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FDA Publishes Final Guidance for UDI Direct Marking Requirements

The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime.  This is known as UDI direct marking.  FDA recently published a final guidance on requirements for the direct marking of medical devices.

According to the guidance, the device labeler is responsible for direct marking a device with a UDI in either human readable or automatic identification and data capture (AIDC) format. The method of marking, such as etching or attaching a permanent tag, is decided at the labeler’s discretion and must account for wear from the intended use of the device.

What is New in the Final Guidance?

FDA recently conducted a webinar explaining the key differences between the final guidance of this regulation and the draft guidance published in 2015.  Notable changes include:

  • FDA established that a device is “intended to be reprocessed” if it is intended to undergo high-level disinfection and/or sterilization before or between each use. High-level disinfection is defined in this guidance as a process in which a sterilant kills “all forms of microbial life, except for large numbers of bacterial spores.”
  • FDA emphasized that implants, which are not mentioned in the draft guidance, do not fall within the scope of UDI direct marking regulation.
  • FDA does not intend to enforce UDI labeling and direct marking compliance for devices that were consigned or loaned to a healthcare facility before the devices’ respective UDI labeling compliance dates. This also applies to devices in the possession of a sales representative pending sale under the same conditions.
  • In June 2017, FDA issued a letter outlining intentions to extend the UDI labeling compliance date for covered class I and unclassified devices to September 24, 2020. During the webinar, the Agency clarified that it does not intend to enforce direct marking requirements for these devices until September 24, 2022.

Remaining Compliance Dates for UDI Direct Marking

Unless exempt from UDI direct marking requirements, the compliance date for class I and unclassified devices is as established above, and the compliance date for direct marking of class II devices remains September 24, 2018, as outlined in the UDI final rule.  Devices manufactured before their respective UDI labeling compliance dates are provided three additional years to comply with labeling and direct marking requirements.

Not sure how UDI requirements apply to your device?  Registrar Corp’s Regulatory Specialists can help determine whether your device requires direct marking and can submit device information to FDA’s Global Unique Device Identifier Database (GUDID).  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Additional UDI Resources: 

Five Steps to FDA UDI Compliance

How Many UDIs Will You Need?

UDI Labeler Responsibilities

FDA Unique Device Identifier Requirements

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 Introduces Annual Certification Requirement for Unchanged Drug Product Listings 

Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31.  The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  This year, registrants must certify that all product listings which were not updated have had no changes occur to the data or labeling.  Product listings that are neither updated within the year nor certified during the renewal period may be considered expired by FDA and removed from the Agency’s database.  Marketing unlisted drugs in the United States is a prohibited act.

How can I obtain “blanket no change certification” for my drug product listings?

Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labeling as part of their annual registration renewal.  The notification must be submitted in structured product labeling (SPL) format.  Structuring data in SPL format requires SPL authoring software.  The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG).  Users may also use CDERDirect to submit for human drug listings.  According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.

Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf.  Our Regulatory Specialists are experienced in navigating FDA’s ESG and can complete your renewal quickly and properly.  Contact us at +1-757-224-0177 or chat with a Regulatory Advisor online 24-hours a day at www.registrarcorp.com/livehelp.

Medical Device and Drug Establishments Must Renew FDA Registrations by December 31, 2017

Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually.  Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.

Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.

Notices for Medical Device Establishments

While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:

  1. The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
  2. As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function.  Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email.  Agents will have ten days accept their designation through FURLS.  If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.

Why Timely Renewal is Important

Failure to renew FDA registration can have adverse effects.  In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.

FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration.  Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed.  It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.

Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

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.

FDA Publishes FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022.  The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017.  All MDUFA and GDUFA fees begin on October 1, 2017.  To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.

Fees for medical device establishments:

MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017.  Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees.  All other facilities are subject to a standard fee.  Some significant changes to MDUFA for this fiscal year are explained below.

Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee.  The fee for this year is $4,624 (a $1,242 increase from FY 2017).  Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.

510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566.  Small businesses are required to pay $2642, facing an increase of $297 from the previous year.

De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications.  A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.

Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.


FY 2018 MDUFA Fees

Fee Type 2017 2018
Annual Establishment Registration $3,382 $4,624
Application Fees Standard Small Business Standard Small Business
510(k) $4,690 $2,345 $10,566 $2,642
513(g) $3,166 $1,583 $4,195 $2,098
De Novo Classification N/A N/A $93,229 $23,307
PMA, PDP, PMR, BLA $234,495 $58,624 $310,764 $77,691
panel-track supplement $175,871 $43,968 $233,073 $58,268
180-day supplement $35,174 $8,794 $46,615 $11,654
real-time supplement $16,415 $4,104 $21,753 $5,438
BLA efficacy supplement $234,495 $58,624 $310,764 $77,691
PMA annual report $8,207 $2,052 $10,877 $2,719
30-day-notice $3,752 $1,876 $4,972 $2,486


Fees for drug establishments:

GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products.  New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees.  Some significant changes to GDUFA for this fiscal year are explained below.

Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder.  These fees are a two-thirds reduction of FDF facility fees for qualifying establishments.  Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.

ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.

ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold.  The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079.  A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.

Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.


FY 2018 GDUFA Fees

Fee Type 2017 2018
Facility Fees Domestic Foreign Domestic Foreign
API $44,234 $59,234 $45,367 $60,367
FDF $258,646 $273,646 $211,087 $226,087
CMO N/A N/A $70,362 $85,362
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) N/A $1,590,792
Medium (6 – 19 ANDAs) N/A $636,317
Small (5 or fewer ANDAs) N/A $159,079
Application Fees
ANDA $70,480 $171,823
Type II DMF $51,140 $47,829

Not sure which user fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your relevant fees and facilitate payment with FDA.   Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Compliance Date Passed for Consumer Antiseptic Wash Final Rule

September 6th, 2017 marked the compliance date for the U.S. Food and Drug Administration’s (FDA) Consumer Antiseptic Wash Final Rule.  As of this date, over-the-counter (OTC) antiseptic washes containing any of nineteen active ingredients deemed by FDA as not “generally recognized as safe and effective” (GRASE) are not permitted to be introduced into interstate commerce without approval of a new drug application (NDA).  The rule applies to antiseptic washes intended to be used with water and does not cover products such as wipes or hand sanitizers.  Soaps, hand washes, and body washes containing these ingredients that are currently in retail establishments do not require removal, but new batches of these products may not enter the market.  You will find the list of affected ingredients below.

Why are these ingredients not GRASE?

Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA.  The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.

In 2013, FDA published a proposed rule to amend the 1994 monograph.  The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought.  According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance.  In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water).  Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.

FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol.  In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients.  Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.

Not sure how this rule affects your products?  Registrar Corp’s Regulatory Specialists can help determine how FDA regulates your specific antiseptic wash products and review your labeling for compliance.  For questions or assistance, call us at +1-757-224-0177. Alternatively you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Consumer Antiseptic Wash Final Rule:

Methylbenzethonium chloride
Phenol (greater than 1.5 percent)
Phenol (less than 1.5 percent)
Secondary amyltricresols
Iodophors (Iodine containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
Sodium oxychlorosene
Triple dye


‘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.

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