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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 regstaging.wpengine.com/livehelp.

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.

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 regstaging.wpengine.com/livehelp.

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 289 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 regstaging.wpengine.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-20^th 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 regstaging.wpengine.com/livehelp.