Amazon recently revealed it has over 100 million Amazon Prime members on its site, representing one of the largest potential markets available. Amazon has made a concerted effort to make cosmetics a larger part of its sales, seeing tremendous growth in the category each of the past three years. However, selling cosmetics on Amazon can often be a confusing experience for new sellers. Because of the nature of these products and the fact that they come into contact with skin, Amazon takes measures to make sure the health and beauty products on their site adhere to a safe standard for their customers. Some subcategories of the health and beauty section are thus ‘gated’ by verification steps to make sure products adhere to Amazon’s standards, which can include proof of a valid U.S. Food and Drug Administration (FDA) registration. One of the most frequently asked questions Registrar Corp receives is how to become eligible to sell cosmetics on Amazon. Here is a brief overview of the potential requirements and how Registrar Corp can help.
What Amazon Requires
Amazon ‘gates’ certain subcategories of cosmetics, such as ‘topicals’, which includes anything put on the skin (lotion, nail polish, etc). In order to remove these ‘gates’ Amazon requires additional levels of verification of the products to be sold. According to a seller forum, Amazon requires that if you are re-selling or distributing topical products, you must supply an invoice directly from the manufacturer that is dated within the last 180 days. In addition to the invoice, Amazon requests one of three things:
- Proof of FDA Registration- must include the manufacturer’s name, contact information, and valid registration number
- Good Manufacturing Practices (GMP) Certificate- proof that the manufacturer is making their products in a safe and consistent manner
- Certificate of Analysis (COA)- Proof that the product has been tested for safety and ingredients
According to seller forums, the most likely method of success is providing proof of a valid FDA registration for the manufacturer or packager of the product.
Registering Cosmetics with FDA
FDA does not currently require cosmetic manufacturers to register, but they offer a Voluntary Cosmetics Registration Program (VCRP). According to FDA’s website, cosmetic facilities located in the United States can register with FDA before or after their products are entered into commercial distribution and for sale to U.S. consumers. However, in Registrar Corp’s experience, FDA will sometimes request that facilities wait until after their products are in distribution. Cosmetic facilities in other countries can register only after their products are exported for sale in the U.S. FDA only allows manufacturers and packing facilities to register under VCRP. Distributors that intend to sell in these ‘gated’ Amazon subcategories can provide the FDA registration of the manufacturer of the product.”
The Future of Cosmetic Regulations
The recent growth of the cosmetics industry has prompted much thought on how U.S. cosmetics are currently regulated due to growing inconsistency and unsafe products flooding the market place. In the past few years, the U.S. Congress has introduced several new bills in an effort to reconfigure and update the current requirements for FDA cosmetics regulations. One of the major changes proposed in these bills is to make FDA registration mandatory for cosmetics manufacturers. Although nothing is official yet, there is an obvious push to revamp cosmetics regulations.
You could say Amazon is simply ahead of the curve by requiring these verifications now. As more and more cosmetic products are imported and the industry grows larger, consumers and regulators alike feel there needs to be more consistency and reliability in what they are buying. It makes sense to register now, given these trends.
Registrar Corp is a leading FDA compliance consultant that assists companies from all over the world in complying with FDA regulations. Registrar Corp can help cosmetic manufacturers and packers register with FDA. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
On March 5, 2019, the U.S. Food and Drug Administration (FDA) published its second installment of the draft guidance outlining the requirement of facilities to develop mitigation strategies to protect food from intentional adulteration, one of the seven major rules under FDA’s Food Safety Modernization Act (FSMA). The deadline to comply for most FDA-registered food facilities is July 26, 2019, leaving only four months.
Under this rule, most FDA-registered food facilities that average more than $10 million in global food sales plus the market value of unsold food inventory must develop and implement a written Food Defense Plan. Food Defense Plans should identify vulnerabilities at each point, step, or procedure in a facility’s food making process as well as outline mitigation strategies. While the Hazard Analysis and Risk Based Preventative Controls rule (HARPC) is used to protect food from hazards that may include intentional adulteration for purposes of economic gain, Food Defense Plans are used to address scenarios where food may be contaminated for economic gain, political gain, or as a weapon against the public specifically.
