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Registering Products with the EPA – What You Need to Know

Environmental Protection AgencyThe US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is a combination of scientific, legal, and administrative procedures through which the EPA examines the ingredients of the pesticide the site or crop where it is to be used the amount, frequency, and timing of its use and storage and disposal practices. 

Pesticides products in the US can be categorized into 3 groups – conventional pesticides, antimicrobial pesticides, and biopesticides. The EPA’s conventional pesticides group includes all ingredients other than biological pesticides and antimicrobial pesticides. As for antimicrobial pesticides, they are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects and surfaces. The antimicrobial category is also known as a “disinfectant” in other countries. Meanwhile, biopesticides are pesticides derived from certain natural materials. Irrespective of the type of pesticides, and/or whether they are produced locally or by foreign manufacturers and imported for sale or distribution in the United States, they are required to be registered with EPA for sale in the United States. 

Registration for a Pesticide Product

If you would like to obtain a registration for a pesticide (or disinfectant) product, you are required to submit complete information and data to support the registration. The information required includes but is not limited to the following:

  1. Company number – a number assigned by EPA to your company
  2. Establishment number (if applicable) – a unique number assigned to each production facility
  3. Identity of the product – the unique brand name of the product
  4. Draft label – critical information about how to handle and safely use the pesticide product and avoid harm to human health and the environment
  5. Applicable scientific data on product chemistry, residue chemistry, environmental fate, toxicology, wildlife, and aquatic organism among others
  6. Efficacy (Product Performance) data – applicable to control pests of public health importance such as roaches, viruses, pathogenic bacteria, ticks, rats among others
  7. Child-resistant packaging certification
  8. Confidential Statement of Formula
  9. US Agent (only for applicants not residing in the US)

Obtaining a Supplemental Registration to Distribute a Product Registered by Someone Else

An applicant who does not wish to register and produce its unique product (but would rather market a product that is currently registered to another company) may become a supplemental registrant for the company that has already registered the product. This supplemental registration allows the new registrant to market the product under its own company and brand name. To use the supplemental registration process, both parties (the original registrant and the supplemental distributor) must submit a complete application detailing the:

  • address of the registrant of the basic registered product
  • basic registered product and the registration number of the federally registered product
  • name and address of the distributor, the distributor’s company number, and the name of the distributor product

It is instructive to note that supplemental registration is an extension of the basic registration and if the basic registered product is canceled, the supplemental registration is automatically canceled effective on the same date as the basic registered product, and existing stocks must be sold in the same time period.

Screening and Review Timelines

As soon as the application for pesticide/disinfectant registration is submitted to EPA, the Agency will screen the application within 21 days to determine if it contains all required forms, labeling, data format, and documentation of fee payment. Any deficiencies identified during the 21-day Content Screen and uncorrected by the applicant may lead to the Agency’s rejection of the application and retention of 25% of the fee. 

Following the 21-day Content Screen, EPA will conduct a Preliminary Technical Screen within 45 days after the start date for pesticide/disinfectant submissions with decision review timeframes ≤6 months, and, within 90 days for pesticides/disinfectant submissions with decision review timeframes > 6 months.

If the application fails the technical screen, and the deficiencies cannot be corrected by the applicant within 10 business days after receipt of EPA’s notification of deficiencies, such application will be rejected and a maximum of 75% fee refund may be provided, if appropriate.

How can we help

Quality Smart Solutions offers EPA registration services that consist of preparing and submitting applications, as well as handling communication with the US Environmental Protection Agency. Our team of experts are happy to help you with future projects or questions!

30 Minutes Free Consultation
References:  Environmental Protection Agency. (n.d.). Pesticide Registration Manual. EPA. Retrieved October 20, 2021, from https://www.epa.gov/pesticide-registration/pesticide-registration-manual 
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Medical Device License (MDL) Renewals

As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process has two purposes, the first is to verify that the MDL will remain active and will continue to be sold in Canada. The second reason is to collect and analyze the appropriate information before invoicing for the right to sell fee.

