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Frequently Asked Fridays: Differentiating Between Statement and Standard of Identity

The U.S. Food and Drug Administration (FDA) requires all food, beverage, and dietary supplement labels to bear declarations called “statements of identity.”  Companies attempting to comply with this requirement will likely encounter a similar term called “standard of identity.” The two are closely related, and understanding what must be included in a statement of identity may depend upon knowledge of the standard.

What is a Standard of Identity?

A “standard of identity” defines properties, features, and specific labeling requirements to which a food product must conform in order to be identified by a specific name.  At a minimum, a standard of identity provides a description of the food’s basic nature and the name that should be used to identify it.  It may also include aspects such as optional ingredients included in the food and different forms in which the food may be prepared.

Standards of identity often reflect traditional consumer understanding and expectations of what constitutes a particular food. They are often implemented in response to situations of fraud and consumer deception. To date, FDA has established almost 300 standards of identity, many dating back to the early and mid-20th century.

For example, 21 CFR 169.150 contains the standard of identity for “salad dressing.”  Per the standard, in order to be labeled as “salad dressing”, a product must be an emulsified, semisolid food composed of at least 30% vegetable oil that contains an acidifying ingredient (e.g. vinegar or lemon juice), an egg yolk-containing ingredient, and a starchy paste prepared from specific starches or flours.  Salad dressing may also contain certain optional ingredients such as salt, spices, and citric acid, some of which have additional requirements and restrictions.

Standards of identity have recently come to the regulatory forefront due to pressure by the dairy industry for FDA to enforce the standard for “milk” on plant-based products that do not conform to the standard, such as soy milk and almond milk. FDA Commissioner Scott Gottlieb M.D. has made public statements asserting the agency’s intent to “modernize” the standards to reflect new understandings of nutrition and encourage innovation in the food industry.

What is a Statement of Identity?

A “statement of identity” is a declaration of a food’s name that must be displayed on the principal display panel (PDP) of its label.  FDA regulations establish a hierarchy regarding the naming of foods:

  1. If a food conforms to a standard of identity, then the name specified in the standard serves as the product’s statement of identity.
  2. If the product is not subject to a standard of identity, the statement of identity should be the common or usual name of the food (e.g. “crackers,” “cookies”).
  3. In the absence of a common name, the statement may use an appropriately descriptive or, if the nature of the food is obvious, a fanciful name commonly understood by the public.

Some foods may have alternate naming requirements established in separate regulations, guidance documents, or Compliance Policy Guides (CPGs).  For example, a CPG for Asian-style noodles determines that these foods may not be labeled solely as “noodles,” as they do not conform to that standard of identity.  However, the CPG permits the statement of identity to contain “noodles” if preceded by qualifying terms such as “Chinese,” “Chow Mein,” “Japanese,” or “Ramen.”

Similarly, FDA has established a CPG that allows for the labeling of foods as “chocolate” in defiance of the standard if the food contains cocoa as the flavoring ingredient and the food is one that consumers do not expect to contain a chocolate ingredient (e.g. chocolate pudding).  Other regulations impose restrictions on non-standardized foods such as peanut spreads, breaded shrimp, fish sticks, and juice blends.

Complying with FDA Statement and Standard of Identity Requirements

FDA requires a statement of identity to be prominently displayed in bold type.  It must be “in a size reasonably related to the most prominent printed matter” on all PDPs and “generally parallel to the base on which the package rests…” A product that fails to bear a compliant statement of identity is considered “misbranded.”

Additionally, a food marketed as a product that has a standard of identity but does not conform to that standard is also considered misbranded. For example, FDA issued a warning letter to Hampton Creek Foods, Inc. in 2015 for marketing a product as “mayo” that didn’t meet FDA’s standard of identity for mayonnaise.  Marketing misbranded food products in the U.S. is a prohibited act that may be met detention, refusal, and other regulatory action.