Strategies for Developing Vulnerability Assessments
FDA’s recent draft guidance outlines two methods that can assist facilities in creating their Vulnerability Assessments, the first step in the Food Defense Plan, as well as outlines education, training, or experience requirements for individuals who perform certain actions under the Intentional Adulteration (IA) rule.
FDA provides two strategies for assisting facilities in conducting their Vulnerability Assessments (VA).
Strategy 1: Four Key Activity Types (KATs)
FDA has identified four key activity types that have been assessed to have the highest risk of contamination.
- Bulk Liquid Receiving and Loading
- Liquid Storage and Handling
- Secondary Ingredient Handling
- Mixing and Similar Activities (e.g. homogenizing, grinding, coating, milling, etc.)
Using the KAT method, facilities should assess each point, step, or procedure to determine whether those activities fall under the KATs. For example, the measuring of an ingredient before it is added to the product stream could be considered a KAT since it is secondary ingredient handling. Those that fit within the KATs are actionable process steps and require mitigation strategies. Facilities’ VAs must explain why each process step is or is not an actionable process step.
Strategy 2: The Three Fundamental Elements
Another method of creating a VA could be to apply the “Three Fundamental Elements”, outlined in the rule, to each point, step, or procedure of a facilities food making process.
- Potential Public Health Impact if a Contaminant were Added
- Degree of Physical Access to the Product
- Ability of an Attacker to Successfully Contaminate the Product
Facilities should consider the possibility of an inside attacker as well as conditions, activities, practices, or characteristics that are integral to the operation of the food making process when evaluating the three fundamental elements.
FDA’s website provides Tables and Worksheets (Chapter 2, Section F) that can help determine if the process steps are considered actionable processes, once the three fundamental elements are applied to every point, step, or procedure. Again, a written explanation is required as to why or why not a process step is an actionable process.
FDA also suggests using a hybrid method of the two outlined strategies to potentially create a more in-depth VA. “In the hybrid approach, a facility first assesses each point, step, or procedure to identify steps that fit within any of the four key activity types. Then, rather than concluding the VA with those steps identified as the actionable process steps, the facility uses the three elements to conduct a more in-depth evaluation of some of the steps.” (fda.gov)
After conducting the VA, mitigation strategies should be applied to steps deemed actionable processes. These can include mitigating accessibility of an inside attacker (such as using locks with access codes for sensitive areas and vetting employees before giving them the code), reducing the potential of a contamination (such as increased supervision in key areas), and introducing facility-wide security measures (such as installing a perimeter fence and locking exterior doors, securing hazardous materials). These strategies require a written explanation as to why they were deployed. Each food facility will have actionable processes and mitigation strategies that are unique to their products and these strategies should reflect that accordingly.
Who Must Develop My Food Defense Plan?
FDA requires activities under the IA rule to be conducted by one or more “Qualified Individuals”. These individuals should have the proper education, training, or experience to carry out these duties as outlined by the rule. Registrar Corp’s Regulatory Specialists have the necessary qualifications to develop a Food Defense Plan for your facility.
Covered facilities with more than 500 full-time equivalent employees must comply with FDA’s IA rule by July 26, 2019. Businesses with fewer than 500 full-time equivalent employees have one additional year to comply.
Very small businesses are exempt from most requirements under FDA’s Intentional Adulteration rule, including the development of a Food Defense Plan. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by July 26, 2021. FDA defines a very small business as “businesses (including any subsidiaries and affiliates) that averaged less than $10,000,000 in global food sales plus the market value of unsold food inventory during the previous three calendar years.”
Facilities that hold food (except food held in liquid storage tanks), manufacture or process food for animals, manufacture or process alcoholic beverages under certain conditions, and activities that fall within the definition of ‘farm’ are exempt from FDA’s Intentional Adulteration Rule. View FDA’s final rule for a complete list of exemptions.
Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including requirements under FSMA. Registrar Corp’s Food Safety Specialists are Qualified Individuals who can develop or review a Food Defense Plan for compliance. For questions or assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This post was originally published in Food Industry Executive.
In March 2019, the U.S. Food and Drug Administration (FDA) removed approximately 2,551 medical device establishment registrations from its database, a decrease of 9% from the 27,289 registrations that were in the database in February 2019.
Why Did FDA Remove These Registrations?