Process 

The renewal process involves manufacturers of medical devices that are licensed for sale in Canada, to inform Health Canada each year before November 1st, that the information on their license has not changed. Health Canada will send each manufacturer who is marketing a licensed class II, III, or IV medical device an annual license renewal package in early August. This package will allow the manufacturer to fulfill their regulatory obligation and contains the Renewal Form with instructions. The Renewal Form contains the following information:

  • Regulatory correspondence address of the manufacturer
  • Name of the regulatory correspondent and their contact information
  • Attestation page
  • Section 43 of the MDR
  • Name of the manufacturer
  • A listing of all the manufacturer’s licensed devices, their license number, and class that are currently on the market

Instructions 

Health Canada has provided the following instructions for the completion of the Renewal form:

  • Correct any changes to the name of the contact person or their contact information in the space provided to the right of the contact information
  • A senior official of the Manufacturer or their designated regulatory correspondent must sign the attestation
  • Indicate medical device licenses that should be discontinued by placing a [X] beside the medical device license number in the discontinue column. This means that the manufacturer has stopped marketing the device or family of devices in Canada
  • If all the products for which medical device licenses that are listed are to remain on the Canadian market, place an [X] in the appropriate column

Failure to Comply 

Please be advised, that any changes to the MDL other than changes to contact information and notification of discontinuation will not be accepted via the Renewal Form. All other changes must be addressed by submitting the appropriate amendment form to Health Canada. The Renewal Form is required to be emailed to the Bureau of Device Licensing Services Division of the Medical Devices Directorate before November 1 of the year it is received license_renewal@hc-sc.gc.ca. Failure to renew by the November 1st deadline may result in the cancellation of existing medical device licenses by the Medical Devices Directorate.  

Invoicing and Payment

Renewal applications are processed on receipt. Therefore, invoices are mailed in December for payment within 30 days. The invoice documentation confirms the renewal of the medical device license(s), describes the license(s) and the associated fee(s). 

Additional Fee Information 

Health Canada carries out post-market monitoring and assessment of medical devices. The fee for the right to sell a licensed medical device is used to pay for a portion of these activities. The fee is charged annually for the twelve months beginning on November 1 of each year. These fees will increase annually to keep up with inflation. 

Conclusion 

Need help filing your MDL Renewal Form or have questions about the renewal process? Our experts at Quality Smart Solutions would be happy to assist! Please contact us today or call us at 1-800-396-5144.

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What to Expect After Submitting an NPN Application

What to Expect After Submitting an NPN Application

In order to sell a Natural Health Product  (NHP) in Canada, you require an NPN. NPN stands for Natural Product Number, this is a product license that is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. The NNHPD oversees all NHP applications submitted by the Natural Health Products Regulation (NHPR).

For starters obtaining an NPN can take anywhere between 60 days to 210 days depending on the class of the application (Class I, II, and III). Safety, efficacy, and quality of products and ingredients are important. 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. Determining the correct Class of NPN application is important, 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

What comes next after you have successfully submitted your NPN application?
  1. Administrative Verification

The NNHPD will verify the NPN application and screen for any deficiencies. You will receive a Notice of Refusal if the application contains any issues or deficiencies. Class II and III applications that meet all screening requirements will receive an Application Acknowledgement Letter before proceeding to the regulatory screening stage. The acknowledgment letter will contain more information regarding the application, you will receive the official date of receipt of the application and a five-digit submission number. This submission number will be important for future communications with Health Canada regarding your application. 

Information Request Notice

The NNHPD will provide you the opportunity to address any non-administrative deficient or missing deficiencies through an Information Request Notice (IRN), as per Section 15 of the NHPR. The IRN will contain a specified response time between 2 to 15 calendar days depending on the information being requested. 

  • Class I applications: may be issued an IRN for brand names or other non-significant deficiencies 
  • Class II and III applications may be issued an IRN for non-significant deficiencies during the regulatory screening stage
  • Class III applications may be issued IRNs during the assessment stage  
  1. Regulatory Screening 

After the applications have undergone administrative verification, all NPN applications will be screened against all regulatory requirements mentioned in the NHPR. The application will be screened against all parameters of the NNHPD monographs, and a Notice of Refusal will be issued, if there are any significant deficiencies during the screening process. 

