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Why Food Facilities Should Get Off FDA Import Alert Before March 2018

The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.

Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation.  An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling.  In some cases, the importer may be unable to approve a supplier because they are under Import Alert.  For these reasons, suppliers not on alert receive a competitive advantage in the market.

The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.

What is an Import Alert?

Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.

For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988.  FDA found excessive mold in 14 of those samples.  This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt.  This is just one instance of over 240 active FDA Import Alerts.

How do I know if my products are on Import Alert?

FDA does not directly notify a facility that it is under Import Alert.  Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in.  Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.

My Products are on Import Alert.  How do I get them removed?

A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA.  This is only a small component of a larger process involving other, potentially extensive requirements.

The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert.  These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.

Many businesses can be intimidated by the extensive requirements of an Import Alert petition.  These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time.  Despite a solution to the problem, some businesses might have no idea how to begin a petition.

Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion.  Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert.  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

FDA Proposes to Revoke Authorized Health Claim for Soy Protein

The U.S. Food and Drug Administration (FDA) recently proposed to revoke an authorized health claim regarding the relationship between soy protein and decreased risk of coronary heart disease (CHD). According to a statement from Dr. Susan Mayne, FDA drafted this proposal after observing inconsistencies in published scientific data surrounding the claim.

Why is FDA changing the status of this claim?

FDA authorizes a petitioned health claim by examining the “totality of scientific evidence” surrounding the relationship between a specified substance and a disease (e.g. fruits and vegetables and the reduced risk of certain cancers).  Publically available data must demonstrate “significant scientific agreement” (SSA) among qualified experts for FDA to authorize the claim.

In the case of soy protein and CHD, Mayne states that “the totality of currently available scientific evidence calls into question the certainty of this relationship.”  Studies conducted following the claim’s authorization in 1999 yielded inconsistent findings between the two and helped influence FDA’s decision to issue the proposed rule.

What does this mean for my food labeling?

Substance/disease relationships that do not meet the standard of SSA may become qualified health claims through petitions to FDA that provide credible scientific support. Such claims require a disclaimer or other qualifying language on a product’s labeling that convey the level of scientific support for the relationship. Examples of qualified health claims include:

  • “Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.”
  • “Although the evidence is not conclusive, tomato products, which contain lycopene, may reduce the risk of prostate cancer.”
  • “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

Should FDA finalize this rule and a petition for the soy protein and CHD relationship provide sufficient scientific support, the Agency may consider it a qualified health claim. FDA issues Letters of Enforcement Discretion that outline specific language, similar to the examples above, for making qualified health claims on a product’s label.  Food manufacturers who previously displayed the authorized claim may need to adjust their labeling to reflect potential changes.

While this proposed rule does not enact certain or immediate changes, food manufacturers should be conscious of health claims on their labeling, especially when updating to comply with FDA’s new label rules. Labels presenting claims that are not authorized or qualified are considered misbranded.  Marketing a misbranded food product in the United States is a prohibited act that may be met with Warning Letters, detentions, or other enforcement actions.

An examination of your labeling by a third party experienced in FDA regulations can be an invaluable business decision. Registrar Corp’s Regulatory Specialists can conduct a full review of your product’s labeling.  In addition to a detailed report of recommended revisions, you will receive a print-ready file of your revised label.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

What’s next for U.S. Importers under FSMA? Registrar Corp reports on recently passed and upcoming compliance deadlines

The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017.  Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six months from this deadline (until March 19, 2018) to implement FSVPs for foreign suppliers of human food that qualify as small businesses (defined as having fewer than 500 full-time equivalent employees).

FSVPs consist of documenting several detailed components for each foreign supplier and each category of their imported food products (i.e. chocolate confectionary, bottled oils, etc.)  In order to ensure compliance before the deadline, Registrar Corp urges importers to begin creating their FSVPs now.

What do I need to develop FSVPs?

FDA requires the following, among other things, of importers covered by the March deadline.

Documentation of supplier compliance:

Importers are required to ensure that they import from suppliers whom they have evaluated and approved through various methods that outline the potential health risks their products pose. A covered importer must ensure that a supplier is compliant with preventive controls rules, including the implementation of a food safety plan, and allergen labeling rules.  The importer must also monitor the supplier’s FDA compliance history.

