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Food Facilities Must Renew Their FDA Registrations Between October 1 and December 31

The U.S. Food and Drug Administration (FDA) requires facilities that manufacture, process, pack, or store food for U.S. consumption to renew their FDA registrations between October 1 and December 31, 2018. During the renewal process, facilities located outside of the U.S. must also designate a U.S. Agent for FDA communications. The renewal will not be considered complete until the listed U.S. Agent accepts this designation.

It should be noted that renewing a registration is distinct from updating a registration, and even food facilities that registered with FDA as recently as September 2018 will be required to renew.  Facilities should ensure they properly renew during this period so their FDA registrations remain valid for 2019.

What are the Consequences of Not Renewing?

FDA will cancel facility registrations that are not properly renewed during the impending Biennial Registration Renewal period. Failure to renew FDA registrations during the 2016 renewal period contributed to a 28% drop in the number of registered food facilities in early 2017.

Food exported to the U.S. by a facility with a canceled registration may be detained or refused at the U.S. port of entry.  Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties.

Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can properly renew your registration and can act as the U.S. Agent for facilities outside the United States. As part of our registration renewal service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more.

To learn more, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

Registrar Corp’s FDA Compliance Monitor Now Includes Recalls

Registrar Corp added recalls to their FDA Compliance Monitor.  Users can now view the recall history of their own company, their suppliers, and potential suppliers, including:

  • The description of the recalled product.
  • The recall classification (the level of health risk involved).
  • The reason for the recall.
  • The current status of the recall (ongoing, completed, etc.).

This capability will help businesses comply with the Food Safety Modernization Act (FSMA), which requires food facilities and US importers to monitor their food suppliers’ FDA compliance as related to food safety. Recalls can damage a brand’s reputation, disrupt supply chains, and delay production and are an important aspect of a facility’s compliance history.

In addition to recalls, the FDA Compliance Monitor includes the FDA inspection history, FDA import alert status, FDA warning letter history, and record of FDA-refused shipments for monitored facilities, making full compliance with FSMA’s monitoring requirements easier than ever before. Schedule a demo of the FDA Compliance Monitor now.

Users can access the FDA Compliance Monitor through MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance, including FDA registrations and prior notice submissions.

For more information about the FDA Compliance Monitor or FSVP monitoring requirements, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

FSMA Deadline Approaching: First Qualified Facility Attestation Period Begins October 1, 2018

Very small businesses generally must comply with the U.S. Food and Drug Administration’s (FDA’s) Preventive Controls for Human Food Rule by September 17, 2018.  Under this rule, very small businesses are eligible for exemption from some of the Preventive Controls requirements, including the requirement to maintain a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan and the requirement to maintain a written Supply-Chain Program. To take advantage of these exemptions, businesses must submit their first attestation to FDA by December 17, 2018.

Who Qualifies for the Exemption

Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years

Other Qualified Facilities: Though FDA has stated that it expects most facilities that qualify for the exemption to be very small businesses, other facilities qualify if they possess both of the two following characteristics:

  • Over the past three years, they have averaged annual sales of food for human consumption below $500,000 (adjusted for inflation)
  • At least half of their food sales over the previous three years have been directly to local consumers, restaurants, or retail establishments that are located in the same state, same Indian reservation, or within 275 miles of the food facility in question

Registrar Corp’s free Qualified Facility Wizard can help you determine whether your facility qualifies for the exemption.

How to Claim Eligibility for an Exemption

In order to claim eligibility for an exemption, a qualified facility must notify FDA of its status by submitting Form FDA 3942a. Using this form, the owner, operator, or agent in charge of a food facility must attest that the facility in question meets the definition of a qualified facility and that the facility is either “addressing identified hazards through preventive controls and monitoring the preventive controls,” or “complying with applicable non-Federal food safety regulations, and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed (FDA.gov).”

When to Claim Eligibility

Qualified facilities that began or will begin processing, packing, or holding food before September 17, 2018 must submit the relevant form by December 17, 2018. Facilities that will begin processing, packing, or holding food on or after September 17, 2018 must submit the relevant form before beginning operations. Facilities must resubmit attestation to FDA every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even numbered year.

