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Frequently Asked Friday: What Happens If I Refuse an FDA Inspection?

The U.S. Food and Drug Administration (FDA) has the authority to inspect any FDA-registered facility.  Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection”.   All products exported to the U.S. by a facility on the Import Alert are subject to Detention Without Physical Examination (DWPE) until FDA is able to inspect the facility.

Import Alerts are public information that can damage a brand’s reputation.  Delayed or refused shipments resulting from Import Alerts can also strain relationships with buyers.  Thus, it is advised to accept an inspection without hesitation. FDA may issue a Notice of Inspection at any time, so you should prepare by ensuring your facility is compliant with FDA Current Good Manufacturing Practices (CGMPs) and other regulatory requirements.

Food Facility Inspections

FDA requires food facilities to respond to inspection requests within 24 hours.  The Agency may interpret a lack of response as refusal of inspection.  FDA communicates an inspection request with a facility’s U.S. Agent, so it’s prudent to designate a reliable Agent.  When preparing for an inspection, you should familiarize yourself with common inspection violations so you can ensure you don’t make the same mistakes.

We invite you to utilize our webinar recording on how to handle an FDA food facility inspection to help you prepare.   For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection.  As part of this inspection service, our Specialist will help identify potential food safety problems in the structure, processes, procedures and documentation used in your daily production.

Drug Facility Inspections              

There are a variety of actions that FDA may interpret as refusal of a drug facility inspection, including refusing an FDA inspector entrance into a facility, trying to postpone a scheduled inspection date without a reasonable explanation, and more.  Registrar Corp’s article on FDA drug facility inspections will help you understand the different types of FDA inspections, how FDA investigators prepare for inspections, and what to expect during an inspection.

Our Facility Is Under Import Alert for Inspection Refusal.  What Can We Do?

To seek removal from Import Alert 99-32, a facility must petition for inspection by FDA.  FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused.  Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.

For more information about FDA inspections or Import Alerts, contact Registrar Corp by phone: +1-757-224-0177, email: [email protected], or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Removed over 20% of Food Facility Registrations from its Database

In February 2019, the U.S. Food and Drug Administration (FDA) removed 47,635 food facilities from its database, resulting in over a 20% decrease in registrations. This was likely caused by facilities failing to properly renew their registrations before the December 2018 renewal deadline. FDA removes all facilities that did not renew shortly after each renewal period. As of February 7, 2019, 186,016 food facilities remained in FDA’s database compared to the 233,651 registered in December 2018. To see the registration totals broken down by country, click here.

What is Registration Renewal?

Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year. The date on which the initial registration was submitted is inconsequential to the renewal requirement. If a facility registers the day prior to the FDA renewal period (October 1), they are still subject to registration renewal.

FDA considers registrations that are not renewed by the deadline to be “expired”. Facilities with expired registrations must re-register with FDA and obtain a new registration number, prior to continuing manufacturing, processing, packing, or storing food for U.S. consumption.

Distributing food in the United States with an expired registration is prohibited and may subject a facility’s owner to civil or criminal penalties. Many facilities do not realize their registrations are expired until their shipments are detained by FDA Compliance Officers at the U.S. Port of Entry. To avoid costly detentions or regulatory action, it is prudent all food facilities verify their registrations were properly renewed for 2019.

If your registration is expired, Registrar Corp specializes in FDA regulatory compliance and can properly re-register  your facility.  As part of our registration service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more. For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

FDA Issues Proposed Rule on Final Monograph for OTC Sunscreen Products

On February 26, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish final monograph regulations for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.

Since issuing an indefinite stay on a 1999 final monograph, FDA has mostly regulated Sunscreen products under enforcement discretion.  In 2011, FDA clarified its enforcement approach to OTC sunscreen products through a draft guidance that was later finalized in 2018.  At that point in time, FDA also issued a final rule for the labeling of OTC sunscreen drug products and established mandatory parameters for broad spectrum, sun protection factor (SPF) and water resistance testing. This final rule was codified in 21 CFR 201.327.