Significant deficiencies include: 

  • Incomplete or inaccurate information on the product license application form 
  • Missing mandatory application requirements, such as FPS, product label text, supporting evidence for safety and/or efficacy, letters of access, animal tissue form, and/or attestation forms 
  • The product does not meet the definition of an NHP
  • Did not meet the parameters of an NNHPD monograph to which the product attested 

A Notice of Refusal will also be issued if you do not submit the requested information in response to an IRN within the timelines specified in the notice. 

  1. Safety and Efficacy Assessment (For Class III NPN Applications Only) 

Upon successful completion of the regulatory screening process, all Class III applications will be further assessed for the safety and efficacy requirements. A Notice of Refusal will be given during assessment if the IRN is not submitted within the timelines specified by Health Canada. 

  1. Withdrawal of an Application 

At any time during the application process, you may withdraw the application by submitting a request to the NNHPD or if the withdrawal is in response to an IRN response, to the submission coordinator via epost Connect™. Any withdrawals will be acknowledged in writing, if you wish to re-submit the application in the near future the application will be treated as a new application. 

  1. Decision Issuance 

Once NNHPD has completed the processing of a Product License Application (PLA) they will come to a regulatory decision of either giving you a product license or refusal. 

A Product License will be issued for applications that meet all the regulatory requirements outline in the NHPR. The Product License will include an eight-digit NPN, or Drug Identification Number-Homeopathic Medicine (DIN-HM) assigned to the product and this number is required to be present on the front panel of the NHP product label. Lean more about what is required on an NHP label here: The Components of an NHP Label All licensed NHPs can be found online on the Licensed Natural Health Products Database (LNHPD) website the status of the licensed product on the LNHPD will appear as “Active”. 

A Notice of Refusal will be issued for applications that do not meet the requirements of the NHPR. A reconsideration is available if you choose to make a valid argument against the refusal. If you wish to submit additional information for the product which you received a Notice of Refusal, a brand-new application must be submitted.

  1. Post Licensing Activities

After you have successfully received your NPN what if you need to make changes to your product or license? Post licensing activities include everything from making a fundamental change to the product formulation, changing the dose, changing the brand name, or discontinuing a Product License. Contact us to learn more about what’s required for these post license changes. 

Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on submitting your NPN applications, responding to potential IRNs, 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: https://qualitysmartsolutions.com/contact/

References

Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 13 Mar. 2020, www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html#6.1.2.

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How to Determine if My Product is a Drug, NHP or Cosmetic

What is a Drug?

Under Section 2 of the Food and Drugs Act, a drug is defined as “any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; restoring, correcting or modifying organic functions in human beings or animals, or; disinfection in premises in which food is manufactured, prepared or kept”.

What is an NHP?

A Natural Health Product (NHP) is regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including Probiotics, Herbal remedies, Vitamins and minerals, Homeopathic medicines, Traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risks, and maintain general good health.

What is a Cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”. This is different from drug and natural health products even though they are all regulated under the Food and Drug Act

Classification of your Product

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). These claims can be in words, sentences, pictures, symbols, and any implications on the product label, inserts, and associated advertisements. 

These claims inform consumers of what this product does and is intended for. The 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 a cosmetic product. However, composition alone may not be sufficient in determining its product classification.

Other Considerations

Another consideration is the level of action. The level of action is how the product exhibits its efficacy through absorption from its dosage form. Some routes of administration such as ingestion, inhalation, and injection cannot be considered cosmetics. Other considerations include new policy/knowledge, classifications by other global authorities, and risk-benefit balance related to product efficacy.

How can we help

QSS offers regulatory services on product classifications, notification submissions for your cosmetics, application submissions for your NHPs/drugs, and label review of your NHP/drug/cosmetic label artwork. Our experts are here to help and offer any cosmetic/drug/NHP-related regulatory advice!