Preventive Controls Compliance for Qualified Facilities

As mentioned above, qualified facilities that attest are exempt from certain requirements of the Preventive Controls rules, but not all of them. Qualified facilities must still:

  • Refrain from selling adulterated food
  • Adhere to Current Good Manufacturing Practices (CGMPs)
  • Ensure that all individuals who manufacture, process, pack or hold food are trained in the principles of food safety and are qualified to perform their assigned duties
  • Maintain detailed records of the food safety training received by workers

A very small business that does not notify FDA of its status as a qualified facility is fully subject to the standard requirements of the Preventive Controls Rule and, generally, must develop and implement a written HARPC Food Safety Plan and Supply-Chain Program by September 17, 2018.

The Preventive Controls Rule compliance deadlines for facilities that do not meet the definition of a very small business have already passed. Thus, many food facilities that have not yet developed and implemented a written HARPC Food Safety Plan and Supply-Chain Program are likely to be in violation of FDA regulations.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses that do not meet the definition of a qualified facility or do not intend to notify FDA of their status as a qualified facility to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet regulatory requirements.

Assistance with Attestation and Food Safety Plans

Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) and can develop or review a facility’s HARPC plan for FDA compliance. Registrar Corp’s Specialists can also provide guidance on qualified facility attestation to firms that designate Registrar Corp to manage their FDA registration or act as their U.S. Agent for FDA Communications. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

The Current Implementation Status of FSMA: What’s Required Now, What’s Next, and FDA’s Enforcement to Date

The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as:

  • Preventive controls for human and animal food
  • Foreign supplier verification programs
  • Prevention of intentional adulteration of the food supply
  • The registration of food facilities

Many of the deadlines for complying with FSMA rules have already passed. There are also multiple upcoming deadlines that covered businesses should be aware of. A summary of several important FSMA requirements and deadlines may be found below.

Rules On Preventive Controls For Human and Animal Food

Preventive Controls Overview
Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each HARPC plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility.

Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.

Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards. Registrar Corp’s Food Safety Specialists are PCQIs and can develop or review a facility’s HARPC plan for FDA compliance.

Rule On Foreign Supplier Verification Programs

Foreign Supplier Verification Program Overview
Under the Foreign Supplier Verification Program (FSVP) rule, U.S. importers must have a written FSVP that is developed by a qualified individual and documents that they have completed risk-based activities meant to verify that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. Among other things, FSVPs must include an analysis of hazards associated with imported products and their suppliers and a plan for conducting verification activities, such as annual supplier audits, testing and sampling imported products, or reviewing a supplier’s HARPC Food Safety Plan. As part of the supplier analysis, importers must monitor and document the FDA compliance status of each of their suppliers by tracking FDA warning letters, import alerts relating to food safety, and other FDA enforcement actions.

Foreign Supplier Verification Program Deadlines
Importers’ deadlines are based on factors such as the size of a foreign supplier, the nature of the importer, and whether the foreign supplier must meet various regulatory requirements. The deadlines for complying with this rule passed for most importers in May 2017 and March 2018. The deadlines for other importers are scheduled to occur on dates ranging from July 26, 2018 to July 27, 2020.

Foreign Supplier Verification Program Enforcement and Compliance
FDA has begun inspecting importers for FSVP compliance. In 2017, failure to develop an FSVP was cited by FDA 108 times. FSVP inspections are based upon a review of records. Though such inspections may take place at an importer’s place of business, FDA may also ask that an importer provide FSVP records electronically or by some other remote means that quickly delivers records to the agency.

Registrar Corp’s Food Safety Specialists can develop new FSVPs on behalf of importers or review existing FSVPs for compliance. Registrar Corp also offers a tool to assist with the supplier monitoring aspects of FSVP.  In order to monitor supplier compliance on their own, an importer would need to routinely search each individual FDA database for each of their foreign suppliers. In order to make this process easier, Registrar Corp developed the FDA Compliance Monitor.  Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, Recalls, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s requirements.

Rule For Mitigation Strategies To Protect Food Against Intentional Adulteration

Intentional Adulteration Overview
Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.

Intentional Adulteration Deadlines
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019.  Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply. If you are unsure of whether your business qualifies as small, you can read Registrar Corp’s earlier blog post on how FSMA defines small businesses.  Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.

Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.

