Nutrasource Blog

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, 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)

 

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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Tags: Claims, Regulatory, Dietary Supplements/Natural Health Products, market access

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

FDA Announces New Policy for New Dietary Ingredient Notifications (NDINS) - An Ingredient Manufacturer Must Read!

Posted by Nutrasource on Wed, Jun 29, 2022

Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

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Tags: Product Testing & Certifications, Regulatory, Concept to Claim, ingredients, market access

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

Non-GMO Testing and Certification: It doesn't have to be complicated

Posted by Ruth Rodrigues, Marketing Manager on Thu, May 05, 2022

Increasingly, over the past few years, the dietary supplement industry has emphasized quality control and claim substantiation. At times, companies conserve on quality control and can end up with a product that doesn't match the claims and ingredients on the label. Many look to third-party organizations that help solve this problem by objectively certifying supplements for purity, safety, and quality. Non-GMO certification has become an useful tool to address some of these concerns. Keep reading to learn more about consumer demand for third-party tested products and ingredients and learn more about the Non-GMO certification process.

Consumers today are far more educated and discerning in their choice of dietary supplements. For context, one in five of US consumers make a transparent vitamin and supplement brand their first choice, according to a consumer market research study, as they seek transparency and third-party certification to back up their claims. Outlined in the 2021 TTC ITC Insights Consumer Supplement User survey, 31% of consumers consider quality certifications and seals on labels/ website a key driver of trust.

This goes beyond consumers, when healthcare practitioners were surveyed, over half of the dietitians surveyed considered quality certifications and seals displayed as the number one driver of trust. 

Needless to say, having third-party certifications back your claims is critical both for consumer consumption and healthcare practitional referral of product. As mentioned, one area that leading dietary supplement brands have leveraged is third-party certifications related to Non-GMO testing. Not only are consumers looking for Non-GMO tested products and ingredients, many retailers require a brand to have third-party certification validating their Non-GMO claims.

Making a Non-GMO claim through traditional supply chain verification is impossible for some ingredients. Certifications by Nutrasource has a streamlined and effective process that assists your product and/or ingredient in acheiving these certifications.

Below we address some of the common questions we receive related to Non-GMO testing and certification.

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Tags: Product Testing & Certifications, Product Marketing, Claims, Regulatory, Non-GMO

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

The Latest in Food Allergen Labelling: Sesame

Posted by Ruth Conroy, Marketing Manager on Mon, Apr 26, 2021

Sesame has recently been added to the list of major food allergens, here's what you need to know for product labelling.

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

How to Develop Cutting-Edge (and Compliant) Dietary Supplements

Posted by Nutrasource on Thu, Aug 20, 2020

Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.

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

The State of Sport Nutrition: a peek into the multi-billion dollar industry

Posted by Douglas Kalman, Ph.D., R.D., CCRC, FACN, Vice President of Scientific Affairs on Wed, May 06, 2020

Sports Nutrition as a business category within foods and dietary supplements have had a relatively short history. From a mass market perspective, it was not until 1965 and into the 1970’s that the nephrologist (kidney specialist) Robert Cade, MD started tinkering with a “homemade” beverage, later named Gatorade (Dr. Cade was the Director of the Renal Division at the University of Florida Medical School) for the sole purpose of helping football players stay hydrated during the hot and humid game conditions in Florida.

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Tags: Clinical Trials, Claims, Regulatory, Sport Nutrition