24/7 Live Chat Call Us

FDA Releases Various Guidances for Food Labeling

The U.S. Food and Drug Administration (FDA) recently released numerous regulatory guidances to help the food and beverage industry comply with labeling rules.  Registrar Corp has compiled some important developments below.

  • FDA published a small entity compliance guide explaining requirements for aspects such as dual-column labeling and serving sizes under one of the label rules finalized in 2016. Many businesses must comply with new food labeling rules by January 1, 2020.
  • FDA released an updated guidance explaining requirements for honey labeling.
  • FDA released an updated list of example products to use as a reference for understanding product categories in the reference amounts customarily consumed table.

Of notable significance, FDA announced intention to exercise enforcement discretion on the use of a “†” symbol immediately following the “added sugar” percent daily value declaration on labels of pure honey, pure maple syrup, and certain cranberry products.

Manufacturers of pure honey and pure maple syrup may use the “†” symbol to reference a statement explaining that these sugars are naturally occurring and were not added during processing.  Meanwhile, certain cranberry products may bear a statement explaining that the sugars are used to improve the palatability of the food and “[do] not exceed the amount of total sugars in comparable product[s] with no added sugars.”

The guidance was issued in response to industry concern that classifying sugars in these foods as added sugars would imply that the products have been rendered unhealthy with additional sweeteners or “are less nutritious than competitive products that have similar amounts of total sugars and nutrients.”

FDA labeling requirements can be complicated.  If you do not want to navigate them on your own, Registrar Corp’s Regulatory Specialists can review your labeling and product ingredients for compliance with FDA regulations.  For more information about FDA labeling requirements, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

2017 in Review – U.S. FDA Food and Beverage Regulations

2017 brought a host of changes for food manufacturers and importers.  The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry.  Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules.  Take a look below at some of the regulatory highlights that occurred this year.

FDA Removed 28% of Food Facility Registrations from its Database

Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database.  The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.

Australia Received Systems Recognition with U.S. FDA

In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States.  Australia follows New Zealand and Canada as the third country to receive this recognition.  U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.

As of this writing, the three recognized countries have not published lists of firms in good compliance standing.  As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.

The FSVP Compliance Deadline for Most US Importers Passed

The first compliance deadline for the FSVP Rule passed on May 30, 2017.  Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation.  In August, FDA began inspecting covered importers for their compliance with FSVP requirements.  The next FSVP compliance date is March 19, 2018.

Compliance Dates Passed under the Preventive Controls Rules

Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017.  These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards.  Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.

FDA Proposed Extension of Label Rule Compliance Dates

In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales.  Smaller businesses would be provided an additional year.  Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.

FDA Proposed to Revoke Authorized Health Claim for Soy Protein

FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease.  Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings.  This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.

FDA Issued Draft Guidance for Refusal of Inspection

In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.”  FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal.  Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.

Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018.  The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming.  Registrar Corp can offer assistance.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Releases FY 2017 Inspectional Observations; Registrar Corp Reports on Common Food Safety Violations

5 Inspection Violations Commonly Found by FDAThe U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017.  The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017.  FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:

  • Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
  • Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs).  Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
  • Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
  • HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
  • Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food.  Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.

The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015.  Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.

It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017.  Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times.  With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.

Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions.  With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility.  Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations.  Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.  For more information, visit our site 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 Requires Responses to Inspection Requests within 24 Hours, According to New Inspection Refusal Guidance

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.”  According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US.  Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry.  In addition, their FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide.  Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection.  Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.

During the inspection, a facility should maintain this cooperation with the FDA inspector.  Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal.  Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.

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

To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA.  The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year.  Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.

Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection.  Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility.  Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.


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 — Why You Should Still Comply Now

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.


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.


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.”


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.