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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.

FDA Draft Guidance Explains Small Business Definition For Preventive Controls Rules

The U.S. Food and Drug Administration (FDA) recently published a draft guidance on how to determine whether a business is a “small business” under the Preventive Controls for Human and Animal Food Rules.  The rules define a “small business” as having fewer than 500 “full-time equivalent employees.” Small businesses are subject to different compliance deadlines and, in some cases, different requirements than other businesses sizes. The recent guidance demonstrates that the definition of full-time equivalent employee may exclude many facilities from small business classification.

What is a Full-time Equivalent Employee?

As outlined by 21 CFR Part 117, the number of full-time equivalent employees for a given facility is determined by dividing the total number of hours worked in one year by all of the business’s staff (including those that do not handle food and those employed by affiliates and subsidiaries) by the number of hours one full-time employee would work in one year (i.e. 2,080).

For example, a facility may employ 150 full-time employees at 40 hours per week and 200 part-time employees at 30 hours per week for food manufacturing roles (a total of 624,000 hours in a year).  The facility may be a division of a legal entity that employs 150 full-time employees and an additional 250 part-time employees across multiple subsidiaries for various roles unrelated to food manufacture (an additional 702,000 hours in a year).  Though the facility only has 150 full-time employees, the legal entity it comprises actually has 637 full-time equivalent employees (1,326,000 hours divided by 2,080).

For this reason, some facilities may not realize that they are actually subject to requirements for large businesses under the Preventive Controls Rules.

How Does Business Size Affect Preventive Controls Requirements?

The rules provide small businesses a longer timeframe than their larger counterparts to develop written Food Safety Plans required by the Preventive Controls Rules; however, the compliance deadlines for most food facilities have passed, and small animal food businesses only have until September 17, 2018 to comply with preventive control requirements.

Certain farms that engage in activities requiring FDA registration (e.g. processing) may be exempt from requirements under the rule if they are considered a small business, but large farms that engage in these activities are required to have Food Safety Plans in place.

Additionally, “very small businesses” (defined by the rules as averaging less than $1,000,000 per year in sold and unsold products during the preceding three-year calendar period) are required to submit a “Qualified Facility Attestation” to FDA.  These facilities receive modified preventive controls requirements, including exemption from developing Food Safety Plans.  Facilities who submit an attestation must ensure that the average value per year of their sold and unsold products does not exceed $1,000,000, or they may be providing false statements to FDA.  Submitting false statements to a U.S. federal agency is a criminal offense.

It is wise for covered facilities to develop Food Safety Plans immediately.  FDA may look for a Food Safety Plan as part of a routine facility inspection, and U.S. importers may request their suppliers’ Food Safety Plan as part of a required supplier approval process.

Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) who can develop a Food Safety Plan for your facility or review your current plan for compliance.  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.

FDA Releases Various Guidances for Food Labeling

The U.S. Food and Drug Administration (FDA) recently released numerous regulatory guidances to help the food and beverage industry comply with labeling rules.  Registrar Corp has compiled some important developments below.

  • FDA published a small entity compliance guide explaining requirements for aspects such as dual-column labeling and serving sizes under one of the label rules finalized in 2016. Many businesses must comply with new food labeling rules by January 1, 2020.
  • FDA released an updated guidance explaining requirements for honey labeling.
  • FDA released an updated list of example products to use as a reference for understanding product categories in the reference amounts customarily consumed table.

Of notable significance, FDA announced intention to exercise enforcement discretion on the use of a “†” symbol immediately following the “added sugar” percent daily value declaration on labels of pure honey, pure maple syrup, and certain cranberry products.

Manufacturers of pure honey and pure maple syrup may use the “†” symbol to reference a statement explaining that these sugars are naturally occurring and were not added during processing.  Meanwhile, certain cranberry products may bear a statement explaining that the sugars are used to improve the palatability of the food and “[do] not exceed the amount of total sugars in comparable product[s] with no added sugars.”

The guidance was issued in response to industry concern that classifying sugars in these foods as added sugars would imply that the products have been rendered unhealthy with additional sweeteners or “are less nutritious than competitive products that have similar amounts of total sugars and nutrients.”

FDA labeling requirements can be complicated.  If you do not want to navigate them on your own, Registrar Corp’s Regulatory Specialists can review your labeling and product ingredients for compliance with FDA regulations.  For more information about FDA labeling requirements, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Drug Establishments Must Use eCTD Format for U.S. FDA Drug Master File (DMF) Submissions Beginning May 5, 2018

*Update: In April 2018, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2019.


Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require electronic common technical document (eCTD) format for all new Drug Master File (DMF) submissions, including reports and amendments.  FDA states that it will reject DMF submissions not in eCTD format following this deadline.

What is eCTD?

eCTD is currently FDA’s standard submission format for new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs).  FDA states that DMFs are typically submissions to these applications and, as such, are subject to electronic submission required by section 745A(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

After the deadline, FDA will require users to submit DMFs in the eCTD version supported by the FDA Data Standards Catalog.  Additionally, an April 2017 FDA guidance document establishes technical specifications for aspects such as submission structure, file formats and versions of submission components, and required locations for datasets and study information.

Existing DMFs that are not in eCTD format, including those in paper form, do not require resubmission; however, additional submissions such as annual reports, supplements, and amendments to these DMFs must be submitted through ESG in eCTD.  Existing paper DMFs voluntarily converted to eCTD will retain their current DMF number.  Companies typically convert their existing paper DMFs to eCTD to expedite the review process of a NDA or ANDA that references the DMF.

How Do I Send an eCTD Submission?

eCTD submissions 10GB or smaller must be sent through FDA’s Electronic Submissions Gateway (ESG).  Prior to accessing ESG, a user must request an application number from FDA, register for an ESG account, and configure their computer to communicate with the gateway.  FDA advises users to perform a series of tests prior to submission.  The process for ESG access may require several weeks.

Alternatively, you can make the process quick and easy by having a Regulatory Specialist, such as Registrar Corp, convert your DMF submissions to eCTD format and submit them to FDA through ESG.  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 Removed Nearly 10% of Medical Device Establishments from its Registration Database

The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database.  As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018.

Why Were These Registrations Removed?

Establishments are typically removed due to failure to renew their annual FDA registrations.  FDA requires medical device establishments to renew their registrations between October 1 and December 31 of each year.  Within two or three months, FDA typically removes any establishments that do not properly renew.

Establishments located outside of the United States must designate a U.S. Agent for FDA communication as part of their annual registration.  During the recently passed renewal period, listed U.S. Agents were required to confirm their designation with FDA.  If a U.S. Agent failed to confirm their designation, FDA did not consider the establishment’s registration complete.

Marketing a medical device in the United States without a valid FDA registration is a prohibited act that may result in detention or refusal of shipments and other FDA enforcement actions.  Many establishments do not realize that their FDA medical device registration is invalid until their shipments are detained.

Registrar Corp can verify that your FDA medical device registration is valid for 2018 at no cost. Simply complete the form below.  For questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: www.registrarcorp.com/livehelp

Verify your FDA Registration:

Sellers of Laser Products Must Have A FDA Accession Number

Online vendors such as Amazon require documentation of a U.S. Food and Drug Administration (FDA) accession number for certain laser products sold through their online platforms.  An accession number is a unique identifier that FDA uses to track reports from specific models of radiation-emitting electronic devices (RED).  FDA requires manufacturers of certain RED products to have an accession number for their product prior to marketing it in the United States.

How Do I Get an Accession Number for my Laser Product?

In order to obtain an accession number, FDA requires manufacturers of most laser products to submit a product report consisting of numerous aspects including:

  • Identifying information for the product and manufacturer
  • Information on components and accessories, as well as functions and uses that may affect the product’s radiation emissions
  • Measures taken to control levels of radiation in the product
  • Warning statements and instructions for use related to the product’s radiation safety

After a manufacturer submits a report, FDA issues an acknowledgement letter containing the product’s accession number.  The letter does not constitute FDA approval of the device.

When a business has an accession number for a laser product, FDA further requires annual reporting for the product to be submitted by September 1st of each year.  Among other aspects, annual reports must contain a description of quality control procedures for the device, as well as test results and copies of communications relating to radiation safety of the device.

FDA reporting requirements apply to most laser products a business may want to sell through online vendors.  Even products as seemingly harmless as spinning tops with laser lights and laser cat toys are subject to reporting.  Failure to report may not only prohibit the sale of your product through Amazon and similar platforms, but may also result in detention of your shipments at the U.S. border.

For companies considering selling laser products through Amazon, Registrar Corp’s Regulatory Specialists can help determine the specific requirements for your product and facilitate reports with FDA.  If you are located outside of the United States, Registrar Corp can also serve as your U.S. Agent for Service of Process.  Simply complete the form below or call us at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.