Establishments that manufacture or distribute medical devices intended for use in the U.S. are required to renew their FDA registrations between October 1st and December 31st of each year. As part of registration renewal, establishments must also pay the annual establishment registration fee. Failure to successfully renew and pay the fee during this period will result in having an invalid registration. FDA removes any registrations that were not renewed from its databases after the annual renewal period.
Establishments selling medical devices must appoint an Official Correspondent at the time of registration. Foreign establishments who export to the United States must also designate a U.S. Agent for FDA communications. U.S. Agents must confirm their designation or FDA may consider the registration incomplete. FDA removes any registrations that are incomplete or invalid from its databases after the annual renewal period.
What Does This Mean For Registrations That Were Removed?
When a registration is deactivated, so are the active listings associated with the registration. All propriety names and importers will be removed from the listings.
Marketing a medical device in the U.S. without a valid registration and listing is a prohibited act and may result in costly detentions or refusals. Many facilities do not realize their registration is invalid until problems like these occur. Facilities whose registrations have been removed will be required to reactivate their registration and device listings with FDA.
Registrar Corp can verify whether a medical device registration is valid for 2019 at no cost. If your registration is invalid, Registrar Corp can reactivate your FDA registration. Registrar Corp can also act as your Official Correspondent and U.S. Agent for FDA communications. For additional questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: www.registrarcorp.com/livehelp.
The multi-billion dollar U.S. cosmetics industry is booming. The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 2.7 million cosmetic line-items entered U.S. ports in Fiscal Year (FY) 2018. However, this immense volume of cosmetic imports poses certain challenges as current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution.
FDA was only able to examine 5,403 (less than 1%) cosmetic line-items in FY 2018. 784 (14.5%) of the examined lines were refused entry into the U.S. because they were found to violate regulations. It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.
Meanwhile, domestically-produced goods, which are not subject to any screening before entering the market, present a different issue. In April 2018, fraudsters in Los Angeles were discovered marketing feces-laced makeup kits using the brand name of celebrity Kylie Jenner’s cosmetics line. The incident caused Jenner’s sister Kourtney Kardashian to lobby with U.S. legislators for stricter cosmetics regulations.
Solutions For Proactive Regulations
Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic.
Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do.
In order to provide comparable regulations for cosmetics, the U.S. Congress has introduced three bills in the past two years: the Personal Care Products Safety Act (S.1113), the FDA Cosmetic Safety and Modernization Act (S.2003), and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903). While these bills have been referred to committees and have not yet been voted on, they share some commonalties that illustrate the direction U.S. cosmetics regulations may take in the next decade. This article will discuss major changes industry should expect if any of these bills becomes law.
Mandatory Registration of Cosmetic Facilities
FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States. Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily.
The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA. S.1113 and H.R.6903 would require annual registration renewal, while S.2003 would require renewal every two years. All bills would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on a facility’s behalf.
Mandatory registration of cosmetics facilities provides FDA a paper trail of who is marketing cosmetics in the United States and grants the Agency authority to detain or refuse products from unregistered establishments. If any of these bills were to pass, FDA could suspend the registrations of facilities that violate regulations, effectively prohibiting them from marketing their products in the United States.
Additionally, S.1113 and H.R.6903 propose to require annual fees from cosmetics businesses averaging over $2 Million and $10 Million respectively in annual gross sales as part of the registration process. Fee amounts would be calculated based on a business’s annual gross sales.
Cosmetic Ingredient Statements
S.1113 and H.R.6903 would both require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements to either be submitted annually under S.1113 or submitted when changes occur in information under H.R.6903.
Similar to registration, cosmetic ingredient statements would notify FDA which products a particular facility processes and would allow the Agency to prohibit a cosmetic from being marketed without a valid statement. S.1113 even includes specific provisions for suspending a cosmetic ingredient statement if the product has “a reasonable probability of causing serious adverse health consequences.”
Serious Adverse Event Reporting
The proposed bills would require cosmetics businesses to submit serious adverse event reports to FDA. The bills’ definitions for “serious adverse events” vary, but they are generally health-related events associated with the use of a cosmetic that result in or require medical intervention to prevent death or other serious injury.
Additionally, both S.1113 and S.2003 would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border.