Should an approved supplier be found non-compliant, FDA requires importers to take corrective actions.  These may involve facilitating the development of the supplier’s Food Safety Plan or ceasing business with them until they become compliant.

Hazard analysis of food products:

The FSVP rule requires importers to document a detailed hazard analysis of each category of food products they import from a given supplier.  The analysis should identify any known or reasonably foreseeable hazards that could pose illness or injury, as well as the potential risks involved in the supplier’s handling of the food during manufacturing procedures, storage, and transport.

The data obtained by this hazard analysis should be used to determine appropriate supplier verification activities relative to the level of risk these products pose, such as sampling or onsite audits of a food facility.

Why should I begin building my FSVPs now?

Developing the required documentation can be a lengthy process. A single supplier may need multiple FSVPs.  Importers should make efforts to ensure they comply in time to be prepared for possible inspection.  Registrar Corp saw evidence of FSVP inspections occurring within three months following the May 2017 FSVP compliance date.

Registrar Corp provides a variety of services to assist U.S. importers and their suppliers with requirements under the Food Safety Modernization Act (FSMA).  Registrar Corp’s Food Safety Team consists of Qualified Individuals who are well-versed in the development of FSVPs and Food Safety Plans.  Additionally, Registrar Corp’s FDA Compliance Monitor provides a simple solution to monitoring and approving suppliers as required under FSVP.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

FDA Proposes Extension of Compliance Dates for Nutrition Facts Label Final Rules

On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to the nutrition facts label for packaged food and beverages sold in the United States.  The extension would provide large food businesses (defined for these rules as grossing ten million dollars or more in annual sales) until January 1, 2020 to comply, while small businesses would have an additional year.

The rules, finalized in May 2016, do not solely consist of formatting changes, but also includes updates to serving sizes, daily values, and nutrient definitions. Despite the compliance deadlines appearing distant, the required changes are not superficial and may be time-consuming to implement. Registrar Corp urges food manufacturers to make proactive efforts now to update their product labeling and ensure compliance.

Why should I start making these changes now?

FDA proposed extending the deadlines due to covered parties’ concerns over complying in time with the initial deadline of July 2018.  They cited “issues regarding (among other things) the need for upgrades to labeling software, the need to obtain nutrition information from suppliers, the number of products that would need new labels, and a limited time for reformulation of products.” (Source)

Also of potential concern are the mandated updates to daily values for certain nutrients, such as dietary fiber, which will require many food manufacturers to readjust certain percent daily values on their labels. In addition, manufacturers will need to account for the daily values of vitamin D and potassium, which will be newly required on a product’s food label.

Many manufacturers will need to conduct laboratory tests for vitamin D, potassium, and other nutrients in their products.  As the deadlines approach, laboratories may see a high volume of food manufacturers requesting nutrient testing, leading to potential difficulties in scheduling tests as laboratories near capacity.  The cost of tests may also increase from high demand, and delays in obtaining results may occur.

Additionally, the daily value updates affect the eligibility for some food manufacturers to make claims associated with the nutrients on their labels. Nutrient content claims that state products are “high in” these nutrients or health claims that state products containing these nutrients “may reduce the risk of” certain diseases require the product in question to contain a specific percentage of the nutrient’s daily value consumed in one serving. In order to continue making these claims, some manufacturers may need to reformulate a product to match the required content of a certain nutrient.

For example, the new rules increase the daily reference value (DRV) of fiber from 25 to 28 grams.   FDA requires a product to contain 20% or more of the DRV per reference amount customarily consumed (RACC) in order to claim it is “high in fiber”.   A product with 5 grams of fiber per 25-gram RACC (20%) may claim to be “high in fiber” now, but once the new DRV of 28 grams takes effect, it will only contain about 18%.  The product may need to be reformulated with more fiber or the claim will need to be removed from the product labeling by the deadline.

