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Therapeutic vs. Non-Therapeutic Claims Classification Guide

What is a claim?

A claim is a representation for sale. It can be presented as “a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites”. It explains what the product is for and what it does. There are two types of health claims: Therapeutic Claim and Non-Therapeutic Claim. Depending on the health claims, your product can be classified as a cosmetic, NHP, or drug.

Therapeutic Claims

These are claims that must be reviewed by the Natural and Non-prescription Health Products Directorate (NNHPD) prior to receiving its market authorization such as Drug Identification Number (DIN) or Natural Product Number (NPN). These claims can be used in advertising or marketing of the product and must be supported through evidence. Examples are: “Stimulates hair growth”, “Prevent hair loss”, and “Eliminates dandruff”.

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Non-Therapeutic Claims

These are claims that are made on product labels and its advertisements. Though they must be true and accurate, they do not require review and authorization from Health Canada prior to use. Examples are: “Strengthens hair”, “Healthy Hair”, and “Removes loose dandruff flakes”.

Classification of your product

In order to classify your product, your product must meet one of the definitions above. Product risk, public health safety, and applicable regulatory framework must also be taken into consideration. Two main factors in determining product classification include representation and composition of the product.

Representation and Composition of your product

The classification of your product depends on two main factors: Representation and Composition. Representation can be its function, purpose, and representation for use (such as proposed claims). Composition of your product is the ingredients and their concentrations contained in the formula. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as an NHP or cosmetic product. However, composition alone may not be sufficient in determining its product classification.

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How Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS

In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be distributed in the Canadian market. Drugs include both prescription and non-prescription pharmaceuticals; biologically derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals. 

Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations.

Health Canada will generally authorize a drug product after a drug review process to assess the safety, efficacy, and quality of a drug and if it is satisfied that:

  • the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product; and
  • the therapeutic product is suitable for its intended purpose and that any risk associated with its use is minimised, based on its formulation, manufacturing process controls, specifications, and shelf life, as well as its stability under the recommended storage conditions.

Steps to obtain authorization to develop, test, and/or market a drug product

It is important to quickly mention that “drug development” as a process of bringing a new drug molecule into clinical practice in its broadest definition encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug. However, before testing a drug in humans, scientists must test whether it has the potential to cause serious harm, also called toxicity via in vivo experiments, in vitro experiments, or both. If the results are promising – demonstrate acceptable safety levels and clear or potential efficacy, the team will proceed to the next step of development. This step requires an application to Health Products and Food Branch of Health Canada for authorization to conduct a clinical trial in Canada.

1. Clinical Trial Application (CTA): If the preclinical research indicates that a substance produces the desired result and is not toxic, the sponsor applies to Health Products and Food Branch (HPFB) of Health Canada to conduct a clinical trial in Canada. According to NIH, “clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment”. 

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The Health Canada review team has 30 days to review a CTA from the date of receipt of a complete application in Health Canada. The application first undergoes a screening phase to ensure that all submission components have been provided. Once screened for acceptability, the application is processed for review and an acknowledgement letter is issued to the sponsor to indicate the start of the review period. Once review is completed, the application is either authorized (a No Objection Letter is issued) or rejected (a Not Satisfactory Notice is issued). It is worth noting that CTAs are required for only phases I to III clinical trials. Clinical trials involving marketed drugs where the investigation is to be conducted within the parameters of the authorized NOC or DIN application (Phase IV clinical trials) do not require a CTA.

2. New Drug Submission (NDS): If clinical trial studies prove that the drug has potential therapeutic value that outweighs the risks associated with its use (e.g. adverse effects, toxicity), the sponsor may choose to file a NDS with HPFB. The NDS must provide information and data about the drug’s safety, effectiveness and quality. And this includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects. 