Good Manufacturing Practices
The proposed bills would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.” In other FDA-regulated industries, GMPs regulate production aspects such as sanitary conditions, hazard controls, and record-keeping. For cosmetics, GMPs would provide enforceable standards for FDA to reference during inspections. Violation of GMPs could result in regulatory actions such as Warning Letters, Import Alerts, and Import Refusals.
GMPs for cosmetics would be determined through FDA rulemaking. During rulemaking, FDA proposes a rule and allows industry and consumers to provide comment. Depending on the comments FDA receives, the Agency may issue an additional proposed rule for further comments, cease rulemaking, or issue a final rule.
A final rule contains compliance deadlines for industry, which are often determined by the size of businesses covered under the rule. It may take years for industry to see a rule’s full implementation as FDA prepares guidance and provides businesses time to process and comply with requirements.
The proposed bills would establish an annual review of cosmetic ingredients by FDA. FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all. FDA would then use these determinations to establish regulations that either permit or prohibit the use of certain ingredients in cosmetics.
H.R.6903 would even immediately prohibit 12 ingredients from being used in cosmetics, including coal tar dyes (commonly used in hair dyes), Styrene or Styrene acrylates (a film-forming agent), and cocamide diethanolamine (an emulsifying agent).
As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant.
As stated previously, none of these bills are near enactment, but the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries.
Even if none of these bills become law, it is likely another that proposes similar measures may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States.
Companies that need assistance with FDA requirements can contact Registrar Corp, a leading FDA compliance consultant. Registrar Corp’s Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.
This post was originally published in Personal Care Magazine.
The U.S. Food and Drug Administration (FDA) has the authority to inspect any FDA-registered facility. Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection”. All products exported to the U.S. by a facility on the Import Alert are subject to Detention Without Physical Examination (DWPE) until FDA is able to inspect the facility.
Import Alerts are public information that can damage a brand’s reputation. Delayed or refused shipments resulting from Import Alerts can also strain relationships with buyers. Thus, it is advised to accept an inspection without hesitation. FDA may issue a Notice of Inspection at any time, so you should prepare by ensuring your facility is compliant with FDA Current Good Manufacturing Practices (CGMPs) and other regulatory requirements.
Food Facility Inspections
FDA requires food facilities to respond to inspection requests within 24 hours. The Agency may interpret a lack of response as refusal of inspection. FDA communicates an inspection request with a facility’s U.S. Agent, so it’s prudent to designate a reliable Agent. When preparing for an inspection, you should familiarize yourself with common inspection violations so you can ensure you don’t make the same mistakes.
We invite you to utilize our webinar recording on how to handle an FDA food facility inspection to help you prepare. For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection. As part of this inspection service, our Specialist will help identify potential food safety problems in the structure, processes, procedures and documentation used in your daily production.
Drug Facility Inspections
There are a variety of actions that FDA may interpret as refusal of a drug facility inspection, including refusing an FDA inspector entrance into a facility, trying to postpone a scheduled inspection date without a reasonable explanation, and more. Registrar Corp’s article on FDA drug facility inspections will help you understand the different types of FDA inspections, how FDA investigators prepare for inspections, and what to expect during an inspection.
Our Facility Is Under Import Alert for Inspection Refusal. What Can We Do?
To seek removal from Import Alert 99-32, a facility must petition for inspection by FDA. FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused. Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.
For more information about FDA inspections or Import Alerts, contact Registrar Corp by phone: +1-757-224-0177, email: [email protected], or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
In February 2019, the U.S. Food and Drug Administration (FDA) removed 47,635 food facilities from its database, resulting in over a 20% decrease in registrations. This was likely caused by facilities failing to properly renew their registrations before the December 2018 renewal deadline. FDA removes all facilities that did not renew shortly after each renewal period. As of February 7, 2019, 186,016 food facilities remained in FDA’s database compared to the 233,651 registered in December 2018. To see the registration totals broken down by country, click here.
What is Registration Renewal?
Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year. The date on which the initial registration was submitted is inconsequential to the renewal requirement. If a facility registers the day prior to the FDA renewal period (October 1), they are still subject to registration renewal.
FDA considers registrations that are not renewed by the deadline to be “expired”. Facilities with expired registrations must re-register with FDA and obtain a new registration number, prior to continuing manufacturing, processing, packing, or storing food for U.S. consumption.