Food labeling consists of several components. The earlier you begin, the more time you allot for the unexpected and improve the chance of avoiding a surplus of outdated labeling inventory.   If you do not want to navigate the changes on your own, Registrar Corp’s Regulatory Specialists are well-versed in FDA’s new food labeling rules and can transition your product labels for you.  In addition to a report explaining all our changes, you will receive a print-ready file of your revised label. For assistance, simply complete the form below or call us at +1-757-224-0177.

‘Natural,’ ‘Healthy,’ ‘Gluten Free’ ‘Organic’ & ‘Non-GMO’ Claim Requirements

More consumers are joining the clean label movement and turning away from artificial ingredients, preservatives, antibiotics and other man-made food modifiers. According to Nielsen, 48 percent of U.S. consumers choose local, natural and organic products when possible, and a study in the Journal of Food Science found consumers are willing to pay more for foods labeled “all-natural”.

Statistics such as these have many food manufacturers wondering what the rules are for playing this clean label game. Manufacturing giants such as Campbell Soup Company and Mondelez have been simplifying their ingredient lines to eliminate artificial colors, preservatives and flavors to incorporate ingredients recognizable to the average consumer. Capturing this consumer trend has a distinct marketing advantage, and it shows no signs of going away.

Defining Natural

FDA currently has no formal regulatory definition for “natural,” but the agency has long considered the term to mean “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.” In November 2015, FDA asked for comments on the use of “natural” in human food labeling after receiving three citizen petitions requesting the agency revisit use of the term. Specifically, FDA asked whether it is appropriate to define the term “natural,” how it should define “natural,” and how it should determine appropriate use of the term on food labels. The comment period closed in May 2016, leaving FDA more than 7,000 comments to comb through. Until FDA comes back with a formal definition, it’s best to go by the agency’s definition.

Defining Healthy

To label most foods as “healthy”, current FDA regulations require that specified amounts of the product:

  • Contain at least 10 percent of the daily value for vitamins A, C, calcium, iron, protein or fiber;
  • Meet FDA requirements for a “low fat” and “low saturated fat” claim, and;
  • Meet cutoff requirements for sodium and cholesterol.

Due to evolving public health recommendations and industry criticism of these current criteria, FDA published a request for information to solicit public input on redefining the term “healthy” in September 2016.

One case that led to re-evaluation of the term involved KIND LLC, which was issued a warning letter in March 2015 after FDA reviewed some of KIND’s food labels and found that, among other things, some of the products were too high in saturated fat to claim they were healthy. In response, KIND submitted a citizen petition to FDA in December 2015, urging the agency to update its definition of “healthy” to reflect modern dietary guidance. For example, FDA’s current definition of “healthy” rules out foods like nuts, avocados, salmon and eggs. While high in fats, these foods are generally recognized as part of a healthy diet. The current definition of “healthy” also factors in vitamins A and C, which have been made voluntary under the new Nutrition Facts labeling rules, but omits potassium and vitamin D, which are now mandatory.

So far, nearly 900 comments have been submitted in response to FDA’s request for information, and the agency will continue accepting comments through April 26, 2017. Until FDA finalizes a new definition for “healthy,” manufacturers should continue to use the current regulatory definition. FDA is also using enforcement discretion to allow a food to be labeled as “healthy” if it:

  • Does not meet the requirement for “low fat,” provided the sum of the mono and polyunsaturated fats is greater than the total amount of saturated fat and that these amounts are declared on the label, or;
  • Contains at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Gluten-Free

FDA issued a final rule for labeling food “gluten-free” in August 2013. In addition to “gluten-free,” the agency’s definition applies to food labeled with the terms “free of gluten,” “no gluten” and “without gluten”.

Before the rule came into effect, there was no federal standard for using these terms. This posed a danger for consumers with the digestive disorder celiac disease, for whom consuming gluten can cause negative health effects.

Under FDA’s rule, a food may be labeled as “gluten-free” so long as it does not contain an ingredient that:

  • Is any type of wheat, rye, barley, or crossbreeds of these grains.
  • Is derived from these grains and has not been processed to remove gluten.
  • Contains 20 or more parts per million (ppm) gluten.

This includes products that are inherently gluten free (like rice) as well as those that have been specifically processed or formulated to remove gluten.

