Nutrasource Blog

Unlocking the Benefits: A Step-by-Step IFOS™ Certification Guide for Korean Manufactured Omega-3 Supplements

Posted by Nutrasource on Tue, Jun 06, 2023

 

Certifications newsletter  (5)-1

 

The dietary supplement industry is growing rapidly in South Korea. On a case by case basis, Korean-manufactured products can now showcase a third-party certification label on their product packaging – the International Fish Oil Standards (IFOS™) certification label. This is a way for brands to distinguish themselves in a highly competitive market while building consumer trust.

Continue reading to learn how Certifications by Nutrasource can assist with achieving this certification.

 

Benefits of IFOS™ certification for Korean supplement brands:

  • Elevate your brand’s reputation by demonstrating your commitment to providing high-quality products through an internationally recognized label.
  • Confirm that the product meets the most stringent industry purity standards, which shows product quality.
  • Gain recognition from the Korea Health Supplements Association (KHSA). highlighting that the necessary regulatory compliance for selling products in Korea has been obtained.
  • Increase consumer confidence in the product and brand, ultimately leading to increased sales and customer loyalty.

 

IFOS process in Korea (1)

 

Once the application has been approved, the IFOS™ logo can be added to product packaging and advertisements for Korean-manufactured Omega-3 supplements. This signifies that the product is reviewed and approved by the KHSA, providing consumers with added assurance of safety and quality.

 

 

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Nutrasource Asia can assist Korean supplement brands in obtaining IFOS™ certification and reaping its benefits. Here's how:

Introduction to the IFOS™ program:

Nutrasource Asia provides expertise to Korean brands on obtaining IFOS™ certification. Despite the high awareness of IFOS™ in the Korean market, many supplement brands are not familiar with the program's origin or the certification process. The team can guide you through the entire process of obtaining IFOS™ certification.

English Language support:

Nutrasource Asia offers a professional solution for brands who require assistance in communicating with the Certifications by Nutrasource team in Canada but do not speak English. The team at Nutrasource Asia can seamlessly manage the entire process, from contracting to sending samples to Canada to receiving IFOS™ certification, ensuring a smooth and hassle-free experience for clients.

Assistance with market access strategy:

Nutrasource Asia offers a range of services to help clients navigate the complex regulatory landscape in Korea. Our team can provide guidance on Korean regulations, assist with the IFOS™ certification process, and explain the product launch process in Korea. Additionally, we offer support in coordinating production and testing plans to ensure a seamless market launch for your products.

Market monitoring for IFOS™ misuse or abuse:

Nutrasource Asia provides ongoing monitoring of the Korean marketplace for clients who have obtained IFOS™ certification, ensuring that the certification is not misused or abused. If any issues are identified, Nutrasource Asia works with clients to promptly correct them.

 

By following this step-by-step guide and working with Nutrasource Asia, eligible Korean brands can obtain an IFOS™ certification and take advantage of the program's benefits.

Ultimately, IFOS™ helps brands differentiate themselves in a competitive market and meet the demands of quality-conscious consumers.

 

Learn more the IFOS™ program.

 

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Tags: Product Testing & Certifications, Omega-3s, Dietary Supplements/Natural Health Products, market access

Consumers Fact Check Their Products, Do You Have What They Are Looking For?

Posted by Kevin Yan, M.Sc., VP Certifications & Analytics on Tue, Apr 25, 2023

Today’s consumers are doing more research about the products they purchase than ever before.

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Tags: Product Testing & Certifications, Omega-3s, Probiotics, Dietary Supplements/Natural Health Products, Non-GMO, market access

What We Saw in 2022: Key Trends

Posted by Santa Al Antwan, Regulatory Affairs Associate on Wed, Feb 22, 2023

As a result of the pandemic, respiratory and seasonal illnesses, and other emerging threats, consumers are more interested, invested, and involved in their wellbeing than ever before. When it comes to health products, consumers are motivated by those that are clean or naturally-sourced, convenient, scientifically substantiated, and tailored to meet their personal needs. Thus, driving industry trends towards transparency, sustainability, personalization, and virtual approaches.

 

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Tags: Product Testing & Certifications, Product Marketing, Regulatory, Dietary Supplements/Natural Health Products, market access

How to Not Get Kicked Off Amazon.ca for Non-Compliant Natural Health Products

Posted by Nutrasource on Thu, Feb 02, 2023

If you're already selling your supplement on Amazon in the U.S. or elsewhere around the globe, Canada is a natural next step to achieve growth and gain market share.