Distributing food in the United States with an expired registration is prohibited and may subject a facility’s owner to civil or criminal penalties. Many facilities do not realize their registrations are expired until their shipments are detained by FDA Compliance Officers at the U.S. Port of Entry. To avoid costly detentions or regulatory action, it is prudent all food facilities verify their registrations were properly renewed for 2019.
If your registration is expired, Registrar Corp specializes in FDA regulatory compliance and can properly re-register your facility. As part of our registration service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more. For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
On February 26, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish final monograph regulations for over-the-counter (OTC) sunscreen drug products. If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.
Since issuing an indefinite stay on a 1999 final monograph, FDA has mostly regulated Sunscreen products under enforcement discretion. In 2011, FDA clarified its enforcement approach to OTC sunscreen products through a draft guidance that was later finalized in 2018. At that point in time, FDA also issued a final rule for the labeling of OTC sunscreen drug products and established mandatory parameters for broad spectrum, sun protection factor (SPF) and water resistance testing. This final rule was codified in 21 CFR 201.327.
FDA’s new proposed rule would lift the stay on the 1999 final monograph as well as establish the following major provisions:
GRASE Status of Sunscreen Active Ingredients
The rule proposes that zinc oxide and titanium dioxide remain classified as generally recognized as safe and effective (GRASE) for use in sunscreens at concentrations of up to 25 percent.
Aminobenzoic acid and trolamine salicylate would be classified as not GRASE for use in sunscreen as FDA has determined the risks posed by these ingredients outweigh their benefits. Drug products containing non-GRASE ingredients are considered misbranded and prohibited from being marketed in the U.S.
Additionally, the rule proposes that the following twelve ingredients would be excluded from the final monograph because there is insufficient data to determine whether they are GRASE:
- Padimate O
Many of these ingredients are considered GRASE under the 1999 monograph, meaning sunscreen products with these ingredients can currently be marketed without a new drug application (NDA). If FDA’s new proposed rule becomes final, sunscreen products with these ingredients may not be introduced into interstate commerce one year after the final rule becomes effective. FDA has proposed an effective date for the final rule of November 26, 2019.
GRASE Statuses of Sunscreen Dosage Forms
The rule proposes to classify oils, lotions, creams, gels, butters, pastes, ointments, and sticks as GRASE dosage forms for sunscreens. Sprays would also be GRASE, contingent on testing to minimize risks from inhalation (particle size restrictions) and flammability (flammability and drying time testing).
Sunscreens in powder form would be eligible for inclusion in the final monograph pending additional scientific data supporting their safety. Powder sunscreens would also be subject to the same particle size restrictions as sprays. Other dosage forms, such as wipes, body washes, and shampoos would be considered new drugs, which require FDA approval of an NDA to market in the U.S.
Changes to Sunscreen Labeling
The rule proposes to require a sunscreen’s statement of identity to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”). The rule would also revise format requirements to make SPF, broad spectrum, and water resistance statements more prominent on a product’s principal display panel (PDP). Products that do not meet broad spectrum requirements must also include an asterisk next to the SPF value and an associated statement “*See Skin Cancer/Skin Aging Alert.”
Due to evidence showing “additional meaningful clinical benefit” from broad spectrum sunscreen products with an SPF of 60, the rule proposes to increase the maximum SPF displayed on sunscreen labels from 50+ to 60+. Sunscreen manufacturers would still be permitted to market products formulated up to 80 SPF as OTC.
Additionally, all sunscreen products over 15 SPF would be required to satisfy broad spectrum labeling and testing requirements. Among the other requirements of broad spectrum testing, the rule proposes that these products must meet a UVA I/UV ratio of 0.7 or higher.
Prohibition of Sunscreen-Insect Repellent Combinations
Given their use as pesticides, sunscreen-insect repellent combination products are also regulated by the Environmental Protection Agency (EPA). FDA has determined that these products cannot be labeled to “sufficiently ensure safe and effective use of the sunscreen component and provide adequate directions for use” due to incompatibility with EPA labeling requirements. The rule proposes to classify these products as not GRASE, which would effectively prohibit them from being marketed in the U.S.