FDA’s new proposed rule would lift the stay on the 1999 final monograph as well as establish the following major provisions:

GRASE Status of Sunscreen Active Ingredients

The rule proposes that zinc oxide and titanium dioxide remain classified as generally recognized as safe and effective (GRASE) for use in sunscreens at concentrations of up to 25 percent.

Aminobenzoic acid and trolamine salicylate would be classified as not GRASE for use in sunscreen as FDA has determined the risks posed by these ingredients outweigh their benefits.  Drug products containing non-GRASE ingredients are considered misbranded and prohibited from being marketed in the U.S.

Additionally, the rule proposes that the following twelve ingredients would be excluded from the final monograph because there is insufficient data to determine whether they are GRASE:

  • Cinoxate
  • Dioxybenzone
  • Ensulizole
  • Homosalate
  • Meradimate
  • Octinoxate
  • Octisalate
  • Octocrylene
  • Padimate O
  • Sulisobenzone
  • Oxybenzone
  • Avobenzone

Many of these ingredients are considered GRASE under the 1999 monograph, meaning sunscreen products with these ingredients can currently be marketed without a new drug application (NDA). If FDA’s new proposed rule becomes final, sunscreen products with these ingredients may not be introduced into interstate commerce one year after the final rule becomes effective. FDA has proposed an effective date for the final rule of November 26, 2019.

GRASE Statuses of Sunscreen Dosage Forms

The rule proposes to classify oils, lotions, creams, gels, butters, pastes, ointments, and sticks as GRASE dosage forms for sunscreens.  Sprays would also be GRASE, contingent on testing to minimize risks from inhalation (particle size restrictions) and flammability (flammability and drying time testing).

Sunscreens in powder form would be eligible for inclusion in the final monograph pending additional scientific data supporting their safety.  Powder sunscreens would also be subject to the same particle size restrictions as sprays.  Other dosage forms, such as wipes, body washes, and shampoos would be considered new drugs, which require FDA approval of an NDA to market in the U.S.

Changes to Sunscreen Labeling

The rule proposes to require a sunscreen’s statement of identity to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”).  The rule would also revise format requirements to make SPF, broad spectrum, and water resistance statements more prominent on a product’s principal display panel (PDP). Products that do not meet broad spectrum requirements must also include an asterisk next to the SPF value and an associated statement “*See Skin Cancer/Skin Aging Alert.”

Due to evidence showing “additional meaningful clinical benefit” from broad spectrum sunscreen products with an SPF of 60, the rule proposes to increase the maximum SPF displayed on sunscreen labels from 50+ to 60+.  Sunscreen manufacturers would still be permitted to market products formulated up to 80 SPF as OTC.

Additionally, all sunscreen products over 15 SPF would be required to satisfy broad spectrum labeling and testing requirements.  Among the other requirements of broad spectrum testing, the rule proposes that these products must meet a UVA I/UV ratio of 0.7 or higher.

Prohibition of Sunscreen-Insect Repellent Combinations

Given their use as pesticides, sunscreen-insect repellent combination products are also regulated by the Environmental Protection Agency (EPA).  FDA has determined that these products cannot be labeled to “sufficiently ensure safe and effective use of the sunscreen component and provide adequate directions for use” due to incompatibility with EPA labeling requirements.  The rule proposes to classify these products as not GRASE, which would effectively prohibit them from being marketed in the U.S.

What Industry Should Expect

FDA’s new proposed rule brings some significant possible changes for the sunscreen industry.  As with any proposed rule, these provisions are not final; however, they illustrate FDA’s current thinking for the direction of sunscreen regulations.  Sunscreen companies should familiarize themselves with the 1999 final monograph (21 CFR Part 352), required labeling based on effectiveness testing for OTC sunscreen drug products (21 CFR 201.327), and the newly proposed rule to prepare for compliance.