  • Within the first 10 day after receiving the application, Health Canada will assign a control number to the submission and subject the application to a thorough screening to ensure that the correct application type has been selected, that the format, structure and attributes of electronic data submitted comply with the CTD format and specifications, and that the submitted dossier is complete. Where the HPFB identifies deficiencies in the dossier, it will send a query stating the same to the applicant and put in place a stop-clock, which ends when the HPFB receives a complete and satisfactory response.
  • Upon acceptance of the application, the HPFB will begin its evaluation. Similarly, a stop-clock starts when the HPFB issues a query to the applicant and ends when a complete and satisfactory response is received. Where necessary, the HPFB may involve external evaluators (whose identities will be kept confidential), experts and advisory committees. The external evaluators and experts are contractually bound to protect information provided to them. In addition to evaluating the safety, efficacy and quality data to assess the potential benefits and risks of the drug, the review team evaluates the information that the sponsor proposes to provide to health care practitioners and consumers about the drug such as the label, product brochure and information sheets. 
  • Following the completion of the review, if the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada. Suffice to mention that following product registration, product registrants are responsible for ensuring the product’s quality, efficacy, and safety throughout its life cycle, and must notify Health Canada of any changes to the same.
  • In instances where there is insufficient evidence to support the safety, efficacy or quality claims, HPFB will not grant a marketing authorization for the drug and a Notice of Non-Compliance (NON) will be issued to the sponsor. Meanwhile, the sponsor has the opportunity to supply additional information, to re-submit its submission at a later date with additional supporting data, or to ask that HPFB reconsider its decision.
  • There are also instances when the application can be approved subject to adequate response to minor deficiencies. The HPFB will inform the applicant of the approval conditions (Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), and the applicant will need to satisfy these conditions within a specified time period.
  • Although HPFB has set internationally competitive performance targets for its conduct of reviews, the review time depends on the product being submitted and the size and quality of the submission, as well as HPFB’s workload and human resources. Other factors include the number of questions that Health Canada raises during the review process, the answers provided by the sponsor and the clock-pauses. Nevertheless, the target review timeline ranges between 7 months (accelerated review and ANDS) to 1 year (standard NDS).
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Top Components of your Class III NHP PLA

Product Licence Application

All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products have 3 different classes of application – Class I, II and III.

Determining the correct Class of NHP is important, and if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II and III NHP Application 

The NNHPD has developed what is known as a Compendium of Monographs. These Monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients. Class III applications usually fall outside of these monographs and therefore require additional safety and efficacy studies. For Class III applications a rationale should be provided for not attesting to the monograph(s).

Components of a Class III Product Licence Application (PLA) 

Class III applications are comprised of general, traditional, and homeopathic applications requiring full assessment (not captured in Class I or II) and can include: 

  • Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles
  • Applications referencing a Master File to support safety, efficacy and/or quality
  • Products with ingredient combination issues that may require safety assessment
  • Partially referencing monograph information but going beyond the parameters established in the relevant monograph(s)
  • Homeopathic applications with specific claims

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In a Class III application, the following are required as part of the Product Licence Application: 

  1. Web-based NHP PLA form – Applications for new products must be provided using the web-based NHP PLA form while amendments to existing products can be submitted using the Amendment and Notification Form (ANF) 
  2. Label text – all PLAs must include a label text that meets all the requirements outlined in the NHPR section 93-94. The label text generator within the PLA form can be used
  3. Evidence summary report – To meet all safety and efficacy requirements summary reports are submitted to help assist all class III applications. summary reports serve to reflect the totality of available information relevant to the NHP and provide context that speaks to what may otherwise appear as gaps/uncertainties in the information concerning the safety, efficacy, and/or quality of the product
  4. Finished Product Specifications (FPS) – Class III applications require an FPS, this should attest to specifications in the Quality of Natural Health Products Guide

Once Health Canada has assessed an NHP and decided it is safe, effective and of high quality, Health Canada issues a product license along with an eight-digit Natural Product Number (NPN), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada. Class III applications have a processing time of around 210 days. Find out What to Expect After Submitting an NPN Application

Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on submitting your NPN applications, keeping your product license updated, and reviewing your NHP labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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11 Ways MoCRA will enhance FDA Cosmetics Regulations in 2023

MoCRA FDA Cosmetic Regulations

Introduction:

The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which has been in the works for years, is the biggest change to cosmetics legislation in recent U.S. history.