What Industry Should Expect
FDA’s new proposed rule brings some significant possible changes for the sunscreen industry. As with any proposed rule, these provisions are not final; however, they illustrate FDA’s current thinking for the direction of sunscreen regulations. Sunscreen companies should familiarize themselves with the 1999 final monograph (21 CFR Part 352), required labeling based on effectiveness testing for OTC sunscreen drug products (21 CFR 201.327), and the newly proposed rule to prepare for compliance.
Registrar Corp assists sunscreen companies with FDA compliance. Our Regulatory Specialists can register your establishment and list your products with FDA, serve as your U.S. Agent, review your sunscreen’s labeling for compliance, and more. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
The U.S. Food and Drug Administration (FDA) requires Nutrition Facts labeling on food products sold in the United States, whether they are produced domestically or outside of the United States. Coffee, tea, and spices may be exempt from FDA nutrition labeling requirements if they contain “insignificant” (by FDA’s definition of the term) amounts of all nutrients required to be included in the “Nutrition Facts” panel (fda.gov). Limitations to the exemption exist, and it is important for companies to understand when their product will qualify. Products that are required to declare nutrition labeling, but do not, may be detained for misbranding and refused entry into the United States.
The exemption from nutrition labeling applies to the finished food product, as packaged. If foods with insignificant amounts of nutrients are combined, the resulting product remains exempt. For example, plain coffee and cinnamon both contain insignificant nutrient amounts; therefore, if combined into a single product, the result is still exempt from nutrition labeling. Once an ingredient with nutrients is added to the product, it no longer has insignificant amounts of nutrients and a Nutrition Facts label is required. Common examples include: chai latte mixes, sugar/sweetener, and candied fruit peel.
Claims and Other Nutrition Information
If any of the following types of claims are made, a Nutrition Facts Label is required:
- A nutrient content claim (“low-fat”, “healthy” or “high in fiber”)
- A health claim (“Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”)
- A structure/function claim (“calcium builds strong bones”)
FDA regulations also state that the exemption does not apply if any nutrition information is present on the label.
In the example above, the tea on the left has no claims or added nutrients and therefore does not require a Nutrients Facts label. The tea on the right, however, does require a Nutrition Facts label because it provides the amount of antioxidants (catechins) present in the product, which could be construed as “nutrition information” by FDA.
If your product is exempt for Nutrition Facts labeling, voluntary information may still be provided. Some consumers seek more information on how the product was manufactured and find value in transparency.
Registrar Corp’s Regulatory Specialists can help you determine if your products require a Nutrition Facts label and keep your company in compliance with FDA regulations. Contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
Registrar Corp’s FDA Compliance Monitor, the food industry’s leading FSMA compliance tool, has been upgraded. The new simplified layout and optimized backend drive user efficiency, making compliance with FDA’s supplier monitoring requirements easier than ever.
On the front end, users now see a series of compact rows that display an overview of supplier compliance; these rows can be further expanded to review detailed company data for each supplier. Best of all, the system is more than 10x faster than before.
The new features are immediately available to all users at no additional cost. Want to experience the new Monitor for yourself? Join our free webinar walkthrough or schedule a 1-on-1 demo today.
What’s Next for the Monitor?
The recent redesign lays the foundation for additional features that will further automate compliance as well as increase user productivity. The next set of rollouts will include:
- Validation of FDA Registration Numbers
- A repository for requesting and storing HACCP and HARPC Food Safety Plans as well as other documentation for supplier compliance
- Enterprise integration capabilities
“We are constantly exploring ways to innovate the Monitor,” says Brendon Sampson, Manager of Registrar Corp’s FDA Compliance Monitor Department. “User feedback is integral to delivering actionable and practical features. We anticipate significant growth in implementing future developments.”
About the Monitor
Registrar Corp developed the FDA Compliance Monitor to assist companies with supply-chain monitoring requirements under the U.S. Food and Drug Administration (FDA) Preventive Controls and Foreign Supplier Verification Program (FSVP) rules. The Monitor aggregates and supplements data from five FDA databases to supply comprehensive, up-to-date compliance reports on all FDA-regulated companies. To verify and document suppliers’ FDA compliance, businesses can easily monitor their suppliers for:
- FDA Inspection Classifications
- Warning Letters
- Import Alerts
- Import Refusals
In addition to monthly compliance reports, the Monitor automatically sends users email alerts whenever the published FDA compliance status of a supplier changes.
