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.
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’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
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.
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.
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.
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.
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:
- If a food conforms to a standard of identity, then the name specified in the standard serves as the product’s statement of identity.
- 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”).
- 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 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.”
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:
|Second certificate for the same product(s) issued in response to the same request
|Subsequent certificates for the same product(s) issued in response to the same request
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.
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.
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.
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.