Avoid preventable food labeling violations.  Registrar Corp’s Regulatory Specialists know which products have standards of identity, their requirements, and the format for compliant statements of identity.  Registrar Corp’s label review service provides a comprehensive report of recommended revisions to your label as well as a print-ready version, compliant with FDA’s updated labeling rules.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Registrar Corp Announces Acquisition of FDA Agents

Registrar Corp has acquired FDA Agents.  FDA Agents has provided FDA registration, U.S. Agent, and product listing services to domestic and foreign FDA-regulated facilities since 2003 and supports more than 1,000 clients worldwide.

“Our goal is to expand Registrar’s reach across the FDA-regulated market,” said David Lennarz, Registrar Corp’s President of Business Development and Operations. “We are excited to partner with all of FDA Agents’ customers and support their ongoing regulatory compliance needs by leveraging Registrar’s 100-plus regulatory advisors and specialists, offices in 17 countries, and unique SaaS technology capabilities.”

“With ever increasing regulations, it was the right time for FDA Agents to partner with a larger organization that could offer our customers a fuller breadth of solutions,” said John Balistreri, Managing Director of FDA Agents.  “Registrar greatly expands the capabilities of FDA Agents and I am confident that our valued clients will benefit from the variety of compliance services Registrar offers and the access to their international offices.”

The investment in FDA Agents represents the first add-on acquisition completed by Registrar Corp.  Registrar Corp, in collaboration with investors Bertram Capital, will continue to actively target add-on acquisitions of FDA regulatory compliance firms that can expand Registrar’s client base and range of services.

“Registrar Corp offers a specialized suite of FDA compliance solutions beyond what can be found in the market,” said Tom Beerle, Principal at Bertram Capital. “With the acquisition of FDA Agents, Registrar continues to expand its position as a leading provider of FDA compliance solutions, and moving forward we will continue to pursue additional, strategic add-on investment opportunities.”

FDA Now Collecting Fees for Export Certificates for Human Food

The Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to charge fees to cover the cost of issuing export certificates for human food.  On October 1, 2018, the agency began issuing and collecting fees for two types of Export Certificates:

  • Certificate to a Foreign Government: certifies that a product (or products) may be marketed in and legally exported from the United States
  • Certificate of Exportability: certifies that an export only product meets the requirements of section 801(e)(1) of the Food Drug & Cosmetic Act and may be legally exported

These certificates are available for human food products, such as processed foods, produce, and grains that are not dietary supplements, medical foods, or foods for special dietary use.

FDA will charge $175 for the first certificate issued for a given product.  Subsequent certificates, issued for the same product in response to the same request, will be made available at a reduced rate in accordance with the following schedule:

First Certificate $175
Second certificate for the same product(s) issued in response to the same request $155
Subsequent certificates for the same product(s) issued in response to the same request $100

 

FDA will continue to provide “Certificates of Free Sale” for dietary supplements, medical foods, and foods for special dietary use at no cost.

Not sure what type of certificate you need for your product? Registrar Corp’s Regulatory Specialists can answer your questions and help you obtain an Export Certificate. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

First FDA Voluntary Qualified Importer Program Application Period Begins October 1, 2018

The U.S. Food and Drug Administration (FDA) will begin accepting applications for its Voluntary Qualified Importer Program (VQIP) on October 1, 2018.  In a September 2018 webinar, FDA stated it intends to review around 200 VQIP applications during Fiscal Year (FY) 2019.

What is VQIP?

VQIP allows eligible importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application.  FDA will limit examination and sampling of these foods to situations where they are linked to a public health risk.

During the recent webinar, FDA estimated that participating importers may see their shipments released in as little as ten minutes.  FDA compared this to an average release of 14.5 hours if manual review is needed, or 6.7 days if documentation or analysis is needed.

How Do I Participate In VQIP?

To take advantage of these benefits, importers may submit an application to FDA that covers aspects such as the foods they wish to import under expedited review, the suppliers of those foods, and a description of procedures used to ensure the safety of foods throughout the supply-chain.  FDA may also examine the foods’ labels for compliance with certain requirements such as allergen labeling.