But if you're looking to enter the Canadian market for the first time via Amazon.ca, be warned - it's not as simple as setting up an account and listing your products!

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Tags: Product Marketing, Regulatory, Dietary Supplements/Natural Health Products

What you need to know about drug submissions

Posted by Paula Guerra. Regulatory Affairs Manager on Tue, Jan 24, 2023

 

Companies looking to obtain authorization to market a new pharmaceutical must either file a New Drug Submission (NDS) to Health Canada or a New Drug Application (NDA) to the United States Food and Drug Administration (U.S. FDA), depending on their market-of-interest.

The regulatory dossier must include data around the following:

  • Pre-clinical (in vitro and in vivo) studies
  • Clinical (human) studies
  • Details on the manufacturing, packaging, and labelling of the drug substance and drug product
  • Therapeutic claims and side-effects

In summary, what this means is that the regulatory dossier must provide enough information to ensure the safety, efficacy, and quality of the drug product, showing that the benefits of the drug outweigh the risks.

 

Common Technical Document (CTD)

The information to be presented to the Agency is organized into five (5) modules, using the CTD format, as follows:

  • Module 1: Regional Administrative Information
  • Module 2: Quality Overall Summaries
  • Module 3: Quality, including Chemical, Manufacture and Controls (CMC) sections
  • Module 4: Non-clinical Study Reports
  • Module 5: Clinical Study Reports

 

Process and Timeline

Drug Submission Flowchart (6)

As seen in this flowchart, the entire regulatory journey from the initial drug application to its approval takes approximately 6 months for drugs that qualify for accelerated approval and up to 2 years for drugs that follow regular processing timelines, avoiding any delays.

Here are some key points of what happens at each stage:

  1. Pre-Submission MeetingAn option to get questions or concerns addressed by the regulatory Agency prior to filing the submission.  
  2. Submission Filing: The application must contain all the necessary information to satisfy the regulatory requirements of the appropriate division or directorate within the Agency.
  3. Review of the Submission: The Agency assigns a review team to evaluate the safety, efficacy, and quality of the product. Additionally, the Agency reviews the labeling of the drug product and inspects the facilities where the drug will be manufactured.
  4. Decision: If the information provided is deemed adequate, a positive decision is made, and the drug is approved to be released to the market. 
  5. Post-Marketing Activities: Post-market management of the product is critical and includes activities like monitoring of adverse events, Phase 4 clinical trials, reporting of post- approval changes (e.g., manufacturing, labeling, stability, etc.), and risk management plans.

 

SGS Nutrasource offers full-service consulting in this to make sure the new drug submission process is smooth. The team of regulatory experts extensively researches, compiles, and reviews drug submissions for compliance in Canada and/or the U.S. and files the application to the appropriate Agency, helping clients to achieve regulatory confidence and market access. 

Speak to a member of our team on how we help you successfully bring your pharmaceutical to market.

 

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The “Do’s and Don’ts” of Claims Substantiation for Dietary Supplements and Natural Health Products

Posted by Santa Al Antwan, Regulatory Affairs Associate on Wed, Nov 23, 2022

In today’s regulatory climate of full accountability and transparency, it is critical to have strong science to back-up any claim made on a health product, be it a dietary supplement sold in the United States (U.S.) or a Natural Health Product (NHP) marketed in Canada. This will be a key component of your dietary supplement and NHP marketing strategy. We know advertising health products is critical to your marketplace success and we want to help you make sure it is done the right way.

Firstly, it is important to note that while dietary supplements are equivalent to the NHP categories, there are some major differences in regulations between the two countries.

U.S. Canada
  • Only new dietary ingredients require pre-market notification to the Food and Drug Administration (FDA)
  • NHPs are subject to pre-market approval.
  • Dietary supplements are regulated post-market, as a subset of foods, and restricted to products taken by mouth (e.g., capsules, tablets, soft gels, gel caps, powders, bars, gummies, liquids, etc.)
  • NHPs are considered a subclass of drugs, and can be formulated in pharmaceutical-like dosage forms (e.g., elixir, suppository, topical ointment, etc.)