Registrar Corp assists sunscreen companies with FDA compliance.  Our Regulatory Specialists can register your establishment and list your products with FDA, serve as your U.S. Agent, review your sunscreen’s labeling for compliance, and more.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

 

Frequently Asked Fridays: Nutrition Facts Requirements for Coffee, Tea, and Spices

The U.S. Food and Drug Administration (FDA) requires Nutrition Facts labeling on food products sold in the United States, whether they are produced domestically or outside of the United States. Coffee, tea, and spices may be exempt from FDA nutrition labeling requirements if they contain “insignificant” (by FDA’s definition of the term) amounts of all nutrients required to be included in the “Nutrition Facts” panel (fda.gov). Limitations to the exemption exist, and it is important for companies to understand when their product will qualify. Products that are required to declare nutrition labeling, but do not, may be detained for misbranding and refused entry into the United States.

Added Ingredients

The exemption from nutrition labeling applies to the finished food product, as packaged. If foods with insignificant amounts of nutrients are combined, the resulting product remains exempt. For example, plain coffee and cinnamon both contain insignificant nutrient amounts; therefore, if combined into a single product, the result is still exempt from nutrition labeling. Once an ingredient with nutrients is added to the product, it no longer has insignificant amounts of nutrients and a Nutrition Facts label is required. Common examples include: chai latte mixes, sugar/sweetener, and candied fruit peel.

Claims and Other Nutrition Information

If any of the following types of claims are made, a Nutrition Facts Label is required:

  • A nutrient content claim (“low-fat”, “healthy” or “high in fiber”)
  • A health claim (“Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”)
  • A structure/function claim (“calcium builds strong bones”)

FDA regulations also state that the exemption does not apply if any nutrition information is present on the label.

In the example above, the tea on the left has no claims or added nutrients and therefore does not require a Nutrients Facts label. The tea on the right, however, does require a Nutrition Facts label because it provides the amount of antioxidants (catechins) present in the product, which could be construed as “nutrition information” by FDA.

If your product is exempt for Nutrition Facts labeling, voluntary information may still be provided. Some consumers seek more information on how the product was manufactured and find value in transparency.

Registrar Corp’s Regulatory Specialists can help you determine if your products require a Nutrition Facts label and keep your company in compliance with FDA regulations. Contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Registrar Corp Debuts Version 2.0 of FSMA Compliance Tool, the FDA Compliance Monitor

FDA FSMA Compliance Monitoring

Registrar Corp’s FDA Compliance Monitor, the food industry’s leading FSMA compliance tool, has been upgraded.  The new simplified layout and optimized backend drive user efficiency, making compliance with FDA’s supplier monitoring requirements easier than ever.

On the front end, users now see a series of compact rows that display an overview of supplier compliance; these rows can be further expanded to review detailed company data for each supplier.  Best of all, the system is more than 10x faster than before.

The new features are immediately available to all users at no additional cost.  Want to experience the new Monitor for yourself?  Join our free webinar walkthrough or schedule a 1-on-1 demo today.

 

What’s Next for the Monitor?

The recent redesign lays the foundation for additional features that will further automate compliance as well as increase user productivity.  The next set of rollouts will include:

  • Validation of FDA Registration Numbers
  • A repository for requesting and storing HACCP and HARPC Food Safety Plans as well as other documentation for supplier compliance
  • Enterprise integration capabilities

“We are constantly exploring ways to innovate the Monitor,” says Brendon Sampson, Manager of Registrar Corp’s FDA Compliance Monitor Department.  “User feedback is integral to delivering actionable and practical features.  We anticipate significant growth in implementing future developments.”

 

About the Monitor

Registrar Corp developed the FDA Compliance Monitor to assist companies with supply-chain monitoring requirements under the U.S. Food and Drug Administration (FDA) Preventive Controls and Foreign Supplier Verification Program (FSVP) rules.  The Monitor aggregates and supplements data from five FDA databases to supply comprehensive, up-to-date compliance reports on all FDA-regulated companies.  To verify and document suppliers’ FDA compliance, businesses can easily monitor their suppliers for:

  • FDA Inspection Classifications
  • Warning Letters
  • Import Alerts
  • Import Refusals
  • Recalls

In addition to monthly compliance reports, the Monitor automatically sends users email alerts whenever the published FDA compliance status of a supplier changes.