Among other requirements, VQIP-eligible importers must:

  • have a three-year history of food importation into the U.S.
  • be in compliance with applicable FDA food safety regulations (i.e. HACCP, HARPC, or FSVP)
  • hold a current certification issued by an FDA-accredited third-party certification body for each foreign supplier listed in the VQIP application.
  • not currently have compliance issues with FDA (i.e. Import Alerts, Class I recalls, Warning Letters, etc.) or have a history of significant non-compliance

What is the Cost to Participate in VQIP?

FDA estimates the VQIP user fee to be $16,400. The Agency states it will request payment of VQIP fees after an application has been approved.  VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.

Registrar Corp offers a variety of services to help interested parties meet VQIP eligibility requirements.  Our Regulatory Specialists can develop your FSVPs, write HARPC  and HACCP plans for your suppliers, or review current plans for compliance. Registrar Corp can also help remove a supplier from Import Alert by developing a petition to FDA. Lastly, the Registrar Corp FDA Compliance Monitor provides a simple solution to supply-chain monitoring requirements.

For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Requires Electronic Submission of Veterinary Master Files Beginning October 1, 2018

Beginning October 1, 2018, the U.S. Food and Drug Administration (FDA) will require electronic format for new Veterinary Master File (VMF) submissions, including amendments.  FDA states that it will not accept paper VMF submissions after this deadline.

What Is A VMF?

FDA defines a VMF as “a submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of veterinary drugs and drug substances.” A VMF holder can authorize third parties to reference the VMF’s material in support of submissions such as investigational new animal drug applications (INADAs) and abbreviated new animal drug applications (ANADAs) without disclosing trade secrets to industry.

What Are FDA’s Requirements For Electronic VMFs?

FDA does not require a specific format for electronic VMFs, but the FDA Center of Veterinary Medicine (CVM) does provide recommended guidelines for files in an electronic submission.  After reaching out to FDA, the Agency has informed Registrar Corp that they will accept and encourage VMF submissions in Common Technical Document (CTD) format.  Note that CTD is not the same as the Electronic Common Technical Document (eCTD) format required for most types of Drug Master Files (DMFs) and drug applications.

Beginning October 1, VMFs must be submitted through FDA’s Electronic Submissions Gateway (ESG) using the CVM version of the eSubmitter software.  Electronic submissions to CVM require registration with both ESG and the CVM Electronic Submission System (ESS).  These registrations may take several weeks as they involve multiple back-and-forth communications with FDA, including written letters and test submissions.

Alternatively, you can make a time-consuming process quick and easy by having an experienced FDA Regulatory Specialist, such as Registrar Corp, assist with your VMF submissions.  Registrar Corp can convert your paper VMFs to electronic format and submit them to FDA on your behalf.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Food Facilities Must Renew Their FDA Registrations Between October 1 and December 31

The U.S. Food and Drug Administration (FDA) requires facilities that manufacture, process, pack, or store food for U.S. consumption to renew their FDA registrations between October 1 and December 31, 2018. During the renewal process, facilities located outside of the U.S. must also designate a U.S. Agent for FDA communications. The renewal will not be considered complete until the listed U.S. Agent accepts this designation.

It should be noted that renewing a registration is distinct from updating a registration, and even food facilities that registered with FDA as recently as September 2018 will be required to renew.  Facilities should ensure they properly renew during this period so their FDA registrations remain valid for 2019.

What are the Consequences of Not Renewing?

FDA will cancel facility registrations that are not properly renewed during the impending Biennial Registration Renewal period. Failure to renew FDA registrations during the 2016 renewal period contributed to a 28% drop in the number of registered food facilities in early 2017.

Food exported to the U.S. by a facility with a canceled registration may be detained or refused at the U.S. port of entry.  Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties.

Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can properly renew your registration and can act as the U.S. Agent for facilities outside the United States. As part of our registration renewal service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more.

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

Registrar Corp’s FDA Compliance Monitor Now Includes Recalls

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.

FSMA Deadline Approaching: First Qualified Facility Attestation Period Begins October 1, 2018

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

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.”

Compliance Deadlines

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.

 

  • (include corporate designation such as: Ltd., SARL, S.A., etc.)
  •  
  • (Add 3 zeros to the beginning of 7-digit FEI numbers. Ex: 0001234567)
  •  

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.