As a result, the potential claims for dietary supplements and NHPs vary significantly with most dietary supplements carrying structure/function claims and NHPs ranging from low- to high-risk health claims.

Given the complexity and nuances between jurisdictions, SGS Nutrasource’s regulatory experts will help you understand how to approach claims substantiation and apply these best practices to both product types. 

 

Label Claims for Dietary Supplements – in US and Canada

  • A health claim (both U.S. & Canada): used to indicate the beneficial effect of a product in reducing the risk of a disease or health-related condition when used in accordance with its recommended conditions of use.
  • A structure/function claim (only for the U.S.): describes the role of a nutrient or dietary ingredient on the normal structure or function of the human body.

In the U.S., dietary supplements may make health claims; however, they are subject to pre-market review and authorization by the U.S. FDA. Structure/function claims are not pre-approved per se, but a notification must be submitted to the FDA no later than 30 days after the dietary supplement is first marketed.

In Canada, an NHP must have a recommended use expressed via its health claim, and that health claim must have a health context in order to attain Health Canada approval in the form of a Natural Product Number (NPN). Therefore, given the conditions under which NHPs are screened, reviewed, and subsequently approved, they cannot carry structure/function claims.

 

This flowchart summarizes the different categories of claims in the U.S. and Canada.

Claims flowchart

Constructed using guidance documents from the FDA and Health Canada.

 

Simply put, in order to avoid unnecessary and potentially costly consequences, we need to know the do’s and don’ts to consider when assessing a product’s claims potential.

 

Claims dos and donts (1)

 

SGS Nutrasource offers claims substantiation consulting to ensure regulatory compliance for your product label in line with the various geographical jurisdictions.

Speak to a member of our team on how we can support your regulatory needs.

 

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New Labelling Requirements for Natural Health Products

Posted by Nidhi Joshi, Regulatory Affairs Manager on Thu, Aug 11, 2022

Background

On July 6th, 2022, Health Canada published new labelling requirements under the Natural Health Products Regulations (NHPR). These changes are driven by a need to help consumers make informed choices and manage preventable harms through consistent, clear, and easy to understand product labels. The amendments also ensure alignment with rules that have already been established for comparable non-prescription drugs. Below is a summary of the key requirements.

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Tags: Regulatory, Dietary Supplements/Natural Health Products

Food vs. Dietary Supplement / NHP vs. Drug in Canada and US

Posted by Stephanie Hall, Regulatory Affairs Associate on Wed, May 11, 2022

Determining the appropriate regulatory pathway is not always straightforward, especially when introducing a product from Canada into the U.S., or vice versa. For example, some foods contain components that when isolated could be a dietary supplement/Natural Health Product (NHP), and under certain circumstances, even a drug ingredient.

By the end of this blog post, you should have a good understanding of who regulates supplements in the US and Canada, and how they differ from food and drug regulations. Continue reading if you are looking for information on how to sell supplements in Canada or the US. Understanding the category definitions as laid out by the respective regulation is one way to discern between frameworks; see table below.

Regulatory Category Definition

Food

Examples: Orange juice, poultry, bread, candy, live microbials

Any article manufactured, sold or represented for use as a food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever. Source

Dietary Supplement (US)

Examples: Vitamin D, echinacea, live microbials/probiotics, multi-vitamin gummy

A product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. Source

Natural Health Product (Canada)

Examples: Multi-vitamin gummy, calcium, omega-3 oil

A substance or combination of substances which is manufactured, sold or represented for use in:

  • The diagnosis, treatment, mitigation or prevention of disease, disorder or abnormal physical state or its symptoms in humans;
  • Restoring or correcting organic functions in humans; or
  • Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Source

Drug 

Examples: Ibuprofen, vaccines, antibiotics

A drug includes 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.

Source

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Tags: Pharmaceuticals, Regulatory, Dietary Supplements/Natural Health Products

Product Classification: A Starting Point for Your Regulatory Strategy

Posted by Paula Guerra, Senior Regulatory Affairs Associate on Mon, Mar 28, 2022

The first steps when developing any health and wellness product is to know first, what it is and second, how its regulated and in each target market as categorization may differ between regions. Many factors are taken under consideration when determining product classification as summarized in the figure below.

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Tags: Product Marketing, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?

Posted by Amy Mozingo, MS - VP, US Nutra Regulatory Sciences on Mon, Feb 07, 2022

You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.

What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?

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Tags: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products