compliance quick and easy.  We can register your facility with FDA, serve as your U.S. Agent, review your supplement’s labeling and MMRs for compliance, and more.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.