Registrar Corp added recalls to their FDA Compliance Monitor. Users can now view the recall history of their own company, their suppliers, and potential suppliers, including:
- The description of the recalled product.
- The recall classification (the level of health risk involved).
- The reason for the recall.
- The current status of the recall (ongoing, completed, etc.).
This capability will help businesses comply with the Food Safety Modernization Act (FSMA), which requires food facilities and US importers to monitor their food suppliers’ FDA compliance as related to food safety. Recalls can damage a brand’s reputation, disrupt supply chains, and delay production and are an important aspect of a facility’s compliance history.
In addition to recalls, the FDA Compliance Monitor includes the FDA inspection history, FDA import alert status, FDA warning letter history, and record of FDA-refused shipments for monitored facilities, making full compliance with FSMA’s monitoring requirements easier than ever before. Schedule a demo of the FDA Compliance Monitor now.
Users can access the FDA Compliance Monitor through MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance, including FDA registrations and prior notice submissions.
For more information about the FDA Compliance Monitor or FSVP monitoring requirements, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.
Very small businesses generally must comply with the U.S. Food and Drug Administration’s (FDA’s) Preventive Controls for Human Food Rule by September 17, 2018. Under this rule, very small businesses are eligible for exemption from some of the Preventive Controls requirements, including the requirement to maintain a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan and the requirement to maintain a written Supply-Chain Program. To take advantage of these exemptions, businesses must submit their first attestation to FDA by December 17, 2018.
Who Qualifies for the Exemption
Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years
Other Qualified Facilities: Though FDA has stated that it expects most facilities that qualify for the exemption to be very small businesses, other facilities qualify if they possess both of the two following characteristics:
- Over the past three years, they have averaged annual sales of food for human consumption below $500,000 (adjusted for inflation)
- At least half of their food sales over the previous three years have been directly to local consumers, restaurants, or retail establishments that are located in the same state, same Indian reservation, or within 275 miles of the food facility in question
Registrar Corp’s free Qualified Facility Wizard can help you determine whether your facility qualifies for the exemption.
How to Claim Eligibility for an Exemption
In order to claim eligibility for an exemption, a qualified facility must notify FDA of its status by submitting Form FDA 3942a. Using this form, the owner, operator, or agent in charge of a food facility must attest that the facility in question meets the definition of a qualified facility and that the facility is either “addressing identified hazards through preventive controls and monitoring the preventive controls,” or “complying with applicable non-Federal food safety regulations, and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed (FDA.gov).”
When to Claim Eligibility
Qualified facilities that began or will begin processing, packing, or holding food before September 17, 2018 must submit the relevant form by December 17, 2018. Facilities that will begin processing, packing, or holding food on or after September 17, 2018 must submit the relevant form before beginning operations. Facilities must resubmit attestation to FDA every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even numbered year.
Preventive Controls Compliance for Qualified Facilities
As mentioned above, qualified facilities that attest are exempt from certain requirements of the Preventive Controls rules, but not all of them. Qualified facilities must still:
- Refrain from selling adulterated food
- Adhere to Current Good Manufacturing Practices (CGMPs)
- Ensure that all individuals who manufacture, process, pack or hold food are trained in the principles of food safety and are qualified to perform their assigned duties
- Maintain detailed records of the food safety training received by workers
A very small business that does not notify FDA of its status as a qualified facility is fully subject to the standard requirements of the Preventive Controls Rule and, generally, must develop and implement a written HARPC Food Safety Plan and Supply-Chain Program by September 17, 2018.
The Preventive Controls Rule compliance deadlines for facilities that do not meet the definition of a very small business have already passed. Thus, many food facilities that have not yet developed and implemented a written HARPC Food Safety Plan and Supply-Chain Program are likely to be in violation of FDA regulations.
Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses that do not meet the definition of a qualified facility or do not intend to notify FDA of their status as a qualified facility 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 regulatory requirements.
Assistance with Attestation and Food Safety Plans
Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) and can develop or review a facility’s HARPC plan for FDA compliance. Registrar Corp’s Specialists can also provide guidance on qualified facility attestation to firms that designate Registrar Corp to manage their FDA registration or act as their U.S. Agent for FDA Communications. 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 Deadline Approaching for Prescription Drug Labels: New Product Identifier Requirements
Under the Drug Supply Chain Security Act (DSCSA), manufacturers, packagers, and repackagers of human prescription drugs must affix or imprint a “product identifier” to each package and homogenous case of product intended to be introduced in a transaction into US commerce. This process is known as “serialization.”
Manufacturers, packagers and repackagers of human prescription drugs must comply with this new requirement by November 27, 2018. After this date, the U.S. Food and Drug Administration (FDA) will consider drug products that do not bear a product identifier to be misbranded and in violation of FDA regulations.
Furthermore, industry will not be permitted to buy or sell prescription drug products that are not encoded with a product identifier after the following dates:
- November 27, 2018 for repackagers
- November 27, 2019 for wholesale distributors
- November 27, 2020 for dispensers
Formatting a Product Identifier
A product identifier should include the product’s National Drug Code (NDC), unique serial number, lot number and expiration date in human and machine-readable formats.
The machine-readable format should be a 2D data matrix barcode when affixed to or imprinted on a package (the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product) or a linear or 2D data matrix barcode when affixed to or imprinted onto a homogenous case of product (a sealed case containing only product that has a single NDC number belonging to a single lot).
Implications for Drug Listings
As of last year, FDA requires that drug establishments “certify” listings that have not been changed since the previous calendar year during the annual registration renewal period. In an email to industry this week, FDA stated that manufacturers and repackagers that have not yet incorporated the new product identifier requirements into their labels should not certify that their drug listings are up-to-date during the upcoming registration renewal period (October 1, 2018 to December 31, 2018). Industry should submit a new sampling of the labeling incorporating the product identifier as an update to their listing.
Registrar Corp can provide guidance on FDA’s new product identifier requirements and update drug listings on your behalf. For more information, complete the form below. You can also reach us by phone 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 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
|Active Pharmaceutical Ingredient (API)
|Finished Dosage Form (FDF)
|Contract Manufacturing Organization (CMO)
|ANDA Program Fees – Based upon the number of approved ANDAs held
|Large (20 or more ANDAs)
|Medium (6 – 19 ANDAs)
|Small (5 or fewer ANDAs)
|Type II DMF
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
|Annual Establishment Registration
|De Novo Classification
|PMA, PDP, PMR, BLA
|BLA efficacy supplement
|PMA annual report
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 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.
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
- Inulin and inulin-type fructans
- High amylose starch (resistant starch 2)
- 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
- Guar gum
- Locust bean gum
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.
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.
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.
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 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.
*Update: In January 2019, FDA extended the eCTD compliance date for Type III DMFs an additional 12 months (May 5, 2020).
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.
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.