The U.S. Food and Drug Administration (FDA) can now impose stricter regulations on the cosmetics business according to MoCRA, which increases the agency’s regulatory jurisdiction over the sector. Cosmetic producers should be aware of the changes in the bill even if FDA has not yet established specific requirements.  Keeping up with the latest FDA cosmetic regulations can be an overwhelming task and in this article, we will help you navigate MoCRA and FDA cosmetic regulations.

What are the FDA Cosmetic Regulations?

The FDA is responsible for regulating cosmetics in the United States and works to protect public health by ensuring the safety of cosmetics. All cosmetic products, including all ingredients used in those products, must comply with FDA rules before they can be sold to consumers. Cosmetic companies are held responsible for the safety of their products under Section 21 CFR 740, which requires them to have a reasonable basis belief that their products are safe before they can enter the market.

What are the Different Types of Cosmetics and Their Regulatory Status?

Cosmetics can be divided into four distinct categories with separate FDA regulatory statuses. The categories are Color Additives, Over Counter Drugs, Prescription Drugs and Devices, and Cosmetics/Soaps. Within each category, there are specific regulations that must be followed, such as listing all ingredients on the product label and submitting safety testing results to the FDA. Companies should thus familiarize themselves with the relevant guidelines to remain compliant with all applicable laws.

How do Companies Register their Cosmetics with the FDA?

To register cosmetics with the FDA, companies must first fill out a Cosmetic Registration Form. The form must include the company’s information and contact details, a comprehensive ingredient list, and any relevant safety testing. Once the form is complete, it must be submitted to the FDA for review and approval. Companies should also maintain appropriate records of their compliance efforts to remain compliant with all applicable regulations.

11 ways MoCRA will enhance FDA Cosmetics Regulations:

  1. Cosmetic Product Listing 

Companies must submit to the FDA a mandatory product listing for each cosmetic product within a year of the law’s adoption. The product must be included in cosmetics sold after the law’s adoption and within 120 days of the sale. Flexible listings allow for the submission of cosmetic products with identical formulas or formulations that only differ in terms of colours, fragrances, flavours, or ingredient counts.

Businesses must renew a product listing every year and include any updates. An abridged listing will be available for products that have not changed since their previous listing.

  1. Registration of Cosmetic Facilities and Renewal

Registration with the FDA is necessary for owners and operators of facilities that create or prepare cosmetic products for sale in the US, and this registration must be updated every two years. After the enactment date, any new facilities that produce or process cosmetic goods for sale in the US must register within 60 days of marketing a product or within 60 days of the registration deadline, whichever comes first. After the law’s passage, existing facilities will have a year to register with the FDA.

Facilities must now update their FDA registration every two years and give the FDA 60 days’ notice of any changes to their registration information.

  1. Cosmetic Good Manufacturing Practices (GMP) 

Facilities will be required to follow Good Manufacturing Practises (GMPs) that adhere to local, national, and international requirements. GMP seeks to protect the general populace’s health and ensure that cosmetics are free from contamination. The FDA will be able to inspect facilities and get access to the data it deems necessary to check that GMP standards are being followed with the help of this law. For the Cosmetic GMP, the FDA has three years from the date of passage in which to publish a Final Rule following the publication of a Notice of Proposed Rulemaking.

  1. Adverse Event Report 

If a major adverse event involving a cosmetic product occurs, the responsible party shall file a report with a copy of the label found on or inside the retail packaging no later than 15 business days after the report is received.

Any new and important medical information relating to the report that surfaced within a year of the first report must be sent by a corporation to the FDA within five business days of its discovery.

  1. New Cosmetic Labeling Requirements

A domestic address, domestic phone number, or electronic contact information must be added to product labels so that a responsible party can receive complaints of adverse events.

The labels of cosmetic goods that include fragrance allergens must be updated to include the allergens. Within 18 months of the law’s passage, the proposed fragrance allergens must be published, and the final determination must be made no later than 180 days after the public comment period has ended.

Labels for professional cosmetic products must clearly and conspicuously say that the product is administered or used only by qualified professionals and that it complies with all applicable cosmetic labeling regulations.