Amendments to the FDA Registration Process

FSMA made significant changes to the FDA registration process. Food facilities are now required to provide an email address for registration and must assure that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, FSMA requires facilities to renew their FDA registrations during each even numbered year. For example, because 2018 is even numbered, food facilities will have to renew their registration later this year between October 1 and December 31. It is very important that facilities comply with renewal requirements. In 2017, FDA removed 28% of food facility registrations from its database. Many of these removals resulted from a failure to properly renew registration as was required in 2016.

Registrar Corp’s Regulatory Specialists can help facilities register or renew their registrations with FDA quickly and properly.

Responding to the Implementation of FSMA

FSMA imposes many complex requirements on food businesses. The deadlines for complying with these various requirements have already passed or will soon pass. Businesses should take measures to ensure that they are in compliance. One such measure would be to enlist the help of Registrar Corp’s Regulatory Specialists who have expert knowledge of FSMA and extensive experience in helping businesses comply with FDA regulations. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

U.S. FDA Permits 8 Additional Non-Digestible Carbohydrates To Be Declared As Dietary Fibers

In a recent guidance document, the U.S. Food and Drug Administration (FDA) announced the intention to permit eight isolated or synthetic non-digestible carbohydrates to be declared as dietary fiber on the nutrition facts label.  Pending rulemaking, FDA intends to exercise enforcement discretion when the following are included in a label’s dietary fiber declaration:

  • Mixed plant cell wall fibers
  • Arabinoxylan
  • Alginate
  • Inulin and inulin-type fructans
  • High amylose starch (resistant starch 2)
  • Galactooligosaccharide
  • Polydextrose
  • Resistant maltodextrin/dextrin

Why Is FDA Permitting These Fibers?

Prior to publication of the 2016 Revision of the Nutrition and Supplement Facts Label Final Rule, existing FDA regulations did not define “dietary fiber.”  Under the revised rule, isolated or synthetic non-digestible carbohydrates may only be included in dietary fiber declarations if FDA determines them to have “physiological benefits.”  The final rule named seven isolated or synthetic fibers that met this requirement:

  • Beta-glucan soluble fiber
  • Psyllium husk
  • Cellulose
  • Guar gum
  • Pectin
  • Locust bean gum
  • Hydroxypropylmethylcellulose

After reviewing petitions and scientific literature surrounding twenty-six isolated or synthetic non-digestible carbohydrates, FDA determined that the eight additional fibers demonstrate the required physiological benefits.

How Does This Affect My Label?

Industry previously expressed concern that FDA’s new definition for dietary fiber would exclude fibers they were already declaring on their labels, limiting their ability to make certain nutrient content or health claims.  For example, in order for many foods to say they are a “good source of fiber,” “contain fiber,” or “provide fiber,” their fiber content must be between 10 and 19 percent (2.8 g – 5.32 g) of the daily reference value (28 g) per reference amount customarily consumed (RACC).  FDA’s inclusion of the above fibers will allow more manufacturers to continue to make fiber claims under updated label requirements.

When Do I Need To Comply?

Changes to the dietary fiber declaration take effect following the compliance deadline for FDA’s new label rules.  Food manufacturers grossing $10 million or more in annual food sales have until January 1, 2020 to update their label for compliance with FDA’s new regulations.  Businesses grossing less than $10 million are provided an additional year.

Start compliance now for a smooth transition.  Registrar Corp can review your food labeling for compliance with new U.S. FDA regulations.  In addition to a report of recommended changes, you will receive a print-ready graphic file of your revised label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Deems Highly Concentrated Caffeine In Dietary Supplements Adulterated

A recent U.S. Food and Drug Administration (FDA) guidance document affirms that certain pure or highly-concentrated caffeine products marketed as dietary supplements are “adulterated” under the Federal Food, Drug, and Cosmetic (FD&C) Act, effectively prohibiting their sale in the U.S. market.

FDA determines that highly-concentrated powder or liquid caffeine supplements sold to consumers in bulk quantities meet the Act’s definition of “adulteration” in that they “[present] a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or…under ordinary conditions of use.”

What Risks Do These Supplements Present?

Many of these supplements are intended to either be taken in very small quantities or diluted prior to consumption.  Some bear warning statements on their labeling urging to not consume more than the recommended serving.  Despite this, FDA maintains that simple measurement errors can result in consumption of toxic or lethal doses of caffeine.