To learn more about how Registrar Corp’s FDA Compliance Monitor can help simplify compliance with FDA monitoring requirements, join our free webinar walkthrough on January 23. Alternatively, you can schedule a demo or call us at +1-757-224-0177.
The U.S. Food and Drug Administration (FDA) recently released its Fiscal Year (FY) 2018 Inspection Observation Data. The data aggregates violations documented during FDA inspections from October 2017 through September 2018. During this period, FDA cited 278 U.S. importers of food and beverages for not developing Foreign Supplier Verification Programs (FSVP), making it the most frequent inspection violation of FY 2018. This article provides an overview of what these FSVP violations mean for industry as well as the other five most commonly cited violations this year.
As of March 19, 2018, most food importers are required to develop FSVPs for their foreign suppliers and monitor their suppliers’ FDA compliance statuses. After the first FSVP deadline in May 2017, FDA cited 108 importers for not developing FSVPs during FY 2017 inspections. FSVP’s prominence on this year’s list of violations suggests that FDA is regularly inspecting importers for compliance.
Importers should be prepared for FDA to examine their FSVP records and verify that they are properly monitoring their suppliers. Non-compliance with FSVP regulations may result in civil penalties.
Registrar Corp’s Qualified Individuals can assist by developing your FSVPs or reviewing your current programs for compliance. Additionally, Registrar Corp’s FDA Compliance Monitor simplifies supplier monitoring by continuously tracking your suppliers’ FDA compliance and issuing monthly reports that support FSVP documentation requirements. Schedule a demo to learn more.
Top Five Food Facility Violations
FDA cited registered food facilities for a variety of food safety issues this year. Below are the top five most common food safety violations discovered by FDA in FY 2018:
- Sanitation Monitoring – FDA cited 188 facilities for not properly monitoring sanitation conditions and practices with sufficient frequency. Facilities are required to monitor aspects such as the safety of water coming into contact with food or food contact surfaces, prevention of cross-contamination, and maintenance of hygiene facilities.
- Pest Control – FDA cited 183 facilities for not properly excluding pests from potentially contaminating food.
- Manufacturing, Processing, Packing, and Holding Controls – FDA cited 175 facilities for not implementing proper controls to mitigate the risk of food hazards, such as growth of microorganisms, allergen cross-contact, and contamination of food.
- Sanitary Operations and Plant Maintenance – FDA cited 167 facilities for either not maintaining cleanliness of their facilities or not keeping them in good repair.
- Personnel – FDA cited 161 facilities for not taking reasonable measures and precautions related to personnel. These may include failing to address hygiene and cleanliness of staff working in direct contact with food.
Food facilities should ensure compliance with the above and other good manufacturing practices. Food safety violations discovered during an inspection may result in FDA enforcement such as Warning Letters, Import Refusals, or Import Alerts. These compliance issues can damage a brand’s reputation and often influence the buying decisions of purchasers.
To prepare your facility for an FDA inspection, Registrar Corp can dispatch a Food Safety Specialist to conduct a Mock FDA Inspection. Our experts will identify potential food safety issues and educate facility staff on FDA expectations during an inspection.
Preventive Controls Violations
While no individual violation of the FDA Preventive Controls rules made it to the top of the list, violations of Preventive Controls requirements in FY 2018 total 396 when combined. These include issues such as not having a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan, not identifying a hazard that requires a preventive control in a HARPC Plan, not utilizing a Preventive Controls Qualified Individual (PCQI) to prepare or oversee a HARPC Plan, not implementing adequate procedures for monitoring sanitation or allergen controls, and more.
The deadlines for most facilities to comply with Preventive Controls requirements have passed, and these violations are evidence that FDA is actively inspecting facilities for compliance with the rules. Facilities should familiarize themselves with Preventive Controls regulations to ensure they are properly accounting for all HARPC requirements and any differences from other food safety systems they may be using to draft their HARPC plans.
Alternatively, Registrar Corp’s PCQI Food Safety Specialists can assist by developing a HARPC Plan for your facility or reviewing your current plan for compliance.
For assistance with FDA food safety regulations, call Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.