Organic

USDA regulates the term “organic” on food labeling, even for foods under FDA jurisdiction. There are four ways that foods may be labeled as organic:

  • Products made with 100 percent organic ingredients may use the USDA Organic Seal or the term “100 percent organic.”
  • Products made with at least 95 percent organic ingredients may use the USDA Organic Seal or the term “organic”.
  • Products made with 70 to 95 percent organic ingredients may use the phrase “made with organic _____________.”
  • Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement.

Water and salt should not be considered when calculating the percentage of organic ingredients in a food product.

USDA’s regulations for labeling food as organic are strict and extensive. For example, the agency will not consider an ingredient to be organic if it is produced with genetic engineering, ionizing radiation or sewage sludge, or if it contains sulfites, nitrates, or nitrites added during the production or handling process. Also, most foods labeled as organic must be overseen by a USDA National Organic Program-authorized certifying agent. Manufacturers should familiarize themselves with all of USDA’s requirements before labeling food with the term “organic.”

Non-GMO

A significant trend within the food industry over the last decade has been the labeling of products as not containing bioengineered ingredients (also known as genetically modified organisms or GMOs). Currently, there is no federal regulation pertaining to the labeling of food as GMO or non-GMO, but this is soon to change. In July 2016, then-President Barack Obama signed a bill into law that requires USDA to develop a mandatory disclosure standard for bioengineered foods. The law gives USDA two years (until July 2018) to determine the standard and establish the regulations to enforce it. The regulations must specify how much of a GMO substance a product may contain before needing to disclose and the way the product must be labeled. The law directs USDA to allow manufacturers to disclose GMO ingredients via text, a symbol or a link. The law applies not only to USDA-regulated products, but those under FDA jurisdiction as well. This statute overrides any state laws that were in place or in progress.

Food manufacturers wishing to ride the wave of the clean label movement should take care to ensure claims made about their products are appropriate. Even in the absence of a regulation, FDA issues warning letters to companies that they deem are making false and misleading statements regarding claims such as “natural” and enforces those for claims such as “gluten-free.” Proper declaration of such claims can help manufacturers maximize sales of their products while also keeping them off FDA’s radar.

This post was originally published on Natural Products Insider.

Compliance Date Approaching for FSMA Preventive Controls Rules

September 18, 2017 marks the next compliance date under the Preventive Controls for Human and Animal Food Rules of the 2011 Food Safety Modernization Act (FSMA).  The U.S. Food and Drug Administration (FDA) will require larger animal food businesses and smaller human food businesses with fewer than 500 full-time employees to begin complying with preventive controls requirements that include the development and implementation of written Food Safety Plans.  Small animal food businesses with fewer than 500 full-time employees must implement Current Good Manufacturing Practices (CGMP) established by the animal food rule and will be expected to comply with remaining preventive controls requirements next year on September 17, 2018.

Compliance with preventive controls and CGMPs may involve considerable time and effort to achieve.  While FDA has stated that it does not plan to conduct routine inspections on these specific areas immediately, the agency has suggested that it may react in response to a food safety issue or complaint.  In order to ensure your facility is prepared for compliance at all times, Registrar Corp provides important information regarding what will be expected of covered food facilities this September.

What does compliance look like?

For larger animal food and smaller human food businesses:

Food businesses complying with preventive controls will be required to develop and implement written Food Safety Plans that feature an analysis of known or reasonably foreseeable food hazards as well as the measures required to prevent or minimize their threat to public health.  Within this plan, covered food facilities should document appropriate monitoring and verification of their specified preventive controls.  Examples include appropriate controls for Salmonella, appropriate controls for potential mycotoxins and for nutrient deficiencies or toxicities, and evidence that scientifically validates proposed preventive measures.

As part of this plan, FDA requires any covered food facility that identifies hazards needing preventive controls to develop a written recall plan.  The plan should establish detailed procedures that outline how the buyer of the food and the public will be notified of the recall and hazard in question.  It should also outline the steps that will be taken to verify that the recall is being enacted and the method that will be used to properly dispose of the recalled food.