To learn more about how Registrar Corp’s FDA Compliance Monitor can help simplify compliance with FDA monitoring requirements, join our free webinar walkthrough on January 23.  Alternatively, you can schedule a demo or call us at +1-757-224-0177.

FDA FY 2018 Inspection Observations: 278 U.S. Importers Cited for FSVP Violations

The U.S. Food and Drug Administration (FDA) recently released its Fiscal Year (FY) 2018 Inspection Observation Data.  The data aggregates violations documented during FDA inspections from October 2017 through September 2018.  During this period, FDA cited 278 U.S. importers of food and beverages for not developing Foreign Supplier Verification Programs (FSVP), making it the most frequent inspection violation of FY 2018. This article provides an overview of what these FSVP violations mean for industry as well as the other five most commonly cited violations this year.

FSVP Violations

As of March 19, 2018, most food importers are required to develop FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses.  After the first FSVP deadline in May 2017, FDA cited 108 importers for not developing FSVPs during FY 2017 inspections.  FSVP’s prominence on this year’s list of violations suggests that FDA is regularly inspecting importers for compliance.

Importers should be prepared for FDA to examine their FSVP records and verify that they are properly monitoring their suppliers.  Non-compliance with FSVP regulations may result in civil penalties.

Registrar Corp’s Qualified Individuals can assist by developing your FSVPs or reviewing your current programs for compliance.  Additionally, Registrar Corp’s FDA Compliance Monitor simplifies supplier monitoring by continuously tracking your suppliers’ FDA compliance and issuing monthly reports that support FSVP documentation requirements.  Schedule a demo to learn more.

Top Five Food Facility Violations

FDA cited registered food facilities for a variety of food safety issues this year.  Below are the top five most common food safety violations discovered by FDA in FY 2018:

  • Sanitation Monitoring – FDA cited 188 facilities for not properly monitoring sanitation conditions and practices with sufficient frequency. Facilities are required to monitor aspects such as the safety of water coming into contact with food or food contact surfaces, prevention of cross-contamination, and maintenance of hygiene facilities.
  • Pest Control – FDA cited 183 facilities for not properly excluding pests from potentially contaminating food.
  • Manufacturing, Processing, Packing, and Holding Controls – FDA cited 175 facilities for not implementing proper controls to mitigate the risk of food hazards, such as growth of microorganisms, allergen cross-contact, and contamination of food.
  • Sanitary Operations and Plant Maintenance – FDA cited 167 facilities for either not maintaining cleanliness of their facilities or not keeping them in good repair.
  • Personnel – FDA cited 161 facilities for not taking reasonable measures and precautions related to personnel. These may include failing to address hygiene and cleanliness of staff working in direct contact with food.

Food facilities should ensure compliance with the above and other good manufacturing practices.  Food safety violations discovered during an inspection may result in FDA enforcement such as Warning Letters, Import Refusals, or Import Alerts.  These compliance issues can damage a brand’s reputation and often influence the buying decisions of purchasers.

To prepare your facility for an FDA inspection, Registrar Corp can dispatch a Food Safety Specialist to conduct a Mock FDA Inspection.  Our experts will identify potential food safety issues and educate facility staff on FDA expectations during an inspection.

Preventive Controls Violations

While no individual violation of the FDA Preventive Controls rules made it to the top of the list, violations of Preventive Controls requirements in FY 2018 total 396 when combined.  These include issues such as not having a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan, not identifying a hazard that requires a preventive control in a HARPC Plan, not utilizing a Preventive Controls Qualified Individual (PCQI) to prepare or oversee a HARPC Plan, not implementing adequate procedures for monitoring sanitation or allergen controls, and more.