For example, FDA explains that 1 teaspoon of pure or highly concentrated powdered caffeine product can contain approximately 3200 mg of caffeine, nearly two and a half times the amount of a toxic dose (1200 mg).  Additionally, safe serving sizes for these products are generally 1/16 of a teaspoon (200 mg) or less, but the smallest standard kitchen measuring spoon is typically 1/4 of a teaspoon (800 mg).  Given this example, an erroneous measure of just 1/8 of a teaspoon (400 mg) is twice the amount of a safe serving.

Does FDA Consider All Caffeine Supplements Adulterated?

FDA states that they do not expect caffeine supplements containing pre-measured or pre-diluted safe quantities of caffeine to be adulterated.  These products may contain caffeine in the form of tablets, capsules, packets, and significantly diluted bulk quantities.  Such products prevent the need for a consumer to precisely measure a safe quantity.  As a result, they “would not normally be expected to lead to toxic or life-threatening symptoms.”

Companies should ensure they are packaging and labeling their caffeine supplements as discussed above in order to avoid potential adulteration charges.  Adulteration charges may result in Warning Letters, Import Alerts, refusal at the U.S. border, and other public information that can damage a brand’s reputation.

Registrar Corp’s Regulatory Specialists are well-versed in FDA supplement regulations and can conduct a full review of your product’s labeling and ingredients for compliance.  In addition to a thorough report of recommended revisions, you will receive a print-ready, FDA-compliant label incorporating these changes.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

Frequently Asked: FDA Labeling Requirements for “Added Sugars”

As part of the U.S. Food and Drug Administration’s (FDA) Revision of the Nutrition and Supplement Facts Labels Final Rule, many foods, beverages, and dietary supplements are required to bear a declaration for “added sugars.”  The requirement is perhaps one of the most perplexing aspects of the rule, leaving many businesses with a lot of questions as they transition their label to meet FDA’s new regulations.

What is the Requirement?

Under the rule, labels for products containing 1 gram or more of “added sugars” per serving must indent “Includes ‘X’ g Added Sugars” beneath a declaration for “Total Sugars.”  Labels for products containing less than 1 gram of added sugars are not required to declare the values if they do not make any sweetener or sugar claims.  These labels may instead be required to display “Not a significant source of added sugars” at the bottom of the table of nutrient values.

The rule defines “added sugars” as “sugars that are added during food processing, or are packaged as such,” meaning they are packaged with the intention of being added to a food.  The definition includes sugars from syrups and honey as well as sugars from concentrated juices that exceed amounts typically expected from 100 percent fruit or vegetable juices of the same volume and type.  Labels for certain honey, maple syrup, and cranberry products are permitted to explain that these sugars are either naturally occurring or used to improve palatability.

FDA requires manufacturers to keep records of sugars added before and during processing as well as sugars packaged with the food as separate ingredients.  If the sugars are reduced through fermentation or caramelization, the manufacturer may keep records of scientific data that verify the declared amount is correct or petition an alternative means of compliance.  The manufacturer must justify the accuracy of all data.  FDA requires records to be kept for two years following the product’s introduction to the U.S. market.

Why is FDA Requiring the Added Sugars Declaration?

Certain public comments to the 1990 proposed rule that mandated nutrition labeling for most foods favored requiring a declaration for added sugars rather than total sugars.  Some comments proposed requiring both.  At the time, FDA determined such a requirement was not necessary, nor was it feasible to differentiate between added and naturally occurring sugars in most foods.

The 2015 Dietary Guidelines Advisory Committee (DGAC) report recommended a reduction of added sugar in the American diet, due to a strong correlation between low sugar intake and a decreased risk of cardiovascular disease.  The DGAC report contributed to FDA’s reconsideration of its previous determination, and the Agency cited this data to rationalize the added sugars declaration in its 2016 final rule.

The added sugars declaration is just one requirement in two comprehensive new food labeling rules, which issue changes to daily values, serving sizes, and more. Businesses averaging $10,000,000 or more in annual food sales have less than two years (January 1, 2020) to comply.  Businesses averaging less than $10,000,000 in annual food sales have an additional year.