  1. Additional powers to FDA in regulating cosmetics

These requirements include, among others:

  1. Registrations for establishments/facilities
  2. Product catalogues
  3. Reporting of adverse events
  4. Version control and safety monitoring

Among these abilities are:

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  • Establish good manufacturing practices that are required of all manufacturers.
  • Possibility of requesting documents that attest to a product’s safety Power to order a required product recall.
  • Create a talc-containing product asbestos testing protocol.
  • Review the PFAS (per- and polyfluoroalkyl) compounds’ safety and usage.

Overall, the Modernization of Cosmetics Regulation Act of 2022 represents a much-needed advancement in laws governing the composition, safety, and efficacy of cosmetic goods.

  1. Cosmetic Records Inspection

If there is a reasonable suspicion that a cosmetic product or ingredient poses a significant risk of ill health consequences or human death when used, the FDA has the authority to inspect and copy certain cosmetic product records.

  1. Cosmetic Mandatory Recall

According to the FDA, there is a good risk that a cosmetic is adulterated or misbranded, and using or being exposed to such a cosmetic will have serious health consequences. If the Responsible Person does not recall the product, the FDA may enforce an immediate halt to distribution and a recall of the items.

  1. Record of Cosmetic Adverse Reports

The FDA must have access to adverse event reports when doing inspections, and they must be maintained on file for six years. FDA may demand a recorded list of all substances in the flavours or fragrances of the product if FDA considers that a component or combination of components has caused substantial adverse effects. This list must be submitted within 30 days of the FDA’s request.

  1. Small Business Exemptions

Some rules do not apply to small firms. The FDA classifies small enterprises as those with average annual gross sales of less than $1,000,000 over the prior three years. This shall not apply to any responsible person or facility engaged in the manufacture of cosmetic products intended for internal use, regularly coming into contact with the eye, being injected, or altering the appearance for a period of time exceeding 24 hours when used as intended or customarily would be done.

  1. Cosmetic Safety Substantiation

Companies are required to maintain records proving their cosmetic products have adequate safety justification. A cosmetic product’s safety must be backed up by “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient.”

Need help understanding MoCRA or need assistance? We’re hear to help! 

You should familiarize yourself with the legislation that will apply to your facility or cosmetic items. One year following MoCRA’s implementation, new required clauses take effect.

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Update on Performance Standards for NHP Applications

Summary of Health Canada Licensing and Update Reports

Product Licensing

A combined 1390/5045 (28%) of NHP product license application submissions were refused from April to September 2021. 

  • Class I – 90% of product applications are meeting the 60-day performance timeline. The refusal rate for these is 14%. 
  • Class II – 90% of applications are meeting the 90-day performance timeline. The refusal rate for these is 36%.
  • Class III – 57% of applications are meeting the 210-day performance timeline. The refusal rate for these is 19%. There were about 200 Class III submissions that have not received an acknowledgment at the time of this posting. There is a Health Canada backlog of applications contributing to a delay in licensing timelines. 
  • Notifications – 99% of notifications received in 2020 have been completed. 46% of notifications received in 2021 have been completed. 

Product License Application Tips:

  • For a Class III application: be sure to include the reason for classification on the cover letter. 

Site Licensing

  • 213/362 (59%) site license submissions were refused during that time. (Apr to Sept 2021)
  • Stream 1 – 54% of applications are meeting the 35-day performance timeline. The refusal rate for these is 31%.
    Stream 2 – 87% of applications are meeting the 65-day performance timeline. The refusal rate for these is 36%.
  • Renewal – 162 complete renewals completed this year. The refusal rate for these is 36%.
  • Acknowledgement letter includes a built-in extension until a decision is reached. 
  • Health Canada expects to have site license renewals submitted in March 2021 to be completed by December 2021.

A risk-based approach is still taken on Site Licence renewals.