Food Safety Plans can be complicated, and FDA requires a “Preventive Control Qualified Individual,” defined by FDA as an individual with appropriate training or job experience to effectively carry out the requirements under these regulations, to develop them.  Registrar Corp’s Regulatory Specialists possess the requisite qualifications to develop a Food Safety Plan for your facility.

For smaller animal food businesses:

Animal food facilities within this category will be required to implement and maintain CGMP standards outlined by FDA.  These standards focus upon fundamental food safety practices in regard to the manufacture of animal food.  Facilities will be required to ensure that daily operations limit possible food contamination from a variety of factors.

Staff in direct contact with food or food-contact surfaces should follow hygienic practices such as consistently washing hands and removing jewelry that could fall into batches of food.  Facility grounds should be properly maintained and free from litter and waste to exclude pests.  Additionally, the construction and layout of facilities should allow for proper cleaning, maintenance, and pest control, while taking measures to prevent potential contamination of food from factors such as condensation dripping off of pipes or fumes that need proper ventilation.

Not sure if your facility is properly following CGMP requirements?  Registrar Corp’s Food Safety Specialists can perform a Mock FDA inspection that identifies potential food safety violations and educates facility staff on FDA expectations.  Mock Inspections are included in Registrar Corp’s U.S. Agent service at no charge, aside from travel and lodging costs.

Registrar Corp assists companies with FDA compliance.  Our Regulatory Specialists are knowledgeable and experienced in the various aspects of FSMA and can help your food facility take the necessary steps to meet FDA’s extensive food safety requirements.  For more information, please call +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Has Started Inspecting U.S. Importers for FSVP Compliance

As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule.  Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line: “FSVP Inspection Requirements, Handouts & Law.” This email informs importers of an upcoming FDA inspection to examine their compliance with FSVP requirements.  In light of these recent events, Registrar Corp provides importers with pertinent information to be prepared for a possible FSVP inspection.

What is a FSVP?

The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier.  This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs.  FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.

In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures.  The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.

An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier.  Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses.  Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.

Provided any food safety issues arise, an importer is required by FDA to take the proper steps toward correcting the issue with the supplier.  Corrective Actions may vary depending upon specific issues, and in severe cases, may require the importer ceasing business with the supplier until they are found compliant.  One such issue may be that a supplier is lacking a Food Safety Plan as required under the FSMA Preventive Controls rule.  Registrar Corp is experienced in the development of these plans and can assist the supplier in becoming compliant so both parties may continue business.

What Does a FSVP Inspection Look Like?

According to an interview with Sharon Mayl at FDA, FSVP inspections are not to be confused with traditional food facility inspections and consist of a document review. This review may examine whether an importer has detailed components required under the FSVP rule for the specified suppliers and food items.  The inspector may also look for evidence that FSVP procedures are followed between importer and supplier for the food items in question and that the importer is documenting appropriate analyses and verification activities, reviewed by a Qualified Individual.

Registrar Corp’s Regulatory Specialists can assist in developing appropriate FSVPs for your food items.  Additionally, Registrar Corp’s FDA Compliance Monitor can monitor suppliers’ compliance history as required under the rule and can serve as proof of compliance during a FDA FSVP inspection.

Registrar Corp assists food and beverage companies with FDA compliance.  For more information or assistance with specific FSVP requirements, please call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

U.S. FDA Announces Reinspection Fees Fiscal Year 2018

The U.S. Food and Drug Administration (FDA) recently published the hourly rates for the reinspection of food facilities during fiscal year (FY) 2018.  The cost of reinspection for a domestic facility is $248 per hour, a $27 increase from FY 2017.  The cost for a foreign facility is $285 per hour, the same as in FY 2017.

The total cost of a reinspection depends upon the amount of time FDA performs inspection-related duties.  This may involve preparation for the inspection, travel to and from the facility being inspected, the physical examination of the premises, and any sample analysis or lab work required.  Reinspection fees can quickly add up to thousands of dollars, especially for facilities in countries where travel alone can take a day’s time. To avoid these potentially high reinspection fees, it is prudent to take measures to ensure that proper food safety procedures are in place when FDA inspects a food facility the first time.