Updating your label to meet new requirements can be a lengthy process. We urge companies to transition now to ensure compliance before the deadline.  Registrar Corp can update your labeling to comply with FDA’s new label rules.  In addition to a comprehensive report explaining our recommended revisions, you will receive a print-ready, FDA-compliant label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Orders First Ever Mandatory Recall Under FSMA

On April 3rd, 2018, the U.S. Food and Drug Administration (FDA) ordered a mandatory recall of all food products that contain powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. The Agency issued the order after several samples of kratom products manufactured by the Las Vegas based company tested positive for salmonella, a potentially dangerous pathogen known to cause diarrhea, fever, and abdominal cramps. This is the first time FDA has ever issued a mandatory recall order. FDA Commissioner Scott Gottlieb, M.D. stated that the action was “based on the imminent health risk posed by the contamination of this product… and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions (FDA.gov).”

Section 206 of the Food Safety Modernization Act of 2011 (FSMA) grants FDA the authority to order responsible parties to recall certain food articles if the Agency determines that there is a reasonable probability that a particular food product is adulterated or misbranded and that the use of or exposure to that food product will cause serious adverse health consequences or death to humans or animals. Despite this authority, FDA still relies on responsible parties to voluntarily recall products that are in violation of regulations. The Agency issued this mandatory order only after Triangle Pharmanaturals LLC failed to comply with earlier requests that the firm cease distribution and recall the product voluntarily.

Both voluntary and mandatory recalls can permanently damage a brand’s reputation. Companies that wish to reduce the risk of facing a recall may take various measures to help ensure that their products meet required regulatory standards and do not pose a threat to human or animal health. Registrar Corp offers a number of services specifically designed to make complying with FDA regulations easier for businesses. For example, Registrar Corp can dispatch a Food Safety Specialist to your facility to help you prepare for an FDA inspection by identifying potential food safety problems in the structure, processes, procedures and documentation used in your daily production. Furthermore, Registrar Corp can develop new food safety plans and programs for your facility or review your current systems and documentation. Businesses may also use Registrar Corp’s FDA Compliance Monitor to track suppliers, importers, and distributors for FDA warning letters, import alerts, and more so that they may become aware of and react to any FDA regulatory difficulties faced by current or potential commercial partners in their supply chain. 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.

Frequently Asked: FDA Regulations for Dietary Supplements

Dietary supplement companies often come to us unsure of how the U.S. Food and Drug Administration (FDA) regulates their products.  The requirements are not immediately clear, especially when label claims and terms such as “nutraceuticals” or “functional foods” (not recognized by FDA) can blur the distinction between supplement and drug.  In fact, FDA regulations for dietary supplements mirror those for food and beverages, but with some significant differences.  Below lists some of the key requirements supplement companies should follow to ensure FDA compliance.

FDA Registration

Facilities that manufacture, pack, or hold dietary supplements for U.S. consumption must register with FDA.  Facilities located outside of the United States must designate a U.S. Agent for FDA communications at the time of registration.

FDA requires supplement facilities to renew their registrations between October 1 and December 31 of each even-numbered year, regardless of when they initially registered.  For example, if a facility registers with FDA in September 2018, it will still need to renew its registration between October 1 and December 31, 2018.

Labeling Requirements

Like conventional foods and beverages, dietary supplements require nutrition labeling, but with different content and formatting. “Supplement Facts” charts identify only those nutrients that are present, as well as any additional “dietary ingredients” such as herbs, botanicals, and amino acids.  In 2016, FDA introduced new labeling requirements for supplements.  Among other aspects, the new rules require:

  • Vitamin D and potassium to be listed on the label
  • A declaration for “Added Sugars”
  • Revised units of measure for vitamins A, D, and E
  • A footnote on products intended for children aged 1-3 stating “Percent Daily Values are based on a 1,000 calorie diet.”

As of this publication, FDA has proposed a deadline of January 1, 2020 for dietary supplement businesses grossing ten million dollars or more in annual sales to comply with new label rules. Small businesses are provided an additional year.

Supplement labels and advertisements are not permitted to bear claims that suggest they “treat, diagnose, prevent, or cure disease.”  Such claims may result in FDA classifying them as drugs, which may require FDA approval and have stricter labeling requirements.  Products shipped with these claims risk being charged as “unapproved new drugs” and subsequently detained. FDA’s regulatory procedures manual does not permit an “unapproved drug” to be relabeled or reconditioned in port, forcing the shipper to re-export or destroy the product.