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Site License Application Tips:

  • Designated Party Authorizations and new site license application forms must be submitted via ePost to be considered. This is considered a secure portal. 
  • Applicants must use the most recent online Site License application form. 
  • Applicants must respond to all items in the Information Request Notice (IRN). Refer to each item by their number to organize your response for a higher success rate. 
  • Risk 2 or 3 observations are expected to be addressed via corrective and preventative actions (CAPA). This will be monitored on the next renewal. 
  • Guidance documents are available to help with site licensing and product/site quality. 
  • All documents should be separated into their own files and named appropriately. Applicants are suggested to name documents less than 15 characters. 
  • All site license applications should be screened and acknowledged within 10 days, a follow-up may be warranted after 30 days without a posted acknowledgment. 

Common Issues:

  • Failure to submit 30 days before site license expiry.
  • Failure to submit through the correct channel. ePost new applications tab. 
  • Failure to respond to an IRN on time. 
  • Failure to submit a complete and compliant application package. 
  • Addition of new sites during renewal. This should be done via amendment. Existing sites only in a renewal. 

Covid Site Licence Transition:

  • If a transition application was filed prior to the September 30th, 2021 deadline, sites can continue to operate until a decision has been reached. 
  • 107/174 sites submitted a transition application on time. Refusal rate of 35%
  • Reasons for refusal: No DPA, no GMP evidence, company code errors, missing application form. 
  • Companies that did not file for transition have been asked to confirm that activities have been ceased. 

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NHP System Updates:

  • Web Product License application form V4.3: release in winter 2022. This will include all monograph validation, improved kit submissions, improved NMI filtering, improved error messages
  • The decommissioning of the V3 PLA form will take place in winter 2022. You will no longer be able to finalize this form. You will be able to view and answer existing IRNs
  • There will be a short transition period to decommission the V3 form. Applicants are encouraged to use the V4 form now. This should result in fewer IRNs and a reduced refusal rate
  • Electronic site form: improvements are being made to assist in processing and screening for higher success rates and fewer IRNs. Improved in-form validation and a new notification table

Consultation on a Secure Portal:

  • A questionnaire for industry and associations will go out
  • Seeking consultation on features a secure portal would need
  • Your feedback is important, two weeks will be allotted

Informatics and Automation:

  • Improved monitoring for files entering post
  • Electronic forms reduce error rates. Allows for increased tracking and management of workload
  • Developing new automated tools. Enhancement of workload tracking and monitoring, identification of trends and forecasting, applying advanced analytics for optimization and efficiency
  • General Health, Traditional Chinese Medicine, and Live Microorganism claim to top the trend list over the last 3 years
  • Heart health, weight maintenance, and Skin, hair nail, claims are trending lower over the past 3 years
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FDA Requests Relevant Info to use NAC as a Dietary Supplement

On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use of N-acetyl-L-cysteine (NAC) in products marketed as dietary supplements.

NAC has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease. Recently, the FDA has been issuing warning letters to companies marketing dietary supplements with NAC that are indicated for the treatment of hangovers. The reason for this is that products containing NAC do not meet the definition of a dietary supplement (since NAC was already categorized as a drug in 1963).

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Earlier this year, the FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement.

The Council for Responsible Nutrition (CRN) was pulled into the matter and requested the FDA consider reversing the agency’s position on NAC-containing products (ie. that NAC-containing products can be dietary supplements). In addition, the Natural Products Association (NPA) requested the FDA to either determine that NAC is not excluded from the definition of a dietary supplement or enact legislation to make NAC a lawful dietary supplement under the Federal Food, Drug, and Cosmetic Act

On November 24, the FDA issued responses to both petitions in which they requested additional information from the petitioners and any interested parties. The agency noted that more time is needed to carefully and thoroughly review the complex questions posed in these petitions.

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As such, to help the agency respond to these petitions, the FDA is interested in receiving data and evidence as to the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns with products containing NAC. The FDA will use the information submitted to the public docket and other applicable information to determine if changes to legislation to make NAC lawful as a dietary supplement is appropriate.

The FDA is asking interested parties to submit any information by January 25, 2022, while the agency continues to evaluate both citizen petitions. The agency will use the information submitted for analysis and provide a final response to both petitioners directly once the review is completed.

Individuals may submit electronic comments or written comments regarding these petitions at any time up until the docket is closed; submissions must be received by January 25, 2022, in order to ensure that the FDA is able to review all information in a timely manner. Submit electronic comments to Regulations.gov.

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