What is a reinspection?

When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.

If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions.  This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).

The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA).  FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health.  High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years.  FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur.  Domestic facilities may receive no notice at all.  Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.

What factors could warrant a reinspection?

FDA’s most recently published data on commonly occurring inspection violations at food facilities indicates food safety issues that FDA may likely search for while inspecting a facility. The most frequent violations in FY2016 included:

  • Lack of Effective Pest Exclusion / Screening – FDA cites a facility for not taking effective preventative measures against pest presence in food processing areas or not implementing controls to protect food from contamination due to pests.
  • Sanitation Monitoring – FDA cites a facility for failing to effectively monitor sanitation practices and conditions consistently.
  • Floors, Walls, and Ceilings – FDA cites a facility for being constructed in a way that inhibits proper sanitation and repair of the floors, walls, and ceilings.
  • Importer Verification – FDA cites a seafood importer for failing to document verification of a supplier’s compliance with Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations.
  • HACCP Plan Implementation – FDA cites a facility for failing to implement procedures established in its written HACCP Plan. It is important to note that following the compliance date in September 2016, FDA is now likely to also check for proper implementation of Hazard Analysis and Risk-based Preventative Control (HARPC) Plans at most food facilities.

Several violations in the above list were just as frequent in 2015 as they were in 2016.  Registrar Corp urges food facilities to examine these issues and take the appropriate measures to prevent FDA citations for these and similar food safety problems.

Proper preparation for an initial inspection may reduce the chance of FDA citing a facility for violations that can cause return visits. Having a third party trained in FDA inspections review your facility for violations is often an invaluable business decision. Poor results from an initial inspection not only can result in an expensive reinspection, but also in Warning Letters and other public information that could damage a brand’s reputation. While there may be costs associated with third-party assistance, it is likely more affordable than the alternative.

Registrar Corp offers a Mock FDA Inspection service in which our Food Safety Specialists identify potential food safety problems and educate staff on FDA expectations.  This Mock FDA Inspection service is included as part of Registrar Corp’s U.S. Agent service at no charge, aside from lodging and travel expenses.

For questions or assistance with FDA compliance, call Registrar Corp at +1-757-224-0177.  Additionally, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Australia Receives Systems Recognition with U.S. FDA

As of April 2017, the U.S. Food and Drug Administration (FDA) officially recognizes the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System, granting it systems recognition.  Australia is the third country to make this arrangement with FDA—the first being New Zealand in 2012, and the second being Canada in 2016.

This recognition allows importation of Australian-produced foods into the United States without the extensive requirements imposed by FSMA’s Foreign Supplier Verification Program.  Instead of conducting detailed hazard analyses and verification activities as is required from food from other countries, U.S. importers now may simply verify that the producing firm is in good standing with the Australian Department for that type of product.

What is Systems Recognition?

Systems recognition is an arrangement where FDA agrees upon a similarity between its own Food Safety System and that of another country seeking this arrangement, where both provide similar protection and monitoring of food products. The concept is based upon the idea that Food Safety Systems adhering to similar standards will produce similar outcomes—ideally the production of safe food.

What are the Benefits of Being Recognized by FDA?

FDA’s Food Safety Modernization Act (FSMA) introduced extensive new food safety regulations for both food facilities and U.S. importers of food products. While still subject to FSMA, food facilities in recognized countries and domestic importers of food manufactured in recognized countries benefit from modified requirements.  As more faith is granted to the Food Safety Systems of recognized countries, these parties may see less FDA intervention as a result.

Under FSMA, food facilities that manufacture, process, pack, or hold food for U.S. consumption are required by FDA to have written food safety plans.  One component of this plan is a supply-chain program that mandates facilities to conduct verification activities on their suppliers, such as onsite audits.  As opposed to conducting these audits themselves, facilities with suppliers in recognized countries are able to verify suppliers through an inspection conducted by that country’s food safety authority within one year of the required audit date, potentially saving resources on travel and personal expenses.