Current Good Manufacturing Practices (CGMPs)

As part of the Dietary Supplement CGMP Rule, FDA requires supplement manufacturers to follow specific procedures and record-keeping to ensure safe production.  Manufacturers must prepare and follow several process controls, including written master manufacturing records (MMRs) for each unique formulation and batch size of supplements.  In order to ensure each batch meets uniform specifications, FDA requires MMRs to outline aspects such as:

  • Identifying information for the supplement, including properties such as concentration or strength of each ingredient for each batch size
  • Specifications for points in the manufacturing process that require controls to ensure quality of the supplement
  • Specific actions needed to implement and verify these controls
  • Corrective actions for when specifications are not met

Prior Notice

Facilities exporting supplements to the U.S. must file prior notice of each shipment with FDA before it enters the country.  The submission timeline for prior notice is dependent upon the shipment’s method of transit.

For more information about FDA dietary supplement regulations, register for Registrar Corp’s free webinar (to take place on April 19) for a comprehensive overview on how to comply.  The webinar will conclude with a live question and answer session.

Don’t want to navigate the requirements on your own?  Registrar Corp makes FDA compliance quick and easy.  We can register your facility with FDA, serve as your U.S. Agent, review your supplement’s labeling and MMRs for compliance, and more.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Draft Guidance Explains Small Business Definition For Preventive Controls Rules

The U.S. Food and Drug Administration (FDA) recently published a draft guidance on how to determine whether a business is a “small business” under the Preventive Controls for Human and Animal Food Rules.  The rules define a “small business” as having fewer than 500 “full-time equivalent employees.” Small businesses are subject to different compliance deadlines and, in some cases, different requirements than other businesses sizes. The recent guidance demonstrates that the definition of full-time equivalent employee may exclude many facilities from small business classification.

What is a Full-time Equivalent Employee?

As outlined by 21 CFR Part 117, the number of full-time equivalent employees for a given facility is determined by dividing the total number of hours worked in one year by all of the business’s staff (including those that do not handle food and those employed by affiliates and subsidiaries) by the number of hours one full-time employee would work in one year (i.e. 2,080).

For example, a facility may employ 150 full-time employees at 40 hours per week and 200 part-time employees at 30 hours per week for food manufacturing roles (a total of 624,000 hours in a year).  The facility may be a division of a legal entity that employs 150 full-time employees and an additional 250 part-time employees across multiple subsidiaries for various roles unrelated to food manufacture (an additional 702,000 hours in a year).  Though the facility only has 150 full-time employees, the legal entity it comprises actually has 637 full-time equivalent employees (1,326,000 hours divided by 2,080).

For this reason, some facilities may not realize that they are actually subject to requirements for large businesses under the Preventive Controls Rules.

How Does Business Size Affect Preventive Controls Requirements?

The rules provide small businesses a longer timeframe than their larger counterparts to develop written Food Safety Plans required by the Preventive Controls Rules; however, the compliance deadlines for most food facilities have passed, and small animal food businesses only have until September 17, 2018 to comply with preventive control requirements.

Certain farms that engage in activities requiring FDA registration (e.g. processing) may be exempt from requirements under the rule if they are considered a small business, but large farms that engage in these activities are required to have Food Safety Plans in place.

Additionally, “very small businesses” (defined by the rules as averaging less than $1,000,000 per year in sold and unsold products during the preceding three-year calendar period) are required to submit a “Qualified Facility Attestation” to FDA.  These facilities receive modified preventive controls requirements, including exemption from developing Food Safety Plans.  Facilities who submit an attestation must ensure that the average value per year of their sold and unsold products does not exceed $1,000,000, or they may be providing false statements to FDA.  Submitting false statements to a U.S. federal agency is a criminal offense.

It is wise for covered facilities to develop Food Safety Plans immediately.  FDA may look for a Food Safety Plan as part of a routine facility inspection, and U.S. importers may request their suppliers’ Food Safety Plan as part of a required supplier approval process.

Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) who can develop a Food Safety Plan for your facility or review your current plan for compliance.  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.