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On November 13, 2015, the U.S. Food and Drug Administration (FDA) released a final rule on Accredited Third-Party Certification.  This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and provides a means for foreign food facilities to obtain certification of their food safety controls.  The certifications will serve two purposes:

  1. Importers may use the certifications to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which will grant expedited importation to importers that demonstrate a high level of control over the safety of their supply chain.
  2. FDA may require certification of certain potentially harmful foods before they may be imported into the United States.

Under FDA’s Accredited Third-Party Certification program, FDA will recognize accreditation bodies. Recognized accreditation bodies will then accredit qualified third-party certification bodies.  Once accredited, certification bodies will audit and issue certifications for foreign facilities and the foods they produce.

The Third-Party Certification rule requires accreditation bodies to:

  • Assess third-party certification bodies for accreditation and monitor the performance of those they accredit
  • Submit monitoring reports to FDA
  • Maintain and provide the FDA access to records required to be kept under the program

The rule requires certification bodies to:

  • Ensure their audit agents are competent and objective
  • Perform unannounced facility audits
  • Notify FDA on discovering a condition that could cause or contribute to a serious risk to public health
  • Verify the effectiveness of facilities’ corrective actions to address identified deficiencies
  • Submit regulatory audit reports
  • Maintain consultative audit reports in records, accessed only under section 414

Both accreditation bodies and certification bodies must also evaluate their own performance, correct any problems, and maintain and provide FDA access to self-assessment reports and other records.

FDA plans to implement the Third-Party Certification program as soon as possible after the agency publishes two additional documents: the final Model Accreditation Standards guidance and the final user fee rule.  Once FDA implements the program, accreditation bodies will be able to apply for recognition.  Certification bodies will be able to seek accreditation as soon as an FDA-recognized accreditation body begins accepting applications. If FDA does not recognize an accreditation body within two years of implementing the Third-Party Certification program, the agency may directly accredit certification bodies.

Registrar Corp assists food facilities and importers to comply with U.S. FDA regulations.  We offer a Mock FDA Inspection service to help food facilities prepare for an unannounced inspection by FDA or a third-party certification body.  Registrar Corp’s Food Safety Specialists will inspect everything from employee habits to the conditions of equipment and provide a detailed report to help bring your facility into compliance.

If you have questions about FDA’s Third-Party Certification rule or any other FSMA rules, contact Registrar Corp at +1-757-224-0177. Regulatory Advisors are available to chat 24-hours a day at


On November 18, 2015, the U.S. Food and Drug Administration (FDA) published a proposed rule concerning the labeling of fermented and hydrolyzed food and beverages as “gluten-free”. Under FDA’s proposed rule, in order to label fermented and hydrolyzed foods as “gluten-free”, manufacturers would be required to maintain records demonstrating that:

  • the food met the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and
  • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

Manufacturers would need to hold these records for at least two years after the food enters interstate commerce.

FDA published a final rule regarding gluten-free labeling of all food products in 2013, but the rule left the industry with “uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten.”  FDA intends for the new proposed rule to provide an additional method for the agency to verify that fermented and hydrolyzed foods comply with the agency’s gluten-free rules.

FDA also included distilled foods in its proposed rule.  FDA states that it would evaluate the compliance of distilled foods that bear the “gluten-free” claim by “verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.”

What are Fermented and Hydrolyzed Foods?

FDA defines fermented foods as foods that have “undergone fermentation—a process that typically involves the conversion of complex organic compounds, especially sugars and other carbohydrates, to simpler compounds such as lactic acid and ethyl alcohol.”  Common examples of fermented foods include yogurt, cheese, and pickles.

FDA defines hydrolyzed foods as foods in which the “chemical components—such as proteins—are broken into smaller organic compounds by reaction with water.”

FDA is accepting public comment on this proposed rule through February 16, 2016.  Submit a comment now.

Registrar Corp can help you determine whether your food product meets U.S. FDA requirements for being labeled as “gluten-free”.  For questions about FDA “gluten-free” labeling requirements or other FDA food labeling regulations, contact Registrar Corp at +1-757-224-0177. Live help is available 24-hours a day at


FDA Requests Comments on Labeling Food as “Natural”

November 23, 2015 by David Lennarz

On November 12, 2015, the U.S. Food and Drug Administration (FDA) began accepting comments on the use of the term “natural” on food labels.  FDA asked three specific questions in its Constituent Update:

  • Is it appropriate to define the term “natural”?
  • How should the agency define “natural”?
  • How should FDA determine appropriate use of the term on food labels?

FDA’s Current View on the term “Natural”

FDA has not established a formal definition for the term “natural”.  According to the agency, FDA has considered the term “natural” to mean “that nothing artificial or synthetic  (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.”

Factors that FDA does not currently consider include, but are not limited to, whether food products may be labeled as “natural” if they:

  • Are produced using genetic engineering
  • Contain high fructorse corn syrup
  • Are produced under certain food processing or manufacturing methods, such as those using pesticides, thermal technologies, pasteurization, or irradiation

FDA also does not currently consider whether the term “natural” should describe a nutritional or health benefit.  FDA is looking for input on all of these factors.

Why Now?

Back in 1991, FDA decided not to define the term “natural” due to its widespread use and evidence that showed consumers regarded many uses of the term as non-informative. The agency felt that defining the term “could remove some ambiguity surrounding use of the term that results in misleading claims”.

FDA is now reconsidering defining “natural” because of recent industry input. Since 2006, FDA has received three Citizen Petitions asking the agency to define the term “natural” for use on food labels and one Citizen Petition asking that the term be prohibited.

FDA is accepting comments through February 10, 2016.  Submit a comment here.

