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

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

Concept to Claim: An abbreviated guide for dietary supplement brands

Posted by Ruth Rodrigues on Wed, Jan 12, 2022

Starting with the end in mind

Budget, timelines, and pressure to be innovative are just a few of the barriers that many companies face when looking to gain market access. The trick is knowing what you want to say about your product, what you can say, and having a clear understanding of the marketplace you’re looking to penetrate. From there, a strategic solution can be developed to assist in achieving your goals.
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Tags: Product Marketing, Claims, Concept to Claim, 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

NDIN’s and Structure Function Claims in the Time of COVID-19

Posted by Amy Mozingo, MS, Director of Operations - GRAS Associates on Wed, Apr 22, 2020

As we are all adjusting to modifying our work practices to stay safe and “flatten the curve” during the time of COVID-19, work must go on. R&D, product development, and regulatory compliance are as important as ever as the FDA has been handing out warning letters for unsubstantiated coronavirus claims.

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Tags: Clinical Trials, Claims, Regulatory

Go to Market in Multiple Countries with One Product Spec

Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery on Tue, Apr 02, 2019

What if you could develop one dietary supplement, with a single product specification, and sell it in multiple countries simultaneously – with no reformulation or regulatory headaches involved?

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

GRAS for Grass: Is Generally Recognized as Safe a Viable Pathway for CBD Market Access?

Posted by Nutrasource on Thu, Mar 21, 2019

Note: The regulatory information provided in this article pertains to the United States.

If you have been following recent CBD (cannabidiol) discussions happening around the world, you'll know that the evolving regulatory landscape is leaving many brands confused about their market access options.

As regulatory consultants, we field questions daily about CBD compliance and marketing, both from food and supplement brands and CBD suppliers looking to get to market quickly.

To help you find an efficient pathway to market, we've put together a list of frequently asked questions about CBD marketing, sales, and compliance—including GRAS—for the U.S. market. Read on for answers, then get in touch with us to discuss options specific to your company's needs and objectives.

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

The Supplement Industry Still Has a Claims Substantiation Problem. Here's How to Fix It

Posted by Douglas Kalman, Ph.D., R.D., CCRC, FACN, Vice President of Scientific Affairs on Wed, Jan 30, 2019

For the past decade, I've written and educated industry about the benefits of substantiating dietary supplement claims, from the rationale of complying with national regulatory rules to remaining ahead of the innovation curve.

But despite policing from the U.S.-FDA and FTC, and the negative media attention surrounding offending brands, the supplement industry still has a substantiation problem. There are far too many instances of companies under fire (or yet to be under fire) for unsubstantiated, misleading, or deceptive claims.

The good news is that this can be fixed with a clearer understanding of what qualifies as substantiation and how companies can benefit from making the investment in quality research. Read on to find out what you need to know.

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

Regulatory Trends That Will Shape 2019

Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Thu, Dec 06, 2018

The past year was a whirlwind of regulatory change that brought exciting opportunities and new challenges in equal measure.

As we look to another game-changing year ahead, our regulatory and scientific team reviews the top regulatory trends expected to shape health product innovation and marketing in 2019 and beyond.

Here's what to expect...

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