FSMA also requires U.S. importers to create a Foreign Supplier Verification Program (FSVP) for each of their foreign suppliers, involving hazard analysis, risk evaluation, supplier verification, and corrective action.  Systems recognition allows importers to forgo certain aspects of the FSVP rule, such as hazard analysis and verification, as long as they continue to monitor and find that each supplier is compliant with its country’s Food Safety System.  As a result, importers are able to save time and effort as well as travel expenses when importing food from recognized countries. This may provide facilities in recognized countries an advantage over competition, as US importers may be more apt to import from facilities that require less work under FSVP.

Use Registrar Corp’s free FSMA Wizard for information on how FSMA rules affect your specific country and facility.

How Does a Country Become Recognized?

In order to meet systems recognition, a country’s governmental Food Safety System must undergo a review of its compliance history by FDA. The Agency will examine data on past refusals of admission, import alerts from products originating in that country, and other areas of concern.  Following this review, the interested country will hold a consultation with FDA to outline its goals for achieving systems recognition and the steps that need to be taken to move forward in this process.

If the country is still interested in becoming recognized after the consultation, its regulatory agency or authority must complete the International Comparability Assessment Tool (ICAT) to determine whether or not its Food Safety System meets ten standards outlined by FDA.  Upon its completion, FDA will review the ICAT along with the data collected during the initial review.  If deemed that the interested country satisfies these standards, FDA will take the steps toward arranging an in-country assessment of the country’s system to attempt to finalize the systems recognition process.

Can I Still Export To The US If My Country Is Not Recognized?

While there are benefits to being recognized, systems recognition is entirely voluntary and is not required to export food to the United States.  A company interested in exporting food to the U.S. must still complete all of the steps necessary for complying with FDA regulations.

If you represent a company looking to export or import food to the United States, Registrar Corp can assist in complying with FDA’s requirements promptly and correctly.  For more information on FDA requirements or Registrar Corp’s services, please call +1-757-224-0177.  Additionally, 24-hour live chat assistance is available at www.registrarcorp.com/livehelp.

 

One Month Until FDA’s FSVP Deadline; Tools for Compliance by Registrar Corp

Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.

Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires “FSVP Importers” to perform certain activities to verify that the food they import is produced in a manner that meets U.S. safety standards. If you are unsure whether you are considered an FSVP Importer, Registrar Corp’s free FSMA Wizard can assist you in determining your potential requirements.

Evaluating and Approving Suppliers

FDA’s FSVP rule requires that FSVP Importers import only from approved foreign suppliers, although they may import from an unapproved supplier on a temporary basis.  To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.

Comments in the final rule regarding this requirement reflect industry concern that FDA’s website and compliance databases can be hard to navigate.  To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier.  Registrar Corp’s FDA Compliance Monitor allows users to easily evaluate food facilities’ FDA compliance statuses.  The Monitor compiles data on FDA Import Alerts, Warning Letters, Import Refusals, and Inspection Classifications for a user’s suppliers in a simple dashboard, which also tracks whether suppliers are approved.

Risk-Based FSVPs

FSVPs must be created by a “Qualified Individual,” defined as an individual with the education, training, or experience necessary to perform their assigned activities and the ability to read and understand the language of any records that must be reviewed in performing an activity. An FSVP must include a hazard analysis and appropriate supplier verification activities to provide assurance that these hazards will be significantly minimized or prevented.  Examples of supplier verification activities include audits, records review, and sampling and testing.

What qualify as “appropriate” verification activities for a particular supplier depends on the types of foods being imported and the supplier’s compliance history.  Registrar Corp’s Food Safety Specialists act as Qualified Individuals and can develop or review FSVPs to ensure they are appropriate for your specific needs.

Corrective Actions

Should an FSVP Importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken.  Registrar Corp can assist in implementing corrective actions. For example, action taken to have a foreign supplier removed from import alert may be considered an appropriate corrective action.  Registrar Corp can help facilities create and submit a petition to FDA for removal from import alert.  Additionally, labeling errors are one of the largest causes for warning letters and detentions.  Registrar Corp can review food labeling and ingredients for FDA compliance.

For more information, attend Registrar Corp’s free FSVP webinar or utilize their 24-hour online Live Help.

This article was originally published as a press release.





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