Registrar Corp stays up-to-date on U.S. FDA food labeling regulations and will continue to update industry as FDA’s decision on use of the term “natural” progresses.  Registrar Corp offers a Label and Ingredient Review Service through which our Regulatory Specialists will review a food label for FDA compliance, including the Nutrition Facts Chart and any claims made on the label. For questions or assistance with FDA food labeling regulations, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at



On November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule for Foreign Supplier Verification Programs (FSVP) for Food for Humans and Animals. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA).  Most importers will be required to comply with FDA’s FSVP rule in May 2017 (18 months after publication).

FDA defines an FSVP as a program that verifies “that [importers’] foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.”  The FSVP rule covers importers of food and beverages, which FDA defines as “the U.S. owner or consignee of a food offered for import into the United States.” If there is no U.S. owner or consignee, the exporter’s U.S. Agent is the importer.

Importers must create an FSVP for each food imported from each foreign supplier.  If they import the same food from two different suppliers, that will require two FSVPs.  One element of an FSVP is a hazard analysis.  Importers must determine potential biological, chemical, and physical hazards posed by each food they import.

Importers must also evaluate the performance of each of their foreign suppliers and use that evaluation to approve suppliers.  This includes evaluating each supplier’s history of compliance with FDA food safety regulations, “including whether the foreign supplier is the subject of an FDA warning letter or import alert.”  Importers should only import from approved foreign suppliers.

For approved foreign suppliers, importers must determine appropriate supplier verification activities, conduct those activities, and conduct corrective actions.  Examples of verification activities may include annual on-site audits of a supplier’s facility, sampling and testing, and review of a supplier’s food safety records.  Importers should choose verification activities that appropriately fit the risks of each supplier.

Importers may designate a third party to conduct a hazard analysis, a supplier risk evaluation, or to perform verification activities on their behalf.  Registrar Corp offers a variety of services to assist importers with FSVP compliance. Registrar Corp’s Food Safety Specialists can develop or review a Food Safety Plan that identifies potential hazards associated with a food or supplier and a plan to control those hazards.  Registrar Corp also offers an FDA Compliance Monitor, which food facilities may use to monitor their foreign suppliers for FDA Inspections, Warning Letters, Import Alerts, and Import Refusals.  The monitor is updated consistently, allowing importers to take prompt corrective action.

Registrar Corp is an FDA consulting firm that helps industry comply with FDA regulations.  For more information, contact +1-757-224-0177 or live help is available 24-hours a day at


FDA Publishes Fortification Policy Guidance

November 11, 2015 by David Lennarz

On November 6, 2015, the U.S. Food and Drug Administration (FDA) published a guidance document regarding FDA’s fortification policy.  FDA allows manufacturers to fortify (add nutrients to) certain food products in order to:

  • correct a dietary insufficiency;
  • restore nutrient levels to those prior to storage, handling, and processing (FDA says if you restore one essential nutrient, you should restore all);
  • provide a balance of vitamins, minerals, and protein in proportion to the total caloric content of the food; or
  • prevent nutrient inferiority in a food that replaces a traditional food in the diet.

FDA’s fortification policy has not changed since it was published in 1980.  This new guidance is intended to remind manufacturers of the policy and answer commonly asked questions. Below are a few key points from the guidance.

What nutrients are covered by FDA’s fortification policy?

FDA’s fortification policy covers all essential nutrients that have been assigned Reference Daily Intakes (RDIs) under 21 CFR 101.9(c)(8)(iv).  The policy also covers protein and potassium. See the chart below for a list of nutrients covered by FDA’s fortification policy.

FDA Fortification Policy

What foods are covered by FDA’s fortification policy?

FDA’s fortification policy applies to certain conventional human foods.  It does not apply to dietary supplements, animal food or infant formula.

May any conventional food be fortified?

FDA does not consider it appropriate to fortify:

  • Fresh produce
  • Meat, poultry, or fish products
  • Sugars
  • Snack foods, including carbonated beverages. This includes unsweetened, low fat, and fat free snack foods.
  • Alcoholic Beverages

Fortifying inappropriate foods can lead to regulatory action.  In April 2015, the Attorney General issued a warning letter to Snap Infusion LLC for marketing its product SmartCandy as a “vitamin infused snack.”  In October 2015, two women filed a class action lawsuit against Welch Foods for allegedly fortifying its fruit snacks with vitamins.

Is fortification voluntary?

Fortification of conventional human foods is voluntary unless required by an FDA standard of identity. FDA standards of identity mandate required and optional ingredients a product may contain to be marketed in the U.S. under a certain name.  Some standards of identity require that a product be fortified with a certain ingredient. For example, the standard of identity for margarine requires that vitamin A be added.

It’s important to be aware that there are labeling requirements for certain voluntarily fortified foods. For example, salt may be fortified with iodine, but it is not required. However, salt fortified with iodine must be called “iodized salt” or “iodized table salt.” Packaging of salt that is not fortified with iodine must include the statement “This salt does not supply iodide, a necessary nutrient”.

How may I indicate that I have fortified a food?

For standardized foods, manufacturers must use the term defined in the standard of identity. “For example, you cannot substitute the term ‘fortified flour’ for ‘enriched flour’,” FDA says in its guidance.

For non-standardized foods, manufacturers can use the following terms interchangeably: “added,” “enriched,” “extra,” “fortified,” “more,” and “plus”.

Registrar Corp’s Label and Ingredient Review Specialists are familiar with FDA’s fortification policy and can help food manufacturers:

  • Determine whether it is appropriate or required to fortify their food products
  • Ensure fortified food labels are in compliance with U.S. FDA regulations

When reviewing your label, Registrar Corp will also check for proper formatting, a compliant Nutrition Facts Chart, and more. For questions or assistance with U.S. FDA fortification and labeling regulations, contact Registrar Corp at +1-757-224-0177.  Live help is available 24 hours a day at

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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