The deadlines for most facilities to comply with Preventive Controls requirements have passed, and these violations are evidence that FDA is actively inspecting facilities for compliance with the rules.  Facilities should familiarize themselves with Preventive Controls regulations to ensure they are properly accounting for all HARPC requirements and any differences from other food safety systems they may be using to draft their HARPC plans.

Alternatively, Registrar Corp’s PCQI Food Safety Specialists can assist by developing a HARPC Plan for your facility or reviewing your current plan for compliance.

For assistance with FDA food safety regulations, call Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

2018 In Review: A Year of FSMA Firsts

With most compliance deadlines having passed under the Food Safety Modernization Act (FSMA) and new requirements on the horizon, 2018 proved to be a busy year for the U.S. Food and Drug Administration (FDA).  See some of this year’s regulatory highlights below.

The Second Compliance Deadline Passed Under the Foreign Supplier Verification Program (FSVP) Rule

As of March 19, 2018, most U.S. importers of food and beverages must implement FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses as required by the FSVP rule.  FDA has been regularly inspecting importers for FSVP compliance since the first deadline passed in May 2017 and cited 278 importers in Fiscal Year (FY) 2018 for failing to develop FSVPs.

FDA Issues First Mandatory Recall Under FSMA

In April 2018, FDA ordered a mandatory recall of food containing powdered kratom from Triangle Pharmanaturals LLC after the Agency discovered salmonella in four separate samples.  FSMA grants FDA the authority to require a recall when there is reasonable probability a food is adulterated or poses a serious risk to public health.  FDA ordered the mandatory recall after Triangle Pharmanaturals did not cooperate with a request to voluntarily recall their kratom products.

FDA Permits 8 New Non-digestible Carbohydrates to be Declared Dietary Fiber

Under the Revision of the Nutrition and Supplement Facts Label final rule, isolated or synthetic non-digestible carbohydrates may only be declared as “dietary fiber” on a food label if FDA determines they have a physiological benefit.  This excludes many carbohydrates commonly listed as fiber from being declared, effectively limiting certain labels’ abilities to make nutrient content or health claims.

After reviewing petitions and scientific literature on twenty-six carbohydrates, FDA intends to exercise enforcement discretion when any of eight additional fibers are declared on a label’s dietary fiber declaration.

The First Qualified Facility Attestation Deadline Passed On December 17, 2018

Under the Preventive Controls for Human Food rule, “Qualified Facilities” receive exemption from certain food safety requirements, such as the development of Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans and Supply-Chain Programs.

To take advantage of these exemptions for 2019 through 2020, most facilities were required to submit a Qualified Facility Attestation to FDA between October 1 and December 17, 2018.  A facility may be eligible to submit an attestation if it averaged less than $1,000,000 in global food sales plus the market value of unsold food inventory during the previous three years.

Facilities that did not submit an attestation prior to December 17, 2018 may be subject to the full requirements of the Preventive Controls rule.

The First Voluntary Qualified Importer Program (VQIP) Application Period Began October 1, 2018

VQIP allows eligible U.S. importers to pay an annual fee for expedited review and release of foods specified in an approved VQIP application.  FDA began accepting applications for VQIP on October 1, 2018.  To participate in VQIP, eligible importers must submit an application and pay an estimated $16,400 upon application approval.  VQIP benefits for approved importers who have paid the fee will begin on October 1, 2019.

FDA Began Collecting Fees for Food Export Certificates

As of October 2018, FDA changed the export certificate program for food.  U.S. exporters may now request a Certificate to Foreign Government or Certificate of Exportability for their food or beverage.  FDA charges a fee of $175 for the first certificate of either type, $155 for a copy, and $100 for subsequent copies of the same certificate.

Registrar Corp will continue to keep the food industry updated as we move into 2019 and encounter more changes to the FDA regulatory landscape.  For assistance with FDA regulations, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

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.