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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How Pet Food Labels Differ from Human Foods

Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and some that will appear different as they are product specific. Consumer packaging rules in Canada aim to ensure we know what we are buying at time of purchase, so that the consumer can make educated decisions. Considering common retail set-ups, products will likely be faced the same for both to show main information such as common name and net weight on the front panel and any additional information on the adjacent panels. 

Veterinary products are similar to foods by classification as well, in the sense that they are broken into similar-regulated subgroups of foods, drugs and health products

This blog will highlight several similarities and differences between Pet and Human Food Labels for Canada. 

Similarities:

All labels in Canada are required to be Bilingual. French and English are to be equal on all labels as they are both official languages. 

The statement or declaration of Net Weight is present on both label types. This allows the consumer to understand how much product is in the container. This can be reviewed against price and serving size at time of purchase. 

The Common Name of the product must be listed. This should provide a clear description of the product, be honest and not mislead the consumer with regards to ingredient quantity or effects. 

The List of Ingredients must be listed by common name of each component. It also must be listed in descending order by weight. To differentiate for pet foods AAFCO publishes a set of guidelines for the inclusion and list of pet food ingredients.

All Claims and statements are truthful and not misleading. All call outs and claims must be accurate and honest and supported by verifiable evidence. Deceptive awards and endorsements must not be used. Comparison to other products and companies is not suggested. 

All labels should clearly indicate the Company Name and Address. This allows the consumer to contact the product owner to report any side effects, leave a review or ask additional questions.

Differences:

Rather than a nutrition facts table, pet foods employ and are required to list a table of Guaranteed Analysis. This explains the total crude protein, crude fat, crude fibre, and moisture within the product. Like NFTs on a human food, this can be compared to other pet foods when trying to decide between two or more products. 

Pet foods must list feeding instructions. This piece can also refer to the product being able to be used as a feed or a supplemental feed. This directional item must be called out on the label. If the product is intended for specific dietary use, the direction to use as recommended by a veterinarian may be required. Human foods often list preparation instructions but not directions as they are often thought of for ad-libitum consumption. 

Pet Foods must list the nutritional adequacy or intended life stage for the product. If the product has passed a feeding test or has specific nutrient values for a specific life stage. Then this can be explained on the label. Human foods are not usually labelled for a specific demographic, this may be part of the marketing campaign, but not overly apparent on the label. 

The Product Identity will need to be made clear. Whether the product is intended for Dogs or Cats. This should be depicted in writing. Often pet foods have graphics/images that show the intended animal.

Summary:

In conclusion there are many differences and similarities between Pet and Human Food labels, most of which are apparent if you were to hold the two side by side. 

Please reach out to our team of specialists to further discuss your human or pet food products. We are happy to help discuss classification, labelling and registration for your products!

References

https://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/01229.html

https://www.aafco.org/

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FDA Warning Letters Targeting N-Acetyl Cysteine (NAC) Supplements

Background on NAC

N-acetyl-L-cysteine (NAC supplement) 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, according to a summary of the study sponsored by the Memorial Sloan Kettering Cancer Center in New York. NAC is an amino acid that was approved by the FDA as a drug in 1963. 

NAC has also been widely marketed in another category of products overseen by the FDA—dietary supplements. However, there have been several instances where the FDA has challenged the legality of NAC use in dietary supplements.

FDA Warning Letters

In 2010, the FDA issued a warning letter indicating that it believed that NAC was a drug and as such is not allowed to be used as an ingredient in dietary supplements. However, the FDA has still received several dietary supplement claims notifications including NAC as an ingredient tied to a structure/function claim. Up until recently, NAC had been successfully marketed as a dietary supplement product with no enforcement action.

As of recently, the FDA has issued warning letters to companies marketing dietary supplements indicated for the treatment of hangovers, as the ingredient NAC is excluded from the definition of a dietary supplement (since it was already categorized as a drug in 1963). Dietary Supplement products containing NAC are considered an unapproved drug product, and therefore illegal.

Response from Retailers

Amazon has recently been quietly removing dietary supplement products containing NAC from their site, shortly after the news of FDA’s warning letters. There has also been a push by Amazon and other retailers such as Walgreens to ensure products that are being sold through their channels are compliant.

How can we help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation